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Tech Leadership ADV

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Advantage [1] is Tech Leadership---

Judicially carved exemptions in patent eligibility destroy the patent system and wreck
innovation
Radar 24 — Randall R. Rader was appointed to the United States Court of Appeals for the Federal
Circuit by President George H. W. Bush in 1990 and assumed the duties of Chief Circuit Judge on June 1,
2010 and retired from the bench on June 30, 2014. He was appointed to the United States Claims Court
(now the U. S. Court of Federal Claims) by President Ronald W. Reagan in 1988. Chief Judge Rader has
received many awards, including the Sedona Lifetime Achievement Award for Intellectual Property Law,
2009; Distinguished Teaching Awards from George Washington University Law School, 2003 and 2008
(by election of the students); the Jefferson Medal from the New Jersey Intellectual Property Law
Association, 2003; the Distinguished Service Award from the Berkeley Center for Law and Technology,
2003; the J. William Fulbright Award for Distinguished Public Service from George Washington University
Law School, 2000; and the Younger Federal Lawyer Award from the Federal Bar Association, 1983.
Randall Rader. "Rader’s Ruminations – Patent Eligibility II: How the Supreme Court Ignored Statute and
Revived Its Innovation-Killing Two-Step," IPWatchdog. 3-24-2024.
https://ipwatchdog.com/2024/03/24/raders-ruminations-patent-eligibility-ii-supreme-court-ignored-
statute/id=174539/, accessed 5-7-2024 //WMK

A New Two-Step That is Hopelessly Off-Beat Ironically, despitethe express terms of the 1952 Act, the Supreme Court
repeated its pattern of returning to confusion. The Court followed the familiar path of its earlier
mistakes (Benson, Flook, Funk Bros.) to make them again in Mayo, Myriad, and Alice. And, no surprise here, this renewed
modern conflation of eligibility and patentability still performs a two-step dance. The lower courts and the USPTO
describe the Supreme Court’s two-step in somewhat misleading terms. According to the lower courts and USPTO, step one asks if the
claim is “directed to” one of the three judge-made exceptions; step two then asks if the claim recites
“additional elements that amount to significantly more” than those unnecessary exceptions. Because
every invention must use natural laws and phenomena and abstractness remains an undefined
“phantom,” it is often not difficult to find some element of a claim within the grasp of the non-statutory
exceptions. Therefore, the real decisive two-step examination starts with identifying the “inventive concept” in the claims — not in the
claim as a whole, but in any element of the claim. Alice, 134 S. Ct. at 2355 (“We have described . . . this analysis as a search for an ‘”inventive
concept—i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more than
a patent upon the [ineligibility exception] itself.’”). This search for a modern inventive concept is almost identical to the search for the “gist” of
the invention before the 1952 Act. Then, as noted above, the second step is a search for “something significantly more”
than the expansive judge-made exceptions that have swallowed the statutory rule. The second part of this
modern test is again practically identical to the search for some undefined “flash of genius” or “synergism”
which judges simply recognize by their reaction (in vast disregard of the dangers of hindsight) upon observation of
the invention. The Court says that this “something more” must transcend the “well-known, routine, or conventional,” see, e,g, Mayo, but
that inquiry proceeds without reference to prior art to define those generalizations. Again, the courts are seeking some visceral
reaction akin to an undefined “flash of genius” to account for an indeterminate “something more” that
impresses enough to survive the claim-by-claim eligibility/patentability test. Tragically, the Court’s
conflation of eligibility and patentability has thus largely revived the vague validity tests supposedly
outlawed in the 1952 Act. The Impact is Impossible to Fully Quantify It is perhaps impossible to quantify the full impact of the
modern eligibility/patentability crisis on U.S. innovation policy. A 2022 Report from the USPTO confirmed: “ . . . the current
jurisprudence has altered the landscape for determining patent subject matter eligibility .” USPTO Report to
Congress: Patent Eligible Subject Matter: Public views on the current jurisprudence in the United States, June 2022. Even lagging and
incomplete statistics will not fully document the shift to trade secrets, the declining availability of
financial investment for important areas of R&D, and the patent applications that were not filed or
abandoned due to the chilling climate of Mayo, Myriad, and Alice. One account five years after Alice reported: “Over
1,000 patents have been invalidated by the federal courts and the U.S. Patent and Trademark Office’s (USPTO’s)
Patent Trial and Appeal Board (PTAB), while over 60,000 patent applications have been abandoned before the USPTO
following rejections for patent ineligible subject matter.” Sachs, Robert, Alice: Benevolent Despot or Tyrant, IP Watchdog,
August 29, 2019. That report also noted that “the Federal Circuit affirms 89% of lower court decisions invalidating
patents” with district courts upholding 57% of motions to invalidate in whole or part under 101. Id. Next Up: The CAFC Strikes Out In sum,
the Supreme Court has revived a claim-by-claim eligibility/patentability test that has harmed a whole
generation of invention. Of course, the Supreme Court has not been alone in this endeavor. The next installment in these ruminations
on eligibility will show that the U.S. Court of Appeals for the Federal Circuit has repeatedly struck out when facing softball
eligibility/patentability pitches. One simple bit of advice would bring more certainty to judicial efforts to interpret and apply patent law: When
all else fails, consult the statute.

The impact is magnified by over extension of exemptions throughout the federal


judiciary. That ruins business certainty.
---CAFC = U.S. Court of Appeals for the Federal Circuit

Radar 24 — Randall R. Rader was appointed to the United States Court of Appeals for the Federal
Circuit by President George H. W. Bush in 1990 and assumed the duties of Chief Circuit Judge on June 1,
2010 and retired from the bench on June 30, 2014. He was appointed to the United States Claims Court
(now the U. S. Court of Federal Claims) by President Ronald W. Reagan in 1988. Chief Judge Rader has
received many awards, including the Sedona Lifetime Achievement Award for Intellectual Property Law,
2009; Distinguished Teaching Awards from George Washington University Law School, 2003 and 2008
(by election of the students); the Jefferson Medal from the New Jersey Intellectual Property Law
Association, 2003; the Distinguished Service Award from the Berkeley Center for Law and Technology,
2003; the J. William Fulbright Award for Distinguished Public Service from George Washington University
Law School, 2000; and the Younger Federal Lawyer Award from the Federal Bar Association, 1983.
Randall Rader. " Rader’s Ruminations – Patent Eligibility III: Seven Times the Federal Circuit Has Struck
Out," IPWatchdog. 3-31-2024. https://ipwatchdog.com/2024/03/31/raders-ruminations-patent-
eligibility-iii-seven-times-federal-circuit-struck/id=174751/, accessed 5-7-2024 //WMK

The U.S. Supreme Court’s flimsy eligibility jurisprudence offers the U.S. Court of Appeals for the Federal Circuit (CAFC)
several “softball pitches” to avoid a patent bloodbath. To date, the Federal Circuit has struck out at
preserving the patent system — at least twice without really even taking a swing! Strike One: A Declined Invitation to Bring Balance
The first softball pitch appears in the High Court’s initial decision to exalt judge-made “exceptions” over the 200-
year-old statutory rule, namely, Mayo v. Prometheus, 566 U.S. 66 (2012): “The Court has recognized, however, that too
broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at
some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Thus, in Diehr the Court
pointed out that ‘a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.’ 450 U. S., at 187. It
added that ‘an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent
protection.'” Diamond v. Diehr, supra, at 187. Id. [emphasis supplied]. This passage from Mayo is the Court’s outright admission of the
weakness of its choice to substitute its exceptions for the language of the Patent Act. After all, the Supreme Court does not often set forth a
new rule (e.g., abortion may be regulated by the states) and then say, but the opposite previous rule (e.g., abortion is per se legal as a matter of
privacy) is fine too. Obviously, the Supreme Court rarely overrides and preserves a rule in the same decision. In Mayo, however, the Court
explains that the previous rule remains in place (an application of a natural law is eligible) because a “broad interpretation” of its new rule
“could eviscerate patent law.” Thus,
even while abandoning the statute on eligibility, the Supreme Court invites
the Federal Circuit to bring balance to eligibility determinations. Tragically, instead of employing a scalpel
to delicately and carefully remove a few unsightly blemishes, the Federal Circuit wields a sledgehammer to
smash even the smallest wart, leaving entire limbs of innovation (software, diagnostics, medical treatments, etc.) broken
and bleeding. Moreover, the Supreme Court’s softball invitation was not a passing thought. The Court again invoked Diehr and repeated
the same caution in Alice two years later to ensure its non-statutory rule does not “swallow all of patent law.” Alice Corp. v. CLS Bank, 573 U.S.
at 304 (2014). Sadly, the Federal Circuit has not even referred to this invitation, let alone implemented it. Strike one! By identifying a “strike,”
this article means that the Federal Circuit has missed an opportunity to recover from an ongoing train wreck after eligibility left the statutory
tracks. Strike Two: Top U.S. Patent Court Allows Patent Law to Be Swallowed The Supreme Court offers a second softball pitch again in both
Mayo and Alice: “Thus, in Diehr the Court pointed out that ‘a process is not unpatentable simply because it contains a law of nature or a
mathematical algorithm.’ 450 U. S., at 187 (quoting Parker v. Flook, 437 U.S. 584, 590 (1978)). It added that ‘an application of a law of nature or
mathematical formula to a known structure or process may well be deserving of patent protection.‘ Diehr, supra, at 187. And it emphasized
Justice Stone’s similar observation in Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86 (1939): ‘While a scientific truth, or
the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific
truth may be.’ 450 U. S., at 188 (quoting Mackay Radio, supra, at 94).” Mayo, 566 U.S. 66. [emphasis supplied]. With these words, the Supreme
Court openly directs the Federal Circuit to use its earlier Diehr case. In this passage, the Court even restated the traditional statutory eligibility
rule with origins in Jefferson’s 1793 language. Yet, Diehr contains an even more important principle. In Diehr, the Court considered a process
for curing synthetic rubber. The process used a computer to run the prior art Arrhenius mathematical equation with a prior art curing press. The
computer’s computational speed, reliability, and automaticity ensured that the press “automatically open[ed] . . . at the proper time.” Diehr, at
187. Although the inventive improvement over prior art was computer software, the Court observed: “In determining the eligibility of
respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the
claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim.
. . .” Id. at 188-89. It cannot be emphasized too much that the Court in Mayo, and again in Alice, expressly endorsed Diehr and its “as a whole”
rule as the path to ensure that the new non-statutory eligibility rule does not “eviscerate/swallow patent law.” Now the Court’s invitation to
use the Diehr rule begs the question of what cases rejected as ineligible by the Federal Circuit were “an application of natural law . . . deserving
of patent protection.” Mayo, supra. Stated in another way, what cases and patents that the Federal Circuit rejected as ineligible would have
survived if the Circuit followed the Supreme Court’s direction to use Diehr’s “as a whole” methodology. In truth, dozens
and dozens of
cases could have survived if the Federal Circuit wielded a scalpel instead of a sledgehammer, b ut this article
will mention only a half dozen to illustrate the point: Ariosa v. Sequenom, 788 F.3d 1371 (Fed Cir. 2015) — a diagnostic replacement for
long-needle amniocentesis by analyzing bodily discharges from the mother; Athena Diagnostics v. Mayo, 927 F.3d 1333 (Fed. Cir.
2019) — a way to detect dangerous neurological disorders using antibodies in a MuSK protein; nonetheless found ineligible on a tragically close
5-7 en banc vote (with 8 different opinions); ChargePoint v. SemaConnect, 920 F.3d 759 (Fed. Cir. 2019) — an apparatus, method,
and system for charging electric vehicles; of particular note, this invention included a charging apparatus and system, not merely a method;
Chamberlain v. Techtronic, 935 F.3d 1341 (Fed. Cir. 2019) — a garage door opening apparatus with a wireless communicator; again
the invention was an apparatus (or “machine” under the statute’s designation); American Axle v. Neapco, 966 F.3d 1347 (Fed. Cir.
2019) — an industrial technique for manufacturing automobile drive shafts (and even the U.S. Solicitor General argued that it was eligible); Yu
v. Apple, 1 F.4th 1040 (Fed. Cir. 2021) — a camera embedded in a phone using multiple exposures and lenses to improve digital images.
These inventions and dozens more would remain eligible for patent protection when viewed “as a
whole,” as Diehr demands. Diehr at 188. Nonetheless, the Federal Circuit’s sledgehammer has fallen on all of
these inventions. Strike two! Strike Three: Failure to Heed the Court’s Suggestion to Apply Diehr As discussed in Part II of this series on
eligibility, the Supreme Court has abandoned the statute and substituted a claim-by-claim validity analysis
devoid of neutral and predictable standards. This new (and unjustified) validity analysis might seem to find minimal support
because section 101 contains the word “new,” suggesting that perhaps novelty ought to be part of an eligibility test. Yet, the Supreme Court
itself has already ruled that out: “It has been urged that novelty is an appropriate consideration under § 101. Presumably, this argument results
from the language in § 101 referring to any “new and useful” process, machine, etc. Section 101, however, is a general statement of the type of
subject matter that is eligible for patent protection “subject to the conditions and requirements of this title.” Specific conditions for
patentability follow and § 102 covers in detail the conditions relating to novelty. The question therefore of whether a particular invention is
novel is ‘wholly apart from whether the invention falls into a category of statutory subject matter.’” Diehr at 188-89. [emphasis supplied]. The
Supreme Court made absolutely clear that validity is “wholly apart” from eligibility. If the Supreme Court in Mayo and Alice had overruled
Diehr, then both the “as a whole” reading of claims and the direction that novelty and claim-by-claim validity analysis is “wholly apart” from
eligibility would not have survived. Far from overruling Diehr, the Supreme Court expressly endorsed this earlier case and counseled its use to
prevent the eligibility “exceptions” from eviscerating or swallowing patent law. In sum, the Supreme Court told the Federal Circuit to use Diehr.
On one level, this counsel might recommend that the Federal Circuit should maintain the statutory test in most cases. At a minimum, the
Supreme Court tells the Federal Circuit to wield a scalpel, not a sledgehammer, when implementing an exceptions-based eligibility test. The
Federal Circuit has done neither. Strike three! Strike Four: Missed Opportunity to Cite Empirical Evidence The Supreme Court’s next softball
pitch involves its only stated justification for substituting its own judge-made exceptions for the statutory rule. The Court in Mayo, Myriad, and
Alice characterized the inventions as endangering “the basic tools of scientific and technological work.” See, e.g., AMP v. Myriad, 133 S.Ct. at
2116. One might question whether a personalized dosage for the man-made drug thiopurine endangers a “basic tool” of science. The answer
seems to be that the
Court labels an invention as merely “a rubber curing press” (Diehr) or a threat to a “basic
tool” of all science (Mayo) according to its own agenda at the moment. The main point for this softball pitch is the
justification that follows: “[M]onopolization of those tools through the grant of a patent might tend to impede
innovation more than it would tend to promote it.” Mayo, 132 S.Ct. at 1923. This theory (and the Court senses the weakness of its sole
justification by using the words “might tend to”) is akin to a theory known in academic circles as the “tragedy of the anti-commons.” The
“tragedy” in a few words is that “too many” patents give too many owners the right to inhibit all future research and progress. This hypothesis
sprang from the 1998 writings of Professors Heller and Eisenberg. Heller; Eisenberg; Can Patents Deter Innovation? The Anti-commons in
Biomedical Research; SCIENCE Mag. (May 1998). In truth, this so-called tragedy has been fully rejected by academic and
empirical studies. See, e.g., Teece, David; The “Tragedy of the Anticommons” Fallacy: A Law and Economics Analysis of Patent Thickets
and FRAND Licensing; Berkeley Tech.L.J. Vol 32:1489 (2017) (“The systematic problem identified here is undercompensation, and possibly
overuse, not underuse.”). Upon reflection, the Supreme Court’s “tragedy” reasoning becomes a floating softball pitch that the Federal Circuit
should hit to knock the entire eligibility doctrine back to statutory sanity. Now, the Supreme Court often advises the use of “common sense” in
patent law settings. See, e.g., KSR v. Teleflex, 550 U.S. 398 (2007). Let’s apply “common sense” to the Court’s “too many” patents justification. If
the United States has “too many” patents endangering technological progress, where is the empirical evidence to prove that hypothesis? See,
e.g., John P. Walsh, Ashish Arora & Wesley M. Cohen; “Effects of Research Tool Patents and Licensing on Biomedical Innovation”; PATENTS IN
THE KNOWLEDGE-BASED ECONOMY 285, 285 (2003) (“[Despite] an increase in patents on . . . ‘research tools,’ . . . we find that drug discovery
has not been substantially impeded.”). Where have fields of research been shut down by “too many” patents? Where have prices soared in
technologies captured by overbearing exclusive rights? Where have groups of companies abandoned technology because it is too expensive or
already locked up? Where is the evidence? The empirical evidence suggests that technology availability has soared and prices have declined as
innovation creates intense cycles of research competition. Indeed, the semiconductor chips that run most high-tech phones cost less than a cup
of designer coffee. Actually, the reason patents do not deter, but spur scientific development, is embedded in the
disclosure doctrines of the Patent Act. By statutory design, each patent on a new, non-obvious invention opens more
doors to future research than it could ever close. Yet, where has the Federal Circuit undertaken to explain that the “too many
patents” theory has no empirical or theoretical foundation? The Supreme Court has served up a pitch that begs to be hit:
After all, the Court’s justification for its new “exceptions” claim-by-claim validity doctrine does not pass the “common sense” test. No empirical
data shows declining patent filing rates; no empirical data shows patents closing down technology markets; no empirical data shows patents
causing research to dry up or grind to a halt. This softball pitch begs the Federal Circuit to show that the Court’s reasoning has no basis. Instead,
the Circuit has yet to swing its bat at this softball pitch, instead swinging only its sledgehammer. Strike four! Strike Five: The Many Missed
Chances to ‘School’ SCOTUS Still another softball pitch is available to the Circuit. Again, the target is the rickety underpinnings of the Court’s
“too many patents” reasoning. In this case, the language of section 101 itself rebuts the Supreme Court’s “too many patents” misstep.
Besides extending protection to “any” invention in the four broad statutory categories, section 101 also
embraces “improvements thereof.” 35 U.S.C. 101. Clearly the statute does not place some eligibility limit on the
number or strength of patents. Instead, the statute clarifies that even “improvements” qualify for protection. Unlike the
Supreme Court’s “exceptions” reasoning, this statutory language passes the common-sense test because
science progresses incrementally — each small improvement building on earlier improvements of any dimension (as long as they
satisfy the “other conditions and requirements” of the Act). Not only the disclosure purpose or the research economics of the Patent Act, but
also its very language rebuts the Court’s tragedy-like defense. This article’s suggestion that the Federal Circuit might “school” the Supreme
Court on patent law’s purpose and economics may seem to be a “bridge too far.” To the contrary, the Supreme Court has already
crossed that “bridge” once in this very area of patent law. In the 1970s, the Supreme Court had issued opinions in Gottschalk v. Benson, 409
U.S. 63 (1972) and Parker v. Flook, 437 U.S. 584 (1978) that moved section 101 toward a claim-by-claim validity doctrine .
The Court threatened to characterize all software patents as ineligible mathematical algorithms. When the Supreme Court granted certiorari in
the Diamond v. Chakrabarty and Diehr cases, Judge Giles S. Rich wrote an extensive opinion for the Court of Customs and Patent Appeals
explaining the operation of Section 101. In re Bergy, 596 F.2d 952, 961 (CCPA 1979). Indeed, the Supreme Court cited both Bergy and the
language of the 1952 Act to declare that eligibility protects “everything under the sun made by man” and that claims in any validity analysis
must be considered “as a whole.” The patent system really needs (and misses) Giles S. Rich. His successors still serve on the Federal Circuit and
might adopt his example to suggest common sense to the Supreme Court. Judge Rich charted the path that converted Benson into Diehr and
Funk Bros. into Chakrabarty. The key to charting that path again is finding the right case that only peripherally involves a natural law or
phenomenon. So far, the Federal Circuit has had the chance to call an e-vehicle charging system an e-vehicle charging system, a garage door
opener a garage door opener, and a cell phone camera a cell phone camera. But instead: so far . . . strike five! Other
cases are coming,
and the Circuit will have other opportunities to lay aside its sledgehammer and pick up a scalpel. Strike Six: Ignoring
Inconsistency with International Standards Strike six involves a rather esoteric point of Supreme Court jurisprudence, but nonetheless worthy of
a mention. The Supreme Court has long abided by the principle that “an act of congress ought never to be construed to violate the law of
nations if any other possible construction remains.” Alexander Murray v. The Schooner Charming Betsy, 6 U.S. 64, 118 (1804). Notably, the
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) has a section under the heading “Patentable Subject
Matter” which requires that “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided
that they are new, involve an inventive step and are capable of industrial application.” Although the TRIPS agreement has some exceptions, it
still demands the availability of “patents . . in all fields of technology.” A careful judicial examination would likely show that some “fields of
technology” have fallen under an eligibility sledgehammer to the degree that the United States is out of harmony with international standards
and obligations. Thus, the longstanding statutory construction counsel of Charming Betsy to avoid inconsistency with international standards
might also advise reconsideration of the Court’s sweeping claim-by-claim validity analyses under the guise of testing
eligibility. Even in the face of concerns about slumping U.S. competitiveness in the world innovation marketplace
(e.g., Bloomberg Innovation Index of nations for 2021does not list the United States in the top ten; South Korea is number 1), these questions of
international harmony and implications of U.S. innovation policy still elude all attention. Strike Seven: Dodging the Duty to Define Finally, the
Supreme Court’s Mayo-Myriad-Alice eligibility regime itself cries out for clarification. The Court’s murky
and indeterminate eligibility doctrine gives the Federal Circuit ample latitude to make improvements and
corrections. For example, the Supreme Court’s largest “exception” category that has replaced the statute — abstractness — has
yet to receive a definition. Moreover “natural laws” or “natural phenomena” are susceptible to sweeping
or narrow interpretations. To continue, the notion of “directed to” is vaguely directional, not specific. The
concept of an “inventive concept” has no defined dimensions. The “significantly more” test to determine if a
vague inventive concept transcends the “exceptions” has no stated parameters. “Well-known,” “routine,” “conventional” are general
labels, not standards for decisions. Each and every facet of the exception-based eligibility regime beseeches,
implores, and pleads for definition. Each and every facet of the exception-based eligibility regime is a
blank canvas that could, under the hand of an inspired Federal Circuit, produce a picture with more consistency and
predictability.

No industry is safe---the Alice test can remove patent eligibility for any invention.
Oliver 22 — J.D. Candidate, 2023, University of Georgia School of Law. B.M.E., 2020, University of
Dayton. Michael Oliver, Greasing the Wheels of Patent Law: Clarifying the Judicial Exceptions via
American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, 29 J. INTELL. PROP. L. 370 (2022). Available
at: https://digitalcommons.law.uga.edu/jipl/vol29/iss2/5 //WMK
While the Alice test has multiple issues, there are two to focus on that impact how the Alice test is carried out: first, the test is vague that is
effectively one step; second, the test is not repeatable as the test is too dependent on which characterization of the patent the court
adopts.108 a. Vagueness In
the Alice decision, the Supreme Court describes step two of the test as “a search
for an ‘inventive concept’—i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice
amounts to significantly more than a patent upon the [ineligible concept] itself.’”109 While the decision goes on to discuss prior Supreme Court
cases, this is effectively the extent of guidance which the Court has offered.110 The Supreme Court has not
granted cert. to any case regarding § 101 patent eligibility since Alice, so the lack of clarity has persisted.111 Due to
the lack of clarity, the two-part Alice test has been whittled down over time until the present, where the
test is effectively treated as a one-step process.112 The second step of the Alice test is only an issue when the judiciary
chooses to apply it. The Federal Circuit’s majority decision in American Axle “collapses the Alice/Mayo two-part test to a single step— claims
are now ineligible if their performance would involve application of a natural law.”113 Over time, the second
step of the Alice test has fallen away in favor of only applying the first step.114 The Supreme Court has consistently warned against this
pitfall.115 The first step of Alice is to “‘determine whether the claims at issue are directed to one of those patent-ineligible concepts,’” laws of
nature, natural phenomena, or abstract ideas.116 The Court has also stated that, “all
inventions at some level embody, use,
reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.”117 This is, in part, due to the
fact that the judicial exceptions are too broadly defined. 118 If the trend of ignoring the first step of the Alice test

becomes solidified precedent, then nothing will be patent eligible.119 b. Unrepeatable The Alice test
is also unrepeatable.120 “The court's rulings on patent eligibility have become so diverse and
unpredictable as to have a serious effect on the innovation incentive in all fields of
technology.”121 Depending on which characterization of the patent a judge adopts, the outcome can
be different.122 In Diamond v. Diehr, 450 U.S. 175, 185 (1981) (“Diehr”), the case hinged on which characterization the Court
adopted.123 The majority defined the patent claim as “a process for molding raw, uncured synthetic rubber into cured precision products.”124
The Court concluded that this was not directed to a natural phenomenon.125 Comparatively, the dissent
stated the “discovery is an improved method of calculating the time that the mold should remain closed during the curing
process.”126 The dissent’s characterization is that the claim is simply a computer-based improvement to an
established art and, in their view, is ineligible to be patented.127 In the end, the court ruled in a 5-4 decision.128 This
narrow margin highlights how the subjective adoption of the characterization plays too large of a role in
determining patent eligibility.129 In Illumina, Inc. v. Ariosa Diagnostics, Inc.,130 the majority characterizes the
claims as “directed to methods for preparing a fraction of cell-free DNA that is enriched in fetal DNA.”131 The majority found that, under
this characterization, “the claims are not directed to that natural phenomenon but rather to a patent- eligible
method that utilizes it.”132 By contrast, the dissent in Illumina stated that the claims “are directed to a natural
phenomenon because they involve a fundamental natural phenomenon , that cff-DNA tends to be shorter than cell- free
maternal DNA in a mother's blood, to produce a ‘mixture’ of naturally- occurring substances.”133 Again, it is clear that the outcome
is purely dependent on what scientific characterization of the invention the court adopts. The subjective
nature of the Alice test affects its repeatability.134 Depending on the judge (or panel of judges) who hears the claims, the
outcome could be drastically different.135 As understood and applied, the Alice test is nothing more than a game of
chance. The judiciary should not be a game of chance; its decisions are meant to be consisten t.136 The
Alice test is neither consistent, repeatable, nor predictable—it is vague and arbitrary. These are not traits that
the judiciary seeks in its rules, and therefore, the test needs to be addressed.137

Uncertainty chills innovation across the board and collapses U.S. tech leadership
Rafetto 23 — Judicial Law Clerk for Chief Judge Colm F. Connolly of the United States District Court for
the District of Delaware. J.D., May 2022, New York University School of Law. Chad Rafetto, "Fostering
Innovation through a Legislative Overhaul of Patentable Subject Matter," Federal Circuit Bar Journal 32,
no. 2 (July 2023): 93-130 //WMK

Currently, there is a perception that certain kinds of inventions are precluded from receiving a patent
because those inventions cannot pass the patentable subject matter requirement ."' This perception creates two
issues. First, without certainty that downstream products in a field will be patentable , there is little incentive

to invest in either the building blocks or the downstream products.'' So there are inadequate incentives to
undergo the costs of innovation in certain fields. Second, when a company decides to invest in innovation,
the uncertainty of whether its inventions are patentable incentivizes the hoarding of information in the
form of trade secrets as opposed to the sharing of information that occurs in the patent system. Both of
these issues are contrary to the core of patent law policy and are evidence that the system is not functioning optimally. The cause of these issues is that
patentable subject matter functions best as a low bar, but the bar has been raised and now § 101 is doing
exclusionary work that is best left to other doctrines. And the effect is that patents are now being granted or invalidated

inconsistently across different fields. a. Patentable Subject Matter Is No Longer a Coarse Filter The idea of patentable subject
matter serving as a coarse filter has been turned on its head. The coarse filter idea once meant that
patentable subject matter was a low threshold to achieve. 7 Thus, all inventions but the bulky building blocks
of science (i.e., laws of nature, physical phenomena, or abstract ideas) would pass through the filter. But now this coarse filter is
being used more frequently. A lot more frequently. Since the Roberts Court's four cases on patentable subject
matter from 2010 to 2014, the number of patent validity challenges on subject matter grounds has grown
twentyfold."' Further, one study found that out of a sample of 104 patent eligibility cases before the Federal Circuit post-Alice,
the court determined that only 7.7% of those patents were valid."' This has created a perception that
certain types of inventions cannot receive patent protection, and this perception has stalled innovation
in those fields. Patent application rejections and patent invalidity rulings on subject matter grounds are more
problematic for innovation than rejections and rulings based on other grounds because of the scope of
the inquiry. Patentable subject matter asks whether inventions of this general kind are patent eligible; the
other doctrines of patentability ask only whether a specific claim is patentable."' So a rejection on subject matter
grounds acts as a cudgel and sends a signal that all inventions of that "general kind" are not patentable,

whereas a rejection on one of the other grounds acts as a scalpel and relates only to the specific claim at hand. Because patentable subject

matter has been used too frequently to invalidate or reject a patent-even though a rejection based on a
different doctrine would suffice-there is now a perception that patents are unavailable in certain fields.' 2 b.
Technical Fields Are Being Treated Unequally Under Patent Law The Supreme Court has refused to categorically ban certain fields of innovation from being
patentable because inventions are often unforeseeable."' As Judge Rader put it in his dissent in In re Bilski,"4 "[W]hy should some categories of invention deserve
no protection?"'"' The Supreme Court retained this policy by rejecting a categorical rule about the patentability of business methods because it would "frustrate the
purposes of the patent law."'"6 Yet the current 5 101 jurisprudence is foreclosing inventions in certain industries from the patent
system. The current subject matter doctrine is preventing inventions in certain fields from being patented not because the advances in these

fields are not valuable to our society, but rather because these inventions do not map well onto the
subject matter requirements for patent law.'"" Alice has had a particularly negative effect on software, business
methods, and biotechnology patents.' 9 Post-Alice, the number of patent applications in each field decreased,
yet even with fewer applications, the number of S 101 rejections increased .90 Another study looked at the invalidation
rates under § 101 of over 800 patents before the Federal Circuit and found that 65% of software or IT patents were invalidated

whereas only 50% of biotechnology or life science patents were invalidated."' These studies exemplify just one of the
discrepancies across fields. That is not to say that all patents should be granted at an equal rate. But if no field is categorically banned from

receiving a patent, then the subject matter rejection rates should be comparable . As explained previously, a
rejection on subject matter grounds has a broader preemptive effect, so having higher subject matter
rejection rates in certain fields forecloses a broader sphere of the field from patent protection than a rejection under
any other doctrine. One example of this inequality is in the field of diagnostics. In Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC"' Mayo v. Prometheus,
and Association for Molecular Pathology v. Myriad, patents for diagnostic inventions were invalidated based on subject matter grounds."' This trio of cases
has signaled to inventors that applying for a diagnostic patent is a risky business. The patent may not be granted at all.
Alternatively, even if the patent is granted, it can be invalidated when one attempts to enforce it ."' If the

patent is invalidated, then the inventor disclosed his invention to the public but reaped none of the
rewards of the patent. This uncertainty incentivizes inventors in the field of diagnostics to seek out other forms of protection or to
abandon research in that field altogether in favor of a more patent-friendly field. For example, the Cleveland Clinic
hospital system has shifted its research focus away from diagnostics because it thinks that inventions in this space will not be patentable under § 101."195 2. A
Comparison to Foreign Countries Demonstrates America Is Falling Behind in Terms of Patenting Inventions and Securing
Investment for Innovation Another indicator that the United States' approach to patent eligibility is not good policy can be seen by comparing our
patent law to that of foreign countries. The United States used to be the "gold standard" for patent protection and

"has led the world in securing stable and effective property rights in cutting-edge innovation ."" But this
statement has become further and further from the truth each day. Currently, the United States is rejecting more

patents than foreign countries and is ceding investment in innovative technologies to other countries. While the
United States is dealing with its § 101 uncertainty, other countries are developing and, perhaps, surpassing the
United States in being the world leader for patent protection.198 A recent study tracked over 17,000 U.S. patent
applications that were rejected and then abandoned on eligibility grounds and found that nearly 10% of
these applications were granted by the European Patent Office, China, or both .'9 ' True, granting fewer patents does
not necessarily mean that innovation is stalling. For example, if the patent system was only invalidating, rejecting, or preventing applications for undesirable
patents, then our system would be functioning optimally. But that is not the case. Though it is difficult to determine whether the patent system is promoting or
preventing innovation,' there
are a couple of key indicators that innovation is being stalled. First, other countries
are now receiving more funding than the United States for innovation. For example, in 2013, the United
States received 77% of capital investments for software driven industries but received only 50% four
years later.20 ' Further, in 2017, 48% of the funding for artificial intelligence startup companies went to China,
and the United States received only 38%.202 Because funding is crucial to developing certain technologies, decreased
investment is likely to result in decreased innovation. There is also evidence to suggest that this reduction in funding
is caused by the change in our patent eligibility jurisprudence. In a recent survey of 475 venture capital
and private equity investors, 74% said that patent eligibility is a key reason to invest or not
invest in a company's developing technology.2 03 And in a different study, 33% of investors said that
the patent eligibility laws caused their firms to shift their capital investment away from new software
or new technology related to the biotechnology, medical device, and pharmaceutical industries. Second, anecdotally the United States is
not allowing patents on some very desirable inventions. One example is the patent that the Federal Circuit invalidated on eligibility
grounds in Ariosa Diagnostics, Inc. v. Sequenom, Inc. 0 That patent was for a technology that utilized cffDNA to detect fetal abnormalities noninvasively2 -a medical
advancement that is unequivocally desirable. The United States invalidated this patent,20 ' but both the United Kingdom"0 and Australia 2 0 upheld the
patentability of the very same technology. To summarize, our
current patentable subject matter doctrine has caused a
trickledown effect in which: (1) section 101 has been used more frequently to invalidate patents, (2)
different subject matter invalidity and rejection rates have led to inequality amongst fields, (3) there is a
perception that patents are unavailable in certain fields, (4) companies and investors fund and conduct
less research in these fields that are perceived to be patent-ineligible, and (5) ultimately, there is less
innovation in these fields. Though the Supreme Court warned that applying the Alice Two-Step too strictly could eviscerate
patent law and cautioned against such an application," in practice that is precisely what happened. As a result, innovation in
America is being curtailed and is lagging behind that of other countries.

Chinese tech leadership leads to nuclear war


Kroenig 18, Deputy Director for Strategy, Scowcroft Center for Strategy and Security Associate
Professor of Government and Foreign Service, Georgetown University (Matthew, Nov 12, 2018, “Will
disruptive technology cause nuclear war?” BAS, https://thebulletin.org/2018/11/will-disruptive-
technology-cause-nuclear-war)

Recently, analysts have argued that emerging technologies with military applications may undermine nuclear stability (see here, here, and
here), but the logic of these arguments is debatable and overlooks a more straightforward reason why new
technology might cause
nuclear conflict: by upending the existing balance of power among nuclear-armed states. This latter concern
is more probable and dangerous and demands an immediate policy response. For more than 70 years, the world has avoided major power
conflict, and many attribute this era of peace to nuclear weapons. In situations of mutually assured destruction (MAD), neither side has an
incentive to start a conflict because doing so will only result in its own annihilation. The key to this model of deterrence is the maintenance of
secure second-strike capabilities—the ability to absorb an enemy nuclear attack and respond with a devastating counterattack. Recently
analysts have begun to worry, however, that new strategic military technologies may make it possible for a state to conduct a successful first
strike on an enemy. For example, Chinese colleagues have complained to me in Track II dialogues that the United States may decide to launch a
sophisticated cyberattack against Chinese nuclear command and control, essentially turning off China’s nuclear forces. Then, Washington will
follow up with a massive strike with conventional cruise and hypersonic missiles to destroy China’s nuclear weapons. Finally, if any Chinese
forces happen to survive, the United States can simply mop up China’s ragged retaliatory strike with advanced missile defenses. China will be
disarmed and US nuclear weapons will still be sitting on the shelf, untouched. If the United States, or any other state acquires such a first-strike
capability, then the logic of MAD would be undermined. Washington may be tempted to launch a nuclear first strike. Or China may choose
instead to use its nuclear weapons early in a conflict before they can be wiped out—the so-called “use ‘em or lose ‘em” problem. According to
this logic, therefore, the appropriate policy response would be to ban outright or control any new weapon systems that might threaten second-
strike capabilities. This way of thinking about new technology and stability, however, is open to question. Would any US president truly decide
to launch a massive, bolt-out-of-the-blue nuclear attack because he or she thought s/he could get away with it? And why does it make sense for
the country in the inferior position, in this case China, to intentionally start a nuclear war that it will almost certainly lose? More important, this
conceptualization of how new technology affects stability is too narrow, focused exclusively on how new military technologies might be used
against nuclear forces directly. Rather, we should think more broadly about how new technology might affect global politics, and, for this, it is
helpful to turn to scholarly international relations theory. The dominant theory of the causes of war in the academy is
the “bargaining model of war.” This theory identifies rapid shifts in the balance of power as a primary
cause of conflict. International politics often presents states with conflicts that they can settle through peaceful bargaining, but when
bargaining breaks down, war results. Shifts in the balance of power are problematic because they undermine
effective bargaining. After all, why agree to a deal today if your bargaining position will be stronger tomorrow? And, a clear
understanding of the military balance of power can contribute to peace. (Why start a war you are likely to lose?) But shifts in the balance of
power muddy understandings of which states have the advantage. You may see where this is going. New technologies threaten to
create potentially destabilizing shifts in the balance of power. For decades, stability in Europe and Asia
has been supported by US military power. In recent years, however, the balance of power in Asia has begun to
shift, as China has increased its military capabilities. Already, Beijing has become more assertive in the
region, claiming contested territory in the South China Sea. And the results of Russia’s military modernization have been
on full display in its ongoing intervention in Ukraine. Moreover, China may have the lead over the United States in
emerging technologies that could be decisive for the future of military acquisitions and warfare,
including 3D printing, hypersonic missiles, quantum computing, 5G wireless connectivity, and artificial
intelligence (AI). And Russian President Vladimir Putin is building new unmanned vehicles while ominously declaring, “Whoever leads in
AI will rule the world.” If China or Russia are able to incorporate new technologies into their militaries before the United States, then this could
lead to the kind of rapid shift in the balance of power that often causes war. If
Beijing believes emerging technologies provide
it with a newfound, local military advantage over the United States, for example, it may be more willing
than previously to initiate conflict over Taiwan. And if Putin thinks new tech has strengthened his hand, he may be more
tempted to launch a Ukraine-style invasion of a NATO member. Either scenario could bring these nuclear powers into
direct conflict with the United States, and once nuclear armed states are at war, there is an inherent
risk of nuclear conflict through limited nuclear war strategies, nuclear brinkmanship, or simple accident
or inadvertent escalation. This framing of the problem leads to a different set of policy implications. The concern is not simply
technologies that threaten to undermine nuclear second-strike capabilities directly, but, rather, any technologies that can result in a meaningful
shift in the broader balance of power. And the solution is not to preserve second-strike capabilities, but to preserve prevailing power balances
more broadly. When it comes to new technology, this means that the United States should seek to maintain an innovation edge. Washington
should also work with other states, including its nuclear-armed rivals, to develop a new set of arms control and nonproliferation agreements
and export controls to deny these newer and potentially destabilizing technologies to potentially hostile states. These
are no easy
tasks, but the consequences of Washington losing the race for technological superiority to its autocratic
challengers just might mean nuclear Armageddon.

Only reversing judicial exemptions can solve declining tech leadership in AI, Quantum,
and 5G
Kappos 19 — David "Dave" J. Kappos is an attorney and former government official who served as
Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and
Trademark Office from 2009 to 2013. Kappos is currently a partner at New York law firm Cravath, Swaine
& Moore. Kappos, David J. “Oral Testimony Before the U.S. Senate Sub-Committee on Intellectual
Property.” The Senate. June 4th, 2019. https://www.judiciary.senate.gov/imo/media/doc/Kappos
%20Testimony.pdf //WMK
Good afternoon Chairman Tillis, Ranking Member Coons, members of the Sub-Committee on Intellectual Property. It is a pleasure to discuss
with you our country’s patent system, and in particular our laws governing the types of inventions considered patent eligible. I’m
testifying today solely on my own behalf. Thank you for focusing on this issue – it is not simple, or easily explained, but it is at the core of
America’s innovation engine. The inventions deemed eligible today drive tomorrow’s jobs, national
competitiveness, economic prosperity and even national security. Our current patent eligibility law truly is a
mess. The Supreme Court, Federal Circuit, district courts, and USPTO are all spinning their wheels on
decisions that are irreconcilable, incoherent, and against our national interest . A few examples. First, under
current U.S. law governing patent eligibility, it is easier to secure patent protection for critical life
sciences and information technology inventions in the People’s Republic of China and in Europe, than in the U.S. This
conclusion results from analyzing many patent applications filed identically in the U.S., China and Europe. Patent
eligibility scholar Robert Sachs and I identified many such applications patented in China and Europe, but rejected in
the U.S. under 101 and ultimately abandoned here. So current U.S. law governing patent eligibility puts us behind China and
Europe in life sciences and information technology--two critical technical areas for national competitiveness. Second, our current
constricted approach to Section 101 is undermining investment in technologies Congress and the
Administration consider critical to national security: artificial intelligence, quantum computing and 5G.
While I’m not a national security expert, I would think a policy disincenting innovation and investment in these
technologies could pose a national security threat. That is exactly the policy we are currently pursuing by default. Robert
Sachs and I examined data showing these technologies are being denied eligibility under current U.S. law. For
instance, 101 is having a significant negative impact on artificial intelligence patent applications. We
reviewed Office Actions for USPTO examination groups 2100 and 2800, the two key groups for AI. In 2018, AI patent applications in
2100 and 2800 had 101 rejections 88% and 51% of the time, respectively. And it’s not just that a majority of AI patent
applications are rejected under 101. Looking year-over-year since the Alice decision, 101 rejections have increased significantly
in both these areas. In 2100 AI 101 rejections increased nearly four times since 2014. In 2800 those rejections increased
nearly nine times from 2017 to 2018 alone. While quantum computing is in its early days, the available data covering
software innovation for quantum computing is troubling. 100% of abandoned patent applications for
advanced programming in quantum computing were rejected under Section 101 between December 2014 and
March 2019. Yes, every single abandoned case rejected under 101. Given the importance of quantum computing, we can’t
ignore even early data. In 5G, where one would not expect 101 issues, we found 101 rejections in 20% of final
rejections. This means 20% of 5G filings are unable to overcome an initial 101 rejection. A similar phenomenon occurs with
appealed applications — 50% unable to overcome a 101 rejection. All three national security critical
disciplines involve research intensive, hard innovation. Patent troll lawsuits are not the issue here. The issue is
disincenting companies that invest in the hard innovation protecting our national security. Congress and the
Administration view AI, quantum computing, and 5G as critical to national security, while the courts say those technologies are ineligible for
patent protection. This is a disconnect. Third, despite concerns over patent quality, our
national preoccupation with 101 puts
us at a quality disadvantage against our economic competitors who deploy their patent examination
resources at the real issues affecting patent quality: novelty, non-obviousness, enablement, written description. USPTO is
expending many thousands of hours per year on the irreconcilable mess of 101 -- time that could be
much more productively spent on issues that should be the focus of quality patent examination , as they are
for our economic competitors.
International Harmonization ADV
1AC---ADV---International Harmonization
Advantage [2] is International Harmonization---

Judicial exemptions discriminate against specific technological industries. That violates


international law and shreds global patent harmonization. The plan restores American
credibility which spills over
Lopez 22 — Joshua A.Lopez,J.D.Candidate,2022,TheGeorgeWashington University Law School; B.A.,
Physics, University of Pennsylvania. Joshua A. Lopez, "Technological Fault Lines: The Problems with
Tailoring Patent Eligibility at the USPTO," AIPLA Quarterly Journal 50, no. 3 (Summer 2022): 487-[v]
//WMK

The TRIPS Agreement prohibits patent rules that discriminate according to technology.91First negotiated in
the early 1990s and effective in 1995, the TRIPS Agreement binds WTO member nations to minimum standards of
regulation, protection, and enforcement of intellectual property rights .92 Article 27 of TRIPS requires that
"patents shall be available and patent rights enjoyable without discrimination as to the place of
invention, the field of technology and whether products are imported or locally produced." 93 This non-discrimination mandate
is considered "the core provision, and the reason of being of the whole TRIPS Agreement." 94 The
provision was intended to prevent member nations from favoring their own inventors or their preferred
technological fields "for purely economic protectionist reasons." 95 To enforce TRIPS compliance and promote consistent
patent protection, WTO member nations may challenge the rules and conduct of other nations by seeking dispute resolution at the WTO.96 In
2000, the WTO applied the non-discrimination mandate to Canada's Patent Act.97 Following the European Communities' ("EC") 1997 request
for consultation at the WTO regarding pharmaceutical patents, a WTO Panel reported on the requirements for violative technological
discrimination.98 The EC challenged Canada's law which allowed generic pharmaceutical companies to test, manufacture, and stockpile
patented pharmaceutical products during a broad regulatory review period before expiration of the incumbent brand's patent.99 The EC
argued that Canada violated TRIPS Article 27 because such specialized treatment of pharmaceutical patents was specifically disadvantageous to
pharmaceutical patent holders and thus discriminatory as to the field of technology."' The WTO panel ultimately found no violation.101 It
acknowledged that TRIPS
Article 27 prohibits both de jure discrimination, which targets technologies explicitly by law, and de facto
discrimination, or "ostensibly neutral" treatment in which the "actual effect is to impose differentially
disadvantageous consequences on certain parties."1 02 Yet, the panel rejected the EC's "strict interpretation of Article 27.1"
that would prohibit 03 any differential effect of patent law regardless of purpose.1 Ultimately, because the WTO panel "received no systematic
information on the range of industries" that Canada's alleged discriminatory practice actually impacted, it "found that the evidence in record
before it did not raise a plausible claim of discrimination under Article 27.1 of the TRIPS Agreement."1 0 Although Canada's shortened effective
patent term for certain process patents violated Article 28.1 and Article 33 of the TRIPS Agreement, the differential treatment of 05 The WTO
panel explained that de jure discrimination in violation of TRIPS Article 27 "arise[s] from explicitly different treatment" under law.1' According
to theWTO, thenormal requirementfor dejurediscriminationiswhenthechallenged standard's "legal scope" is limited to a particular technology.
07 It exists "where unjustified differentiation is evident from the very nature of the law."" 8 The panel concluded Canada's regulatory exception
was not de jure discrimination because the exception was available "not just to pharmaceutical products but to 'any product' that requires
regulatory approval for marketing (including agricultural products, certain foods, cosmetics, automobiles, ships, and aircraft)." 09 Canada's
regulatory scheme was therefore not dejurediscrimination. In contrast to Canada's law, de jure discrimination would be found where the law
explicitly impacts a technologicalclass and not simply a regulatory class of products.O De
jure discrimination may also arise if
certain technology areas are altogether excluded from patentability without a "bona fide reason" or TRIPS-
enumerated exception.1"' For example, United States legislators introduced the Genomic Research and Accessibility Act to remove DNA
statutorily from patentable subject matter." 2 Because it would be discriminatory to eliminate or hinder patent protection for certain
technology, it would have likely violated TRIPS-it ultimately failed."' Conversely, the European Parliament introduced the Bio-Tech Directive to
uphold patent rights for genes." 4 Because the Directive would enhance patent protection of certain technology, a European Parliament panel
found that it would not likely violate TRIPS, unlike the Genomic Research and Accessibility Act." 5 Further discussed below, countries may also
exclude certain technologies if explicitly allowed in the TRIPS Agreement, as justified for ethical concerns around animal patents or to enable
greater access to medical 16 2. The WTO Prohibitsdefacto DiscriminationUnless the Nature of the Technology Requires Different Rules. De facto
discrimination exists if a country's patent law is facially neutral but exhibits different effects for different areas of technology. In the EC's
challenge to Canada's Patent Act, the WTO panel adopted a practical, flexible standard for measuring de facto discrimination rather than
mandating a "one-size-fits-all" patent system.117 De facto discrimination often requires (1) that the challenged treatment's effects are limited
to a particular industry, and (2) a demonstrated intention to impose disadvantages on a particular industry.118 The panel explained de facto
discrimination exists if treatment exhibits different "legal effect" for different types of technology
without justification, which is "the type of exploitation TRIPS was intended to protect." 1 19 Canada's differentiation of pharmaceutical
patents resulted in a mere "commercial or economic effect" because stockpiling generic pharmaceutical products only created potential
competitive advantages. 20 The panel allowed such differential "commercial or economic effect" as a byproduct of Canada's policy, which was
"necessary for regulatory review" of pharmaceutical products during the patent term. For the second requirement of discrimination, because
Canada had a "bona fide" reason to differentiate according to technology, in its case "to deal with problems that may exist only in certain
product areas," its pharmaceutical differentiation did not violate TRIPS.1 2 The differential timing of regulatory approval for pharmaceutical
products in Canada was a permissible justification because it was specific to the nature of the impacted technology.2 3 Thus, effective
differentiation based on an inherent aspect of the field of technology is often appropriate and allowable under TRIPS Article 27.124 On the
contrary, a member 2 differential regulatory schemes that purposely disfavor certain patent owners.126 TRIPS sought to harmonize
pharmaceutical and medical patenting despite the variation of regulatory schemes for health-related products around the world.1 27 Broad
discriminatory treatment, such as "categorically preclud[ing] entire classes of inventions from patent protection, even if they are genuinely
novel," is violative unless a practical or commercial justification exists and is inherent to the excluded technology.128 Illustratively, Wolrad Prinz
zu Waldeck und Pyrmont has discussed patent schemes in Switzerland and Belgium that may constitute de facto discrimination.129 Countries
like Switzerland may require compulsory licenses for research patents to enable and spread the costs of biotechnology research, which is useful
if patent standards lack international uniformity.130 But requiring compulsory licenses for research tools would likely constitute de facto
discrimination against the biotechnology field because of the high number of "dependent inventions" in biotechnology that require underlying
research tools.131 This discrimination likely could not be justified under TRIPS because forcing certain patent holders to license their research
tools does not involve inherent features of the products at issue, unlike the necessary regulatory requirements found in Canada's law." 2
Switzerland's statutory licensing requirement tends to discriminate according to technology without justification inherent to the targeted
technology; therefore, it is arguably an example of de facto discrimination.133 Belgium similarly contemplated a broad experimental use
exception to patent enforcement for research tools, which may also have the requisite "differentially disadvantageous treatment" to be de
facto discrimination.134 Belgium, therefore, changed its statute to comply with the TRIPS Agreement.13 3. TRIPS Allows Limited Exceptionsfor
PatentEligibility. Limited exceptions exist to the TRIPS non-discrimination mandate for certain medical methods, plants, and animals other than
micro-organisms.1 36 First, under TRIPS Article 27.3(a), methods of treatment may be excluded from patent protection to promote access to
healthcare, but TRIPS does not allow the broad exclusion of all underlying product protection.1 37 Therefore, gene treatments may be excluded
properly under TRIPS, but the underlying research substances or equipment, such as the challenged genes in Myriad, cannot be broadly
excluded.138 Next, under TRIPS Article 27.3(b), member nations may exclude "plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other than non-biological and microbiological processes."139 This exception reflects
the different ethical standpoints recognized during TRIPS negotiations.43 Additional interpretations of these exceptions suggest that TRIPS
should reflect different philosophical and cultural understandings of genetic modification.'14 Relatedly, under TRIPS Article 27.2, member
nations may exclude patenting if necessary to protect "ordre public or morality."142 Some authors suggest that this exception can justify the
exclusion of genetic engineering and gene sequencing patents because of their ethical ambiguity. 143 DIFFERENTIAL USPTO ELIGIBILITY RULES
WOULD VIOLATE TRIPS ARTICLE 27 AND DISADVANTAGE CERTAIN PATENT HOLDERS Pyrmont explains that legislation targeting gene patents or
predominantly affecting gene patents without justification is defacto discrimination in violation of TRIPS Article 27.14 Extending this argument
to other classes of technology, USPTO authority to craft different
patent eligibility standards for different technologies
would likely violate the TRIPS Agreement. First, the rules would affect "different technology areas to
different degrees," and second, the legislation would likely discriminate without proper justification inherent to the
nature of the technology. 145 The current splintered rules of patent eligibility likely meet the first requirement for defacto discrimination, and
the second requirement is met if the 1 United States cannot present a "legitimate purpose" for its differentiation. The
current
categorized judicial exceptions to eligibility likely meet the first requirement for de facto discrimination
because of their differential "legal effect."147 Splintered case law demonstrates that epigenetic innovation and
software are held to different standards under the eligibility law.1" Even if the differential rules involve "ostensibly
neutral" treatment of different technologies, lopsided requirements constitute requisite discrimination when they tend to impact patent rights
in certain areas more than in others.149 As Loznev explains, such
discriminatory rulemaking threatens epigenetic
innovation by uniquely diminishing the incentives for this research.'50 Other patent requirements, such as enablement
or obviousness, could properly filter overly broad patents without isolating the entire fields of epigenetics and software.151 Additionally,
amicus briefs have indicated that theSupreme Court's differentiation of patent-eligible subject matter have
discriminatory legal effect.152 For example, Alnylam Pharmaceuticals has argued that the Myriad line of cases, which
exclude isolated DNA from patent protection, undermines TRIPS compliance,5 3 and the Chartered Institute of
Patent Attorneys has urged the Supreme Court to revisit this area of law because patent exclusion for specific technological
classes violates TRIPS.154 The second requirement for de facto discrimination is the lack of a "bona fide" reason to discriminate.155
Countries can typically justify technological discrimination if necessary to handle unique characteristics
of an industry, such as regulating pharmaceutical products or effectively enforcing patents in "complex product industries," but the scope
of differentiation cannot be "broader than necessary."156 Currently, the Supreme Court's case-by-case judicial exceptions to patent eligibility
are "sufficiently limited" to assessing whether a given patent claim is a "process, machine, manufacture, or composition of matter," as
enumerated in 35 U.S.C. § 101.157 Under TRIPS, legislation cannot expand the scope of this exclusion and allow the USPTO to hamper entire
technology areas 58 without a "legitimate purpose" specific to the impacted areas of technology.1 Unlike Canada's justification for
differentiating pharmaceutical products because of their health-related regulatory scheme, the USPTO's apparent justification for discriminating
against swaths of technologies merely to be flexible and "respond to new developments in scientific research" would likely fail to meet the
"bona 59 fide" justification requirement-it would be "broader than necessary."1 The current differential eligibility law likely meets the first
factor of de facto discrimination, and broad, unjustified exclusions would likely meet the second requirement, violating TRIPS and harming
innovation.'" Lastly, general authority to draft different rules for different types of technology is not allowed by the limited TRIPS exceptions to
eligibility. The TRIPS exceptions do not broadly include all applications of biological material, only method patents related to diagnostics or
treatment.1 61 Although biomedical research should enable the use of discoverable tools, innovators in this space are protected from
discriminatory treatment under TRIPS.162 When gene sequencing patents involve isolating DNA to further explore the functional relationship
between a gene and protein, incentives through patent protection should be granted even if the isolation method is not the inventor's primary
contribution.16 3 C. USPTO ELIGIBILITY RULEMAKING WOULD DELEVERAGE U.S. POSITIONS AGAINST OTHER NATIONS' DISCRIMINATORY
POLICIES The
United States should seek rigorous compliance with international treaties, like TRIPS, if it hopes to
advance patent harmonization among the vastly different systems of national patent regulation.16 A
country cannot argue against problematic discriminatory practices unless it serves as an
example of harmonization itself.63 Patent systems throughout the world are crucial instruments to incentivize
groundbreaking industries in biotechnology and life sciences, but countries have expressed reservations in providing
relevant patent protection.166 Certain African nations and Bolivia have expressed that the patent system should not "become an
instrument of privatisation and commoditisation of life itself on a worrying scale and magnitude."1 67 Proponents of this policy
differentiation reference the flexibility intended in TRIPS negotiations. 1 U.S. cases like Myriad may align
with this viewpoint by preventing naturally existing biological features from earning a patent, but the United
States should nonetheless seek to comply with TRIPS Article 27. Despite calls to allow developing countries to tailor their patent rules for local
needs, countries
should be wary of drawing bright lines around areas of technology that remain
unexplored.169 These bright lines could disincentivize and ultimately forestall beneficial exploration, and the United States should
instead seek to uphold uniformity and promote innovation.

The plan is key---Alice/Mayo violations spillover


Crouch 17 — Professor, University of Missouri School of Law. Dennis Crouch. "Alice and TRIPS
Compliance," Patently-O. November 30, 2017. https://patentlyo.com/patent/2017/11/alice-trips-
compliance.html, accessed 6-10-2024 //WMK

The United States is obligated under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) treaty to make patent
rights available and enjoyable without discrimination as to the “field of technology” of the invention.[i] No specific areas of
technology may be singled out for unjustified special treatment. In a new paper (Business Methods, Technology, and
Discrimination, 2018 Mich. St. L. Rev. __ (forthcoming), available at https://ssrn.com/abstract=3071000), I argue that the United States is doing just

that with respect to computer-implemented business methods. Doctrinally, such methods are subject to an especially high bar
for patent eligibility. Statutorily, patents on such methods may be challenged in invalidity proceedings that are exclusively available for so-called
“covered business method patents.” The law seems to reflect a skepticism that computer-implemented business

methods should be broadly eligible for patenting, as well as a distaste for the aggressive enforcement of many such patents by patent
assertion entities. While these may be real problems and serious policy challenges, discrimination by technological field is not a TRIPS-

compliant solution. Discrimination can be de jure—where the law facially discriminates—or de facto. De facto discrimination can be shown by evidence
of the discriminatory effects of the law, as well as by showing that a discriminatory purpose can be inferred from the objective characteristics of the law. From a
doctrinal standpoint, Alice v. CLS Bank[ii] appears to have caused at least de facto discrimination against what the Court considered “mere” computerization of
business methods. Though rooted in Mayo v. Prometheus’s[iii] field-neutral analysis, Alice
fashioned a new rule against “generic
computer implementation” of business practices. The result is that the vast majority of challenged
patents in the computer-implemented business method space have been rendered ineligible in district courts,
in the Federal Circuit, and in the PTAB. For applications still in prosecution, Alice rejections are disproportionately affecting the

technology center that includes business method art units, with most rejections being applied in the e-commerce art units. The upshot of the post-Alice
landscape seems to be that improving computer technology per se is patent eligible, as is using computers to solve industrial or computer-centric problems, but
using computer technology to facilitate a business process is not. When Alice purports to exclude generic computerization from patenting, it essentially draws a line
between using technology and creating technology. Alice calls the former non-technology when what it really means is non-inventive, which is beside the point.
Many have criticized Alice for how the framework’s “search for an inventive concept” improperly blurs the line between § 101 and §§ 102-103, flying in the face of
Diamond v. Diehr’s proclamation that the novelty of the components used or steps performed in a method should have “no relevance” to a § 101 determination.[iv]
TRIPS art. 27.1 itself expressly distinguishes the idea of being within a “field of technology” from the notion that patentable inventions must also be “new” and
“involve an inventive step.” For
Alice to exclude almost all computerized business methods from the patent
system for these reasons, but on § 101 grounds, lacks coherence and appears at least de facto discriminatory. By
contrast, the Covered Business Method Review (“CBM”) program presents a fairly clear case of de jure discrimination. Alongside the creation of two other
technology-neutral proceedings (inter partes review and post-grant reveiew), Congress created the CBM program, limited it to “covered business method patents,”
and allowed for challenges on § 101 grounds to be made.[v] Although Congress purported to exclude “technological inventions” from the program, the Federal
Circuit and the USPTO have closely tied the reach of the CBM program to Alice, such that CBM patents are now largely coextensive with the computerized business
methods that the courts, following Alice, deem ineligible.[vi] As expected, patent claims that reach a final judgment in the CBM program are being invalidated at
very high rates, especially on § 101 grounds. On top of that, the CBM program even includes two provisions that uniquely disadvantage the owners of CBM patents:
(1) a narrow estoppel provision that gives petitioners broader abilities to challenge CBM patents in both the PTAB and district court;[vii] and (2) a rare right for
interlocutory appeal of any decision denying a motion to stay parallel litigation—with even rarer de novo appellate review.[viii] To be clear, not all differential
treatment rises to the level of TRIPS-violating discrimination. In the pharmaceutical context, for example, the inventions are subject to regulations and market
restrictions that can justify some special accommodations. A member country’s patent laws may properly extend the term of a drug patent to offset a lengthy
regulatory review period, or may properly allow generic drug makers to begin seeking their own regulatory approval during the patent term.[ix] But the United
States’ handling of computer-implemented business methods seems to go beyond the kind of justifiable differential treatment that TRIPS tolerates. For computer-
implemented business methods, the legal differences in treatment discussed above correspond to nothing unique about the subject matter, but arguably reflect
broader problems in the United States patent system concerning patent examination quality and litigation abuse. None of this discrimination is in violation of the
treaty, of course, unless computer-implemented business methods are a “field of technology” under art. 27.1. Congress and the USPTO have ostensibly assumed
not, but there are several good reasons to interpret TRIPS as deeming such methods technological. First, most definitions of “technology” encompass not only
creation but also use of technological tools—a view that is consistent with Diehr’s proscription against novelty forming a part of the § 101 analysis. Second, although
business methods per se were not clearly patent eligible in the U.S. until 1998[x] (three years after TRIPS went into effect), many computerized processes had long
been eligible for U.S. patent protection when TRIPS was negotiated. Third, the U.S. has on ten separate occasions questioned, for TRIPS compliance purposes,
whether the laws of other countries provided adequate protection for software and business methods.[xi] Fourth, though the U.S. has been an outlier among TRIPS
members in patenting non-computerized business methods, it is not alone.[xii] Fifth, patenting computer-implemented business methods not only accords with the
broad “useful arts” scope of patent systems historically,[xiii] but also reflects modern trends applying more scientific and technological rigor to business and
financial practices.[xiv] The fact that at least some computer-implemented business methods are patent eligible in the U.S. itself suggests that the field is
technological, even if many methods in the field ultimately fall short on inventive merit. Eligibility at the threshold is a long way from patentability, and what Alice
would view as mere computerization of a well-known business process will rarely be inventive enough to be patented as a novel, nonobvious process. But arranging
and employing computers and software for practical business purposes is nonetheless a technological endeavor that brings such methods under TRIPS’ protections.
As the United States considers more changes to the availability and enjoyment of patent rights, it should end this discrimination in
favor of technology-neutral practices or reforms.[xv] Otherwise, it sets a precedent of singling out
disfavored technologies for disadvantageous treatment on a country-by-country
basis, which could undermine the international patent law harmony that TRIPS is intended to facilitate.

Patent harmonization drives international technology trade


Ito and Shirai 23 — Banri Ito is a Professor of Economics at Aoyama Gakuin University and a
Research Associate at the Research Institute of Economy, Trade and Industry (RIETI). Ito, Banri, and
Katsunori Shirai. "Patent law harmonization and international trade." International Journal of Economic
Policy Studies 17.1 (2023): 289-306. //WMK
A series of earlier studies on the relationship between IPR and trade has argued that the efects of patent protection in destination countries are
indefnite in the sense that exports to the destinations possibly increase or decrease owing to the market expansion efect and market power
efect [15, 20]. Therefore, the main objective of most previous studies is to examine whether strengthening protection of intellectual property
rights has positive or negative impacts on trade. For example, Maskus and Penubarti [15] found that there is a positive correlation
between Organisation for Economic Co-operation and Development (OECD) countries’ exports and the strength of patent
protection in destination countries and this relationship is especially significant in developing countries.
Similarly, Smith [20], who examined the effect of strengthening patent protection in foreign countries on US exports, indicated that US
exports increase when a destination country with high threat of imitation strengthens patent protection
while they increase in countries where the threat of imitation is weak. In addition, Awokuse and Yin [2] examined the efect of patent protection
in China on imports from 36 countries and confirmed its positive efect, which accords with the prior results from the perspective of developed
countries. Ivus [13] found that imports of high-technology products from developed countries to 18 developing countries significantly increased
developing countries with room for improvement of
after reform of the patent system. These previous findings suggest that
their patent systems cause the market expansion effect by strengthened patent protection. As described
earlier in this section, most studies on this topic are characterized by a focus on bilateral trade, particularly between developed and developing
countries, motivated by the question of how TRIPS implementation affects international trade. However, it is a fact that patent-sensitive
products are traded intensively among OECD member countries that have similar systems. Table 1 shows the
distribution of trade volumes in 2010 for both patent-sensitive products and patent-insensitive products.1 Obviously, the trade volume for
patent-sensitive products is concentrated in trade among OECD members compared to patent-insensitive products, accounting for 67% of the
total trade volume in patent-sensitive products. One possible explanation for why such trade is so much more concentrated in
OECD is institutional harmonization of patent protection. It is likely that exports of patent-sensitive
products enjoy the market expansion effect in destination countries with similar patent systems that
reduce transaction costs related to security of intellectual property rights and contract enforcement. Although
market expansion effects are expected in the case in which patent law is closely harmonized between trading
partners, by contrast, bilateral trade is likely to decrease as the institutional distance of patent protection
increases. For example, when patent protection in a destination country is substantially stronger than in an
origin country, exports from the origin to the destination might slow down owing to the dominance of monopolistic
power of frms in the destination country. In the opposite case, exports from countries with a high level of protection to
countries with weaker protection would decrease due to the threat of piracy, copying, and imitatio n. If
these predictions hold, the distance in terms of the patent system between exporters and importers matters
for bilateral trade flows rather than patent protection for importers. This intuition raises an empirical question as to whether
harmonization of patent law spurs bilateral trade. To answer the question, this study intends to reveal how the difference in the level of patent
protection infuences trade among countries, applying a structural gravity equation.

And increases global trade flows


Rassenfosse et al. 22 — Gaétan de Rassenfosse is a Belgian economist, whose research is
specialized in the field of economics of innovation. He is a professor at EPFL, where he heads the
Science, Technology and Innovation Policy Laboratory at the College of Management of Technology.
Marco Grazzi is full professor of Economic Policy at Università Cattolica del Sacro Cuore, Milan. Daniele
Moschella is Associate Professor in Economic Policy at the Institute of Economics, Scuola Superiore
Sant'Anna Gaétan de Rassenfosse, Marco Grazzi, Daniele Moschella, Gabriele Pellegrino, International
patent protection and trade: Transaction-level evidence, European Economic Review, Volume 147, 2022,
104160, ISSN 0014-2921, https://doi.org/10.1016/j.euroecorev.2022.104160. //WMK

This paper reports novel evidence on the extent to which international trade hinges on patents. It analyzes the export and
patenting activities of a panel of French exporting firms from 2002 to 2011. The noticeable feature of our study is that we observe the
worldwide patenting activity at the product level, which enables a fined-grained exploration of the effect of patents on trade. Furthermore, we
also exploit information on rejected patent applications to alleviate concerns about the endogeneity between the patenting and export
decisions. The results of the empirical analysis provide an unprecedented perspective on the patenting and exporting behavior of firms. First,
there is overwhelming evidence suggesting that patenting activity precedes exporting in a given
product–country destination. This finding is not surprising, but it establishes the validity of our empirical setup. Patent law stipulates
that offering a product for sale counts as a ‘public disclosure’ of the invention—and inventions disclosed to the public cannot be patented.
Therefore, inventions relating to products should first be submitted to the patent office before the product is commercialized. Second, we
assess the effect of a patent filing on exports. Controlling for a comprehensive set of fixed effects, we find that patenting
is associated
with an increase in the value of exports of around six percent. This result is primarily driven by greater quantities
exported to the destination market rather than higher prices. We interpret it as evidence that firms value
foreign patent protection for the legal security that it brings rather than for the possibility of setting
monopoly prices. The findings are robust to a series of alternative specifications and a placebo test. Furthermore, acknowledging that the
patenting decision is endogenous to exports, we exploit information on rejected patent applications. We find that exports collapse
when patent applications are rejected by the local patent office, providing further evidence on the causal effect
of patents on trade. Taken together, the results point to the existence of a patent premium on the export
values for transactions associated with a patent. The very limited evidence of a positive premium on unit values, our proxy for
the price, poses some challenges to future empirical and theoretical analyses. Large-scale empirical works matching product varieties, or even
actual products, to patents are needed to confirm the findings of the present work. Currently, since we work at the product class level, we
cannot exclude the possibility that the introduction of patented products with a higher price (e.g., a new mobile phone) is compensated by a
decline in the price of the pre-existing phones in the same product category, with an average effect of zero. Thus, the finding of a lack of price
effect needs to be taken with a pinch of salt. On a more theoretical viewpoint, our results suggest exploring models in which a substantial part
of the value residing in foreign patent protection is in the legal security that it offers, rather than in the possibility of setting monopoly prices as
the literature traditionally assumes.

But, harmonization of international standards is key


Ito and Shirai 23 — Banri Ito is a Professor of Economics at Aoyama Gakuin University and a
Research Associate at the Research Institute of Economy, Trade and Industry (RIETI). Ito, Banri, and
Katsunori Shirai. "Patent law harmonization and international trade." International Journal of Economic
Policy Studies 17.1 (2023): 289-306. //WMK

Harmonizing patent law is a controversial issue in trade liberalization debate. Previous studies have paid attention to how bilateral
trade is related to patent protection in destination countries, but very few researchers have attempted to empirically examine the relationship
between trade and diferences in patent systems. This study builds on the framework of translog gravity equation and empirically examines
the association between institutional distance of patent law systems between exporters and importers, using bilateral trade data for the years
1995, 2000, 2005, and 2010. The results of the translog gravity model reveal that institutional distance in terms of patent law h as
an
inverted U-shaped relationship with bilateral trade. More specifcally, as the diference in the level of patent
protection increases, import share tends to decrease for patent-sensitive products. From the results, it is
concluded that the effect of patent law harmonization on trade differs in accordance with patent sensitivity of products. In
previous literature, it has been highlighted that it is important to promote patent protection in destination country to
increase bilateral trade, in the context of WTO-TRIPS implementations in developing countries. The present study argues that patent
law harmonization between exporters and importers is a crucial factor to increase bilateral trade and to
show that they are strongly correlated with each other only for patent-sensitive products.

Otherwise, trade disputes spillover and cause nuclear war


Oppenheimer 21 [Dr. Michael F. Oppenheimer, Clinical Professor at the Center for Global Affairs at
New York University, Senior Consulting Fellow for Scenario Planning at the International Institute for
Strategic Studies, Former Executive Vice President at The Futures Group, Member of the Council on
Foreign Relations, The Foreign Policy Roundtable at the Carnegie Council on Ethics and International
Affairs, and The American Council on Germany, “The Turbulent Future of International Relations”, in The
Future of Global Affairs: Managing Discontinuity, Disruption and Destruction, Ed. Ankersen and Sidhu, p.
23-30]

Four structural forces will shape the future of International Relations: globalization (but without liberal rules, institutions,
and leadership)1; multipolarity (the end of American hegemony and wider distribution of power among states and non-states2); the
strengthening of distinctive, national and subnational identities, as persistent cultural differences are accentuated by the disruptive effects of
Western style globalization (what Samuel Huntington called the “non-westernization of IR”3); and secular economic stagnation, a product of
longer term global decline in birth rates combined with aging populations.4 These structural forces do not determine everything.
Environmental events, global health challenges, internal political developments, policy mistakes,
technology breakthroughs or failures, will intersect with structure to define our future. But these
four structural
forces will impact the way states behave, in the capacity of great powers to manage their
differences, and to act collectively to settle, rather than exploit, the inevitable shocks of the next decade.

Some of these structural forces could be managed to promote prosperity and avoid war. Multipolarity (inherently more
prone to conflict than other configurations of power, given coordination problems)5 plus globalization can work in a world of
prosperity, convergent values, and effective conflict management. The Congress of Vienna system achieved relative
peace in Europe over a hundred-year period through informal cooperation among multiple states sharing a fear of populist revolution. It ended
decisively in 1914. Contemporary neoliberal institutionalists, such as John Ikenberry, accept multipolarity as our likely future, but are confident
that globalization with liberal characteristics can be sustained without American hegemony, arguing that liberal values and practices have been
fully accepted by states, global institutions, and private actors as imperative for growth and political legitimacy.6 Divergent values plus
multipolarity can work, though at significantly lower levels of economic growth-in an autarchic world of isolated units, a
world
envisioned by the advocates of decoupling, including the current American president. 7 Divergent values plus globalization can
be managed by hegemonic power, exemplified by the decade of the 1990s, when the Washington Consensus, imposed by American leverage
exerted through the IMF and other U.S. dominated institutions, overrode national differences, but with real costs to those states undergoing
“structural adjustment programs,”8 and ultimately at the cost of global growth, as states—especially in Asia—increased their savings to self
insure against future financial crises.9

But all four forces operating simultaneously will


produce a future of increasing internal polarization and cross
border conflict, diminished economic growth and poverty alleviation, weakened global institutions and norms of
behavior, and reduced collective capacity to confront emerging challenges of global warming,
accelerating technology change, nuclear weapons innovation and proliferation. As in any effective scenario, this
future is clearly visible to any keen observer. We have only to abolish wishful thinking and believe our own eyes.10
Secular Stagnation

This unbrave new world has been emerging for some time, as US power has declined relative to other states, especially China, global liberalism has failed to deliver on its promises, and totalitarian capitalism has proven effective in leveraging globalization for economic growth and political
legitimacy while exploiting technology and the state’s coercive powers to maintain internal political control. But this new era was jumpstarted by the world financial crisis of 2007, which revealed the bankruptcy of unregulated market capitalism, weakened faith in US leadership,
exacerbated economic deprivation and inequality around the world, ignited growing populism, and undermined international liberal institutions. The skewed distribution of wealth experienced in most developed countries, politically tolerated in periods of growth, became intolerable as
growth rates declined. A combination of aging populations, accelerating technology, and global populism/nationalism promises to make this growth decline very difficult to reverse. What Larry Summers and other international political economists have come to call “secular stagnation”
increases the likelihood that illiberal globalization, multipolarity, and rising nationalism will define our future. Summers11 has argued that the world is entering a long period of diminishing economic growth. He suggests that secular stagnation “may be the defining macroeconomic
challenge of our times.” Julius Probst, in his recent assessment of Summers’ ideas, explains:

…rich countries are ageing as birth rates decline and people live longer. This has pushed down real interest rates because investors think these trends will mean they will make lower returns from investing in future, making them more willing to accept a lower return
on government debt as a result.

Other factors that make investors similarly pessimistic include rising global inequality and the slowdown in productivity growth…

This decline in real interest rates matters because economists believe that to overcome an economic downturn, a central bank must drive down the real interest rate to a certain level to encourage more spending and investment… Because real interest rates are so
low, Summers and his supporters believe that the rate required to reach full employment is so far into negative territory that it is effectively impossible.

…in the long run, more immigration might be a vital part of curing secular stagnation. Summers also heavily prescribes increased government spending, arguing that it might actually be more prudent than cutting back – especially if the money is spent on
infrastructure, education and research and development.

Of course, governments in Europe and the US are instead trying to shut their doors to migrants. And austerity policies have taken their toll on infrastructure and public research. This looks set to ensure that the next recession will be particularly nasty when it
comes… Unless governments change course radically, we could be in for a sobering period ahead.12

The rise of nationalism/populism is both cause and effect of this economic outlook. Lower growth will make every aspect of the liberal order more difficult to resuscitate post-Trump. Domestic politics will become more polarized and dysfunctional, as competition for diminishing resources
intensifies. International collaboration, ad hoc or through institutions, will become politically toxic. Protectionism, in its multiple forms, will make economic recovery from “secular stagnation” a heavy lift, and the liberal hegemonic leadership and strong institutions that limited the
damage of previous downturns, will be unavailable. A clear demonstration of this negative feedback loop is the economic damage being inflicted on the world by Trump’s trade war with China, which— despite the so-called phase one agreement—has predictably escalated from
negotiating tactic to imbedded reality, with no end in sight. In a world already suffering from inadequate investment, the uncertainties generated by this confrontation will further curb the investments essential for future growth. Another demonstration of the intersection of structural
forces is how populist-motivated controls on immigration (always a weakness in the hyper-globalization narrative) deprives developed countries of Summers’ recommended policy response to secular stagnation, which in a more open world would be a win-win for rich and poor countries
alike, increasing wage rates and remittance revenues for the developing countries, replenishing the labor supply for rich countries experiencing low birth rates.

Illiberal Globalization

Economic weakness and rising nationalism (along with multipolarity) will not end globalization, but will profoundly alter its character and greatly reduce its economic and political benefits. Liberal global institutions, under American hegemony, have served multiple purposes, enabling
states to improve the quality of international relations and more fully satisfy the needs of their citizens, and provide companies with the legal and institutional stability necessary to manage the inherent risks of global investment. But under present and future conditions these institutions
will become the battlegrounds—and the victims—of geopolitical competition. The Trump Administration’s frontal attack on multilateralism is but the final nail in the coffin of the Bretton Woods system in trade and finance, which has been in slow but accelerating decline since the end of
the Cold War. Future American leadership may embrace renewed collaboration in global trade and finance, macroeconomic management, environmental sustainability and the like, but repairing the damage requires the heroic assumption that America’s own identity has not been
fundamentally altered by the Trump era (four years or eight matters here), and by the internal and global forces that enabled his rise. The fact will remain that a sizeable portion of the American electorate, and a monolithically pro- Trump Republican Party, is committed to an illiberal
future. And even if the effects are transitory, the causes of weakening global collaboration are structural, not subject to the efforts of some hypothetical future US liberal leadership. It is clear that the US has lost respect among its rivals, and trust among its allies. While its economic and
military capacity is still greatly superior to all others, its political dysfunction has diminished its ability to convert this wealth into effective power.13 It will furthermore operate in a future system of diffusing material power, diverging economic and political governance approaches, and
rising nationalism. Trump has promoted these forces, but did not invent them, and future US Administrations will struggle to cope with them.

What will illiberal globalization look like? Consider recent events. The instruments of globalization have been weaponized by strong states in
pursuit of their geopolitical objectives. This has turned the liberal argument on behalf of globalization on its head. Instead of interdependence
as an unstoppable force pushing states toward collaboration and convergence around market-friendly domestic policies, states are exploiting
interdependence to inflict harm on their adversaries, and even on their allies. The
increasing interaction across national
boundaries that globalization entails, now produces not harmonization and cooperation, but friction
and escalating trade and investment disputes.14 The Trump Administration is in the lead here, but it is not alone. Trade and investment friction with
China is the most obvious and damaging example, precipitated by China’s long failure to conform to the World Trade Organization (WTO) principles, now escalated by President Trump into a
trade and currency war disturbingly reminiscent of the 1930s that Bretton Woods was designed to prevent. Financial sanctions against Iran, in violation of US obligations in the Joint
Comprehensive Plan Of Action (JCPOA), is another example of the rule of law succumbing to geopolitical competition. Though more mercantilist in intent than geopolitical, US tariffs on steel
and aluminum, and their threatened use in automotives, aimed at the EU, Canada, and Japan,15 are equally destructive of the liberal system and of future economic growth, imposed as they
are by the author of that system, and will spread to others. And indeed, Japan has used export controls in its escalating conflict with South Korea16 (as did China in imposing controls on rare
earth,17 and as the US has done as part of its trade war with China). Inward foreign direct investment restrictions are spreading. The vitality of the WTO is being sapped by its inability to
complete the Doha Round, by the proliferation of bilateral and regional agreements, and now by the Trump Administration’s hold on appointments to WTO judicial panels. It should not
surprise anyone if, during a second term, Trump formally withdrew the US from the WTO. At a minimum it will become a “dead letter regime.”18

As such measures gain traction, it will become clear to states—and to companies—that a global trading
system more responsive to raw power than to law entails escalating risk and diminishing benefits. This
will be the end of economic globalization, and its many benefits, as we know it. It represents nothing less than the
subordination of economic globalization, a system which many thought obeyed its own logic, to an international
politics of zero-sum power competition among multiple actors with divergent interests and values. The
costs will be significant: Bloomberg Economics estimates that the cost in lost US GDP in 2019- dollar terms from the trade war with China has
reached $134 billion to date and will rise to a total of $316 billion by the end of 2020.19 Economically, the just-in-time, maximally efficient
world of global supply chains, driving down costs, incentivizing innovation, spreading investment, integrating new countries and populations
into the global system, is being Balkanized. Bilateral and regional deals are proliferating, while global, nondiscriminatory trade agreements are
at an end.

Economies of scale will shrink, incentivizing less investment, increasing costs and prices, compromising growth, marginalizing countries whose
growth and poverty reduction depended on participation in global supply chains. A
world already suffering from excess savings
(in the corporate sector, among mostly Asian countries) will respond to heightened risk and uncertainty with further
retrenchment. The problem is perfectly captured by Tim Boyle, CEO of Columbia Sportswear, whose supply chain runs through China,
reacting to yet another ratcheting up of US tariffs on Chinese imports, most recently on consumer goods:

We move stuff around to take advantage of inexpensive labor. That’s why we’re in Bangladesh. That’s why we’re looking at Africa.
We’re putting investment capital to work, to get a return for our shareholders. So, when we make a wager on investment, this is not
Vegas. We have to have a reasonable expectation we can get a return. That’s predicated on the rule of law: where can we expect the
laws to be enforced, and for the foreseeable future, the rules will be in place? That’s what America used to be.20

The international political effects will be equally damaging. The four structural forces act on each other
to produce the more dangerous, less prosperous world projected here. Illiberal globalization represents
geopolitical conflict by (at first) physically non-kinetic means. It arises from intensifying competition
among powerful states with divergent interests and identities, but in its effects drives down growth and fuels
increased nationalism/populism, which further contributes to conflict. Twenty-first-century protectionism
represents bottom-up forces arising from economic disruption. But it is also a top-down phenomenon, representing a strategic effort by
political leadership to reduce the constraints of interdependence on freedom of geopolitical action, in effect a precursor and enabler of war.
This is the disturbing hypothesis of Daniel Drezner, argued in an important May 2019 piece in Reason, titled “Will Today’s Global Trade
Wars Lead to World War Three,”21 which examines the pre- World War I period of heightened trade conflict, its contribution to
the disaster that followed, and its parallels to the present:

Before the First World War started, powers great and small took a variety of steps to thwart the
globalization of the 19th century. Each of these steps made it easier for the key combatants to conceive of a general war. We
are beginning to see a similar approach to the globalization of the 21st century. One by one, the
economic constraints on military aggression are eroding. And too many have forgotten—or never knew—how
this played out a century ago.

…In many ways, 19th century globalization was a victim of its own success. Reduced tariffs and transport costs flooded Europe with
inexpensive grains from Russia and the United States. The incomes of landowners in these countries suffered a serious hit, and the
Long Depression that ran from 1873 until 1896 generated pressure on European governments to protect against cheap imports.

…The primary lesson to draw from the years before 1914 is not that economic interdependence was a weak constraint on military
conflict. It is that, even in a globalized economy, governments can take protectionist actions to reduce their interdependence in
anticipation of future wars. In retrospect, the 30 years of tariff hikes, trade
wars, and currency conflicts that preceded 1914
were harbingers of the devastation to come. European governments did not necessarily want to ignite a war among the
great powers. By reducing their interdependence, however, they made that option conceivable.
…the backlash to globalization that preceded the Great War seems to be reprised in the current moment. Indeed, there are ways in
which the current moment is scarier than the pre-1914 era. Back then, the world’s hegemon, the United
Kingdom, acted as a brake on economic closure. In 2019, the United States is the protectionist with its foot on the accelerator. The
constraints of Sino-American interdependence—what economist Larry Summers once called “the financial balance of terror”—no
are far too many hot spots—the Korean peninsula, the South China Sea,
longer look so binding. And there
Taiwan—where the kindling seems awfully dry.
1AC---Plan+Solvency
Thus the plan: The United States federal government should significantly strengthen
its protection of domestic intellectual property rights in patents by eliminating judicial
exemptions to patent subject-matter eligibility.

Now, Solvency---

The plan eliminates judicial exemptions rewarding innovation and rejecting faulty
patents, while harmonizing U.S. policy with international law. Congress solves best.
Rafetto 23 — Judicial Law Clerk for Chief Judge Colm F. Connolly of the United States District Court for
the District of Delaware. J.D., May 2022, New York University School of Law. Chad Rafetto, "Fostering
Innovation through a Legislative Overhaul of Patentable Subject Matter," Federal Circuit Bar Journal 32,
no. 2 (July 2023): 93-130 //WMK

Patentable subject matter should be its own doctrine-one that the Federal Circuit and Supreme Court
apply consistently-as opposed to a Frankenstein-esque amalgamation of subject matter, novelty, and
nonobviousness. Additionally, subject matter doctrine should further the patent system's goals and encourage innovation as opposed to
hindering the sharing of information and leading to reduced investment in U.S. innovation. Finally , it should be a doctrine that
abides by the bedrock principle of courts deciding questions of law and juries deciding questions of fact.
This Article proposes a patentable subject matter statute that eliminates the judicially created carve-outs,
consists solely of inclusion categories-e.g., process, machine, manufacture, or composition of matter-and
enumerates many more inclusion categories to accommodate advancing technologies. The goal of this
proposal is to prevent a blending of doctrines and to ensure that subject matter, a question of law decided by the
court, has minimal factual inquiries creep into it. By eliminating the judicially created carve-outs, more of
the exclusionary work will be shifted to the other requirements of patentability. And contrary to what the Supreme
Court has said, the other doctrines of patentability are capable of preventing undesirable patents.`" A. Why a
Legislative Change? In Mayo, the Supreme Court relied heavily on precedent in formulating its new test and
recognized "the role of Congress in crafting more finely tailored rules where necessary."22 What has emerged under the patentable
subject matter doctrine is an unworkable standard, which is typically viewed as a signal for legislative intervention.2 " Additionally,
the Supreme Court has refused to further clarify the doctrine by denying certiorari for at least thirteen
patent eligibility cases2 4 in the last four years.2 5 Beyond the possible signal for legislative intervention from the
Supreme Court, there are three reasons why a legislative change is preferred. First, the Supreme Court does
not have technical expertise, and the underlying inventions of patent law can be quite complex . True,
Congress does not inherently possess technical expertise either, but it does have the ability to delegate and get input from a
wider range of sources. Accordingly, Congress is better equipped to handle the technical aspects of patent law and
the underlying technologies. Second, the Supreme Court and the Federal Circuit have disagreed
repeatedly in developing patent law doctrine. Historically, the Federal Circuit has tried to impose bright-line
rules, and the Supreme Court has thought that the Federal Circuit was being too "rigid" and adopted more
flexible standards. 6 When attempting to apply these flexible standards, the Federal Circuit has lacked the
guidance necessary to effectuate the Supreme Court's intended test."' This pattern has happened in other areas of
patent law,"" and it is bound to continue to happen for subject matter if the doctrine continues down
the judicial correction route. Finally, patentable subject matter is a messy doctrine with conflicting case
law.2 " It would be nearly impossible for a judicial change to effectuate a clear doctrine without
essentially starting from scratch. A legislative change-particularly one with clear-cut rules-can more
effectively give patentable subject matter the "do-over" it requires. B. The Proposal Within patent law's
current § 101, the four inclusion categories are "process, machine, manufacture, or composition of
matter."220 But parties litigate only whether an invention is directed to a judicial carve-out category, and
presumably every invention that is currently patented falls within one of the inclusion categories. If an invention
was not a process, machine, manufacture, or composition of matter, then it could not receive a patent
under § 101.`2 So even if it was not addressed in the prosecution or litigation of a patent, every issued, valid patent must fall
into one of those categories. Those inclusion categories-or perhaps fragmenting each of those categories into several narrower
categories-can provide some guiding precedent and examples for courts to follow at the outset. Essentially, all of the current kinds of
patented technologies will be grandfathered in for patent eligibility purposes . To determine what other
categories will be present, the types of inventions with patent filings can be analyzed by using the
USPTO's Patent Classification system. For example, there will be categories to reflect pharmaceuticals,
diagnostics, medical devices, tech, and software. Recently, certain senators have asked the USPTO to prepare a report on the
effect of current § 101 jurisprudence on investment and innovation for quantum computing, artificial intelligence, precision medicine,
diagnostic methods, and pharmaceutical treatments.2 2 2 Because this call for information is likely a signal that Congress wants to foster
development in these areas, each of those areas can also be used as inclusion categories. To
ensure that the current carve-outs
do not regain relevance, the statute should also affirmatively negate the inclusion of these carve-outs.
For example, the statute could state that the sole criterion for patentable subject matter is whether the
invention fits into one of these categories. It could even go further and specifically state that any relation of
the invention to a law of nature, physical phenomenon, or abstract idea is not to play a role in the
patentable subject matter analysis. If the sole criterion is whether the patented invention falls into one of the categories, the
statute will need to be flexible or else it may quickly become antiquated. One way to accommodate this flexibility
would be to have the statute merely list "examples" of fields where patenting is legislatively approved, and these examples can help
guide courts when they contemplate new endeavors. Another route could be to include a discretionary catch-all category
along the lines of "or other useful arts that satisfy the other elements of patentability ." Since
innovation is dynamic and unpredictable, the catch-all category may be necessary so as to not exclude an
invention because it is so innovative that it was not contemplated at the time of the legislative change.
As a practical matter, the emphasis on this proposal is to shift the work away from patentable subject matter
and to the other elements of patentability. The precise contours of what is and is not an inclusion category is not
paramount. What is paramount is conveying that patentable subject matter is to return to its former
status as a low bar, a seldom-used coarse filter, and a threshold issue that is not meant to exclude any
technological field even if it may exclude individual inventions. If most of the screening function is going to be shifted
from subject matter to the other elements of patentability, this raises the question of why even keep patentable subject matter doctrine at all?
One advantage is comity with international IP laws. For example, Article 27 of the TRIPS Agreement deals with
patentable subject matter and states, "[P]atents shall be available for any inventions, whether products or
processes, in all fields of technology, provided that they are new, involve an inventive step and are
capable of industrial application.",2 2 Notably, "inventive step" and "capable of industrial application" are
equated with nonobviousness and usefulness, respectively.2 2 1 So this proposal would actually put U.S.
patent law in greater conformity with the TRIPS Agreement by making subject matter available more
broadly to any invention which is new, nonobvious, and useful. More importantly for this Article, the inclusion
categories can be used to target fields, such as diagnostics, that have recently had patents rejected or invalidated at a high rate.
Enumerating these inclusion categories will create a presumption-and a boost of confidence for
inventors and investorsthat patent protection is available in these fields. Essentially, the inclusion
categories will serve as a signal that inventions will no longer be rejected or invalidated on subject matter
grounds solely because they are too similar to a law of nature, physical phenomenon, or abstract idea .
But, of course, inventions will still have to satisfy the other patentability criteria. Additionally, the list will act as guidance and help
courts see that material that is susceptible to being considered a law of nature, for example, is
nonetheless considered by Congress to be patentable subject matter.

Congressional elimination overcomes investor uncertainty and bolsters innovation


Falati 19 — Shahrokh (Seve) Falati is a Professor of Law from Practice, and Co-Director of the
Innovation Center for Law and Technology (New York Law School). He teaches Intellectual Property (IP)
law, Trademarks and Unfair Competition, and is Director of the Patent Law Clinic. Falati, Shahrokh. "To
Promote Innovation, Congress Should Abolish the Supreme Court Created Exceptions to 35 US Code Sec.
101." Tex. Intell. Prop. LJ 28 (2019): 1. //WMK

Yet, from
a pure practical standpoint, especially one that patent examiners can easily apply when examining patent applications in the trenches
with little time and many Office Actions to write, the "practical
application," test is a very reasonable approach, yet may be difficult to
universally implement. Indeed, to have some 10,000 patent examiners and over 200 Administrative Patent
Judges at the USPTO trained to then effectively examine based on what would remain a convoluted legal
framework when the vast majority of examiners are not even attorneys, and to do this examination consistently in a
technology-neutral way, may be too ambitious. Other proposals, including one from David Kappos, the Director of the US Patent & Trademark Office (USPTO) from
2009 to 2013, have invited Congress to repeal the entire 35 U.S.C. §101 statute from the Patent Act on the basis that it is unworkable and is outdated since it has
virtually remained unchained since the 18th century. And although the Intellectual Property Owners Association's position may have evolved, they adopted a
resolution recently to support legislation to amend the statute by adding two subsections. In their statement, they indicated that the "proposed legislative

language would address patent-eligibility concerns by reversing the Supreme Court decisions and
restoring the scope of subject matter eligibility to that intended by Congress ... ; defining the scope of
subject matter eligibility more clearly and in a technology-neutral manner; ... ; and simplifying the ...
eligibility analysis."233 I respectfully proffer yet another option, and one I rank highly on available options, and that is to encourage the lawmakers to look
at Europe or even Japan, both equally industrialized nations with developed legal frameworks, and analyze their patent laws as a model framework on this patent
eligibility issue. For example, Paragraph 2 of Article 52 of the European Patent Convention states: 234 (1) European patents shall be granted for any inventions, in all
fields of technology, provided that they are new, involve an inventive step and are susceptible of industrial application. (2) The following in particular shall not be
regarded as inventions within the meaning of paragraph 1: (a) discoveries, scientific theories and mathematical methods; (b) aesthetic creations; (c) schemes, rules
and methods for performing mental acts, playing games or doing business, and programs for computers; (d) presentations of information. (3) Paragraph 2 shall
exclude the patentability of the subjectmatter or activities referred to therein only to the extent to which a European patent application or European patent relates
to such subject-matter or activities as such. Under this framework, the European Patent Office determines the patentability based on a pair of hurdles: an eligibility
hurdle (Article 52 EPC), which requires the claimed subject matter to have a technical character; and a patentability hurdle (Articles 54, 56 EPC), which requires the
claimed subject matter to contribute a technical solution to a technical problem. Thus, any legislative fixes to current U.S. patent eligibility laws, could model itself
to be a "threshold," like Article 52 of the European Patent Convention, and thereby list subject matter that doesn't possess technical character, such as
mathematical methods, methods for performing mental acts or doing business, and presentations of information. This may be an easier approach to implement in
practice, especially at the U.S. Patent and Trademark Office with its approximately 10,000 patent examiners. Indeed, it appears that as of Fall 2019, a bipartisan
framework for 35 U.S.C. § 101 reform is under consideration by a number of Senators and House Representatives, and one of their goals is indeed to name a short
exclusive list of categories, much like in Europe. Under consideration are to list and thereby explicitly exclude mental activities, pure mathematical formulas,
products that exist solely and exclusively in nature, fundamental scientific principles and economic principles. It remains up for discussion what the final bills will say
and how lawmakers will attempt to remedy the current status of affairs. One thing remains obvious, 35
U.S.C. §101 cannot remain as is
because America's leadership position on innovation and entrepreneurial new technology development
and commercialization is at stake. Congress's light fix would be to effectively set aside the Mayo decision; a proper fix would be to
effectively set aside the three back-to-back Supreme Court decisions on patent eligibility, namely Mayo
(2012), Myriad (2013) and Alice (2014), and thereby abolish, in toto, the Supreme Court created exceptions to the statutory

language and intent governing patent eligible subject matter found in 35 U.S.C. §101.235 VII. Conclusion The Patent Act, as noted above, defines four
independent categories of subject matter that are eligible for patent protection: 1) processes; 2) machines; 3) manufactures; and 4) compositions of matter.236
While it is clear from the Statute that Congress intended to give a wide scope to patent eligible subject
matter, from these four broad categories that are listed in the statute, the Supreme Court has judicially created three exceptions of subject matter that the
Court considers are ineligible for patent protection: 1) laws of nature; 2) products of nature; and 3) abstract ideas. Thus, under current law, a claimed invention is
only patent-eligible under 35 U.S.C. §101 if it is a process, machine, manufacture, or composition of matter, and also if it falls outside the three Supreme Court
promulgated judicial exceptions. For all the reasons outlined supra, this paper advances the proposition that American
society stands to benefit
from abolishing the non-statutory, Supreme Court promulgated, exceptions to U.S. Code Section 101
altogether. These Supreme Court created exceptions to the statutory language have no foundation and
have caused great uncertainty in patent laws. This has negatively affected certain technology-focused industries
and otherwise damaged America's standing as a leader in new technology development and
commercialization. As outlined supra, the time is ripe for Congress to act to correct the patent eligibility legal
landscape and thereby promote innovation; to do so, they have good options at hand.

Congressional legislation repealing judicial exemptions is key


Robert 22 — Manderson School of Business, University of Alabama, M.B.A. 2017. Rollins School of
Public Health, Emory University, M.P.H. 2018. St. Mary's University School of Law, J.D. 2022. Maggi
Robert, "From Patients to Patents: The Disappearing I of Innovation," St. Mary's Law Journal 53, no. 4
(2022): 1203-1244 //WMK

Patents, innovation, and the legislature are a crossroads. Congress heard the call from inventors, investors, academics, and
judges to take action against the uncertainty of patent-eligible subject matter. 2 7 7 They have proposed a two-step test to address the

concerns: (1) whether the Mayo/Alice framework should be repealed; and (2) if/how should Section 101
reformed? As with all things, there are pros and cons to each. A. The First Step: To Repeal or Not Repeal As discussed, this test for patentable
subject-matter has received criticisms from numerous sources. However, the principal complaints are the same: (1) vague and
subjective; (2) over-reaching; (3) diminishing innovation; and (4) uncertainty and chaos.2 78 First, the framework
has been repeatedly admonished for its lack of clarity. 2 7 9 The Court failed to define key terms, such as "abstract idea," or what

constitutes enough to transform a claim, i.e., "an inventive concept." 28 0 While a framework existed, there was no objective
criteria. Instead, judges were left to analyze the language and specificity of the claims. All of this meant that the

eligibility of your patent was largely determined by the panel of judges assigned. 2 8 ' In response, defenders of the
framework interpret the vagueness and subjectivity as flexibility and adaptability to new technologies. 28 2 Second, the framework reaches far

beyond the statutory language for subject matter eligibility. 2 8 3 In fact, the test is focused on the three
judicially created exceptions, "law of nature, natural phenomenon, or abstract idea ," and the "inventive
concept," none of which exist in the statute.28 4 Further, the framework blends the analyses of subject matter eligibility, novelty, and
non-obviousness through the "inventive concept" requirement. 28 5 Here, defenders rely on stare decisis. 28 6 While the language may not be included in the
statute, it has been treated as such for years. Additionally, commentators argue that the "inventive concept" analysis goes beyond the novel and non-obvious
requirements to consider future impact and moral dilemma. 28 7 Third, the
framework has diminished innovation.28 This impact
was particularly felt in the healthcare sector. Given the claims in the cases described above, it is clear that the biotechnology,
medical device, and pharmaceutical industries have been severely affected. 28 9 Without promise of
protection, inventors in these industries are looking elsewhere. 2 90 Defenders assert that the framework prevents the issuance of
overbroad claims, which slow innovation.291 Fourth, the framework has caused uncertainty and chaos. 2 92 The uncertainty

led to a weakened patent system, which in turn led to the loss of the competitive edge the United
States had as a global innovation leader.29 3 Defenders relish the thought of increasing national competition, lowering costs, and increasing
access to innovations as the weakened patent system fails to protect innovation.2 94 B. The Second Step: Section 101 Reform? This option may be surprising given
that the
statutory language of Section 101 has remained virtually unchanged since before the enactment
of the Patent Act of 1952. In evaluating whether and how to reform Section 101, it is important to consider the reason a call for
reformation was made in the first place-not the statutory language, but instead the judicial framework.
Parallel to the four principal criticisms of the framework, there are four potential statutory reformations. First, stay out of it. Congress can leave Section 101
unchanged and allow the courts to continue to define patent-eligible subject matter.2 95 This option will please those who support the Mayo/Alice framework,
those who feel the court is on the path to clarity, and those who fundamentally believe that the language of Section 101 fits the framework's purpose.29 6 Second,
make a list. Congress can choose to replace the Myo/Aice framework with an amended Section 101 that contains a list of subject matter that is or is not patent-
eligible. 2 9 7 This option would provide concrete, objective criteria for eligibility. In doing so, however, it would completely take away any flexibility. 2 9 8 Third, a
new framework. Congress can repeal the Mayo/Alice framework in favor of a new, legislative standard. 29 9 This option would leave the statutory language as is and
provide a new test for subject matter eligibility. However, the determination and eventual impact of the new standard leave room for uncertainty. Finally, goodbye
Mayo/Alice. Congress
can simply repeal the Mayo/Alice framework, leaving the statutory language as the
guide for patent-eligible subject matter. 30 0 C. Through the Patient's Eyes Every individual approaches a decision with a unique perspective
influenced by upbringing, ethnicity, socioeconomic status, etc. But one perspective that everyone can relate to is that of being a patient. At some point in our lives,
we have all felt, seen, or experienced the impact of medical innovation. With that in mind, the first step of the Congress-proposed
twostep solution is easy-repeal the Mayo/Aice framework. This test created hysteria in the healthcare
sector, diminished innovation, pushed research and development out of the United States, and cost the
country its innovation crown. The fact is, innovation spurs economic growth, and the healthcare industry is
one of the country's most innovative. These innovations, protected by patents, pushed the United States to be a first choice amongst patients
as they seek access to the newest tests and treatments.3 1 The United States has a reputation for providing quality, innovative healthcare to every patient. The

second step of the solution, while not as clear given the possibilities, is still discernable-leave the statute alone. The United
States rose to innovative healthcare prominence on the coattails of a strong patent system created by
the language in Section 101. The history of patent-eligible subject matter under the statute was clear,
understandable, and easily applicable. In the years before Mayo/Ace, the statute allowed for various medical patents ranging from diagnostic
tests to gene therapy. There was no reason to fix what was not broken. A return to the strong patent system

that built our healthcare sector is in the interest of all patients and people. Despite the slight increase in cost and slight
decrease in access, patents create quality healthcare and push innovation. When healthcare innovation booms, patients win-which means we all win.

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