1

0
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1
1
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2
3
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Patentability
/
1
1
/
2
3
Ø What is the standard for getting a patent?
New
Useful
Non-obvious
Ø What do you get if you meet the standard?
Right to exclude others from the using the invention for a limited
time
Ø What do you give up by getting a patent?
You have to teach others how to make and use the invention
Ø What do you risk by not patenting your invention (trying to keep it
a trade secret)?
Someone else can patent it and exclude you from using it.
S U N N
least one new reactant
animals and biological
processes, but excluding
micro-organisms
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1
1 BILSKI V. KAPPOS (2010)
/
2
3
1
0
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1
1
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BILSKI V. KAPPOS (CONTD.)
2
3 Ø Petitioners, Bernard Bilski and Rand Warsaw applied for a patent
for a method for hedging risks for commodities trading
Ø The method included a simple mathematical concept and familiar
statistical approaches
Ø Their application sought patent protection for a claimed invention
that explained how buyers and sellers of commodities in the
energy market can protect or hedge, against the risk of price
changes
Ø The key claims were claims 1 and 4:
§ Claim 1 described a series of steps instructing how to hedge risk
§ Claim 4 put the concept articulated in claim 1 into a simple
mathematical formula
1
0
/
1
1
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BILSKI V. KAPPOS (CONTD.)
2
3 Ø Claim 1 consists of the following steps:
(a) initiating a series of transactions between the said commodity provider
and consumers of the said commodity wherein the said consumers purchase
the said commodity at a fixed rate based upon historical averages, the said
fixed rate corresponding to a risk position of the said consumers;
(b) identifying market participants for the said commodity having a counter-
risk position to the said consumers; and
(c) initiating a series of transactions between the said commodity provider
and the said market participants at a second fixed rate such that the said
series of market participant transactions balances the risk position of the said
series of consumer transactions.
Ø The remaining claims explain how claims 1 and 4 can be applied to allow
energy suppliers and consumers to minimize the risks resulting from
fluctuations in market demand for energy
1
0
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1
1
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BILSKI V. KAPPOS (CONTD.)
2
3 Ø The Patent Examiner rejected the application, claiming it
involved an abstract idea which was not implemented on a
specific apparatus
Ø The Petitioners appealed and the Federal Circuit affirmed.
Ø The Federal Circuit adopted the machine-or-transformation test
to judge patentability under § 101, according to which a patent
applicant may show that-
(1) the claimed process was tied to a particular machine; or
(2) the process transformed an article into something else
1
0
/
1
1
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BILSKI V. KAPPOS (CONTD.)
2
3
Ø One of the judges argued it failed because it was a method of
conducting business
Ø A second judge argued that the invention was an abstract idea,
and therefore, unpatentable
Ø A third judge remanded to determine patentability under other
provisions

Ø The Petitioners appealed to the Supreme Court

1
0
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1
1
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BILSKI V. KAPPOS (CONTD.)
2
3 Ø The Supreme Court affirmed the Federal Circuit’s decision but
overturned the “machine−or−transformation test”
Ø The Patent Act § 101 defines patent eligibility with exceptions
for “laws of nature, physical phenomena, and abstract ideas.”
Ø Despite upholding the patentability of business methods, the
majority nonetheless rejected the Petitioners' application for
“falling outside of § 101 because it claimed an abstract idea.”
Ø A majority opinion authored by Justice Kennedy agreed that
the Federal Circuit’s “machine-or-transformation” test at the
least is a useful and important clue, an investigative tool” for
patentability, but not the sole or exclusive test.
1
0

BILSKI V. KAPPOS (CONTD.)

/
1
1
/
2 Ø Neither the text of the Patent Act nor Supreme Court precedent
3
supported the “machine−or−transformation” test as the sole test for
deciding which processes are patent−eligible
Ø The five-judge majority opinion also rejected a rule that all business
methods are unpatentable
Ø The Judges did, however, leave a certain question unanswered- By
watering down the Circuit Court’s “machine-or-transformation” test,
the Supreme Court failed to provide guidance about business method
patents for the future
Ø For example, suppose a patent claim is not clearly unpatentable as
just an abstract idea, but it does fail the now-optional “machine-or-
transformation” test. When will such a claim be patentable?
Ø The Court did not answer the said question, nor did it provide details
about how to apply the test in such a case.
1
0
/
1
1
/
BILSKI V. KAPPOS (CONTD.)
2
3 Ø If business methods could be patented, then many business
decisions, regardless of how small they are, could be potential
patent violations
Ø Businesses would either live in constant fear of litigation or
would need to undertake the costs of searching through patents
that describe methods of doing business, attempting to decide
whether their innovation is one that remains in the public
domain
Ø This would greatly inhibit business innovation and competition
Ø For these and other reasons, the Court should have clearly
stated that the claims at issue were not patentable because
business methods are not patentable.
1
0
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1
ALICE CORPORATION V. CLS
BANK (2014)
1
/
2
3
1
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1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
Ø Alice Corporation (Alice) owned 4 patents('479,'510,'720, and '375),
all of which had to do with a computerized trading platform that
dealt with financial transactions in which a third party settled
obligations between two others to eliminate settlement risk
Ø The concept of a third-party to confirm a complete transaction is
called escrow and has been used in finance for thousands of years
Ø The patents in question described how the escrow function could be
performed by a general-purpose computer. However, they did not
describe how such a computer would work and did not include
any source code or specifications
Ø Alice alleged that CLS Bank International and CLS Services
Ltd. (collectively "CLS Bank") began to use similar technology in
2002
1
0
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1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
Ø Alice accused CLS Bank of infringement of its patents, and when
the parties could not resolve the issue, CLS Bank International
(CLS) sued Alice and sought a declaratory judgment of non-
infringement and invalidity of Alice’s patents in 2007
Ø Alice countersued CLS Bank for infringement of the patents
Ø The District Court held all claims to be patent ineligible because
the claims concerned abstract ideas
Ø Alice appealed to the Federal Circuit. Divided judges; separate
opinions
Ø The panel did not agree on a single standard to determine whether
a computer-implemented invention is a patent-ineligible abstract
idea
1
0
/
1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
Ø The SCOTUS had to answer the question- Is implementing an
idea on a computer enough to transform a non-patentable,
abstract idea into patentable subject matter?
Ø The keen interest of the software industry and patent
professionals in the issue was illustrated by the filing of
52 amicus curiae briefs urging the Supreme Court to decide the
issue of software patent eligibility
Ø The Court held that a software implementation of an escrow
arrangement was not patent eligible because it amounts to
implementation of an abstract idea
Ø Escrow is not a patentable invention, and merely using a
computer system to manage escrow debts does not rise to the
level needed for a patent
1
0
/
1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
Ø The Supreme Court, in relying on Mayo v. Prometheus, articulated
a two-step process (Mayo Framework) for assessing patent-eligible
subject matter in the context of computer-related inventions-
1. In the first Mayo step, the court must determine whether the patent
claim under examination contains an abstract idea, such as, an
algorithm, method of computation, or other general principle. If the
answer is in the affirmative, the court must proceed to the next step.
2. In the second step of analysis, the court must determine whether the
patent adds to the idea "something extra" that embodies an
"inventive concept.”
The Court described the second step as a search for an “inventive
concept” to ensure that the patent amounts to “significantly more” than
an abstract idea.
1
0
/
1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
• For the second step, the Supreme Court in Alice explained that
“the mere recitation of a generic computer cannot transform a
patent-ineligible abstract idea into a patent-eligible invention.”
• The Court held that Alice's claims did no more than require a
generic computer to implement this abstract idea of
intermediated settlement by performing generic computer
functions, which is not enough to transform an abstract idea
into a patent-eligible invention.
1
0
/
1
ALICE CORPORATION V. CLS
BANK (CONTD.)
1
/
2
3
“We need not labor to delimit the precise contours of the 'abstract
ideas' category in this case.”
-Justice Clarence Thomas
Ø The Court agreed with those filing amicus curiae briefs and
unanimously invalidated the patent.
Ø Although the Alice opinion did not mention software as such,
the Case was widely considered as a decision on software
patents or patents on software for business methods.
1
0
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1
1
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BACKGROUND TO NOVARTIS
2
3
Ø The Patents (Amendment) Act, 2005, was passed by the Indian
Parliament to comply with its TRIPS obligations, leading to the
introduction of the product patent system in India
Ø The loss in the India – Patent Protection for Pharmaceutical
and Agricultural Chemical Products case was one of the main
reasons for this
Ø The US and EU complained to the WTO Dispute Settlement
Body (DSB) regarding the absence of patent protection for
pharmaceutical and agricultural chemical products, or formal
systems in India that permit the filing of patent applications for
pharmaceutical and agricultural chemical products, and that
there was a need to provide for the grant of exclusive
marketing rights (EMRs) for such products
1
0
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1
BACKGROUND TO NOVARTIS
(CONTD.)
1
/
2
3
Ø Even though India was a founder member of the WTO since
1995, it had opted for the Mailbox System according to Article
70(8) of the TRIPS agreement
Ø The “mailbox” system is a TRIPS-imposed obligation on
developing countries that wished to benefit from the TRIPS
transitional period by delaying granting of patents for
pharmaceutical products until 2005. In exchange for not
granting patents, these countries had to establish a “mailbox”
system for receiving and filing patent applications from the
beginning of the transitional period in 1995.
1
0
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1
BACKGROUND TO NOVARTIS
(CONTD.)
1
/
2
3
Ø During the transitional period from 1995 to 2005, Exclusive
Marketing Rights were to be granted for a period of 5 years
from the date of obtaining marketing approval in any country, or
until a product patent is granted or rejected, whichever was
shorter with a cut-off date from January 1, 1995
Ø India granted only a few EMRs for pharmaceuticals and
agrochemicals during the transition period, out of which
Novartis AG got one for a blood cancer drug called
“Glivec/Gleevec”
Ø The EMR was granted in November 2003, for a period of 5
years
1
0
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1
BACKGROUND TO NOVARTIS
(CONTD.)
1
/
2
3
Ø However, EMRs were subject to a few preconditions:
(a) A patent application is pending in that member country where
EMR is being sought;
(b) A patent should have been granted for the same product in
another WTO member country after 1995; and
(c) Marketing approval should have been obtained for this product in
such other member country
Ø EMRs were supposed to prevent others from coming onto the
market until the patent would be granted or rejected
NOVARTIS AG V. UOI (2013)
1
0
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1
1
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NOVARTIS AG V. UOI (CONTD.)
2
3 Ø Glivec is based on the original drug “imatinib”
Ø In 1992, Novartis filed a patent application for “imatinib”, which
also covered pharmaceutically acceptable salt forms of “imatinib”
This patent was granted by the US Patent and Trademark Office
(USPTO)
Ø Novartis received US Food and Drug Administration (FDA)
approval for one salt form of imatinib, i.e., “imatinib mesylate”,
in 2001. As opposed to the original (“free base”) substance
imitanib, the salt form (i.e., mesylate) is soluble in the human
body
Ø In 1997, Novartis filed a US patent application for a specific
variation of imatinib mesylate, i.e., its “beta crystalline form”, for
which the USPTO eventually granted a patent. The beta
crystalline form enables oral administration of imatinib mesylate
1
0
/
1
1
/
NOVARTIS AG V. UOI (CONTD.)
2
3 Ø In 1998, Novartis also applied for product patent protection for
the beta crystalline form of imatinib mesylate in India
Ø In 2006, the Madras Patent Office refused the patent application
for Glivec stating that the said drug did not exhibit any major
changes in therapeutic effectiveness over its pre-existing form,
which was already patented
Ø The said decision was based on Section 3(d) of the Indian Patents
(Amendment) Act, 2005, which provides for a known substance
to be patented only if its new form exhibits “enhanced efficacy”
1
0
/
1
1
/
WHAT IS SECTION 3(d)?
2
3
Ø The sub-section states that inventions that are a mere
"discovery" of a "new form" of a "known substance" and do
not result in increased efficacy of that substance are not
patentable
Ø This effectively means that if there is an old molecule in a new
substance you cannot patent it by making a minor modification
and passing it off as a completely new invention
1
0
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1
1
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NOVARTIS AG V. UOI (CONTD.)
2
3
Ø In May 2006, Novartis filed two writ petitions before the High
Court of Madras – one appealing against the order of Madras
Patent Office rejecting its patent application, and the other
claiming that Section 3(d) of the Indian Patents Act is not in
compliance with TRIPS, and violates Article 14 of the Indian
Constitution, in being vague and arbitrary
Ø The Madras High Court refused the writ petitions holding that it
did not have the jurisdiction to determine whether a domestic
law is contrary to an international treaty, therefore, it cannot
decide whether Section 3(d) is in compliance with TRIPS.
Ø Further, it transferred the case to the Intellectual Property
Appellate Board (IPAB)
1
0
/
1
1 NOVARTIS AG V. UOI (CONTD.)
/
2
3 Ø The new phase of litigation started at the IPAB
Ø The IPAB considered the beta-crystalline form of Imatinib
Mesylate as new and having an inventive step but refused to
grant a patent to the Novartis’ drug since it was hit by Section
3(d) of the Act
Ø The IPAB defined “efficacy” for the purposes of Section 3(d)
to mean “therapeutic effect in healing a disease or having a
good effect on the body”
Ø The IPAB, however, held that the Appellant could not be
denied the process patent for preparation of Imatinib Mesylate
in beta crystalline form.
1
0
/
1
1
/
NOVARTIS AG V. UOI (CONTD.)
2
3
Ø Novartis challenged the said order by filing a Special Leave
Petition before the Supreme Court
Ø The main issues that came up before the Supreme Court were-
i. Whether the invention is inconsistent with Section 3(d) of the
Patents Act?
ii. What is the correct interpretation of Section 3(d) of the Patents
Act?
iii. Whether the invention qualifies for the test of novelty and
inventive step for the alleged product?
1
0
/
1
1
/
NOVARTIS AG V. UOI (CONTD.)
2
3 Ø In order to meet the statutory requirement of enhanced efficacy under Section
3(d), Novartis in 2005 conducted studies to show inter alia a 30% increase in
bioavailability of beta crystalline imatinib mesylate over the original substance
imatinib
Ø The Court clarified that increased bioavailability alone does not always result in
higher therapeutic efficacy, no matter whether the latter is understood in a
narrow or a broader sense
Ø The patent applicant needs to show, through the submission of clinical trials
data, that in the particular case, higher bioavailability does result in increased
therapeutic efficacy
Ø This may be explained by the fact that bioavailability as such only indicates the
extent to which a drug reaches its site of action. This does not necessarily say
anything about the actual effect the drug generates on the body
Ø The Court emphasized that Novartis had failed to submit any evidence to show
that increased bioavailability of the beta crystalline form actually increased the
therapeutic effect of the substance on the human body
1
0
/
1
1
/
NOVARTIS AG V. UOI (CONTD.)
2
3 Ø Novartis claimed that the subject matter of its patent application, i.e., beta
crystalline imatinib mesylate, was based on two separate patentable inventions:
• The selection of the imatinib mesylate salt from the original substance imatinib;
• The development of the specific beta crystalline form of imatinib mesylate
Ø The Court concluded that imatinib mesylate lacked novelty, as it was already
included in the claims to the original substance imatinib, and based its opinion on
several scientific articles that describe not only the free base “imatinib”, but also
its salt form “imatinib mesylate”, and its anti-tumoral properties
Ø In addition, Novartis, in its patent infringement proceedings in Europe, had
argued that the imatinib patent encompassed claims to the salt mesylate
Ø According to the Court, a patent holder cannot claim a wide scope of an existing
patent in infringement litigation, and subsequently claim a narrow scope of the
same patent in the context of examining novelty of a salt derivative
Ø The scope of the original patent claims thus defines the teachings that are
pertinent for the novelty test
1
0
/
1
1
/
NOVARTIS AG V. UOI (CONTD.)
2
3 i. The Court accepted the IPAB’s view that the original patent
claims to imatinib did not encompass the claims to the beta
crystalline form of imatinib mesylate. While the beta
crystalline form could thus be considered novel, the Court
decided that it did not meet the requirement of enhanced
efficacy under Section 3(d) of the Patents Act, and therefore
constituted a non patentable “invention” (i.e., rejection on
subject matter grounds)
ii. Novartis contended that the physio-chemical properties of the
polymorph form of the Imatinib molecule, i.e., better flow
properties (more processable), better thermodynamic stability
(facilitating storage) and lower hygroscopicity (increased shelf
life), resulted in improved efficacy, and hence was patentable
under Indian law
1
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NOVARTIS AG V. UOI (CONTD.)

/
1
1
/
2 Ø The Apex Court rejected this contention stating that in the case of
3
medicines, efficacy meant “therapeutic efficacy” and these properties
while they may be beneficial to some patients, did not meet the
required standard
Ø The Supreme Court further held that neither the Act nor international
practice gave a clear definition of efficacy
Ø The true intention to enact Section 3(d) was to prevent the concept of
ever-greening, and thus if the invention does not fulfil the test of
Section 3(d), it cannot be granted a patent
Ø Regarding the field of medicine, especially in cases of life-saving
drugs, great care and caution needs to be taken to protect the right to
life of the masses
Ø The Supreme Court, in its judgement, made it clear that India is a
developing country and the availability of medicines at a cheaper rate
is necessary for the lives of 1 billion people.
1
0
/
1
DIAMOND V. CHAKRABARTY
(1980)
1
/
2
3
Ø The Case was heard by the US Supreme Court in 1980
Ø It entailed the patentability of genetically modified organisms
(GMOs)
Ø Ananda Mohan Chakrabarty, a microbiologist, developed a
bacterium called Pseudomona Putida, while working with
General Electric (GE)
Ø The said bacterium could break down crude oil which made it
suitable for treating future oil spills
DIAMOND V. CHAKRABARTY
(CONTD.)
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0
/
1 DIAMOND V. CHAKRABARTY
1
/
2
(CONTD.)
3
Ø The application was rejected by the patent examiner and
the Board of Patent Appeals and Interferences agreed with the
original decision
Ø However, the United States Court of Customs and Patent
Appeals overturned the case in Chakrabarthy's favour
Ø Sidney A. Diamond, Commissioner of Patents and Trademarks,
appealed to the Supreme Court
1
0
/
1 DIAMOND V. CHAKRABARTY
1
/
2
(CONTD.)
3
Ø For the purpose of patent law, the fact that micro-organisms are
alive is not relevant
Ø Although it is true that naturally-occurring products may not be
patented, a genetically-engineered micro-organism is not
naturally occurring
Ø Since the patent laws clearly include materials, such as are at
issue here within their scope, and no specific law exists to
exclude them, the only appropriate holding is that recombinant
DNA-produced micro-organisms are patentable
1
0
/
1 DIAMOND V. CHAKRABARTY
1
/
2
(CONTD.)
3 Ø “Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new
and useful improvement thereof, may obtain a patent therefor,
subject to the conditions and requirements of 35 USC 101
Ø Judged in this light, the Respondent's micro-organism plainly
qualifies as patentable subject matter
Ø His claim is ... to a non-naturally occurring manufacture or
composition of matter—a product of human ingenuity.
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (2001)
3
§ The Patent Applicant filed by
the Appellant involved an
invention relating to a process
for preparation of the vaccine
for Bursitis
§ The Vaccine would essentially
protect the contagious Bursitis
infection which was found in
poultry
§ However, the process for the
preparation of this vaccine
contained a living virus as the
end-product
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø The patent application filed by Dimminaco A.G. was examined
by the Patent Examiner and he gave a finding that the said
patent application did not constitute an invention under 2(j)(i)
of the Patents Act, 1970
Ø Dimminaco appealed to the Controller of Patents and Designs
and the Assistant Controller, acting under the authority of the
Controller, too refused to accept the patent application and
upheld the objection
Ø The Appellants approached the Calcutta High Court
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø During the arguments before the Court, the Patent Office
maintained that an inventive process must lead to an article or a
substance
Ø An article, according to the Patent Office, implied a material
thing or item, a thing of a particular class or kind as
distinguished from a thing of any class or kind
Ø It was further argued, that only an inanimate object can be
denoted as a thing or item and not a living one
Ø Thus, the Controller concluded that a vaccine with the living
organism could not be considered a substance
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø The Appellants filed a supplementary affidavit, wherein it was stated that
several patent applications in the field of bio-technology and drugs had been
accepted by various Branch Offices of the Patent Office other than the
Patent Office at Calcutta
Ø From those applications, it appeared that live cells, viruses and micro-
organisms were involved in those applications, but the patents had been
granted in respect of those applications
Ø The stand of the Respondents was that the process for which a patent is
claimed may involve a living organism, but the end-product produced by
the process must come within the meaning of manufacture and it cannot
contain any living organism
Ø In other words, the end product must satisfy the meaning of manufacture
which rules out any living entity. But the process for the end-product, even
if it contains any living organism, is patentable
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø The Appellant argued that the terms ‘manufacture’ and
‘substance’ had not been defined in the Act and therefore, one
would have to rely on the dictionary meaning
Ø The Calcutta HC held that the Controller erred in law by holding
that merely because the end-product contained a live virus, the
process involved was not an invention
Ø The Court held that there is no statutory bar to accept a manner of
manufacture to be patentable if the end-product contains a living
organism
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø To decide whether in a particular case, the process of manufacture
that is involved in the invention ought to be patented or not, the
vendibility test can be used
Ø A vendible product is one that can be passed on from one man to
another upon the transactions of purchase and sale
Ø The vendibility test, therefore, is satisfied if either of the following
conditions are met-
1. The invention results in the production of some vendible product; or
2. It improves/restores former conditions of a vendible product; or
3. Its effect is the preservation and prevention from deterioration of some
vendible product.
1
0
/
1 DIMMINACO AG V. CONTROLLER
1
/
2
OF PATENTS & DESIGNS (CONTD.)
3
Ø Since the claim process for the patent, i.e., the manufacture of a
vaccine, led to a vendible product, it was certainly a substance,
after going through the process of manufacture
Ø Therefore, the process was an invention and as a result,
patentable.
 HARVARD COLLEGE V. CANADA (THE
ONCOMOUSE CASE)

Ø Researchers at Harvard Medical School in the early 1980s produced

a genetically modified mouse that was highly susceptible to cancer,
by introducing an oncogene that could trigger the growth of tumours
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
Ø In 1985, the President and Fellows of Harvard College
(Harvard) applied for a Canadian patent for a technology for
creating transgenic non-human mammals that are prone to
cancer
Ø The Patent was sought for a process for producing mice that
have cancer-promoting genes (oncomice), as well as for the
end-product of the process, namely the "founder" mice and the
oncomice (offspring whose cells are affected by the gene)
Ø Since oncomice have a heightened susceptibility to cancer and
tumour development, they are useful for animal carcinogenic
studies, such as tests for evaluating suspected carcinogens or
cancer-protective agents
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
The disclosure portion of the patent application stated that:
(i) The desired oncogene is obtained from the genetic code of a
non-mammal source, such as a virus;
(ii) A vehicle for transporting the oncogene into the mammal’s
chromosomes is constructed using a small piece of circular
bacterial DNA referred to as a plasmid; the plasmid is
chemically cut and the oncogene is chemically “spliced” into the
plasmid;
(iii) The plasmid containing the oncogene is then mechanically
injected into fertilized eggs at a site called the male pro-nucleus;
1
0
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1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
(iv) The eggs are then implanted in a host mammal or “foster
mother”;
(v) The eggs are permitted to develop, and the offspring are
delivered by the foster mother;
(vi) After delivery, the offspring are tested for the presence of the
oncogene; the offspring that contain the oncogene are called
“founder” animals;
(vii) Founder animals are subsequently mated with ordinary
animals and the offspring are again tested for the presence of the
oncogene before the offspring are used in research.
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
Ø The Patent Examiner rejected the product claims on the ground
that higher life forms were outside the definition of "invention"
under the Canadian Patent Act and were therefore, non-
patentable subject matter. The process claims were allowed.
Ø This decision was upheld by the Federal Court (Trial Division)
but was overturned by a majority of the Federal Court of
Appeal.
Ø The Federal Court of Appeal, in directing the Commissioner of
Patents to issue a patent, stated that the Patent Act does not
explicitly exclude living organisms such as non-human
mammals from the definition of "invention”
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
Ø The Court concluded that the Oncomouse "must be considered
to be the result of both ingenuity and the laws of nature" and is
an invention, as it is both non-obvious and a new and useful
"composition of matter”
Ø The minority stated that in a morally divisive case such as the
one at hand, the Court should defer to the Commissioner, the
decision to refuse the grant of a patent
Ø Leave was granted for an appeal to the Supreme Court.
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
Ø Majority opinion- The Patent Act was not designed to apply to
higher life forms and cannot easily be applied to them. If we decided
that the Patent Act applied to higher life forms, there would be no
clear reason why it couldn't apply all the way up to human beings. In
summary, it is appropriate to let the Patent Commissioner forbid
this kind of patent until the Parliament creates applicable
legislation.
Ø Minority opinion- Even though Parliament may not have anticipated
the Patent Act's application to higher life forms when they wrote the
Act, this invention is nonetheless a "profound and far-reaching"
"scientific accomplishment" - the kind of thing the Patent Act was
meant to apply to. The inventors deserve to have their work
recognized, protected, and rewarded.
1
0
/
1 HARVARD COLLEGE V. CANADA
1
/
2
(CONTD.)
3
Ø "The massive private sector investment in biotechnological
research is exactly the sort of research and innovation that the
Patent Act was intended to promote. Many other jurisdictions
have allowed this patent, and important policy goals argue for
our patent regime to be consistent with that of the rest of the
world. For these reasons, the patent should be allowed."
1
0
/
1
EUROPEAN PATENT
CONVENTION
1
/
2
3
Ø The European Patent Office (EPO) applies the patent standards
of the European Patent Convention (EPC), which contains two
key provisions:
1. Article 53(a) excludes patents for inventions "the publication
or exploitation of which would be contrary to ordre public or
morality"
2. Article 53(b) excludes patents on "animal varieties or
essentially biological processes for the production
of…animals"
1
0
/
1
1
/
EPO- THE UTILITARIAN TEST
2
3
Ø In order to address the public order or morality exception, the
EPO developed a utilitarian balancing test
Ø The Test aimed to assess the potential benefits of a claimed
invention against negative aspects, which in this case involved
weighing the suffering of the oncomice against the expected
medical benefits to humanity
Ø The EPO concluded that the usefulness of the oncomouse in
furthering cancer research satisfied the likelihood of substantial
medical benefit, and outweighed moral concerns about
suffering caused to the animal.
1
0
/
1
1
/
THE UPJOHN MOUSE
2
3
Ø The EPO adopted the same utilitarian approach to the morality
issue in the Upjohn case in 1992, but with a different outcome
Ø The patent filed by Upjohn pharmaceutical company was on a
transgenic mouse, into which a gene had been introduced such
that the mouse would lose its hair
Ø The objective was to test products to treat human baldness and
wool production techniques
Ø The EPO yet again weighed the benefits (usefulness in research
to cure hair loss) and harm (suffered by the mice) but
concluded that in this case the latter outweighed the former,
such that the exploitation of the invention was contrary to
morality, and therefore, not patentable.
1
0
/
1 ASSOCIATION FOR MOLECULAR
1
/ PATHOLOGY V. MYRIAD GENETICS
2
3
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø Breast cancer is a leading cause of cancer deaths in women,
second only to lung cancer. About 12% of women in the
United States (U.S.) develop breast cancer at some point in
their lives, and approximately 3% die from the disease.
Ø In 2022, breast cancer claimed the lives of an estimated 43,250
women and resulted in 287,850 new diagnoses in the U.S.
Ø BRCA1 and BRCA2 are genes (i.e., pieces of DNA) that
normally help repair damaged DNA
Ø A mutation in one of these genes means that cells are more
likely to develop genetic alterations that can lead to cancer
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø Someone with mutations in the BRCA1 or BRCA2 genes has a
significantly higher risk of getting cancer, especially breast,
ovarian, and prostate cancer
Ø Women with mutations in the BRCA1 and/or BRCA2 genes
can take steps to mitigate the risk of cancer, including
enhanced screening, medications, and preventive surgery to
remove breasts and/or ovaries (Angelina Jolie suffered from
the same disease)
Ø According to its court filings, Myriad Genetics was the first
company to discover the precise location and sequence of the
BRCA1 and BRCA2 genes, which allowed it to determine their
typical nucleotide sequence
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø Myriad's competitors disputed this history, arguing that
multiple researchers, many of whom are publicly funded,
contributed to the discovery of the locations of BRCA1 and
BRCA2
Ø Based on these discoveries, Myriad developed medical tests to
detect BRCA1 and BRCA2 gene mutations, the presence of
which would indicate an increased risk of cancer
Ø The tests involved two processes-
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø The first process involved separating segments of DNA containing the
sequences of nucleotides (which comprise the “ladder rings” in the
double helix of DNA) typically found in the BRCA1 and BRCA2
gene sequences
Ø The second process involved creating a copy of the original natural
DNA sequence that contains only exons (i.e., nucleotides that code for
amino acids, the building blocks of proteins), called cDNA
Ø After it identified the location and sequence of BRCA1 and BRCA2
genes, Myriad obtained a number of patents
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø The patents covered the act of isolating the genes and the
creation of cDNA, giving Myriad exclusive rights to control
those processes for 20 years
Ø Although the actions described in the patents are part of the
process of Myriad's BRCA1/2 testing, it is important to note
that Myriad's patents did not cover any unique testing methods
Ø When scientists at other institutions began offering BRCA
testing after Myriad had discovered the genes, Myriad ordered
them to stop, asserting that the testing infringed Myriad's
patents
1
0
/
1 ASSOCIATION FOR MOLECULAR PATHOLOGY
1
/ V. MYRIAD GENETICS (CONTD.)
2
3

While asserting these patents to exclude other testing providers, Myriad was the only
company that could administer the BRCA1/2 test, for which it charged $3,000–$4,000,
yielding a profit of $57 million through June 2013.
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø One of the scientists who had been ordered to stop, Dr. Harry
Ostrer, sued to declare Myriad's patents invalid, joined by other
doctors, patients, and advocacy groups
Ø The Federal District Court granted summary judgment to Dr.
Ostrer, finding that Myriad's patents were invalid because they
covered products of nature
Ø On appeal, the Court of Appeals for the Federal Circuit
reversed, holding that both isolated DNA strands and cDNA
may be patented.
Ø The patents claimed by Myriad Genetics would, if upheld, give
it the exclusive right to isolate BRCA1 and BRCA2 genes, or
any strand of 15 or more nucleotides within them, and the
exclusive right to create BRCA cDNA
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3

Ø The question before the Supreme Court was whether Myriad's

patents pertain to a “new and useful composition of matter” or
simply a “naturally occurring phenomena”
Ø In a unanimous decision of 9-0, the Court ruled that cDNA is
patentable, while segmented natural DNA is not
Ø “A naturally occurring DNA segment is a product of nature
and not patent eligible merely because it has been isolated…”
Ø Regarding segmented DNA, the Court explained that...
“Myriad did not create anything. To be sure, it found an
important and useful gene, but separating that gene from its
surrounding genetic material is not an act of invention”
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø Myriad's patent description explained the iterative process and
extensive efforts that led to the identification and isolation of
the gene sequences
Ø However, the process of discovery does not necessarily yield a
patentable product where the discovered item is naturally
occurring
Ø Myriad had argued that the act of severing chemical bonds to
isolate the DNA created a non-naturally occurring molecule
1
0
/ ASSOCIATION FOR MOLECULAR
1
1 PATHOLOGY V. MYRIAD GENETICS
/
2 (CONTD.)
3
Ø On the other hand, cDNA is not naturally occurring. In cDNA,
“the non-coding regions have been removed”
Ø The petitioners argued that, despite this modification, cDNA is
not patent-eligible because the sequence of nucleotides is
dictated by nature, simply copied into an exons-only version
Ø The Court disagreed, holding that even though the cDNA
follows the nucleotide sequence of the natural DNA segment
and retains its naturally occurring exons, the cDNA is a new
creation and, therefore, patentable
Ø Immediately after the Supreme Court ruling invalidating some
of Myriad's patents, other companies began offering lower-cost
BRCA1/2 testing at approximately $1,000–$2,300 per test.
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY
1
/
2
THE SHEEP CLONING CASE
3
Ø On 5th July 1996, Keith
Henry Stockman Campbell
(“Campbell”) and Ian
Wilmut (“Wilmut”) of the
Roslin Institute of
Edinburgh, Scotland
(“Roslin”), successfully
produced the first mammal
ever cloned from an adult
somatic cell: Dolly the
Sheep
Ø BBC News and Scientific
American called Dolly “the
world's most famous sheep”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY
1
/
2
THE SHEEP CLONING CASE
3
(CONTD.)
Ø The cloning method Campbell and Wilmut used to create Dolly
constituted a breakthrough in scientific discovery
Ø Known as somatic cell nuclear transfer, this process involves
removing the nucleus of a regular body cell and implanting that
nucleus into an egg cell that has had its cell nucleus removed
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø Campbell and Wilmut
obtained a U.S. Patent for the
method they used to produce
Dolly: somatic cell nuclear
transfer, which involves
removing the nucleus of a
somatic cell that has been
arrested in the quiescent
phase (where the cell is
dormant and non-replicating)
of the cell cycle and
implanting that nucleus into
an enucleated oocyte (an egg
cell prior to maturation)
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø If implantation occurs at a certain stage, the resulting fused cell
will develop into an embryo, and ultimately a baby animal,
which is an exact genetic replica of the adult mammal from
which the somatic cell nucleus was taken.
Ø Roslin is the assignee of the ’233 application, which claims not
the cloning method, but rather the cattle, sheep, pigs, and goats
that are the products of the cloning method
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Representative claim 155 recites:
155. A live-born clone of a pre-existing, non-embryonic, donor
mammal, wherein the mammal is selected from cattle, sheep,
pigs, and goats.
Ø The Examiner rejected the claims at issue as being directed to
non-statutory subject matter under 35 U.S.C. § 101, and as
being anticipated and obvious under §§ 102 and 103.
Ø The Board affirmed the Examiner's rejections, finding that the
claimed subject matter was ineligible for patent protection under
§ 101 because it constituted a natural phenomenon that did not
possess “markedly different characteristics than any found in
nature.”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø In affirming the Board's affirmation of the Examiner's
rejections, the Federal Circuit began by noting that “[e]ven
before the Supreme Court's decision in Association for
Molecular Pathology v. Myriad Genetics, Inc. (2013), the
Court’s opinion in Diamond v. Chakrabarty (1980) made clear
that naturally occurring organisms are not patentable.”
Ø In Chakrabarty, however, a genetically engineered bacterium
that was capable of breaking down various components of
crude oil was found to be patent eligible because “it was 'new'
with ‘markedly different characteristics from any found in
nature’ and one having the potential for significant utility.”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3 Ø From these two cases, the Court concluded that “discoveries that possess
'markedly different characteristics from any found in nature' are eligible for
patent protection [and] any existing organism or newly discovered plant
found in the wild is not patentable.”
Ø In other words, the Court held that even if something is made by man, it is
not patentable if what it results in is an exact copy of what occurs in nature.
Ø On appeal, the Roslin Institute argued that unlike the donor sheep used to
create Dolly, clones like Dolly are eligible for protection because they are
“the product of human ingenuity” and “not nature's handiwork, but [their]
own.”
Ø The Court disagreed, stating that “Dolly herself is an exact genetic replica
of another sheep and does not possess ‘markedly different characteristics
from any [farm animals] found in nature,’” and thus, “Dolly's genetic
identity to her donor parent renders her unpatentable.”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø Analogizing the instant case to Myriad, the opinion states that:
Roslin… “did not create or alter any of the genetic information”
of its claimed clones, “[n]or did [Roslin] create or alter the
genetic structure of [the] DNA” used to make its clones. Instead,
Roslin's chief innovation was the preservation of the donor DNA
such that the clone is an exact copy of the mammal from which the
somatic cell was taken. Such a copy is not eligible for patent
protection.
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø Roslin Institute also argued that its clones should be patent
eligible because they are distinguishable in at least two respects
from the donor mammals used to create them.
Ø In particular, Roslin argued that:

(1) environmental factors lead to phenotypic differences that

distinguish the clones from their donor mammals, and

(2) the clones are distinguishable from their original donor

mammals because of differences in mitochondrial DNA, which
originates from the donor oocyte rather than the donor nucleus.
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø In response to both arguments, the Court noted that neither the
phenotypic differences nor the differences in mitochondrial
DNA were claimed.
Ø Moreover, with respect to the phenotypic differences, the
opinion indicates that “Roslin acknowledges that any
phenotypic differences came about or were produced quite
independently of any effort of the patentee.”
Ø Thus, “[such] phenotypic differences do not confer eligibility
on their claimed subject matter because any phenotypic
differences between Roslin's donor mammals and its claimed
clones are the result of 'environmental factors,' uninfluenced by
Roslin's efforts”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø The Court did appear to leave the door slightly ajar for other
cloned animals, stating that:
“There is nothing in the claims, or even in the specification, that
suggests that the clones are distinct in any relevant way from
the donor animals of which they are copies. The clones are
defined in terms of the identity of their nuclear DNA to that of
the donor mammals. To be clear, having the same nuclear DNA
as the donor mammal may not necessarily result in patent
ineligibility in every case. Here, however, the claims do not
describe clones that have markedly different characteristics
from the donor animals of which they are copies.”
1
0
/
1 IN RE ROSLIN INSTITUTE: DOLLY THE
1
/ SHEEP CLONING CASE (CONTD.)
2
3
Ø As a result, the Federal Circuit affirmed the Board's finding
that Roslin Institute's clones constitute unpatentable subject
matter under § 101.