Patents are a form of Intelle: tual Property (IP). In addition to patents, trademarks, copyrights and trade secrets are all consis ‘ered IP. The purpose of a patent is to turn an idea into property that has rights, Specifically, in ‘exchange for a full disclosure of how to make and use the claimed invention, you obtain the right to ‘exclude others from making, using ‘or selling the claimed invention for a defined period of time. Patents are provided in nearly ‘every country but patent law is rot globally harmonized and is very nuanced. The purpose of this ‘summary isto provide an overview ‘of the patent process. We take a US-centric view, focus on pharma: ‘ceuticals and consider only some ‘of the more common approaches. However, even within this nartow area, this is not an exhaustive ‘treatment and variations exist. Many consider the patent sys tem a comerstone of capitalism and even democracy. Mark Twain noted that "... for | knew that @ ‘country without a patent office and ‘good patent laws was just a crab, and couldn't travel any way but sideways or backwards.” Systems for protection of IP have been around since at least the 1400's. In the US, Thomas Jetferson cre ated the Patent Act in 1790 which ‘established the Board of Arts that eventually became the Ui Slates Patent and Trademark OF fice (USPTO). In fact, he person ally reviewed each application for the frst three years of the office's existence. There are three broad types of patents: utility, design and plant A utility patent covers. inven: tions that are methods, appara tus, compositions of matter and improvements thereon. A design patent covers a unique shape that is not necessary to the function of the physical article. A plant patent covers asexually reproduc ible plants. Virually all patents wwe are concemed with are utility patents, which will be the focus of this technical brief. These would include, for example, chemical structures, drug delivery systems, formulations, genes, biologics and The Patent Process medical devices. To obtain a utility patent, four requirements must be met (Fig- ure 1). Of these, the mast dif cull hurtle is obviousness. For an invention to be unobvious in the USPTO’s view, the idea has to be Uunobvious to “one skilled in the art". Exactly what is_unobvious to this hypothetical skilled person has been the subject of countless debates, numerous court deci sions and failed attempts at legis- lative standardization, It is in the construction of the unddviousness argument that the inventor most needs stilles help, usually a pat ent attorney. The actual mechanics of apply- ing for and prosecuting a patent are well aid out. Having said that, there are various routes that can be taken and the process can be quite confusing to the uninitiated integrated into the various paths are associated costs. Paramount among the questions an inventor reeds to ask are what costs can helsie support and in what geog- raphies will patent protection be important. The answers to these questions often lie in how the inventor hopes to monetize the invention. A meaningful discus- sion of this is beyond the scope of this brief put nate that, prior to spending the time and money on 2 patent, the inventor should have a plan to commercialize the inven= tion and some idea as to the value of that invention, Inherent in the above discussion of the patent rationale is what the inventor is trying to achieve with the patent. Reasons for patent- ing an invention can range from the desire to prevent others from practicing the invention (block- ing) to ensuring that the inventor has the right to practice the inven- tion (freedom to operate or FTO) to establishing 2 public record of the invention so that others can't “lock” the inventor fram practic- ing. Increasingly, companies. are primarily concerned with FTO and then, asa secondary matte, block ing. Of course, obtaining blocking IP is always most desirable but many areas of commercial interest are so crowded from an IP perspec tive that insuring FTO is the first step. If blocking IP is possible, it is often only fora relatively narrow field covering perhaps a specific formulation oF compound, The lat- ter apptoach of using 2 patent, of simply a published patent applica tion, to establish a public record is used by, for example, not-for profit Figure 1 PATENTABILITY CRITERIA < < < (©2010 Parle Sciences, nc. Al rights reserved groups interested in making sure 2 given technology is truly in the public domain, ‘With answers to the abave ques: tions, the inventor can determine the proper patent strategy and imap that against the available re sources, Usually the frst step isto search existing patents and litera- tute, referred to as prior art, for pre Vious descriptions of the supposed invention or things closely related. Once a thorough understanding on the prior art exists, the patent can be drafted to distinguish the inven- tion from those things previously descrited. Patent and other litera: ture resources are so deep at this point that its rare that no relevant artis found with 2 good search. It is important to realize that just because same relevant prior artis found, obtaining patent protection cean still be possible. The skil ies in the ability to craft the patent in light of existing data in such a way that meets the inventor's commer. cial needs. Or, if not possible, to determine that as early as possibie so that @ minimum amount of re sources are expended. Last, as prior artis inventoried, one should always keep in mind the possibility of in-licensing prior at as a way of obtaining the desired IP position ‘The following summarizes several of the mast common ap- proaches for US. inventorsleom- panies to seek patent protection. To understand the global patent system and the US system in the global context, a few organizations and treaties must be explained, ‘The Paris Convention, signed in 1883 was one of the frst IP trea ties and now has over 170 signa- tory countries of which the US is. cone. The fundamental benefit of this treaty is that the filing date of a patent application filed in any fone of the convention countries ccan seve as the priority date tor patent applications filed within fone year in any other member country. There are other treaties with similar reciprocal printy Tights. The US, for example, has cone with Taiwan, Members ofthe European Union (EU) are included in the European Patent Convention (EPC). The EPCallows you to file a single patent in the The European Patent Ottice (EPO) and name the EU coun- tries you want coverage in. Also, the EPC is considered as a single country under the Par's Conven tion for purposes of examination, Ultimately, for enforcement in a given country however, each ind: Vidual country must have a patent. There are the African Intellectual Property Organization (OAPI) and ‘rican Regional Industrial Prop- erty Organization (ARIPO) 2s wel ‘The Patent Cooperation Treaty (PCT) Is perhaps the most impor tant treaty when it comes to com- ‘mon pathways US entilies use to gain international utility patent protection, The PCT is a search: ing authority administered by the World Intellectual Property Orgeni- zation (WIPO). WIPO is an agency of the United Nations and has as its mandate to promate the protec: tion of intellectual property around the world. The PCT, entered into in 1978, allows US residents to file in the US and then, within ‘one year, file 2 single application searched for patentability by the PCT which reserves the rignt to file an application in all PCT coun- tries. These include those cov fered by the EPO as well as most other industrialized countries like Canada, Australia, China, Brazil, India ané many othets. Note the PCT process does not cover plant or design patents | one is only interested in ob- taining US protection, there are ‘wo common choices for filing. The first is to simply file an_ap- plication with the USPTO. This is most often done with the aid of 2 patent attorney although many inventors do this alone. The con: struction of a patent andits claims is an acquired skil. The quality of the work often only comes to light if the patent is of value and is challenged or attempts are made to circumvent it. Once the patent application is filed one receives 2 series of office actions (OAs) which are formal reports from the USPTO indicating what is and isn't allowable and the reasons for each indication. The inventor or their attorney replies to each OA and argues the case seeking grant: ing of the patent. At the time of this writing, the average time from submission to the frst office ac- Figure 2 Process Time finmonths) 0 6 "hier 30 months, the prozessng time wil vry based on choice of country and tye of apoiaton PATENT OPTION TIMELINE Stages of Processing 12° 18 «24 © 30" Particle Sciences tion and final decision is roughly 18 months and 3 years, respec- tively The second route to US-only protection is to first fle a prov sional patent application (PPA). A PPA is a document filed with the USPTO establishing a filing date for priority ourgoses. Within one year offing a PPA, the inventor either convers it toa regular utility application or abandons it. At that point it is treated just lke a regu- lar utility application. However, the priority date is the date of the PPA filing. A PPA does not have to be in the same form or as complete as a patent application. Its gener- ally cheaper and easier to prepare. However, it would be a mistake to assume a PPA does not have to be a well thought out ang constructed ‘document for it lays the founda- tion of the utility application If international patent protec tion is desirable, there are several ‘common paths’ to achieve this (Figure 2). First though, one must carefully consider if protection abroad is worth the considerable effort and cost required. As outlined in Figure 2, for a US ‘entity to gain non-US patent pro- tection, one can start with a USP. 0 patent application, PPA or go straight toa PCT application. Most ‘commonly, one first files at the USPTO. Then, within 12 months the inventor files under the PCT ‘or in individual national countries. ‘At 30 months post USPTO filing in the PCT process, the patent enters the “national phase* where the ponement of fees inventor needs to select the PCT Not all countries are covered countries in which to pursue the under the PCT. For instance, Ta- application. The EPO will gener- wan isnot. In general, you may fie aly be selected as @ “country” in non-covered countries at any time this scenario covering all U coun- prior to your invention being made tries. Non-EU counties are named public. Note that publication of separately. There is an EPO fling a patent application is viewed as fee as well as fling fees for each making the idea public. other selected country. This stage Once a patent application is an be quite expensive ranging filed, there are limited ways to from $5,000 to several $100,000 expand the coverage. Common in depending on strategic decisions the US is a Continuation-in-Part and the resulting geographic COW (CIP), A CIP claims priority based erage being soup. Adsitioally, onthe fling date ofthe parent ap the ongoing expense at this point plication. A CIP is substantially inereases substantially since one the same as the parent ut some is answering OAS from multile new and relaled subject matter patent offices, js added providing basis for ox- Increasing, PAS are being panding the arignal claims. Other used as a fist step in obtaining countries do not provide for CIP international patent protection. applications. Thus, if international Under this scenario a PPA is fled patent protection’ is desited. for ‘and 12 months later the inventor new claims, the expanded claims files a CT application using the must be novel and Unobvious over PPA filing date asthe priority date. the disclosure in the orginal ap- ‘The US can be named inthe PCT plication oF a separate US application can Patents are a key part of any be fled a the same time. At 22 commercialization process, Obtain. months past PPA filingor3 months ing patent protection is complicat- atter receipt of the International ee and costly In tac, IP suppor Search Report and Written Opin’ often becomes. a significant por ion on Patentability one can elect tion ofthe averll budget, Propery to obtain examination at either the integrating an IP strategy into the USPTO or EPO PCT Receiving Of product. development timeline! fice, Advantages to starting With Qudget is fundamental to success. PPA isthe lowe intial cost ané This is true whether the goal i to the extra time to better document sell the technology, license it or and develop the invention. How- bring it to market. However, each fever, since most financial clocks goal mht cetatea diferent pat. starttickingat the PPA fling, there ent strategy thus the earlier the is, ultimately, little savings or post- options are considered, the better. 3894 Courtney Street PARTICLE SCIENCES Phone: +1 610 8 61 4701 Particle Sciences isa leading integrated Fox: + 1 610 861 4702 provider of formulation and analytic services Email: [email protected] and bath standard and nanotechnology Bethlehem, PA 18017-8920, USA wor particlescien es.com approaches to crug development and delivery.