PREP Course 32: Intellectual Property (IP) in Research Kirk R. Manogue, PhD Vice President, Technology Transfer

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1 PREP Course 32: Intellectual Property (IP) in Research Kirk R. Manogue, PhD Vice President, Technology Transfer The Feinstein Institute for Medical Research North Shore-LIJ Health System

2 CME Disclosure Statement The North Shore LIJ Health System adheres to the ACCME s new Standards for Commercial Support. Any individuals in a position to control the content of a CME activity, including faculty, planners, and managers, are required to disclose all financial relationships with commercial interests. All identified potential conflicts of interest are thoroughly vetted by the North Shore-LIJ for fair balance and scientific objectivity and to ensure appropriateness of patient care recommendations. Course Director and Course Planners, Kevin Tracey, MD, Cynthia Hahn, Emmelyn Kim, MPH & Tina Chuck, MPH have nothing to disclose. Kirk R. Manogue, PhD, has nothing to disclose

3 What is Intellectual Property? Intellectual: Property: Creations of the mind Products belong to their creator Ownership Exclusive rights Dilemma of Intellectual Property How can the rights of the creator be secured if IP ownership is lost by disclosure?

4 Laws to Protect Intellectual Property Vietnam War (1970) World War II (1940) World War I (1910) Civil War (1860) War of 1812 (1812) Revolutionary War (1776)

5 Legal Basis of Intellectual Property Laws The Congress shall have the power to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive rights to their respective writings and discoveries. The US Constitution, Article I, Section 8, Clause 8

6 Social Contract of Patent Law Need to protect BOTH Inventor Rights AND Promotion of Progress The Congress shall have the power to promote the progress of science and the useful arts, by securing for limited times to authors and inventors the exclusive rights to their respective writings and discoveries.

7 Types of Intellectual Property IP laws protect the rights arising from creative mental activities: Trademarks: Copyrights: Identifies the source Protection of specific expression of creative works Trade Secrets: State law and jurisdiction Patents: Protection of inventor rights Inventions of new and useful processes, machines, articles of manufacture, and compositions of matter

8 History of Patent Law First patent law: Venice, 1474 Galileo, 1593 Evolution of European patent laws Statute of Monopolies; British Parliament, 1624 Early patents in America to Samuel Winslow by Mass. General Court, 1641 First United States Patent Law, 1790 Act to Promote the Progress of the Useful Arts First United States Patent, 1790 to Samuel Hopkins for Method of Making Potash

9 What is a Patent? 35 USC 154 a grant to the patentee of the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States for a term beginning on the date on which the patent issues and ending 20 years from the date on which the application was filed NB: This time-limited monopoly is the critical requirement for investment in product development!

10 A contract A property What is a Patent? between the government and the inventor that may be transferred in whole (assigned) or in part (licensed) A monopoly in the marketplace (time-limited, exclusionary)

11 What a Patent is Not! Not a license to make, use or sell your invention Does not give the patentee the right to practice the invention this is independent of patent rights A patent conveys the right to exclude others, but the right to practice is independent Not uncommon that inventor is granted a patent but does not have the right to practice it! Dominant and subordinate patent rights

12 Knife Patent Granted to K a tool or weapon that has a cutting blade and a handle I claim: 1. A tool or weapon comprising: a. a blade portion having at least one cutting edge; and, b. a handle portion in coaxial relation to said blade portion. Grant of patent gives K the right to exclude others from making, using or selling knives, as claimed. K also has the independent right to make, use and sell knives.

13 Pocketknife Patent Granted to P I claim: 1. A folding knife comprising a slotted handle member and a blade member having at least one cutting edge, wherein said handle member is articulated with said blade member such that the blade may be folded into the slotted handle to shield the blade when not in use. Grant of patent gives P the right to exclude others (including K) from making, using or selling pocketknives; BUT: P is excluded from making, using or selling pocketknives for the life of the dominating knife patent to K.

14 What is Patentable? Title 35 of the US Code, Sections USC 101 Whoever invents any new and useful process, machine, manufacture, or composition of matter, or any new or useful improvement thereof may obtain a patent therefor, subject to the conditions and requirements of this title (Additional requirement of non-obviousness and no statutory bars; requirements for written description, enablement, best mode)

15 What is Patentable in Biotechnology? Biotechnology: Use of living organisms to provide useful products and processes, with applications in therapeutic, agricultural and industrial settings. Representative Subject Matter Nucleic Acids: isolated genes, cdna, recombinant and synthetic DNA, DNA fragments, anti-sense Recombinant vectors and host cells Gene sequencing techniques: PCR Proteins: peptides, gene products and fragments; protein production by expression of recombinant DNA; methods of using purified or recombinant proteins

16 What is Patentable in Biotechnology? Representative Subject Matter Receptors: cell surface, cytosolic, ligands Antibodies: polyclonal, monoclonal, neutralizing, blocking, engineered (humanized, single chain, Fab fragments) Transgenic animals: knockouts, knock-ins Diagnostics: reagents and kits Pharmaceutical compositions: related therapeutic methods Gene therapy: protocols and reagents

17 What is Patentable in Biotechnology? Diamond v. Chakrabarty, 1980 USPTO Examiner: claims rejected Patent Office Board of Appeals: upheld Examiner United States Court of Customs and Patent Appeals: Overturned: the fact that micro-organisms are alive is without legal significance for purposes of the patent law US Supreme Court (5-4): courts should not read into the patent laws limitations and conditions which the legislature has not expressed" Living organisms constitute statutory patentable subject matter under 35 USC 101: anything under the sun that shows the hand of man

18 Patentable Inventions Must: Fall within a Statutory Class Utility Patents Process: Method Machine: Operable structure Composition of Matter: Unite two or more substances Manufacture: Tangible object Substance of nature: Isolated or purified Improvements in the above Design patents Plant patents

19 Patentable Inventions Must: Fall within a Statutory Class Not patentable: Printed matter Naturally occurring in nature Business methods Scientific principles or truths; Laws of nature Mental processes; abstract ideas Algorithm Computer program See Mayo vs Prometheus

20 Patentable Inventions Must: Be New Novelty requirement (mainly 35 USC 102, statutory bars) Must be different from the Prior Art ( dead ringer anticipation) Not known or used in the US or published or patented anywhere in the world before being invented by the person applying for the patent Not published or patented anywhere in the world nor in use or on sold in the US more than 1 year prior to the date of application for the patent

21 Patentable Inventions Must: Be Useful Must perform at least one object of the invention Must be practical: cannot be immoral, frivolous or mischievous

22 Patentable Inventions Must: Be Non-Obvious In light of the scope and content of the Prior Art (mainly, 35 USC 103) But considering differences between the Prior Art and the claims at issue Considering Level of Ordinary Skill in the Art Secondary considerations: commercial success, longfelt but unresolved need, failure of others in the art Not negatived by the manner of making the Invention

23 Who may be an Inventor? 35 USC 101 Whoever Sole Inventors: man, woman, child Group of persons (Co-Inventors) Dead and legally incapacitated Inventors: obtain grant through legal representative Not the Assignee nor patent attorney or agent Those and only those who contribute to the creation of the claimed Invention: conception and reduction to practice (actual vs constructive)

24 Who Determines Inventorship? IP Policy (North Shore-LIJ Health System Policy on Intellectual Property) Consistent with US Patent Law Patent attorney who prepares the case Misjoinder of Inventorship Correctable if no deceptive intent Ethicon v US Surgical decided by CAFC 1998

25 What are the Benefits of Inventorship? IP Policy: Presumptive assignment to Feinstein for commercialization Since 2007, Feinstein Institute has paid out more than $1 million to inventors at the on commercialization proceeds exceeding $3 million Feinstein / NSLIJ Inventors share, in aggregate, 40% of net commercialization revenues

26 North Shore-LIJ IP Policy (1) General Policy: Bring Health System Inventions into public use for the benefit of the public at the earliest possible time Health System Inventions: Conceived or reduced to practice by HS employees or others in the course of their work using the facilities or resources of the HS Office of Technology Transfer / CCI Alliance: Facilitate the evaluation, protection, development and commercialization of Health System Inventions

27 North Shore-LIJ IP Policy (2) Feinstein Institute: Established primarily to conduct and facilitate medical research. Holds title to all Inventions. Only Feinstein President may enter into binding commercialization contracts. Disclosure of Inventions: Inventors must disclose timely, to OTT, and then cooperate in securing IP protection.

28 North Shore-LIJ IP Policy (3) Feinstein Ownership of IP: Employees formalize assignment to Feinstein Institute Holds title to all Inventions May release to Inventors In collaborations between inventors from different institutions, ownership tracks inventorship

29 North Shore-LIJ IP Policy (4) Licenses and Distribution of Income: Exclusive vs non-exclusive licenses Negotiated by Innovation Alliance Royalty Income (sales, fees, milestones, minimums): Distribution to co-owners; Inter-Institutional Agreements Set-aside: 25% to CCI / Innovation Alliance Recovery of investments by Feinstein / NSLIJ Inventors share of net: 20% phase, 40% phase

30 North Shore-LIJ IP Policy (5) Publication: Academic Freedom prevails BUT Research Institute may impose temporary delays to prepare and file for IP protection. Disclose inventions to OTT as early as possible BUT IN ANY CASE prior to making a public disclosure!

31 North Shore-LIJ IP Policy (6) Employee-owned Entities (EOE) Treated arms-length in negotiations Subject to all policies for commercially sponsored research by non-eoe Requires a Development Plan Research Plan with scientific and development objectives and milestones Budget and Financial Plan for development of the licensed Invention Oversight Committee: reviews research validity and relationship to Inventor and Institute

32 North Shore-LIJ IP Policy (7) Copyright Policy Feinstein owns copyrights by default Authors may petition for copyright transfer, royalties Materials Transfer Agreements Institutions; companies; repositories; agencies OTT negotiates and executes all outbound & inbound Investigators may not sign MTAs Waiver Requests Submitted to OTT for decision

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