Biotechnology and Pharmaceutical Patenting Rodney L. Sparks, J.D., Ph.D. S enior Biotechnology Patent Counsel University of Virginia Patent Foundation

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  • Biotechnology and Pharmaceutical Patenting Rodney L. Sparks, J.D., Ph.D. S enior Biotechnology Patent Counsel University of Virginia Patent Foundation rodney@uvapf.org 434-243-6103
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  • Disclaimer Please note that no legal advice is being offered and no attorney-client relationships will arise during this presentation.
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  • IP Rights are Provided for in the Constitution Article I, Section 8: The Congress shall have power to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries
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  • Policy Behind IP Rights IP Law seeks to promote creativity The property rights granted protect the creators opportunities to recoup their investment and earn a profit, and encourages them to invest their time and efforts in developing new products and services
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  • Four Types of Intellectual Property patents copyrights trademarks trade secrets
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  • Four Types of Intellectual Property cont. Patents cover compounds, machines, and processes Give the right to exclude others from making, using, offering for sale, selling, importing (they do not necessarily allow you to practice your own patent!) Copyrights cover works of authorship reduced to a tangible means of expression Give exclusive rights to copy, distribute, perform, display, make derivative works
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  • Four Types of Intellectual Property cont. Trademarks indicate source of goods and services prevent others from passing off Trade Secrets are legally protected secrets misappropriation is unlawful, but reverse engineering is fair game
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  • Utility (useful): proposed or demonstrated use Novelty: not previously described in a publication Non-obvious: not suggested by combinations of publications Enablement: one of ordinary skill in that field can carry it out (lack of data) Written Description: you can only claim as much as you actually invented (lack of data) Best Mode: at the time of filing Patent requirements An invention is not patentable unless it is useful, novel, and non-obvious
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  • What is Patentable?
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  • Anything under the sun made by man New chemical compounds, e.g., drugs, pesticides Methods of producing new compounds Methods of diagnosing or treating diseases, including biomarkers, delivery systems, and vaccines (no gene therapy in humans) New uses for old compounds Purified natural materials, e.g., DNA, enzymes New formulations or mixtures, e.g., alloys, shampoo Transgenic animals or plants (excluding humans) Devices (stents, machines, orthopedic devices, prosthetics, etc., and novel and non-obvious modifications thereof) Methods of performing a function by computer software Methods of doing business Methods of processing digital signals
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  • WHAT IS NOT PATENTABLE? Patent law provides for what is patentable and for what is not patentable. An invention is not patentable if it falls into one of the following categories: perpetual motion device; anti-gravity device; abstract ideas or mental processes; laws of nature or scientific principles; naturally occurring substances; an invention disclosed publicly more than 12 months ago (includes sale, offer to sell, exhibit at a trade show, publication); substituting superior material for inferior material; (cont).
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  • WHAT IS NOT PATENTABLE? (cont.) a mere change in size, form, or shape; literary, dramatic, musical, and artistic works (these are subject to copyright laws); data structures or programs per se; mere mathematical algorithms; nonfunctional descriptive material; electromagnetic signals; human beings; an invention that is inoperative; an invention which can only be used for illegal or immoral purposes (such as a torture device); and an invention solely useful in making atomic weapons.
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  • WHAT IS NOT PATENTABLE? (cont.) Mere discoveries are not patentable A discovery can be thought of as something which adds to human knowledge, but does so by observation. Discoveries include such things as identification of a new species of plant, a new biochemical pathway, naturally occurring substances, or laws of nature. Once a discovery is made a modification or new use of the discovery might be patentable.
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  • Correlation Between Patentability and Commercial Value of an Invention NONE! (not quite true, but it makes my point) A patentable invention may have little or no commercial value An invention with a lot of commercial value my have little chance of being patented Dilemma- Without the potential for adequate patent protection, most companies will not invest in a technology
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  • Invention Disclosure Triage Patent Protection ??? Copyright 2003 UVA Patent Foundation All Rights Reserved Evaluation of New Invention Disclosures
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  • To File or Not to File? General Triage Factors to Consider: 1. Preliminary Assessment of Patentability (with an eye toward written description and enablement issues due to too little data and on novelty and obviousness issues exposed in a prior art search) 2. Pre-market Analysis 3. Commercial Potential
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  • From invention to patent Bad things- Public disclosure before filing- results in lack of novelty (kills foreign rights; starts one year clock for filing in the U.S.); also possible obviousness issues Presentations Publications (remember abstracts, web) Grant applications (once awarded- if federal) In use Good things- Inventors are diligent in filing invention disclosures Lab notebooks (identify inventors and dates)
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  • Good Invention Disclosure- for a cheaper and better result Invention has been fully completed and many examples are in the invention disclosure; make it easy for the licensing associate and attorney to review it and to be able to cut and paste necessary portions of the disclosure in an efficient manner
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  • Good Invention Disclosure- for a cheaper and better result Well organized- such as draft manuscript; a grant proposal, but only if there are a lot of preliminary data; (keep total documents to a minimum if possible) Editable (Word, etc.) Keep cited references to a minimum
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  • Bad Invention Disclosure- results in a more expensive and less desirable result Unorganized Incomplete - missing sections such as materials and methods; incomplete description of results or figures; figures with no accompanying legend or which are not described in the text of the disclosure Multiple unrelated documents (meeting abstract + manuscript rough draft + grant proposal draft + PowerPoint presentation = piecemeal disclosure) Uneditable files (pdf, etc.) A poster in PowerPoint
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  • Invention- disclose to UVAPF (180/year) Triage File Provisional application- 1 year (perform inventorship determination if necessary; remember- authorship is not the same as inventorship) File International/PCT application- 1.5yr Nationalization: file in US, other countries then you wait 2-3 years Prosecution, 1-2 years- Issued patent (maybe), 20 year term from filing date (costs from $50k to $750k, depending on the global scope)- Patents can be challenged The patenting process
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  • Provisional Patent Applications The current PTO filing fee is $110 With in-house patent counsel you can draft and file many more provisional patent applications than with outside law firms where reasonable applications cost from $2,500 to $12,000 in attorneys fees. We file 150/year!
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  • Conversion of a Provisional Patent Application to a PCT Application This decision requires more effort and is tougher to make because the expenses are much higher at this point (about $5k just in government filing fees) If a licensee has been found in the year since the provisional has been filed or if there is a good chance for a license agreement, a PCT application is usually filed.
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  • How do universities use patents? Universities patent and license the invention (allowed by Bayh-Dole Act) A license is a contract in which the patent owner allows a company to make, use, offer for sale, sell, and/or import the patented article or use the patented method In exchange, the licensee company pays the patent owner royalties (usually a % of sales) and other payments (e.g., up-front fees, milestone fees) Royalties on successful products can be huge! (even more than a graduate students stipend)
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  • Ownership of IP at UVA Patents UVA owns inventions by contract Bayh-Dole Act (allows universities to own federally funded research) Co-ownership with other entities MTAs, sponsored research agreements, consulting can modify ownership
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  • The UVA Patent Foundation- (technology transfer) Protection and licensing of UVAs inventions Bayh Dole government reporting Advice on intellectual property for UVA (primarily for patents; some for trademarks and copyrights)
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  • UVA and the UVA Patent Foundation Honor Inventors 2010 UVA Inventors of the Year Tim Macdonald and Kevin Lynch
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  • Some Familiar UVA Inventors
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  • PATENT MYTHS Myth #1: An inventor needs to know ho