MARK BARNES SENIOR ASSOCIATE PROVOST AND UNIVERSITY CHIEF RESEARCH COMPLIANCE OFFICER September 14, 2012 Responsible Conduct of Research Lecture 2 Intellectual Property

Overview Intellectual property = creations of the mind that are subject to legal protection; tangible and intangible Intellectual property framework rests on patents, copyrights, trademarks, trade secrets… Patent owner can protect IP (exclude others from reproducing, manufacturing, distributing, selling etc.) but must make public how the invention is made etc. The U.S. Patent and Trademark Office (USPTO) issues patents

Overview Copyrights “protect the expression or presentation of ideas, but they do not protect the ideas themselves” National Academy of Sciences, ON BEING A SCIENTIST, National Academies Press, 3 rd Ed., p.40 Research can have immense commercial value and public benefit U.S. academic institutions generated $2.3 billion in licensing income in 2009 (Association of University Technology Managers) See also:

Before Bayh-Dole Academic technology transfer first articulated as a formal concept by Vannevar Bush in 1945 "Science - The Endless Frontier” The Bayh-Dole Act: A Guide to the Law and Implementing Regulations, The Council on Governmental Relations, 1999 Federal government owned the rights to thousands of patents but would not grant exclusive licenses to companies No unified federal patent policy Lack of clear ownership and commercialization rights was disincentive to develop technologies

Bayh-Dole P.L , The Patent and Trademark Law Amendments Act (1980) Co-sponsored by Senators Birch Bayh of Indiana and Robert Dole of Kansas. Major provisions of Bayh-Dole (from Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding Universities are expected to file patents on inventions they elect to own Universities are expected to give licensing preference to small businesses The government retains a non-exclusive license to practice the patent throughout the world The government retains march-in rights

After Bayh-Dole 1980 – government held title to 28,000 patents; <5% licensed to industry for commercialization* University patents: 495 in 1980; 3,278 in 2005* “In the 30 years since the Bayh-Dole Act was enacted, federally funded research has resulted in >6,000 new US companies and >4,350 university- licensed products.” nature methods | VOL.8 NO.10 | OCTOBER 2011 | 779 doi: /nmeth.1728 Growth of University technology transfer offices: *Association of University Technology Managers:

After Bayh-Dole Benefits to public health from technologies derived under the Bayh-Dole Act*: Synthetic penicillin Hepatitis B vaccine Citracal calcium supplement Cisplatin and carboplatin (cancer therapeutics) Human growth hormones Treatments for Crohn’s disease Avian Flu vaccine Clean water technologies *Association of University Technology Managers:

Criticisms of Bayh-Dole “The growing aggressiveness of some technology-transfer offices in asserting their patents is now souring relationships between universities and industry, especially in information technology.” B.N. Sampat, Lessons from Bayh-Dole, Nature, 9 December 2010, Vol.468, p.755 Roche v. Stanford (  Stanford sued Roche for patent infringement  Research fellow had “signed a standard agreement indicating that anything he invented as a university employee would belong to the University … [then] signed a non-disclosure agreement (NDA) assigning to Cetus rights to anything he invented as part of that collaboration.” J.P. Roberts, Supreme Court ruling prompts universities to tighten employee contracts, Nature Biotechnology, 29, 678 (2011)  Supreme Court ruled in favor of Roche  Interpreted as meaning that “the inventor still needs to actively transfer the rights to the university” J.P. Roberts, Supreme Court ruling prompts universities to tighten employee contracts, Nature Biotechnology, 29, 678 (2011)

Harvard IP Policy States obligations and guidance re: reporting an invention Supported Inventions (those created with HU resources etc.), generally owned by the University Incidental inventions generally owned by the inventor Copyrights generally owned by the author Unpatented materials (e.g. cell lines) generally owned by the University Single uniform structure for distributing royalties

Filing a Patent Seek guidance from the Office of Technology Development From For an idea to be patentable, it must consist of statutory subject matter. United States patent law permits the granting of a patent on the following statutory subject matter: A process, such as a method of applying a vapor barrier for silicon materials. A machine, such as a new instrument to deposit uniform layers of metallic compounds. An article of manufacture, such as an assay kit for an infectious disease or class of diseases. A composition of matter, such as a new molecule (characterized by amino acid sequence or base-pairs) or a new chemical compound. New and useful improvements of the above. Any distinct and new variety of plant which is asexually reproduced. Any new, original, and ornamental design for an article of manufacture.

Patent, then Collaborate Collaborations with Industry Collaborations with industry often crucial to commercialization public benefit Also – industry-sponsored research; start-ups Issues: e.g.  Potential limits on researchers’ rights (to publish, present etc.)  Use of resources, student involvement etc.  Conflicts of interest … topic of week 7 lecture …  Harvard University Policy on Individual Conflicts of Interest for Persons Holding Faculty and Teaching Appointments  Updated NIH Rule: Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors