,What Publication and Intellectual Property Rights Can Academic Medical Centers Conducting Multi-Center Industry Sponsored Clinical Trials Realistically Expect?,SRA International Annual Conference W88 Wednesday, October 19, 2005,David D. King Industry Contracts,2,The Tension Between Intellectual Property (“IP”) Rights and Publication Rights,3,IP and Publication Rights Tension,If an individual (inventor) prepares a publication that discloses the inventors invention, it prevents the possibility of obtaining a patent on the invention In the U.S. and Canada, one year after the date of publication In almost all other countries, immediately upon publication (principal exception: Japan, where it is six months after publication) What can be a disclosure (besides the typical journal article)? A publicly available website is usually the equivalent of publication in a journal An oral disclosure at an open conference, is usually the equivalent of publication in a journal,4,IP & Publication Rights Tension (cont.),Since pharma companies typically operate on a global basis, publication prior to the filing of a patent application is not something that pharma companies want to occur as it impacts their ability to protect the invention Even publication after a patent application has been filed (but before the patent application itself has been published in accordance with the patent laws) can create a problem in that it can prevent the obtaining of patent protection on later discovered obvious variations of the invention,5,Example,Consider the following hypothetical: Patent application disclosing Invention A filed October 1, 2005 Publication disclosing Invention A published October 15, 2005 Patent application disclosing Invention B filed October 16, 2006, Invention B being an obvious variation of Invention A In the U.S. and Canada, Invention B is not patentable (the October 15, 2005 publication disclosing Invention A renders Invention B unpatentable); but for this publication, it would have been possible to secure patent protection on Invention B,6,Example (cont.),To avoid this scenario, most pharma companies would not permit their own employees to publish on inventions for 18 months (or at least for 12 months) after the patent application disclosing Invention A has been filed Typically, pharma companies are far more liberal with external inventors, such as PIs at AHCs, often permitting publication as early as one day after the patent application is filed,7,The Different Focus of Pharma Companies and Academic Medical Centers,8,Differences in Mission,Academic Medical Center (AMC) Quest for and desire to share intellectual property/knowledge Non-profit, tax exempt status Pharma (drug/device/medical products) company Protection of intellectual property assets For profit, maximize return on investment,9,Trial/Study Factors that Impact IP and Publication,Investigator vs. Sponsor initiated Protocol authorship Site investigator, cooperative group, sponsor Phase of the study Early stage Phase 1 Later stage Phase 4 Scientific merit CRO involvement,Multiple sponsors Multiple drugs Level of support by Sponsor Full cost Partial cost Drug/device only Holder of IND Master agreement vs. study specific,10,Pharmas Perspective of Key Factors Determining IP & Publication Rights,Whose protocol is it? Sponsors, Institutions, PIs, or Cooperative group What is the phase of the clinical trial ? I, II, III or IV What is Pharmas level of support for the clinical trial? full cost, overhead and provision of Study Drug or part of cost and provision of Study Drug or just provision of Study Drug What is Pharmas obligations to third parties, such as a licensor or co-developer, regarding IP relating to the Study Drug?,11,Pharmas Perspective of Key Factors Determining IP & Pub Rights (cont.),What is Pharmas patent position on the Study Drug? Is the CTA a “master” or for a single clinical trial? What are Pharmas internal policies? including the level of corporate authorization required to enter into a CTA that does not comply with its internal policies What is Pharmas level of “desperation” ?,12,AMCs Perspective of Key Factors Determining IP & Publication Rights,Who wrote or authored the protocol? Was it provided to others via confidentiality agreement? What is the phase of the clinical trial? What is the scientific merit? Will this likely create or spawn new intellectual ground? Is it a comparative or marketing study? What is the level of Pharma support?,13,AMCs Perspective of Key Factors Determining IP & Pub Rights (cont.),What is the IP position of Pharma in this field of use? Is this groundbreaking/foundational or merely filling in around the edges of Pharmas protected IP? Is this a master CTA or can the particular nature or specifics of the study be used to justify an exception to policy? Does Pharma want or need the AMCs PI vs. does the AMCs PI want or need to participate in the study?,14,Examples of IP and Publication Language You Can Expect,