Docs at BIO: Lilly Counsel Discusses Patent Issues Regarding Personalized Medicine

    By Donald Zuhn --

In a Breakout Session entitled "The Emerging Promise of Personalized Medicine," a panel consisting of Cindy Collins, Group Vice President at Beckman Coulter, Inc.; Brian Barrett, Associate General Patent Counsel at Eli Lilly & Company; Dr. Courtney Harper, Associate Director for Toxicology at the Office of In Vitro Diagnostic Device Evaluation and Safety of the Food and Drug Administration; and Sheldon Bradshaw, a partner and regulatory attorney at Hunton & Williams, LLP, addressed the business, scientific, and legal challenges for the commercialization of personalized medicine on Tuesday at BIO 2009.  Mr. Barrett's presentation would likely have been of most interest to Patent Docs readers, as his focus at Lilly is on patent procurement.  In Mr. Barrett's portion of the presentation, entitled "Unpredictable Patent Protection and Inadequate Data Protection:  Key Obstacles to Developing Personalized Medicine," he listed a number of patent obstacles for personalized medicine and then briefly touched on data exclusivity with regard to proposed follow-on biologics legislation.

With regard to patent-related obstacles for personalized medicine, Mr. Barrett discussed the recent Association for Molecular Pathology v. U.S. Patent and Trademark Office gene patenting case, and noted that the Supreme Court has not had an opportunity to address the patentability of "isolated DNA."  He also noted that the landmark Diamond v. Chakrabarty decision involved human intervention rather than isolation.  Mr. Barrett also discussed the impact of Laboratory Corp. v. Metabolite Laboratories, Inc. (LabCorp), In re Bilski, and the pending appeal in Prometheus v. Mayo on medical diagnostics.  He next addressed the possible impact of the Supreme Court's decision in KSR International Co. v. Teleflex Inc. on optimization (i.e., tailoring) of therapeutics to individual patients, and then touched on a number of decisions impacting nucleic acid patentability, including In re Fisher, In re Kubin, and Ariad v. Eli Lilly & Co.  Patent Docs readers are no doubt quite familar with the above cases.  Mr. Barrett concluded the patent obstacles portion of his talk by briefly discussing anticipation by experimental use, inherent anticipation, inequitable conduct, compliance with the best mode requirement, inducing infringement, and injunctions in view of eBay Inc. v. MercExchange, L.L.C.

On the topic of data exclusivity, Mr. Barrett highlighted the exclusivity periods in the two pending House follow-on biologics bills (the Waxman and Eshoo bills), and noted that because data protection and patent protection were not additive, the Waxman bill would provide insufficient protection for innovator drug companies.  He stated that innovators, who learn a lot about a therapeutic "deep into" Phase II clinical trials, would be well past the 5.5 years of data protection afforded under the Waxman bill by the time such knowledge had been gathered.  When asked during the question and answer portion of the session whether there was a compromise level of data exclusivity that innovators could live with (i.e., something lower than the maximum 14.5 years provided under the Eshoo bill), Mr. Barrett responded that the Eshoo period "was the compromise" since the data protection period is "currently unlimited" (in the absence of a follow-on biologics regulatory pathway).  Perhaps not surprisingly, Mr. Barrett's response was identical to the one BIO President and CEO Jim Greenwood gave Patent Docs at the BIO IPCC conference in March.

For additional information regarding many of the obstacles discussed in Mr. Barrett's presentation, please see:
• "Association for Molecular Pathology v. U.S. Patent and Trademark Office," May 17, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009
• "In re Kubin (Fed. Cir. 2009)," April 5, 2009
• "Second Follow-on Biologics Bill Is Introduced in House," March 18, 2009
• "Waxman Introduces Follow-on Biologics Bill," March 11, 2009
• "Applying In re Bilski to Diagnostic Method Claims," February 5, 2009
• "Personalized Medicine: A Patent Office Perspective," December 11, 2008
• "KSR Int'l Co. v. Teleflex Inc. (2007)," April 30, 2007
• "In re Fisher (Fed. Cir. 2005)," November 9, 2006

Comments

[Saddlepack Maker]

Donald,

Very nice report. What was his take on the impact of Bilski, etc on personalized medicine?

[Donald Zuhn]

Saddlepack:

I believe Mr. Barrett's objective was to highlight the patent-related obstacles facing companies involved in the field of personalized medicine. Since the well-attended session included only a handful of patent attorneys, Mr. Barrett's decision to provide an overview (and touch on a number of different topics) was probably a good one. As a result, he did not go into too much detail regarding the possible impact of Bilski and its progeny. Nevertheless, I think Mr. Barrett would likely agree that until the Federal Circuit provides more direction on this issue, or the biotech patent community figures out a good strategy for claiming inventions in this field, Bilski and its progeny will, at least for now, have a negative impact.

Thanks for the comment.

Don