Eli Lilly and Company v. Canada (ICSID Case No. UNCT/14/2), Witness Statement of Robert A. Armitage (September 27, 2014)
I. Personal Background
1. My name is Robert Armitage. I am a citizen of the United States and a resident of Marco Island, Florida. I received a Bachelor of Arts in Physics and Mathematics in 1970 from Albion College, a Master’s degree in Physics in 1971 from the University of Michigan and a Juris Doctor in 1973 from the University of Michigan Law School.
2. From January 1, 2003, until my retirement on December 31, 2012, I was Senior Vice President and General Counsel of Eli Lilly and Company (“Lilly”). I joined Lilly as Vice President and General Patent Counsel in October 1999. From 1993 to 1999 I was a patent attorney in private practice in Washington, D.C., with the law firm Vinson & Elkins LLP. Prior to that I was chief patent counsel of another multi-national pharmaceutical company, The Upjohn Company, from 1983 to 1993. I own common stock in Lilly that I received under several bonus, incentive and savings plans that the company had established.
3. As Lilly’s General Counsel, I had overall supervisory responsibility for the company’s patent litigation, particularly the lawsuits that were material to the company’s business, both in the United States and internationally. I also had ultimate responsibility for the work of Lilly’s patent professionals, who file for patents on Lilly’s behalf in jurisdictions worldwide.
4. Patents today are the lifeblood of Lilly as well as of the research-based biopharma industry as a whole. A large percentage of the market capitalization of research-based biopharma companies, including Lilly, is attributable to the existence of valid and enforceable patents. In my experience, patent challenges by generic firms are common in our industry, but “lack of utility” challenges brought against patents protecting marketed medicines have historically – and for good reason – been all but unknown. Indeed, for medicines that have been approved by regulatory bodies on the basis that they are safe and effective therapies, “inutility” challenges are essentially unheard of outside of Canada. To the best of my knowledge, successful challenges of this type are unknown except in the Canadian courts.
5. As General Counsel, I had oversight of Lilly’s responses to the cases brought by generic manufacturers in Canada against the Strattera patent (Canadian Patent No. 2,209,735) and the Zyprexa patent (Canadian Patent No. 2,041,113). These patent challenges were, in my view, of material importance to the company, which dictated that I exercise such oversight. My job required that I remain updated on and able to converse fluently about the status of patent challenges with respect to Lilly’s commercially significant patents globally. To this end, I received regular reports from the attorneys in my office on litigation risks across Lilly’s global patent portfolio, as well as on significant changes to patent law and policy in each of Lilly’s major markets. With respect to Zyprexa and Strattera, both medicines have been major commercial successes for Lilly. I am therefore familiar with the general history of both patents, not just in Canada but internationally. I have reviewed company records and other documents to refresh my recollection of certain facts contained in this statement.