By Donald Zuhn --
In anticipation of the upcoming oral argument in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., scheduled for December 7th, we have been reviewing a number of the briefs submitted by various amici. (We learned of an additional amicus brief that was filed last week, this one by William Mitchell College of Law in support of Defendant-Appellant-Respondent Eli Lilly & Co., which brings the total number of amicus briefs filed in the rehearing en banc to twenty-five, and the number filed in support of Lilly and/or affirmance to nineteen.) Today, we examine the amicus brief filed by GlaxoSmithKline ("GSK") in support of Lilly.
GSK's brief focuses primarily on the importance of the patent system to the biotech/pharma industry, and the need by that industry for certainty that comes from having well-settled requirements for patentability. GSK opens the brief by noting that it invests sizeable amounts of money in R&D -- more than $6.5 billion in 2008 -- and that it protects this investment by seeking patent protection on its innovations -- filing more than 300 U.S. patent applications per year. The pharmaceutical company explains that "[p]rotecting and encouraging scientific investment like GSK's large research and development effort is not possible without a long-term predictable, stable, legal system that provides sufficient confidence to invest and sufficient time to recoup investment and secure a reasonable return," and contends that "[r]etroactively changing standards for patent protection, standards that for the most part have been in place since at least the enactment of the 1952 Patent Act, introduces uncertainty and instability, risks the invalidation of once valid patents, and potentially nullifies investment-backed business decisions based on then-correct interpretations of the law."
GSK argues that changes in well-settled requirements for patentability will inject uncertaInty and instability into long-term business decisions. The company points to the Federal Circuit's recent decision in In re Kubin as illustrative of the impact resulting from a change in judicial law, stating that "[l]ost with [the] patent application on that invention was any chance to recover the research money and lost employee time invested in the invention's discovery and development based on a good faith compliance with the law in effect at the time the application was flIed."
After providing a summary of several CCPA and Federal Circuit decisions that have helped establish the current legal regime, including In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967); In re DiLeone, 436 F.2d 1404 (C.C.P.A. 1971); In re Wilder, 736 F.2d 1516 (Fed. Cir. 1984); and Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991), GSK notes that:
Since the Vas-Cath decision in June of 1991, more than 2.5 million patents have been prosecuted and issued based on the fundamental premise that 35 U.S.C. § 112, first paragraph contains a written description section separate and distinct from an enablement requirement. Should the Court change that well settled understanding of the law by either removing the written description requirement from the current § 112 analysis or by changing the interpretation of the enablement requirement, some patents that businesses thought were valid might now be considered invalid if litigated, and patents that have been thought invalid might now be held valid. This particularly affects pharmaceutical and biotech patents that seem to be more often the focus of a § 112 review. Both outcomes can change prior long-term investment-backed decisions with the potential result of wasted capital and research or new-found patent infringement exposure.
Stating that "the Supreme Court stresses that the doctrine of stare decisis is of particular importance in patent law," GSK argues that "[w]here corporations collectively have invested billions based on settled interpretations of law, stare decisis counsels against departure from prior interpretations of the law."
GSK concludes its brief by stating that "[p]harmaceutical companies must be able to trust that they can make long term decisions based on current law that will remain correct over the 10-15 years needed to get a product approved and then during its patented years," and asserting that "[f]or this reason, the Court should protect the investment-backed expectations of patent holders by ensuring the law remains stable and predictable, and is not subject to dramatic changes in statutory interpretation."
For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: United States," November 23, 2009
• "Amicus Briefs in Ariad v. Lilly: Google, Verzion Communications Inc. and Cisco Systems, Inc.," November 22, 2009
• "Amicus Briefs in Ariad v. Lilly: Professor Christopher Holman," November 19, 2009
• "Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc," November 16, 2009
• "Next Up: Ariad v. Lilly Rehearing En Banc," November 10, 2009
• "Federal Circuit Grants En Banc Review in Ariad v. Lilly," August 21, 2009
• "Ariad Files Petition for Rhearing in Ariad v. Lilly," June 3, 2009
• "Ariad Decision Voids Attempt to Use Broad Claiming to Avoid the Written Description Requirement," April 14, 2009
• "Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co. (Fed. Cir. 2009)," April 6, 2009