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