Summary of Ariad Pharmaceuticals Inc . v. Eli Lilly

							December 10, 2009

Summary of Ariad Pharmaceuticals
Inc. v. Eli Lilly & Co. oral arguments
at the U.S. Court of Appeals for the
Federal Circuit
On December 7, 2009, the U.S. Court of Appeals for the Federal Circuit heard oral arguments in the
en banc rehearing of Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., Fed. Cir., No. 2008-1248 (April 3,
2009).

WHAT’S AT STAKE?
This highly-anticipated case considers fundamental issues related to the written description
requirement for patentability under 35 U.S.C. § 112, fi rst paragraph and has particular relevance to
the chemical and biotechnology sectors.

Specifically, the following issues were considered by the Federal Circuit:

•     Whether 35 U.S.C. § 112, fi rst paragraph, contains a written description requirement separate
from an enablement requirement?
•     If a separate written description requirement is set forth in the statute, what is the scope and
purpose of the requirement?

It is hoped that an en banc decision will clarify the statutory requirements for written description,
which until now have been decided by the Federal Circuit on a case-by-case basis. On one side of
the argument, Lilly argues that the written description requirement is a separate requirement from
enablement. On the other side of the argument, Ariad argues that it is not.

BACKGROUND
The claims of the patent at issue, U.S. Patent No. 6,410,516, are broadly directed to methods of
inhibiting the expression of the transcription factor NF-κB which regulates the expression of genes
involved in inflammation, infection, and cancer. Ariad, the licensee of the ‘516 patent, fi led suit
against Lilly alleging infringement by Lilly’s drugs Evista® (a small molecule drug approved for the
treatment and prevention of post-menopausal osteoporosis and reduction in risk of invasive breast
cancer) and Xigris® (a recombinant human protein approved for the treatment of severe sepsis). A
jury found Evista® and Xigris® infringed certain claims of the ‘516 patent and that the ‘516 patent
was not invalid for anticipation, lack of enablement or lack of written description. Ariad v. Lilly, 529
F. Supp. 2d 106 (D. Mass. 2007).

On appeal at the Federal Circuit, Judges Linn, Prost and Moore held that the asserted claims of
the ‘516 patent were invalid for inadequate written description because the inventors were not in
“possession” of the claimed subject matter at the time the patent application was fi led. Ariad v.
Lilly, 560 F.3d 1366, 1373 (Fed. Cir. 2009) (relying on Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir.
2005)).

HIGHLIGHTS FROM SOME AMICUS BRIEFS
Over twenty amicus briefs were fi led in the Ariad v. Lilly case, including an amicus brief by the
United States Government. Of these, eighteen amicus briefs were fi led in support of Lilly, six amicus
briefs were fi led in support of neither party, and no amicus briefs were fi led in support of Ariad.

•      Petitioner’s brief (Ariad): Referred to the creation of the written description doctrine set forth in
Regents of the University of California v. Eli Lilly, 119 F.3d 1559 (Fed. Cir. 1997) as a “super enablement”
test. Asserts that this separate written description requirement “presents severe consequences for
biotechnology” and disadvantages research universities and small biotechnology companies.
•     Professor Christopher Holman’s brief in support of neither party: The genus and species
possession requirements unjustifiably discriminate against biotech inventions by creating a
“technology-focused super-enablement requirement.”
•     Respondent’s brief (Lilly): Stressed that “if the law should be changed, it should be done
by Congress” and that the written description requirement “keeps the overreaching inventor in
check.”

SUMMARY OF THE ORAL ARGUMENTS
Respondent: Charles E. Lipsey, representing Lilly, argued that there is, and always has been, a
written description requirement separate from enablement. The Court questioned Lilly’s counsel
regarding whether written description is a question of fact or law, and whether there is any
context for a written description inquiry outside that of priority. Lilly acknowledged that a written
description inquiry usually arises with regard to priority, but argued that an independent and
strong written description requirement (i.e., a showing of “possession” of the invention) is necessary
for public policy reasons to ensure that an inventor actually invented what is claimed, regardless
of whether one could make and use the invention based on the description.
The Court also requested Lilly’s counsel to provide examples of when it would be possible to meet
the enablement requirement and not meet the written description requirement. Lilly responded
that such a scenario occurs when considering whether there are a sufficient number of species
disclosed to support a claimed genus.

U.S. Government: The Government’s amicus brief was fi led in support of Lilly, arguing for a written
description requirement that is distinct from enablement. Mark R. Freeman, representing the U.S.
Patent and Trademark Office, argued that such a requirement is essential to the operation of
the patent system and necessary for the U.S. Patent and Trademark Office to perform its basic
examination functions by preventing the issuance of overly broad claims. The Court noted that it
appeared very seldom that a case would reach the Federal Circuit solely on the issue of written
description without the issue of enablement. However, the Government responded that by not
following stare decisis a significant impact would be felt.

Petitioner: John M. Whealan, representing Ariad, argued that the text of the statute supports the
construction of a written description requirement that is tied to enablement. Ariad argued that
the Federal Circuit’s decision in Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559
(Fed. Cir. 1997), and the cases that followed, created an improper and heightened disclosure
requirement of possession for written description that has no basis in the statutory text. Ariad
argued that such a requirement disadvantages research universities and small biotechnology
companies. While the Court appeared to indicate that it found Ariad’s arguments at times
circular and suggested that Ariad was retreating from positions asserted in its original brief, it
appeared that at least some members of the Court were open to Whealan’s arguments, allowing
him uninterrupted time to voice his arguments at length and questioning him about specific tests
he proposed for an analysis under 35 U.S.C. § 112, fi rst paragraph

WHAT TO EXPECT
The Court’s formal decision is not expected to issue for several months, but is likely to maintain a
separate written description requirement. In the meantime, it is advisable to provide as much
explicit support as is possible upon the original fi ling of an application to meet the written
description and enablement requirements of 35 U.S.C. § 112, fi rst paragraph.



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