By
Donald Zuhn —

In
anticipation of tomorrow's oral argument in the rehearing en banc of Ariad
Pharmaceuticals, Inc. v. Eli Lilly & Co. (scheduled to begin at 2:00 pm
(EST) in Courtroom 201), Patent Docs has
spent the past three weeks reviewing a number of the briefs submitted by
various amici.  By the November 20th filing deadline,
twenty-five amicus briefs had been
submitted (by our count), with nineteen briefs filed in support of
Defendant-Appellant-Respondent Eli Lilly & Co. and/or judgment of affirmance, six
briefs filed in support of neither party, and no amicus briefs filed in support
of Plaintiffs-Appellees-Petitioners Ariad Pharmaceuticals, Inc., Massachusetts
Institute of Technology, the Whitehead Institute for Biomedical Research, and
the Presidents and Fellows of Harvard College ("Ariad").  Amici
supporting Lilly and/or affirmance include:

• Abbott Laboratories
(see Patent Docs report);
• The American Intellectual
Property Law Association (AIPLA) (see
Patent Docs
report);
• Amgen Inc. (see Patent Docs report);
• Professor Christopher A.
Cotropia (brief);
• The Federal Circuit Bar
Association (see Patent Docs report);
• GlaxoSmithKline (see Patent Docs report);
• Google Inc., Verizon
Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
• Hynix Semiconductor Inc.
and Samsung Electronics Co., Ltd. (see Patent Docs report);
• The Intellectual Property
Owners Association (IPO) (see Patent Docs
report);
• Oskar Liivak (brief);
• Medtronic, Inc. (see Patent Docs report);
• Microsoft Corp. (see Patent Docs report);
• Monsanto Co. (see Patent Docs report);
• Public Patent Foundation
(PUBPAT) (brief);
• RealNetworks, Inc.
(see Patent Docs report);
• The Regents of the
University of California, Wisconsin Alumni Research Foundation, The University
of Texas System, University of Rochester, Rensselaer Polytechnic Institute,
STC.UNM, The Research Foundation of State University of New York, NDSU Research
Foundation, and Research Corporation Technologies, Inc. (discussed below);
• United States (see Patent Docs report);
• Washington Legal
Foundation (brief); and
•
William Mitchell College of Law (brief).

Amici supporting neither party
include:

• Professor Christopher M.
Holman (see Patent Docs report);
• Mark D. Janis and Timothy
R. Holbrook (brief);
• Dr. Roberta J. Morris (brief);
• The New York Intellectual
Property Law Association (brief);
• Novozymes A/S (see Patent Docs report);
and
• University of Kentucky
Intellectual Property Law Society, Universal Support Systems LLC, Polymer Construction
Products Ltd., and Safeteccs LLC (brief).

On
the eve of oral argument, we examine the amicus brief filed by The Regents of the University of California, Wisconsin Alumni
Research Foundation, The University of Texas System, University of Rochester,
Rensselaer Polytechnic Institute, STC.UNM, The Research Foundation of State
University of New York, NDSU Research Foundation, and Research Corporation
Technologies, Inc. in support of affirmance of judgment.  The university amici begin their brief by describing written description as a
doctrine once used only to police claims to priority of invention,
but having "evolved judicially into a separate and oftentimes insurmountable
requirement, particularly when applied to biological inventions."  The amici
argue that "[t]he Federal Circuit's creation of this separate barrier to patentability
. . . effectively imposes an actual reduction to practice requirement on
biotechnology inventions," and that "[s]uch a requirement prejudices universities
and research institutions that do not have the resources to reduce each
pioneering biotechnological innovation to a 'precise definition.'"

Stating
that "[t]here is no statutory support and certainly no policy rationale
for the technology-specific impact the current written description law has on
the university and scientific research community," the university amici contend that:

[T]he current incarnation of written description is not only at odds with the
Federal Circuit's
own jurisprudence bestowing broader patent protection to pioneering inventions,
it muddies clear federal policy with respect to the role of the patent
system.  Patent exclusivity granted
for pioneering biological inventions fuels the creation and recruitment of
commercial entities willing to undertake the huge investments necessary to
refine and develop foundational university research into medical and
biopharmaceutical products widely accessible to the general public.

The
amici suggest that the Federal
Circuit "take the opportunity now to realign the written description law
with the constitutional, statutory, and policy rationales that underlie the
patent system, and return the doctrine to its proper role of assessing new
matter rejections and claims to priority."

In
arguing that § 112, first paragraph, does not contain a written description
requirement separate from the enablement requirement, the university amici spend some time discussing In re Ruschig, 379 F.2d 990 (CCPA 1967),
a decision the amici contend was not
based on § 112, but rather concerned the issue of whether a new claim added
during prosecution was properly rejected as new matter.  The university amici believe it is "noteworthy that the cases after Ruschig purporting to
apply a separate written description requirement were limited to
those involving (1) the presentation of claims not presented in the application
when originally filed, (2) entitlement to the benefit of an earlier filing
date for claims in a later-filed application, and (3) interference proceedings,"
adding that "[e]ach of those 'written description' cases
involved evaluating the sufficiency of the claims in accordance
with statutes governing a patent claim's entitlement to priority and
the prohibition against adding new matter."  Noting the written description case for which one of the amici is closely associated, especially in the minds of biotech practitioners (i.e., The Regents of the University of California
is v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)), the brief states
that:

It was not until Lilly that a truly
separate written description requirement — untethered to any other patent
statute — was first created.  Beyond
evaluating the sufficiency of claims added during prosecution, written
description became a device for evaluating the sufficiency of disclosures in
already-issued patents.  There was,
however, no statutory change or legislative pronouncement to justify departing
from the previous thirty years of precedent that limited written description to
its corollary function of policing priority.

The
university amici also argue that there
was no need to expand written description, because through In re Wands, "[t]he enablement inquiry already considers
factors intended to assess the sufficiency of the disclosure."

Returning
to the impact of a separate written description requirement on universities,
the amici argue that the separate
requirement "operates to prejudice inventors at universities and other
research institutions who often make the most important basic scientific
discoveries," as "[u]niversities do not have the resources to support
the time and labor-intensive process of reducing every species of a genus to
practice or describing, for example, every possible amino acid or DNA sequence
in exhausting detail as needed to 'precisely define' and adequately describe a
biological invention." 
According to the university amici,
the impact of a separate written description requirement on universities also
frustrates federal patent policy:

A statutory interpretation of the written description requirement that unfairly
prejudices biotechnology and university inventions impedes . . . growth and
frustrates the goals of the patent system.  It limits universities' ability to obtain biotechnology
patents, depriving the public of the full economic benefits and potentially
life-saving products that flow from licensing relationships between universities
and private corporations.

The
amici also argue that a separate
written description requirement conflicts with the broad patent scope the
Federal Circuit has bestowed on pioneer patents, stating that "what this
Court grants to pioneering inventions with one hand, it takes away with the
other."  In particular, the
university amici contend that the
Federal Circuit has used the separate written description requirement to
invalidate some patents, "claiming the patent disclosures do not support
the breadth of their claims," and that "[s]uch a requirement values
minor incremental improvements well-suited to precise description over the
monumental advances in technology often incapable of precise written
description."  The amici state
that "[i]t is inconsistent for Federal Circuit jurisprudence to
acknowledge pioneer patents' entitlement to broad claims, while applying a
written description standard that invalidates them on those same grounds."

The
university amici conclude by asking
the Federal Circuit to return the written description requirement "to its
historic role in the priority context, ensuring that later-filed claims are supported
by the disclosures in an earlier-filed patent application."

For additional information regarding this topic, please see:
• "Amicus Briefs in Ariad v. Lilly: Briefs by Companies," December 6, 2009
• "Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association," December 1, 2009
• "Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association," November 29, 2009
• "Amicus Briefs in Ariad v. Lilly: Intellectual Property Owners Association," November 25, 2009
• "Amicus Briefs in Ariad v. Lilly: GlaxoSmithKline," November 24, 2009
• "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