By Donald Zuhn --
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
• 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).
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