Amicus Briefs in Ariad v. Lilly: United States

    By Donald Zuhn --

With oral argument in the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co. scheduled for Monday, December 7, 2009, last Friday marked the deadline for the filing of amicus curiae briefs.  Twenty-four amicus briefs were submitted (by our count), with eighteen briefs filed in support of Defendant-Appellant-Respondent Eli Lilly & Co. and/or 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 (brief);
• The American Intellectual Property Law Association (AIPLA) (brief);
• Amgen Inc. (brief);
• Professor Christopher A. Cotropia (brief);
• The Federal Circuit Bar Association (brief);
• GlaxoSmithKline (brief);
• Google Inc., Verizon Communications Inc., and Cisco Systems, Inc. (see Patent Docs report);
• Hynix Semiconductor Inc. and Samsung Electronics Co., Ltd. (brief);
• The Intellectual Property Owners Association (IPO) (brief);
• Oskar Liivak (brief);
• Medtronic, Inc. (brief);
• Microsoft Corp. (brief);
• Monsanto Co. (brief);
• Public Patent Foundation (PUBPAT) (brief);
• RealNetworks, Inc. (brief);
• 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. (brief);
• United States (brief); and
• Washington Legal Foundation (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 (brief); and
• University of Kentucky Intellectual Property Law Society, Universal Support Systems LLC, Polymer Construction Products Ltd., and Safeteccs LLC (brief).

The amicus brief filed by the United States in support of Lilly begins by noting that "[a] complete and exact description of the claimed invention is the sine qua non of the patent system:  it allows USPTO to examine applications, the courts to construe claims, and the public to recognize and avoid the boundaries of the patentee's exclusive rights."  Stating that the Supreme Court has "repeatedly recognized that the function of the written description is not merely to enable, but also to describe the claimed invention itself and thereby provide notice to the public of the boundaries of the patentee's rights," the United States asserts that "[t]o construe Section 112, ¶ 1 as a bare enablement requirement would defy the text and history of the statute and disregard nearly two hundred years of judicial and administrative interpretation."  Contending that the written description requirement "is as venerable as the patent system and remains instrumental to its operation," the United States asserts that "Petitioners identify no basis for discarding it now."

The United States devotes the first portion of its brief to an analysis of several Supreme Court decisions interpreting the written description provision of the 1870 Act, including Gill v. Wells, 89 U.S. 1 (1874); Permutit Co. v. Graver Corp., 284 U.S. 52 (1931); and Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938).  The United States then concludes that "[n]othing in the new statute [i.e., the 1952 Act] or its legislative history indicated that Congress intended to abrogate cases such as Schriber-Schroth, Permutit, and Gill, or to break from more than a century of accumulated decisions interpreting the disclosure requirements of the patent laws."

With respect to Ariad's argument that the grammatical structure of § 112 creates a single description requirement whose sole measure is enablement, the United States asserts that "it is petitioners who overread the statutory text," adding that:

[N]othing in the statute requires petitioners' additional inference that any description that enables the invention will suffice.  That inference disregards two centuries of judicial and administrative interpretation and collapses Congress's careful distinction in the statutory text between a "written description of the invention" and a description of the "manner and process of making and using the same" -- a dichotomy that, as noted, Congress has preserved in every iteration of the patent laws since 1790.

The United States points out that in Ariad's view:

[A]ny description that enables others to make and use the invention is sufficient, whether or not it describes "the invention" itself.  Thus, for example, if an applicant's description of how to make and use a new chemical compound enabled others skilled in the art to make and use five, fifty, or even five hundred thousand additional compounds, it would be irrelevant that the applicant had neither described those compounds nor provided any reason to believe they would function as claimed.  The applicant could claim them all -- or, more likely, amend his claims later when it became clear that a particular compound was commercially valuable.  . . .

Likewise, under petitioners' construction of the statute, any scientist with a promising plan of research need only file a patent application describing her research plan and its expected outcome.  If the plan produces the desired outcome, the application may have enabled others skilled in the art to make and use the "invention."  And if the research plan fails, all that is lost is the filing fee and the cost of preparing the patent application.  Such abusive tactics -- which allow opportunistic claimants to withdraw from the public domain entire fields of nascent scientific endeavor while setting down a priority stake for all future work in the field -- cannot properly be attributed to the statutory design.

Noting that "[p]etitioners argue that Section 112 requires not only a description of how to make and use the invention, but also a description of 'what the invention is, for otherwise it fails to inform a person of skill in the art what to make and use,'" the United States observes that "the similarity between the enablement test advocated by petitioners and this Court's written-description jurisprudence is striking."  According to the United States, "[t]hat petitioners prefer to characterize this inquiry as a component of enablement, rather than as a distinct written-description requirement, is irrelevant -- nothing turns on the doctrinal labels."

The United States also contends that the U.S. Patent and Trademark Office requires a written description of the invention in order to carry out its examination function:

Though [a biological or chemical molecule claimed solely by reference to its function or effect] may be enabled, USPTO is not an experimental laboratory:  it lacks both the facilities and the statutory mandate to determine, through empirical testing, whether any of millions of prior art inventions may have exhibited the recited function.  By insisting that each applicant provide a full and exact "written description of the invention" as part of the specification, Congress protected the ability of USPTO to perform its essential function of distinguishing patentable inventions from the prior art.  Indeed, this is one of the original and enduring purposes of the written description requirement:  to "distinguish the invention or discovery from other things before known and used."

Noting that written description principles are firmly embedded in the U.S. Patent system, the United States asserts that:

[E]ven if Section 112 could have been construed to require enablement only, the plain fact is that it has not been.  The patent laws have been understood to require more than bare enablement since the inception of the patent system.  This Court alone, by the government's count, has issued at least twenty precedential decisions distinguishing between written-description and enablement.  When CCPA cases drawing the same distinction are included, the total rises to at least thirty-five published decisions issued over fifty years -- an average of more than one precedential decision every two years under the 1952 Patent Act.  That total, moreover, does not include the Supreme Court and CCPA cases predating the 1952 Act.

The United States concludes that "[i]t is rare that a federal court contemplates upsetting statutory interpretations as settled as this, and only the most extraordinary justification could warrant doing so."  With respect to Ariad's embrace of Judge Markey's dissenting opinion in In re Barker, 559 F.2d 588 (CCPA 1977), the United States argues that:

[P]etitioners' arguments were fully aired and resolved more than thirty years ago.  In the subsequent decades, this Court has repeatedly reaffirmed the holding in Barker, the USPTO has examined millions of patent applications under the principles established by this Court's precedents, and Congress has not intervened to change the law.  Even if petitioners were correct that Judge Markey's view should have carried the day in 1977, that would not warrant reopening the question now.

Patent Docs thanks David Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for kindly providing us with many of the amicus briefs.

For additional information regarding this topic, please see:
• "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

Comments

[Gena777]

Thank you for this synopsis; most of the written description requirement arguments that I have read seem pretty compelling. Not only is the requirement logical, but it also supported by centuries of patent law jurisprudence.
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