En Banc Federal Circuit Rules That Written Description Requirement of §112, ¶1, Is Separate From Enablement
March 22, 2010
The en banc U.S. Court of Appeals for the Federal Circuit Mar. 22 ruled that the Patent Act at 35 U.S.C. § 112, ¶ 1, contains a written description requirement that is separate and distinct from the statute’s enablement requirement (Ariad Pharms. Inc. v. Eli Lilly & Co., Fed. Cir., No. 2008-1248, 3/22/10).
However, Judge Richard Linn, joined by Judge Randall R. Rader, argued that the majority’s “creation of a separate, additional requirement—with a poorly defined standard—is unnecessary and ill advised.” Forcing original claims over an additional hurdle beyond enablement “perpetuates an unnecessary tension between the claims and the written description as the definition of a patented invention,” Linn argued.
Briefs Addressed if Written Description Is Separate Requirement.
As reported in an earlier Intellirights story, the parties in this appeal to the Federal Circuit were asked to brief:
a. Whether 35 U.S.C. § 112, paragraph 1, contains a written description requirement separate from an enablement requirement?
b. If a separate written description requirement is set forth in the statute, what is the scope and purpose of the requirement?
On Aug. 21, 2009, the per curiam court issued an order that vacated the April 3 invalidity ruling in favor of Eli Lilly & Co., which was sued for infringing a patent (6,410,516) directed to gene regulation. Ariad Pharms. Inc. licensed the patent from Harvard University, the Massachusetts Institute of Technology, and the Whitehead Institute for Biomedical Research.
A jury had found the patent on “Nuclear factors associated with transcriptional regulation” valid and infringed by Lilly's sales of Evista® and Xigris®, and the district court had ruled that the asserted claims were directed to patentable subject matter and that the patent was not unenforceable due to inequitable conduct or prosecution laches.
The Federal Circuit’s April 2009 decision found that the claims failed to satisfy the written description requirement at 35 U.S.C. § 112, ¶ 1, but affirmed the ruling that the patent was not unenforceable for inequitable conduct.
The ’516 patent specification hypothesizes three classes of molecules potentially capable of reducing NF-κB activity: specific inhibitors, dominantly interfering molecules, and decoy molecules. To Lilly, this disclosure amounts to little more than a research plan, and does not satisfy the patentee’s quid pro quo as described in Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004).
In the panel decision, Judge Kimberly A. Moore agreed with Lilly’s argument that the asserted claims are not supported by written description because the specification fails to adequately disclose how the claimed reduction of NF-κB activity is achieved.
However, Judge Richard Linn argued in a dissenting opinion that neither case relied on by the majority—Univ. of Rochester or Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997)—mandates a separate and distinct written description requirement. Linn said that “our engrafting of a separate written description requirement onto section 112, paragraph 1 is misguided” because “the claims—not the specification—define the invention.”
The en banc court heard oral arguments on December 7, 2009.
En Banc Court Finds Written Description a Separate Requirement.
The Patent Act at 35 U.S.C. §112, ¶1 states that:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Judge Alan D. Lourie, writing for the majority, agreed with Lilly’s position and read the “shall contain a written description of the invention” language to mean that the statute has two separate description requirements: a “written description [i] of the invention, and [ii] of the manner and process of making and using [the invention]. “If Congress had intended enablement to be the sole description requirement of § 112, first paragraph, the statute would have been written differently,” Lourie said. “Furthermore, since 1793, the Patent Act has expressly stated that an applicant must provide a written description of the invention, and after the 1836 Act added the requirement for claims, the Supreme Court applied this description requirement separate from enablement.”
Lourie continued:
[A] separate requirement to describe one’s invention is basic to patent law. Every patent must describe an invention. It is part of the quid pro quo of a patent; one describes an invention, and, if the law’s other requirements are met, one obtains a patent. The specification must then, of course, describe how to make and use the invention (i.e., enable it), but that is a different task. A description of the claimed invention allows the United States Patent and Trademark Office (“PTO”) to examine applications effectively; courts to understand the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and to avoid the claimed boundaries of the patentee’s exclusive rights.
Lourie went on to explain that “[t]he written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts.” Paralleling this case to Rochester and Eli Lilly, he stated:
In Rochester, we held invalid claims directed to a method of selectively inhibiting the COX-2 enzyme by administering a non-steroidal compound that selectively inhibits the COX-2 enzyme. … We reasoned that because the specification did not describe any specific compound capable of performing the claimed method and the skilled artisan would not be able to identify any such compound based on the specification’s function description, the specification did not provide an adequate written description of the claimed invention. … Such claims merely recite a description of the problem to be solved while claiming all solutions to it and, as in Eli Lilly and Ariad’s claims, cover any compound later actually invented and determined to fall within the claim’s functional boundaries—leaving it to the pharmaceutical industry to complete an unfinished invention.
Impact on Universities Addressed.
In response to Ariad’s argument that this new requirement would adversely impact universities’ work in basic research, Lourie said that “the patent law has always been directed to the “useful Arts,” U.S. Const. art. I, § 8, cl. 8, meaning inventions with a practical use.” He continued:
Much university research relates to basic research, including research into scientific principles and mechanisms of action, … and universities may not have the resources or inclination to work out the practical implications of all such research, i.e., finding and identifying compounds able to affect the mechanism discovered. That is no failure of the law’s interpretation, but its intention. Patents are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. “[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” … Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention”—that is, conceive of the complete and final invention with all its claimed limitations—and disclose the fruits of that effort to the public.
That research hypotheses do not qualify for patent protection possibly results in some loss of incentive, although Ariad presents no evidence of any discernable impact on the pace of innovation or the number of patents obtained by universities. But claims to research plans also impose costs on downstream research, discouraging later invention. The goal is to get the right balance, and the written description doctrine does so by giving the incentive to actual invention and not “attempt[s] to preempt the future before it has arrived.” … As this court has repeatedly stated, the purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” … It is part of the quid pro quo of the patent grant and ensures that the public receives a meaningful disclosure in exchange for being excluded from practicing an invention for a period of time.
The en banc court reversed the ruling of no invalidity for inadequate written description, but affirmed the finding of no inequitable conduct.
The opinion was joined by Chief Judge Paul Michel and Judges Haldane Robert Mayer, William C. Bryson, Arthur J. Gajarsa, Timothy B. Dyk, Sharon Prost, Kimberly A. Moore, and Pauline Newman, who filed an opinion expressing “additional views.”
Linn Reiterates That Claims Define the Invention.
As in the panel decision, Judge Richard Linn agreed that there was no inequitable conduct, but argued that “the majority’s creation of a separate, additional requirement—with a poorly defined standard—is unnecessary and ill advised.” Since the 1836 Patent Act, claims have served the purpose of “distinguishing” the invention, while the specification as a whole must “enable,” Linn stressed.
Linn stated:
In my view, there is no justification for reading the statute, beyond the priority context suggested by 35 U.S.C. § 120, as requiring anything other than a written description sufficient to enable a skilled artisan to make and use the invention particularly pointed out and distinctly recited in the claims.
The enablement requirement provides an established standard for the propriety of the written description offered to support a set of claim. ... The enablement requirement also ensures that the full extent of claims asserted by an applicant have utility, such that the public can make and use the invention recited therein.
Forcing original claims over an additional hurdle beyond enablement “perpetuates an unnecessary tension between the claims and the written description as the definition of a patented invention,” Linn insisted.
Linn’s opinion was joined by Judge Randall R. Rader.
Ariad was represented by John M. Whealan of Silver Spring, Md. Eli Lilly was represented by Charles E. Lipsey of Finnegan, Henderson, Farabow, Garrett & Dunner, Reston, Va. Mark R. Freeman of the U.S. Department of Justice, Washington, D.C., represented amicus curiae United States. Amicus curiae Roberta J. Morris, of Menlo Park, Calif., represented herself. Kenneth J. Burchfiel of Sughrue Mion, Washington, D.C., represented amicus curiae Novozymes A/S. Amicus curiae Christopher M. Holman of the University of Missouri-Kansas City School of Law represented himself. Amicus curiae Mark D. Janis of the Indiana University Maurer School of Law, Bloomington, Ind., represented himself and Timothy R. Holbrook. Charles A. Weiss of Kenyon & Kenyon, New York, represented amicus curiae New York Intellectual Property Law Association. Lynn H. Pasahow of Fenwick & West, Mountain View, Calif., represented amici curiae The Regents of the University of California and others. Charles Lee Thomason of Spalding & Thomason, Bardstown, Ky., represented amici curiae The University of Kentucky Intellectual Property Law Society and others. Amicus curiae Christopher A. Cotropia, professor, Intellectual Property Institute, University of Richmond Law School, Richmond, Va., represented himself. Amicus curiae Intellectual Property Owners Association, Washington, D.C., was represented by Herbert C. Wamsley, Intellectual Property Owners Association. William P. Atkins of Pillsbury Winthrop Shaw Pittman, McLean, Va., represented amicus curiae Medtronic Inc. Amicus curiae Oskar Liivak of Cornell Law School, Ithaca, N.Y., represented himself. Robert F. Kramer of Howrey, San Francisco, represented amicus curiae RealNetworks Inc. Amicus curiae Federal Circuit Bar Association was represented by James E. Brookshire, Federal Circuit Bar Association. Walter Dellinger of O’Melveny & Myers, Washington, D.C., represented amicus curiae Hynix Semiconductor Inc. R. Carl Moy of the William Mitchell College of Law, St. Paul, Minn., represented amicus curiae William Mitchell College of Law, Intellectual Property Institute. William F. Lee of Wilmer Cutler Pickering Hale and Dorr, Boston, represented amicus curiae Abbott Laboratories. Nancy J. Linck of Rothwell, Figg, Ernst & Manbeck, Washington, D.C., represented amicus curiae Monsanto Co. Amicus curiae GlaxoSmithKline, King of Prussia, Pa., was represented by Sherry M. Knowles, GlaxoSmithKline. Constantine L. Trela Jr. of Sidley Austin, Chicago, represented amicus curiae Microsoft Corp. Amicus curiae Washington Legal Foundation, Washington, D.C., was represented by Richard A. Samp, Washington Legal Foundation. Lloyd R. Day Jr. of Howrey, East Palo Alto, Calif., represented amicus curiae Amgen Inc. Teresa Stanek Rea of Crowell & Moring, Washington, D.C., represented amicus curiae American Intellectual Property Law Association. Paul D. Clement of King & Spalding, Washington, D.C., represented amici curiae Google Inc. and Verizon Communications Inc. Joshua D. Sarnoff of the Glushko-Samuelson Intellectual Property Law Clinic, Washington College of Law, American University, Washington, D.C., represented amicus curiae Public Patent Foundation.
Read the Ariad Pharms. Inc. v. Eli Lilly & Co. opinion.
