Lilly Files Principal Brief for Ariad v. Lilly Rehearing En Banc

    By Donald Zuhn --

Last week, Defendant-Appellant Eli Lilly & Co. filed its principal brief for the rehearing en banc of Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., which is scheduled for December 7th.  (Patent Docs provided a summary of Ariad's principal brief, which was filed on October 5th, last Tuesday; see "Next Up: Ariad v. Lilly Rehearing En Banc.")  In response to the two questions presented by the Federal Circuit's en banc order -- i.e., whether 35 U.S.C. § 112, first paragraph, contains a written description requirement separate from an enablement requirement, and if so, what the scope and purpose of that requirement is -- Lilly answered that "there has always been a robust written description requirement separate from enablement that is supported by almost two hundred years of precedent," and that the requirement "applies to both original and amended claims and ensures that inventors have actually invented the subject matter claimed in their patents."

Lilly begins its brief by observing that in the U.S., "[t]he statutory scheme has always been a delicate balance between providing an incentive for innovation and protecting the public's right to use technology that does not qualify for the incentive."  In addition to excluding from the incentive that which is old, obvious, or non-enabled, Lilly contends that "subject matter that the patent application shows had not been invented by the applicant, i.e., was not within his possession, at the time the application was filed" is also excluded from the incentive.  According to Lilly, this last exclusion, known as the written description requirement, exists "for good reason," because:

Even inventors as distinguished as Samuel Morse have fallen prey to the temptation to preempt the future before it has arrived.  See O'Reilly v. Morse, 56 U.S. 62 (1853).  Based on little more than an outline of the research program that would be required to make the invention, patent applicants have sought broad, dominating patent protection covering every means of attaining a desired result.  When others later succeed in attaining the sought after result, it is alleged that the research plan was "enabling," confirming the validity of the preemptive claim.  From at least as early as the nineteenth century, however, the courts have recognized that the patent statute requires something more.

Stating that "there is and always has been a written description requirement separate from enablement, and Ariad's arguments to the contrary are simply wrong," Lilly points out that "[t]he statute itself says so, requiring a description of the invention and of the manner of making and using it, and no amount of parsing can read that conjunction out of the statute."

Lilly spends the bulk of its brief reviewing a number of cases that it believes support its argument for the existence of a separate written description requirement.  Among the Supreme Court decisions that Lilly discusses are Evans v. Eaton, 20 U.S. 356 (1822), where the Court "explained that the written description requirement protects the public from an inventor who may 'pretend[] that his invention is more than what it really is'"; O'Reilly v. Morse, 56 U.S. 62 (1853), where the Court "explain[ed] that Morse claimed 'an exclusive right to use a manner and process which he has not described and indeed had not invented, and therefore could not describe when he obtained his patent'" (emphasis in Lilly's brief); and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), where "the Court made abundantly clear that § 112, first paragraph, has three requirements: '[T]he patent application must describe, enable, and set forth the best mode of carrying out the invention" (emphasis in Lilly's brief).  Following its summary of Supreme Court precedent, Lilly states that "[t]he above cases consistently indicate the existence of a separate and robust written description requirement, and Ariad has not cited a single Supreme Court case that says otherwise."

Lilly next moves to the U.S. Court of Customs and Patent Appeals, contending that "[c]onsistent with the above Supreme Court precedent, the C.C.P.A. repeatedly held that § 112 contains a separate written description requirement, and Ariad has failed to cite a single case from the C.C.P.A. that states otherwise."  In support of its argument for a separate written description requirement, Lilly cites In re Moore, 155 F.2d 379 (C.C.P.A. 1946); In re Sus, 306 F.2d 494 (C.C.P.A. 1962); Jepson v. Coleman, 314 F.2d 533 (C.C.P.A. 1963); In re Ruschig, 379 F.2d 990 (C.C.P.A. 1967); In re DiLeone, 436 F.2d 1404 (C.C.P.A. 1971); In re Moore, 439 F.2d 1232 (C.C.P.A. 1971); Fields v. Conover, 443 F.2d 1386 (C.C.P.A. 1971); and In re Barker, 559 F.2d 588 (C.C.P.A. 1977).  With respect to Ruschig, which Ariad cites in support of its argument that there is no separate written description requirement, Lilly states that:

Ariad's strained reading of this case to argue that this inquiry was part of "enablement" should not be accepted, and, to this date, has been rejected by many judges on this Court.  Enzo [Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 971 (Fed. Cir. 2002)] (Lourie & Newman, JJ., concurring); id. at 977-78 (Rader, J., dissenting and writing that Ruschig applied a separate written description requirement); Moba[, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1327] (Bryson, J., concurring).

In view of the above C.C.P.A. decisions, Lilly concludes that "there is simply no basis in the precedent of the C.C.P.A. for the proposition that a separate written description requirement does not exist."

Lilly finishes its discussion of relevant case law with an analysis of Federal Circuit precedent, which "also makes clear that there is a separate written description requirement."  Many of the cases cited by Lilly should be quite familiar to patent practitioners, and include:  In re Alonso, 545 F.3d 1015 (Fed. Cir. 2008); Carnegie Mellon University v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008); LizardTech, Inc. v. Earth Resource Mapping, Inc., 424 F.3d 1336 (Fed. Cir. 2005); University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir. 2004); Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997); Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993); and Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991).  Lilly notes that "[t]he existence of a separate written description requirement has been so clearly established by this Court's precedent that Ariad did not argue at the merits stage of this appeal that a separate written description requirement does not exist," and states that "Ariad's en banc brief relies on dissenting opinions and fails to cite even a single panel decision from this Court supporting its position."

In response to Ariad's statutory construction of 35 U.S.C. § 112, first paragraph (see "Next Up: Ariad v. Lilly Rehearing En Banc"), Lilly contends that the first paragraph of § 112 contains three requirements (emphasis in Lilly's brief):

(1) "The specification shall contain a written description of the invention, and"
(2) "The specification shall contain a written description . . . 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"
(3) "The specification . . . shall set forth the best mode contemplated by the inventor of carrying out his invention."

Lilly notes that "[t]he principal argument advanced by Ariad (and its supporting amici) for why this Court should abandon its long-standing precedent is based upon a fine grammatical parsing of the statute."  However, Lilly points to Judge Rich's concurrence in In re Barker, and argues that Judge Rich "wrote separately because he did not agree that § 112 should be construed by parsing the language of the statute and examining whether words were superfluous," but rather, believed that "construction of 112 should be based on the precedent interpreting the statute over the last hundred or so years."

As for Ariad's argument that the statute does not provide a standard for written description, Lilly counters that "as is often the case with statutes, the legal standards for applying them are developed by courts over time, particularly with respect to a statute such as § 112 where the words were specifically retained to preserve the previously existing precedent."  Lilly also notes that:

Ariad does not seem troubled by the fact that the statute also does not state that enablement must be measured at the time of the filing of the application, that the specification must enable the ''full scope" of the claim, and that a specification is not enabling if it takes more than "undue experimentation" to practice the invention's full scope -- to say nothing of the omission of the factors under In re Wands, 858 F.2d 731,737 (Fed. Cir. 1988).  Similarly, there is nothing in the first paragraph of § 112 that specifies when the best mode analysis is conducted or whether an inventor has an obligation to supplement the best mode in continuing applications.  That these standards were developed by previous and subsequent case law does not mean that the applicable statutory requirement does not exist.

With respect to whether the written description requirement should apply to both original and amended claims, Lilly states that:

For both original and amended claims, a written description of the invention may either be satisfactory or deficient depending on whether the patent specification, including the original claims, provides a demonstration that the patent applicant actually invented and was in possession of the claimed subject matter.  In cases where an original claim provides an adequate written description of the claimed invention, the inquiry need not go any further.  Where an original claim read in light of the specification fails to provide an adequate written description of the invention because, for example, it claims the invention by what it does rather than what it is, then the original claim is invalid.  An amended claim warrants the same inquiry, and there is no logical reason to treat such claims differently.

Lilly also argues that if written description precedent is to be changed, such a change should be made by Congress and not the Federal Circuit sitting en banc.  In support of this argument, Lilly cites Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997), and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002), where "the Supreme Court explicitly stated that this Court should not upset the settled expectations of the patent community."  Noting that "Congress has amended the patent statute many times and is currently in the process of changing the statute yet again," Lilly concludes that "[i]f Ariad is truly correct that all of the above precedent is wrong or unwise, it should be changed by Congress, not this en banc Court."

Patent Docs thanks David Forman of Finnegan, Henderson, Farabow, Garrett & Dunner, LLP for kindly providing us with a copy of Lilly's Principal Brief.

Comments

[Feigin, Patent Attorney]

It shows you how little is really written on the topic of the written description... Lily is citing cases from 1853 and before!

[Skeptical]

cf "fine grammatical parsing" with the letter of the law.