Ariad v. Lilly: Federal Circuit Upholds Separate Written Description and Enablement


03.20.11 Posted in Federal Circuit Opinions by

In an en banc decision, the majority opinion of the Federal Circuit affirmed, in Ariad Pharms., Inc. v. Eli Lilly Co., that there are separate written description and enablement requirements in 35 U.S.C. § 112 first paragraph, and that the requirement applies to original claims as well as amended claims. (598 F.3d 1336 (No. 2008-1248) (Fed. Cir. March 22, 2010)).  However, Judges Rader and Linn filed vigorous dissents, arguing that no such distinction should exist.

The patent at issue was U.S. Patent 6,410,516 (the ‘516 patent), which disclosed a transcription factor called “NF-KB” (Nuclear Factor Kappa B) which is involved in the body’s response to infection.  The claims at issue recited generic methods of reducing NF-KB activity and the binding of NF-KB to NF-KB recognition sites, but did not recite actual compounds capable of effecting the claimed activity.

Ariad sued Lilly, alleging that Lilly’s products Evista® and Xigris® infringed the claims of the ‘516 patent.  At the district court, the claims were found infringed by Lilly, and not invalid for anticipation, lack of enablement, or written description.   On appeal to the Federal Circuit, the original panel reversed the district court on the question of written description, holding the claims invalid for lack of written description (Ariad Pharms., Inc. v. Eli Lilly Co., 560 F.3d 1366 (Fed. Cir. 2009)).

Ariad petitioned for rehearing en banc (filed June 2, 2009), arguing that the written description requirement employed by the Federal Circuit “is tantamount to a ‘superenablement’ test,” in which patent validity will be based on a non-statutory “written description” requirement rather than enablement.  Ariad petition at 10.  Ariad took the position that the § 112 ¶ 1 only requires enablement, and that the legal sufficiency of the two-prong description requirement of  § 112 ¶ 1 is judged by whether it enables one of skill in the art to make and use the claimed invention. Ariad thus contends that the written description requirement exists, not for its own sake as an independent statutory requirement, but only to identify the invention that must comply with the enablement requirement. It appeared that the parties accepted that Ariad’s patent was enabled, but did not meet a purported separate written description requirement that allegedly first arose in Regents of the Univ. Calif. v. Eli Lilly & Co., 119 F. 3d 1559, 1566–1569 (Fed. Cir. 1997). See Rader dissent at 5.  Accordingly, if the court was to rule that there was no such separate written description, Ariad would prevail.

The court granted Ariad’s petition in light of controversy in recent years surrounding the question.  The parties were asked to brief the questions of whether §112, paragraph 1 contains a written description requirement separate from an enablement requirement, and the scope of the written description requirement, if a separate requirement does exist.

The Ariad side of this controversy is that there is no separate written description and enablement requirement.  The parties began with grammatical arguments.  Ariad parses § 112 first paragraph as:

[A] a written description

[i] of the invention, and

[ii] of the manner and process of making and using it,

[B] 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 . . .

Lourie majority opinion, slip op. at 8.  By contrast, Lilly parses the statute as:

(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 the invention.” Id. at 9

Thus, Lilly would parse the statute as requiring distinct requirements for a written description of the invention, and of enablement.  Enablement is defined here as “the manner and process of making and using” the invention.  Id.

The majority opinion, written by Judge Lourie, holds that § 112 first paragraph contains two separate description requirements: “[i] of the invention, and [ii] of the manner and process of making and using [the invention].”  The opinion states that Ariad’s position relegates either “the manner and process of making and using it” or “[a written description] of the invention” as surplusage.  The opinion goes on to assert that this interpretation is consistent with the 1793 and 1836 Patent Acts, and Supreme Court precedence.  Furthermore, although recodified in the 1952 Act, Lourie says the legislative history did not suggest that Congress intended to remove the separate description requirements. Id. at 11–12.

Lourie discusses Supreme Court precedence supporting the separate description requirements going back to Evans v. Eaton (1822), and including O’Reilly v. Morse (1853), Schriber-Schroth v. Cleveland Trust Co. (1938), and Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. (2002).  The opinion asserts that the Supreme Court has held, before and after Schriber-Schroth, that the “statute serves a purpose other than enablement.” Id. at 14.

The opinion included a substantial discussion on whether there is a different written description standard for originally filed claims than for claims amended in prosecution.  Ariad argued that because original claims are part of the application as filed, they constitute their own written description of the invention, and there is no need for any further written description of originally filed claims “as long as the claim language appears in ipsis verbis in the application as filed.”  Id. at 19. But, the majority opinion disagreed with this analysis, and sided with Lilly’s response that the written description requirement applies to all claims, originally filed and amended in prosecution.  The requirement requires that the “specification objectively demonstrate that the applicant actually invented—was in possession of—the claimed subject matter.”  Thus, the court rejects separate standards for original and amended claims.

Furthermore, the opinion asserts that original claims do not necessarily adequately describe the subject matter claimed. Id. at 20.   For example, a broad genus to a chemical compound is not patentable if sufficient species to support the claim to the genus are not described.  The opinion notes this problem can be especially acute with genus claims that use functional language to define the boundaries of the claimed material.  In such a case, the functional claim may be merely a desired result, without describing species that achieve that result.  Id. at 21.  An applicant may not claim “only a definition of a useful result rather than a definition of what achieves that result.” Id.

Functional claim language can meet the written description requirement when there is a correlation between structure and function, but merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus.  Id. Claim language that amounts to no more than a wish or a plan is not adequately described and not patentable.   Id. at 22. Thus, generic language in application, even as originally filed, does not automatically satisfy the written description requirement.  Id. at 23.

The opinion has a substantial discussion affirming the test for sufficiency (i.e., written description) affirming the standard from Vas-Cath Inc. v. Mahurkar (Fed. Cir. 1991).  Id.  The description must allow a person of ordinary skill to recognize that the inventor invented what was claimed.  Sufficiency exists when “the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.”  Id. The term “possession” means that “the specification must describe an invention understandable to [a] skilled artisan and show that the inventor actually invented the invention claimed.”  Id. at 24.

The inquiry into sufficiency is a question of fact.  The level of detail required to satisfy the written description requirement “varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”  Id.  This test is applied “at the time the invention enters the patent process,” i.e., the time of filing, to show that the patented advance is novel with respect to the “art from which it emerges.”  Id.

This factual inquiry raises questions of reduction to practice and the propriety of functional claiming.  The written description requirement does not require examples or an actual reduction to practice. Id. at 25. Lourie rejects any bright line rules governing, for example, the number of species that must be disclosed to describe a genus claim. Id. at 24–25. A constructive reduction to practice “that in a definite way identifies the claimed invention” can satisfy the written description requirement.  This is not a “superenablement requirement,” as alleged by Ariad.  Id. at 26. But, in some fields there may be little difference in the requirements for description and enablement (they “rise and fall together”), but that is not true for other fields, in particular chemistry.  Id.

With regard to functional claiming, where a genus is claimed by its function or result, the specification must recite sufficient materials to accomplish that function.  Id. at 27.  In Univ. Rochester v. G.D. Searle (Fed. Cir. 2004), claims directed to a method of selectively inhibiting COX-2 by a nonsteroidal compound were held to be invalid, 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.  Id. Thus, claims that merely recite a description of a problem to be solved, while claiming all solutions to it, leave the task to others to “complete an unfinished invention.”

Ariad countered that the separate written description doctrine will disadvantage basic research performed at universities, but Lourie responds that “[p]atents are not awarded for academic theories, no matter how groundbreaking ….”  Id. at 28.  “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.” Id.  Lourie asserts that claims to research plans would “impose costs on downstream research, discouraging later invention.”  Id.  Thus, the written description requirement is part of the quid pro quo of the patent grant. Id. at 29.

The en banc decision then affirmed the panel decision.

Judge Newman concurred in the opinion, but noted that whether a basic discovery is patentable is highly fact dependent.  Newman argues principally that the “overriding policy of patent systems requires both written description and enablement.”  Newman concur at 2.  “Basic scientific principles are not the subject matter of patents, while their application is the focus of this law of commercial incentive. The role of the patent system is to encourage and enable the practical applications of scientific advances, through investment and commerce,”  id. at 3, but any invention of basic science must have an “embodiment demonstrating its application and illustrating its breadth.”  Id. at 4.  Thus, Newman argues that any description of basic academic research must be enabled with an example to meet the policy requirements of patentability.

Gajarsa also concurred in the majority opinion, arguing that whether or not there is a distinct written description requirement has no “significant, practical impact.”  Gajarsa concur at 2.  Gajarsa cites several studies as empirical evidence that “outside the priority context the written description doctrine seldom serves as a separate vehicle for invalidating claims.” Id.  Gajarsa would therefore limit the written description doctrine to the priority context, which he asserts will provide greater clarity to district courts and practitioners.

Judge Rader wrote a strenuous dissent, joined by Judge Linn, asserting that the majority relies on an “undefined ‘written description’ doctrine,” that results in “standardless decision making and serious conflicts with other areas of patent law.”  Rader dissent at 1. Rader asserts that the majority’s written description requirement (he uses the words “petrified today”) has no statutory support. Id. at 2.  Rader believes § 112 first paragraph is unambiguous, in requiring a description in sufficient terms to enable a skilled person to use the invention. Id. at 3.  By contrast, Gajarsa described the statute as a “model of legislative ambiguity.”  Gajarsa concur at 1.

A large part of Rader’s disagreement with the majority is over whether the statute requires that the “inventor satisfy some quixotic  possession requirement.”  Rader dissent at 3. Rader believes the majority holds that written description is a “vague possession notion,” and has the practical effect of not requiring a full, clear, concise, or exact description of the invention.  Id. Rader also alleges that the Federal Circuit “fabricated” the current “written description doctrine” in Regents of the Univ. of Calif. v. Eli Lilly & Co., (Fed. Cir. 1997).  Id. at 5.  Yet, the majority makes a point of linking “possession” to Vas-Cath v. Mahurker, (Fed. Cir. 1991), which in turn cited to older cases using the word “possession” in the context of compliance with written description and enablement (see majority opinion at 23–24).

In Rader’s view, written description is satisfied when the specification identifies the invention and tells a person of ordinary skill what to make and use. Id. at 5. Rader makes a central point that this is applicable to original claims in the priority context, and is appropriately used to prevent the addition of new matter to an original disclosure. Id. Rader then alleges that after Univ. Calif. in 1997, the written description requirement was extended outside the priority context.  Rader asserts that the majority can cite no Supreme Court precedent for its interpretation of the written description requirement.

Rader finally asserts that the “possession” requirement is meaningless because inventors are “always quite certain that they possess their invention.”  Id. at 7.  This is disingenuous because the majority sets forth a framework for analyzing possession, and an inventors opinion on any legal question is subjective, which is an improper standard.

It appears that the difference here may turn on the different standards for originally filed applications compared to amended applications.  It is not clear why this is an issue at all, but Rader makes a lot of hay out of this.

Rader also complains that Eli Lilly caused a plethora of problems, and specifically discusses claim construction and blocking patents.  With regard to claim construction, Rader believes that under  the majority analysis, claims can never logically have a scope that exceeds the disclosure, so a claim can never “lack support.”  Id. at 8. This assertion is not cogently explained.  With regard to blocking patents, Rader believes that a later improvement claim, which is junior to a generic blocking patent, will not be blocked unless the pioneering patentee chose not to claim the improvement.  Id. at 9.  As with the claim construction analysis, this assertion does not appear to be cogently supported.  Evidently, under the Eli Lilly analysis, improvement claims cast doubt on the written description of a pioneering patent, id., which if true, reduces the incentive of parties to cross-license each others patents (which is undesirable).  Id. at 10.

Rader further complains that making the sufficiency test a question of fact creates a situation where there are objective inquiries into a subjective question.  Id. at 10.  The subjective question is whether the inventor possessed the claimed invention, but the objective inquiry is whether the four corners of the specification support the asserted possession from the perspective of a skilled person.  Id.  By contrast, claim construction and enablement are questions of law.  Rader asserts that the statute supplies a strong enablement test that has stood the test of time and needs no “new rules,” presumably referring to the bifurcated enablement and written description requirement. Id. at 11.  Rader sounds an alarmist tone that seems overblown.

Judge Linn also dissented, and asserts that the only reasonable interpretation of the written description requirement of § 112 first paragraph is Ariad’s, “because it conforms to the long-recognized purpose of the statute in policing new matter violations and because it tethers the written description of the invention to an understood standard: such full, clear, concise, and exact terms so as to enable.” Linn dissent at 2, internal quotes omitted.  Linn believes that Congress provided a legal standard for § 112 first paragraph, which is to “enable a skilled artisan to make and use the invention particularly pointed out and distinctly recited in the claims.” Id. at 3.  Linn says that the bifurcated standard of the majority opinion is “poorly defined” and “unnecessary and ill advised.” Id. at 2–3.  The standard includes the prohibition against undue experimentation, from In re Wands (1988).

Linn states that the separate test is not justified, and the majority fails to distinguish the test for written description from the test for enablement. Id. at 4.   Linn says that the written description factors at 24 of the majority opinion mirror the Wands factors for enablement. Id. The majority attempts to distinguish enablement by asserting that enablement curtails claims that do not require undue experimentation, but that have not been invented.  Id.  This seems to refer to claims to a hypothetical embodiment.  Linn asserts that if a POSA can make and use the invention, it has been invented and needs no “undefined level of additional description.” Id. at 4–5.

Linn next rejects that majority’s assertion that the separate written description and enablement requirement was not created in the Eli Lilly decision in 1997, but rather was created by the Supreme Court in the 19th Century, and therefore has weighty stare decisis effect. Linn asserts that the history of the Patent Acts do not provide for separate written description.  Linn also discredits the majority’s reliance on Schriber-Schroth (1938), O’Reilly v. Morse (1854), and Festo (2002).  Id. at 6–7. Linn concludes by asserting that prior to Eli Lilly in 1997, the written description doctrine was used to “control patent applicant’s claims to priority, but not to invalidate originally filed claims.” Id. at 8.  “Only since Lilly have we forced original claims over a description hurdle extending beyond enablement.” Id.

With regard to original claims, Linn rejects Lilly’s argument that original claims are not necessarily an adequate written description of the invention.  Id.  Linn is not convinced of the policy reasons that original claims need a written description requirement.  Id.  Linn arguues that original claims are part of a patent’s disclosure, so original claims constitute their own description.  Id., at 8–9. Linn asserts that it is “inconsistent” that original claims do not show possession and enablement.  Id. at 9. With regard to overly broad or functional claims, such claims will not be enabled.  Id. at 10.

Linn concludes that the majority leaves unanswered the question over whether Ariad’s ‘516 claims are enabled.  Id. at 12.  Linn would have held that the question before the en banc court (whether there is a separate written description and enablement requirement) should have been answered in the negative, and the case should have been remanded to the panel for resolution of whether the ‘516 claims were enabled and Lilly’s remaining defenses.  Id.



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