Evolving Door?

Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.

It looks like the rules of grammar may have become part of patent litigation's natural selection process.  In Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., the Federal Circuit en banc took up the issue of whether 35 U.S.C. § 112 contains a written description requirement separate and apart from the enablement requirement.  A majority of the Federal Circuit decided it does, relying principally on rules of grammar regarding conjunctions to guide a significant part of that determination.  However, patent law naturalists may want to wait before declaring patents that lack a clear and separate written description extinct.  Two vigorous dissents made compelling arguments regarding prepositional supremacy-as well as challenging the majority's creationism vis-à-vis a new "parallelism" doctrine of statutory interpretation.  Accordingly, before Ariad propagates, the Supreme Court may weigh in. After all, determining whether a separate written description requirement under§ 112 is a favorable patent law characteristic or undesirable statutory mutation may be a determination best left to a higher power.

The patent in Ariad covered regulation of a human genetic component and pathway first identified by the patent's inventors.  As discoverer of the component / pathway and its potential harmful effects / therapeutic treatments, the patent holder sought to encompass use of all substances with the potential to affect those pathways - that is, the entire genus of molecules responsive to the newly discovered component.  The patent holder sued Eli Lily for marketing a pharmaceutical in the genus in the identified claims.  On appeal of the jury's verdict in patent holder's favor, a panel of the Federal Circuit found that Eli Lily should have been granted JMOL.  The panel found the patent did not contain a valid written description because (in part) the patent's claims never identified a specific species of molecule(s) capable of effecting the component's pathway.  The patent holder then petitioned for an en banc rehearing of the panel's ruling.

The fundamental question before the en banc court was whether § 112 should be read to contain two separate requirements (written description and enablement) or rather a single unitary one.  Relying on the language of the statute itself, a majority of the court found that § 112 contains a dual requirement.  The key portion of the statute says:

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 . . . to make and use the same . . . .

Looking at the phrase that begins ", in such full, clear, concise . . . .", the Ariad court said adopting the unitary requirement advanced by the patent holder (and the dissents) would turn the written description language following the conjunction "and" into surplusage.  The majority reasoned that if Congress had intended enablement to be the sole requirement, the statute would have been written differently so as not to distinguish the "description of the invention" from the "manner and process of making and using it."  The Majority also relied on a substantial case history regarding written description (beginning with the original 1793 Patent Act) to argue that a separate requirement of describing one's own invention was fundamental to patent law-characterizing the need to identify what one considered to be his/her invention as part of the quid pro quo of patent law. 

Siding with patent holder, the two separate dissents argued that accepted grammatical use required that the statute's prepositional clause be seen as modifying all of the language preceding it-creating a single statutory requirement.  Both dissenting judges argued that reading a separate written description requirement into the statute (as established by the majority) results in a second, undefined standard for evaluating compliance with the section.  In the dissents' views, the written description need not be full, clear, concise or exact, but need only satisfy a vague - and judicially created - notion that the specification must show that the inventor was "in possession of" the invention.  The dissenters also pointed out problems with the Majority's handling of precedent and noted that the test for evaluating the written description requirement essentially relegates it to a question of fact, rather than a question of law-different from how similar issues such as claim construction and enablement are treated.

What adaptations will be necessary in Ariad's wake?  Certainly, Ariad shows how much words and grammar still matter even in the texting stage of our evolution.  Whether an endangered patent perishes or is preserved may depend upon who best communicates the nuances of the language under consideration. Much will be made of the specific language used in a patent's claims.  The Ariad Majority chose not to establish any "bright line" test for determining sufficiency under the dual writing requirement.  Instead, the necessary level of detail "varies depending on nature and scope of the claims and on the complexity and predictability of the relevant technology."  This test purports to be an objective one, so future litigants will have to identify specific examples in the specifications in addition to general teachings in order to determine whether a patent satisfies the written description requirement.  Survival of the fittest, then, depends upon meeting the "in possession of" standard in light of the relevant field of art- making the question of what constitutes sufficient detail potent protoplasm in patent litigation's ever-evolving primordial soup.

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