Ariad Pharmaceuticals, Inc. v. Eli Lilly and Company
598 F.3d 1336 (2010)
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Rule of Law:
The patent specification must contain a written description of the invention that is separate and distinct from the requirement to enable one of skill in the art to make and use the invention. This written description must demonstrate that the inventor was in possession of the fully-claimed invention as of the patent application's filing date.
Facts:
- Scientists, the inventors of the '516 patent, were the first to identify the transcription factor NF-κB and uncover its mechanism in activating gene expression.
- They discovered that NF-κB is normally kept in an inactive state by a protein inhibitor, IκB.
- Extracellular stimuli, like bacterial lipopolysaccharides, trigger a biochemical reaction that releases NF-κB from IκB.
- Once free, NF-κB travels into the cell nucleus and binds to genes, activating them and causing an immune response which, in excess, can be harmful.
- The inventors recognized that artificially interfering with NF-κB activity could reduce the harmful symptoms of certain diseases.
- On April 21, 1989, the inventors filed a patent application disclosing these discoveries.
- The application claimed methods for reducing NF-κB activity but only hypothesized three general classes of molecules that could potentially achieve this result, without disclosing any specific working examples.
- Eli Lilly & Company (Lilly) manufactured and sold pharmaceutical products named Evista® and Xigris®.
Procedural Posture:
- Ariad sued Eli Lilly for patent infringement in the United States District Court for the District of Massachusetts.
- Following a trial, a jury found that Lilly had infringed the asserted claims of Ariad's '516 patent and that the claims were not invalid for lack of written description or enablement.
- The district court denied Lilly's post-trial motion for judgment as a matter of law (JMOL).
- Lilly (as appellant) appealed the district court's judgment to the U.S. Court of Appeals for the Federal Circuit.
- A three-judge panel of the Federal Circuit reversed the district court's denial of JMOL, holding the asserted claims invalid for lack of an adequate written description.
- Ariad (as appellee) petitioned for rehearing en banc, which the Federal Circuit granted to address the existence and scope of the written description requirement.
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Issue:
Does 35 U.S.C. § 112, first paragraph, contain a written description requirement that is separate from the enablement requirement and applies to all claims, including original claims?
Opinions:
Majority - Lourie, J.
Yes, 35 U.S.C. § 112, first paragraph, contains a written description requirement separate from the enablement requirement. The statutory text "The specification shall contain a written description of the invention, and of the manner and process of making and using it..." establishes two distinct requirements, with the enablement language modifying only the latter. This interpretation is supported by Supreme Court precedent, such as Schriber-Schroth and Festo, and is necessary to fulfill the quid pro quo of the patent system, which requires inventors to disclose what they have actually invented in exchange for exclusive rights. This requirement applies to all claims, including original claims, to prevent inventors from claiming more than they possessed at the time of filing, particularly with broad, functionally-defined genus claims. Ariad's patent fails this test because its claims cover all methods for reducing NF-κB activity, but the specification only hypothesizes three classes of molecules without describing any specific, working embodiments, thus failing to show possession of the claimed invention. The specification amounts to a mere research plan or a wish for a particular result, not a description of a completed invention.
Dissenting-in-part, concurring-in-part - Rader, J.
No, the Patent Act does not contain a written description requirement separate from enablement. The plain language of § 112, paragraph 1, judges the sufficiency of the 'written description of the invention' by the enablement standard—whether it is described in such terms 'as to enable any person skilled in the art... to make and use the same.' The majority's 'possession' test is a standardless judicial creation that has no statutory support and conflicts with other areas of patent law like claim construction and the doctrine of blocking patents. Historically, the written description concept was used only to police priority and prevent the addition of new matter to an application, not to invalidate original claims. The enablement requirement is fully sufficient to police overbroad claims and fulfill the patent system's quid pro quo.
Dissenting-in-part, concurring-in-part - Linn, J.
No, the statutory language does not support a written description requirement separate from enablement beyond the priority context. The only reasonable interpretation of § 112, paragraph 1, is that the description of the invention is judged by the enablement standard. The majority's 'possession' test is vague and its factors mirror the established factors for enablement analysis. The Supreme Court precedent cited by the majority does not support its conclusion, as cases like Schriber-Schroth dealt with new matter and priority issues. Original claims, as part of the initial disclosure, constitute their own description, and the enablement requirement is the proper and sufficient tool to invalidate overbroad or purely functional claims.
Concurring - Gajarsa, J.
Yes, the statute contains a separate written description requirement. While the statutory text is ambiguous, the majority’s interpretation is reasonable and provides needed clarity to the law. However, this separate requirement has little practical impact outside the priority context, as empirical evidence shows it seldom serves as the sole vehicle for invalidating claims. The enablement requirement is a more than adequate tool for policing claims that are broader than their disclosure.
Additional views - Newman, J.
Yes, the holding correctly prevents the patenting of basic scientific research before a practical application is demonstrated. The patent system is designed to incentivize the practical application of scientific advances, not abstract theories. Both the written description and enablement requirements serve the critical function of ensuring that an inventor has moved from a research plan to a demonstrated utility, thereby justifying the grant of a patent monopoly. Ariad's patent claimed a basic discovery without providing a single working embodiment, failing to cross the threshold from theory to practice.
Analysis:
This en banc decision firmly established that the written description requirement is a separate and distinct patentability hurdle from enablement under 35 U.S.C. § 112. It significantly impacts the biotechnology and pharmaceutical fields by limiting the patentability of broad, functionally-defined genus claims. The ruling requires that for such claims, the specification must describe either a representative number of species or common structural features to demonstrate the inventor's 'possession' of the invention, thus preventing patents on mere scientific discoveries, research plans, or desired results. This holding increases the disclosure burden for inventors in unpredictable arts, requiring them to have invented and described concrete embodiments before they can claim a broad functional genus, thereby shaping the patenting strategy for foundational research.
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