Abbvie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.
2014 U.S. App. LEXIS 12372, 759 F.3d 1285, 111 U.S.P.Q. 2d (BNA) 1780 (2014)
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Rule of Law:
A patent claiming a genus defined by a functional characteristic, such as binding affinity, fails to meet the written description requirement if the specification only discloses a narrow and structurally similar subset of species, which are not representative of the full structural diversity of the genus.
Facts:
- AbbVie developed fully human antibodies that neutralize human interleukin 12 (IL-12) using a 'phage display' technique, starting with a lead antibody named 'Joe-9'.
- All antibodies described in AbbVie's '128 and '485 patents were derived from Joe-9, had VH3 type heavy chains and Lambda type light chains, and shared 90% or more amino acid sequence similarity.
- The patents claim a genus of antibodies defined by their function—specifically, their ability to bind to IL-12 with a specified high affinity (a low koff rate).
- Centocor independently developed its own IL-12 antibody, Stelara®, using a different 'transgenic mice' technology.
- Stelara® has VH5 type heavy chains and Kappa type light chains and shares only about 50% sequence similarity with the antibodies described in AbbVie's patents.
- Despite its structural differences, Centocor's Stelara® antibody falls within the functional definition of the genus claimed in AbbVie's patents.
Procedural Posture:
- Centocor initiated a patent interference proceeding against AbbVie's '128 patent at the PTO Board of Patent Appeals and Interferences (the 'Board').
- The Board awarded priority to AbbVie and held the patent claims were not invalid for obviousness.
- AbbVie sued Centocor for patent infringement in the U.S. District Court for the District of Massachusetts (trial court).
- Centocor filed a civil action in federal district court under 35 U.S.C. § 146 seeking review of the Board's interference decision, which was consolidated with the infringement suit.
- The district court denied AbbVie's motion for summary judgment, which had argued that Centocor was collaterally estopped from challenging the patent's validity.
- After a trial, a jury found the asserted patent claims invalid for lack of written description, lack of enablement, and obviousness.
- The district court denied AbbVie's post-trial motions for judgment as a matter of law (JMOL) and for a new trial, entering a final judgment of invalidity.
- AbbVie, the appellant, appealed the judgment to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does a patent claiming a genus of antibodies defined by function satisfy the written description requirement of 35 U.S.C. § 112 if the specification only discloses a narrow family of structurally similar antibodies, while the claim covers structurally diverse antibodies?
Opinions:
Majority - LOURIE, Circuit Judge.
No. A patent does not satisfy the written description requirement when its claims cover a broad and structurally diverse genus, but its specification only describes a narrow, structurally homogenous subset of that genus. The essence of the written description requirement is to ensure the inventor was in possession of the claimed invention, which for a genus claim requires disclosing either a representative number of species or common structural features. Here, AbbVie's patents only describe antibodies derived from a single source (Joe-9), which are all structurally similar (VH3/Lambda, >90% sequence similarity). The claims, however, are broad enough to cover structurally distinct antibodies like Centocor's Stelara (VH5/Kappa, 50% similarity). The disclosed species only 'abide in a corner of the genus' and are not representative of its full scope. In an unpredictable art like antibody engineering, claiming a genus by a functional result (a specific koff rate) without adequately describing the structural diversity of molecules that can achieve that result amounts to claiming a 'research plan' rather than a completed invention.
Concurring - O’MALLEY, Circuit Judge
I concur in the judgment to affirm the invalidation of the patents, but for a different reason. The court should have affirmed based on the jury's finding of obviousness, which AbbVie did not substantively appeal, rather than reaching the more complex written description issue. AbbVie's only challenge to the obviousness verdict was a claim of erroneous jury instructions. Since the jury instructions were not prejudicially erroneous, the obviousness verdict should stand, making the patents invalid on that ground alone. The majority's extensive analysis of written description is therefore unnecessary dicta.
Analysis:
This decision solidifies a high bar for satisfying the written description requirement for functionally-claimed genera in unpredictable arts like biotechnology. It confirms that merely disclosing numerous examples is insufficient if those examples lack structural diversity and fail to represent the full scope of the claim. The ruling makes it more difficult for patentees to claim broad protection covering future innovations that achieve the same functional result through different structural means. This incentivizes innovators to disclose a wider range of representative species or identify common structural features, thereby limiting overbroad claims that could stifle subsequent innovation.
