Genus Claims Require Disclosure of “Representative Species Encompassing the Breadth of the Genus”

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AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc.

Finding that a patent specification did not disclose a representative number of antibody species within the claimed genus, the U.S. Court of Appeals for the Federal Circuit upheld a jury verdict finding claims were invalid for lack of written description.  AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., Case Nos. 13-1338; -1346 (Fed. Cir., July 1, 2014) (Lourie, J.) (O’Malley, J. concurring).

AbbVie’s patent claims were drawn to human antibodies that are useful for treatment of psoriasis and rheumatoid arthritis.  The claims require that antibodies bind to a protein called IL-12 at a certain measurable binding strength (koff).  The specification disclosed about 300 different antibodies with these characteristics, all of which were derived from a single “parent” antibody.  As such, these 300 antibodies are more than 90 percent identical to one another within the region that binds to the IL-12, and over 200 of these share a 99.5 percent amino acid sequence similarity in that region.  At trial, Janssen established that its allegedly infringing IL-12 antibody was structurally different from AbbVie’s disclosed antibodies and, further, that antibodies with 80 percent sequence identity to AbbVie’s disclosed antibodies could bind to totally different targets than IL-12.  The jury found that the claims invalid as lacking a sufficient written description, enablement and for obviousness.  AbbVie appealed.

On appeal the Federal Circuit agreed that the written description did not provide a representative number of species evincing that the inventors truly invented the full scope of the genus.  The Court concluded that the claims recited antibodies based on functional characteristics and that this functional genus would encompass antibodies with a wide variety of structural characteristics.  The Court noted that, “[a]lthough the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”  Analogizing the scope of a genus to a plot of land, the Court found that AbbVie’s disclosed antibodies were concentrated within one “corner of the genus” and that AbbVie did not describe “sufficient representative species encompassing the breadth of the genus,” but only “a research plan, leaving it to others to explore the unknown contours of the claimed genus.”

In response to AbbVie’s argument that the koff limitation provided the requisite representativeness across the genus, the Court found that “[t]he koff rate is merely a desired result, rather than the actual means for achieving that result.”  The Court reiterated the importance of providing “a reasonable structure-function correlation” when pursuing functional claims:

Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.

Practice Note:  Although not explicit, the Court’s warning seems to be directed to patent holders in the “highly unpredictable” life sciences space.  Sufficient written description support for functional genus claims in the life sciences space seems to require either an explicit disclosure of a structure-function correlation, or else a disclosure of multiple species sharing the claimed function, but having a wide variety of different structures.

Topics:  AbbVie, Patent Litigation, Patents, Pharmaceutical, Pharmaceutical Manufacturers, Pharmaceutical Patents

Published In: Civil Procedure Updates, Intellectual Property Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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