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20 May 2019AmericasJohn H. Heithaus and Gerald M. Murphy

Antibody patents: Danger ahead for biologics

In recent years, the written description requirements at the US Patent and Trademark Office (USPTO) for broadly claiming antibodies have been significantly raised. These heightened requirements follow a series of cases by the Court of Appeals for the Federal Circuit (CAFC) over the last few years.

This article will explore what requirements are “mandated” by CAFC precedents, how USPTO is currently examining claims that recite an antibody using broad terms, and when and how applicants can push back when claims that recite antibodies broadly are necessary to protect an invention.

CAFC precedent

Before 2014, the majority of antibody patents invalidated for lack of written description involved issues of claiming embodiments which were clearly not possessed. For example, in Chiron v Genentech, 363 F.3d 1247 (Fed Cir 2004), a humanised antibody claim was later added to a case that was filed before humanised antibodies were in fact in existence. After 2014, several patents with functional claims against certain antigens have been invalided, eg, “an antibody against protein X”.

The primary case in 2014 invalidating an antibody product claim was AbbVie v Janssen, 759 F.3d 1285 (Fed Cir 2014). AbbVie sued Janssen for infringement of several claims of US patent 6,914,128 and US patent 7,504,485. An exemplary claim of the ‘128 patent read as follows: “29. A neutralising isolated human antibody, or antigen-binding portion thereof that binds to human IL-12 and dissociates from human IL-12 with a koff rate constant of 1 × 10-2s-1 or less, as determined by surface plasmon resonance.”

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