A Cure for Written Description and Enablement Headaches: Prior Art

Written by: Ben K. Shiroma and Alistair J. McIntyre

TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY

Before Prost, Cunningham, and Andrews. Appeal from the United States District Court of the District of Massachusetts.

Summary: A functionally defined genus recited in a method of treatment claim may be adequately described and enabled by a single example if, at the priority date, the members of the genus were well-known.

Teva sued Eli Lilly for infringing several patents claiming the use of humanized anti-CGRP antagonist antibodies (“Antibodies”) to treat headaches. A jury found that Eli Lilly willfully infringed Teva’s valid patents. Eli Lilly moved for JMOL of invalidity due to failure to satisfy the written description and enablement requirements. The district court granted Eli Lilly’s motion on both grounds. Teva appealed.

On appeal, the Federal Circuit reversed and remanded. The specification disclosed one Antibody as well as prior art anti-CGRP antagonist antibodies and humanization methods. The court found that the claimed invention was the use of a well-known, albeit functionally defined, genus; the claimed invention was not a new genus of antibodies. The court also relied upon the jury’s verdict and noted that the jury could have found, in support of its verdict, that a POSITA would have understood from the specification that the class of anti-CGRP antagonist antibodies and techniques for humanizing antibodies were well-known. The jury also could have found, in support of its verdict, that all Antibodies could be used to treat headaches. Accordingly, the court found that the disclosure of a single Antibody was, under these circumstances and based on this record, sufficiently representative to describe and enable the functionally defined genus recited in the claimed method of treatment.

Editor: Sean Murray