• Sep 28 2020
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  • Category: CAFC Updates

Biogen MA, Inc. sued EMD Serono, Inc. and Pfizer alleging contributory and induced infringement of Biogen’s U.S. Patent Number 7,588,755 by the sale and marketing in the United States of Rebif, a recombinant interferon-β (“IFN-β”) product used for the treatment of Multiple Sclerosis. After a five-week trial, a jury found that the ’755 patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases, but the district court granted judgment as a matter of law (“JMOL”) of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation. In evaluating the evidentiary record presented to the jury on the question of anticipation, the district court: (1) declined to apply a product-by-process analysis to the claimed recombinant IFN-β source limitation; and (2) in its alternative ground analysis, required identity of three-dimensional structures not specifically recited in the claims rather than the claimed and lexicographically defined “polypeptide.” The CAFC finds that both of these determinations led to an erroneous conclusion on anticipation. Biogen’s only basis for novelty of the method of treatment claims is the novelty of the recombinant IFN-β composition that is administered, and that composition is claimed in terms of the process by which it is manufactured. However, the CAFC notes that there is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated. With respect to identity of 3-D structure, the CAFC finds that the claims, in calling for antiviral activity, do not recite any specific folded 3-D structure that gives rise to that activity. Because a reasonable jury could find the claims of the ’755 patent anticipated on the record presented in this case, the CAFC reverses the district court’s JMOL of no anticipation and remands with instructions to reinstate the jury verdict of anticipation.

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