GENENTECH, INC. v. HOSPIRA, INC.

Before Prost, Newman, and Chen. Appeal from the Patent Trial and Appeal Board.

Summary: Prior art disclosing a temperature range that partially overlaps with the claimed temperature range, establishes a prima facie case of anticipation and obviousness even if the overlap is slight. Also, IPR proceedings apply even to pre-AIA patents.

Hospira petitioned for IPR against a Genentech patent. The claims at issue relate to reducing impurities that result from protein A affinity chromatography by using a specific temperature range “from about 10℃ to about 18℃.” Prior art disclosed a temperature range of “18-25℃.” The Board determined that all the challenged claims were anticipated by this reference or rendered obvious by the reference alone or in combination with other references. Genentech appealed and challenged the Board’s findings as well as the constitutionality of the IPR process itself, because Genentech’s patent issued before the AIA was enacted.

The Federal Circuit affirmed. The Court noted that an overlapping range can be anticipatory, even if the overlap is slight. Also Genentech did not establish that the claimed range was critical to the operability of the invention. The Court added that an overlapping range created a presumption of obviousness and that the patentee must provide evidence that the overlapping range would not have been obvious. The Board considered Genentech’s evidence on the importance of the range to be unpersuasive, and concluded that substantial evidence supported the Board’s decision. Lastly, in view of its prior holding in Celgene Corp. v. Peter, 931 F.3d 1342 (Fed. Cir. 2019), the Federal Circuit held that it is not unconstitutional to apply IPR proceedings to pre-AIA patents.

Editor: Paul Stewart