Genentech, Inc. v. Hospira, Inc., No. 18-1933 (Fed. Cir. 2020)Annotate this Case
Genentech’s patent is directed to methods of purifying antibodies and other proteins containing a CH2/CH3 region from impurities by protein A affinity chromatography. Protein A affinity chromatography is a standard purification technique employed in the processing of therapeutic proteins, especially antibodies, which involves “using protein A . . . immobilized on a solid phase.” The Patent Trial and Appeal Board instituted inter partes review (IPR) and determined that all the challenged claims were unpatentable as anticipated or obvious in light of prior art references. The Federal Circuit affirmed, finding substantial evidence in support of the findings. The court also rejected Genentech’s argument that retroactive application of IPR to a patent issued prior to the passage of the America Invents Act violates the Fifth Amendment’s Takings Clause; pre-AIA patents were issued subject to both district court and Patent Office validity proceedings. Though IPR differs from district court and pre-AIA Patent Office reexamination proceedings, those differences are not sufficiently substantive or significant such that a “constitutional issue” is created when IPR is applied to pre-AIA patents.