Thursday, December 22, 2022

Genentech v. Sandoz' Genentech loses appeal

The outcome:

Genentech, Inc. and InterMune, Inc. (collectively, “Genentech”) appeal from a decision of the United States District Court for the District of Delaware holding that: (1) the claims of its Liver Function Test (“LFT”) patents1 are unpatentable as obvious, (2) sale of Sandoz Inc.’s and Lek Pharmaceuticals, D.D.’s (collectively, “Sandoz’s”) generic product would not induce infringement of the LFT patents, and (3) sale of Sandoz’s generic product would not directly infringe Genentech’s Drug-Drug Interaction (“DDI”) patents.2 See Genentech, Inc. v. Sandoz, Inc., No. 19-0078, 2022 WL 842957 (D. Del. Mar. 22, 2022) (“Decision”). We affirm.

Genentech's arguments

With respect to obviousness, Genentech argues that the district court improperly supplied missing claim limitations, read the prior art in ways that cannot be supported based on plain meaning, and failed to make any legal or factual findings with respect to claim 9 of the ’729 patent and claim 12 of the ’462 patent. Genentech asserts that neither Azuma nor the Pirespa® label literally discloses Grade 2 elevated liver enzymes or the claimed continued treatment of patients with pirfenidone. It adds that these elements are not within the knowledge of those skilled in the art. Genentech also argues that the court’s analysis of the Pirespa® label is not entitled to deference, and should be reviewed de novo, because it involved no fact finding. Lastly, Genentech asserts that objective indicia of nonobviousness weighed in its favor because it showed skepticism regarding pirfenidone’s efficacy and safety, as well as evidence of a long-felt and unmet need of treating patients following Grade 2 AST/ALT elevations.


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