Patent infringement: Roche loses US appeal in Sandoz lung disease drug case

The U.S. Court of Appeals for the Federal Circuit upheld a decision rejecting Genentech's bid to block the generic idiopathic pulmonary fibrosis (IPF) drug.

The Federal Circuit said Sandoz's drug would not infringe Genentech patents related to methods for managing side effects while using Esbriet. Other patents Genentech accused Sandoz of infringing were invalid, the appeals court said.

Representatives for both Genentech and Sandoz declined to comment, citing ongoing litigation.

San Francisco-based Genentech's Esbriet is used to treat IPF, a serious chronic lung disease. Roche earned over $1 billion last year from worldwide Esbriet sales.

Genentech sued Switzerland-based Sandoz and several other drugmakers, including Amneal Pharmaceuticals Inc and Teva Pharmaceutical Industries Ltd, for patent infringement in 2019 over their proposed Esbriet generics. Sandoz defeated Genentech's lawsuit against it in Delaware federal court in March and launched its generic in May.

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The Federal Circuit agreed with the district court that Sandoz's generic would not infringe patents covering ways to avoid adverse interactions between Esbriet and another drug. It also upheld the decision that some of Genentech's patents were invalid.

"Varying doses in response to the occurrence of side effects would seem to be a well-established, hence obvious, practice," the appeals court said. "Thus, claiming it as an invention would appear to be at best a long shot."

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The case is Genentech Inc v. Sandoz Inc, U.S. Court of Appeals for the Federal Circuit, No. 22-1595.

For Genentech: Daralyn Durie of Durie Tangri

For Sandoz: William Jay of Goodwin Procter