Roche loses bid to block Sandoz generic lung-disease drug

U.S. District Judge Richard Andrews on Tuesday rejected Genentech's infringement claims and found that parts of the Genentech patents were invalid.

Genentech's Esbriet is used to treat idiopathic pulmonary fibrosis (IPF), a serious chronic lung disease with no cure. Roche earned over $1 billion last year from worldwide Esbriet sales.

San Francisco-based 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 generic versions of Esbriet.

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Genentech's patents cover methods of using Esbriet to treat IPF, and Genentech said the label of Sandoz's generic would encourage doctors to prescribe it in a way that infringes.

Andrews ruled for Sandoz on Tuesday and found Sandoz's label only encouraged non-infringing uses of the drug.

Sandoz's label included some infringing uses as "options, not recommendations," Andrews said.

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Andrews also said that parts of some of the patents were invalid based on earlier publications that, taken together, made Genentech's innovations obvious.

Genentech and its attorneys declined to comment. Sandoz and its attorneys did not immediately respond to a request for comment.

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The case is Genentech Inc v. Sandoz Inc, U.S. District Court for the District of Delaware, No. 1:19-cv-00078.

For Genentech: Mark Waddell and Alexandra Cavazos of Loeb & Loeb

For Sandoz: Emily Rapalino of Goodwin Procter