Roche loses bid to block Sandoz generic lung-disease drug

A sign at a diagnostics site for Swiss pharmaceutical giant Roche in Burgess Hill, Britain, October 7, 2020. REUTERS/Peter Nicholls
  • Judge said Sandoz's generic label would not encourage infringement
  • Parts of Esbriet patents owned by Roche's Genentech invalid

(Reuters) - Sandoz Inc has persuaded a Delaware federal judge to throw out a lawsuit that claimed its proposed generic version of a blockbuster lung-disease drug would violate the patent rights of the drug's original maker, Roche's Genentech Inc.

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.

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.

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.

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

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Blake Brittain reports on intellectual property law, including patents, trademarks, copyrights and trade secrets. Reach him at