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4 April 2022Big Pharma

Roche asks court for halt of Novartis unit’s generic launch

Roche’s subsidiary Genentech has asked a Delaware court to block two of Novartis’ units from selling a generic version of the blockbuster lung-disease drug Esbriet (pirfenidone).

In an emergency motion, filed Thursday, 31 March, Genentech and Intermune asked the US District Court for the District of Delaware to put in a place a temporary restraining order while District Judge Richard Andrews considers the duo’s request for an injunction pending Roche’s appeal to the US Court of Appeals for the Federal Circuit.

Genentech had sued Sandoz and several other drugmakers for patent infringement in 2019, after the drugmakers filed Abbreviate New Drug Applications.

Following a trial in November last year, On March 22, 2022, Andrews dismissed Roche’s lawsuit that claimed Sandoz’s and Lek Pharmaceuticals’ proposed generic versions of Esbriet would infringe six patents directed towards treatment methods involving pirfenidone.

While Genentech argued that the generic’s label would encourage doctors to prescribe it in a way that infringes the patents, the court found that Sandoz’s label only encouraged non-infringing uses of the drug.

“The infringing uses are presented as options, not recommendations,” said Andrews. “Sandoz's label merely provides physicians with multiple dose modification options, some covered by the asserted patents and some not, and leaves it to the physician's clinical judgment to determine how to modify the patient's dosage.”

Genentech has now appealed against the decision to the Federal Circuit, and filing its notice of appeal at the Delaware court on Friday, April 1.

The opening brief to support Genentech’s emergency motion is sealed. Sandoz and Lek Pharmaceutical’s response to the emergency motion is due on April 8, with any reply brief due by 12 April.

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