Patent infringement: Roche sues Novartis unit over generic lung disease drug

In a complaint filed on Monday in federal court in Newark, New Jersey, Genentech said Sandoz, a unit of Switzerland-based Novartis, had launched its drug in May 2022 despite knowing that it infringed Genentech's patent.

It said the competition "eviscerated" its market share. Genentech is asking for unspecified money damages, but is not seeking to halt sales of the generic drug.

A Sandoz spokesperson said the company would defend itself and that it "remains proud" of providing generic Esbriet to U.S. patients.

Genentech's Esbriet is used to treat idiopathic pulmonary fibrosis (IPF), a fatal chronic lung disease with no cure. Roche earned over $1 billion worldwide from Esbriet in 2021, but sales fell to under $820 million in 2022.

Sandoz filed an application with the U.S. Food and Drug Administration to make generic Esbriet in 2019. Genentech sued the company in an effort to block the proposed generic, saying it would infringe several of its patents.

A federal judge ruled against Genentech, finding the patents were either invalid or would not be infringed, and the U.S. Court of Appeals for the Federal Circuit upheld that ruling.

The patent in Monday's lawsuit was issued in 2019 and added to the FDA's Orange Book, which lists which patents cover each approved drug, as a patent on Esbriet while the earlier lawsuit was pending. It was never part of the earlier case.

Genentech said that Sandoz in 2020 amended its application to the FDA to state that the new patent was invalid, but did not give any reason. After Sandoz launched its generic, other companies followed, further cutting into Genentech's market share, the company said.

Genentech said that in addition to a reasonable royalty, it was entitled to be paid for its attorneys' fees because Sandoz had "deliberately continued to infringe in a wanton, malicious, and egregious manner, with reckless disregard for plaintiffs' patent rights."

The case is Genentech Inc v. Sandoz Inc, U.S. District Court, District of New Jersey, No. 2:23-cv-04085.