Aug 1 (Reuters) – Swiss pharmaceutical company Roche’s Genentech [RIC:RIC:ROGING.UL] The subsidiary said Novartis (NOVN.S) sold a generic version of the company’s blockbuster pulmonary drug Esbriet and acquired one of the company’s patents after an earlier lawsuit failed to take generic drugs out of the market. accused of infringement.
and Complaint Genentech filed a lawsuit Monday in federal court in Newark, N.J., in which Sandoz, a division of Swiss-based Novartis, knowingly infringed Genentech’s patents, filed a lawsuit against the company in May 2022. He said the drug was released.
It said its market share had been “watered down” by competition. Genentech seeks unspecified monetary damages, but does not seek to stop the sale of generic drugs.
A Sandoz spokeswoman said the company intends to protect itself and “remains proud” to offer generic Esbriet to patients in the United States.
Genentech’s Esbriet is used to treat idiopathic pulmonary fibrosis (IPF), a fatal chronic lung disease with no cure. Roche made more than $1 billion in global revenue from Esbriet in 2021, but sales in 2022 fell to less than $820 million.
In 2019, Sandoz filed with the U.S. Food and Drug Administration to manufacture a generic version of Esbriet. Genentech sued the company to block the proposed generic drug for infringing several of its patents.
A federal judge ruled against Genentech that the patent was invalid or not infringed, and the US Court of Appeals for the Federal Circuit upheld that decision.
The patent in Monday’s lawsuit issued in 2019 and was added to the FDA’s Orange Book, which lists the patents covering each approved drug, as the patent on Esbriet while an earlier lawsuit was pending. It wasn’t part of the previous incident.
Genentech said Sandoz amended its filing with the FDA in 2020 to say the new patent was invalid, but did not specify why. After Sandoz launched a generic drug, other companies followed suit, further cutting Genentech’s market share, the company said.
Genentech said it was entitled to reasonable royalties plus attorneys’ fees because Sandoz “recklessly disregarded plaintiff’s patent rights and continued to intentionally infringe them in an unjust, malicious, and egregious manner.” Stated.
The action is Genentech Inc v. Sandoz Inc, United States District Court, New Jersey, No. 2:23-cv-04085.
For Genentech: David Gindler of Orrick Herrington & Sutcliffe.Loewenstein Sandler with Matthew Oliver
For sand: not available
read more:
Roche Loses U.S. Appeal in Sandoz Lung Drug Patent Lawsuit
Roche loses Sandoz bid to block lung disease generic drug
Report by Brendan Pearson, New York
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