Exelixis, Teva settle Cabometyx patent litigation with 2031 generic license

2023-07-24

专利侵权上市批准免疫疗法专利到期

Exelixis, Teva settle Cabometyx patent litigation with 2031 generic license

Preview

来源: FiercePharma

Exelixis had filed a pair of lawsuits against Teva centered on patents that expire in the 2030s, but now the companies have settled the cases.

With stalwart cancer drug Cabometyx driving its commercial performance, Exelixis has put plenty of effort behind defending the drug's intellectual property. Now, a patent deal with generics giant Teva adds one more layer to its defenses.

Sunday, Exelixis said it has resolved the patent litigation it brought against Teva in response to the latter company's generic application with the FDA. Under the settlement, Exelixis will grant Teva a license to market its Cabometyx generic starting on Jan. 1, 2031, Exelixis said in a release. Before launching, Teva's copycat would also have to win FDA approval.

The companies didn't disclose the financial terms of the deal.

Last year, Exelixis filed a patent lawsuit (PDF) in response to Teva's advancement of a generic application with the FDA. The lawsuit asserted infringement of Exelixis' patent No. 11,298,349, which expires in February 2032.

Before that, Exelixis filed a lawsuit in 2021 centered on three patents, the latest of which expires in July 2033.

The new settlement resolves all existing patent litigation between the companies in Delaware federal court. The deal is subject to review by U.S. authorities.

Aside from Teva, Exelixis is pursuing patent claims against India's MSN Labs. In January, Exelixis said the Delaware federal court ruled in its favor, rejecting MSN's challenge to patent No. 7,579,473.

After that ruling, Exelixis said it planned to ask the court for an order barring regulatory approval of MSN's generic until August 2026.

Since its original approval in April 2016 to treat certain patients with renal cell carcinoma, Cabometyx has been a commercial driver for Exelixis. It's also picked up approvals in hepatocellular carcinoma and thyroid cancer and the franchise generated $1.4 billion last year.

But the Teva deal also follows some clinical setbacks for the pair of Cabometyx and Roche's Tecentriq. In March, the company disclosed that the combo failed to stave off cancer progression or death compared with Cabometyx alone in kidney cancer patients who’ve progressed on initial immunotherapy.