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13 June 2022Big Pharma

Teva settles patent dispute with Aurobindo

Israel-headquartered Teva has settled its dispute with Indian generic maker Aurobindo over a drug used to treat Huntington’s disease.

In an announcement shared on Thursday, June 9, Teva announced that the litigation between the parties in the US District Court for the District of New Jersey will end and Aurobindo will have a licence to sell its generic product beginning April 2033 (or earlier under certain circumstances).

The drug at issue, Austedo (deutetrabenazine), is indicated in adults for the treatment of chorea (abnormal involuntary movement disorder) associated with Huntington’s disease. Huntington’s disease is a rare disease that causes the progressive breakdown of nerve cells in the brain.

Back in July last year, Teva filed lawsuits against Aurobindo and fellow India generics maker Lupin Pharmaceuticals, claiming that the companies had filed Abbreviated New Drug Applications (ANDAs) to develop a generic of Austedo prior to the expiration of the related patents.

At the time, Teva accused Aurobindo of infringing six patents. Aurobindo, in its letter notifying Teva that it had filed Paragraph IV Certifications—an FDA certification that asserts that certain patents are invalid, unenforceable or won’t be infringed by the manufacturing of a generic—claimed that all six patents were invalid.

In March, the US Patent Trial and Appeal Board declined to institute an inter partes review of Teva’s compound patent for deutetrabenazine in response to a petition submitted by Apotex.

Last month, Teva settled its dispute with Lupin. Lupin will also have a licence to sell its generic product beginning April 2033.

“Teva believes that today’s settlement with Aurobindo is a further reflection of the strength of its IP covering its Austedo product,” said the press release.

Chief Judge Freda Wolfson ordered the dismissal of the case without prejudice on Friday, June 10.

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More on this story

Generics
6 July 2021   Teva Pharmaceuticals has filed lawsuits in New Jersey against two Indian generics manufacturers to stop them from developing a generic version of its Huntington’s disease treatment.
Americas
10 August 2022   Parties to withdraw lawsuit over lung cancer drug | ANDA generic would have displaced sales of patented version in Delaware, said plaintiff.
Europe
11 October 2022   European Commission says pharma firm blocked generics over blockbuster MS drug| Teva “engaged in abusive conduct” to “artificially prolong the exclusivity” of Copaxone | Teva could be found to have infringed Article 102 of TFEU.