Cipla files defensive patent suit over Ofev generic

Mumbai-based pharma company Cipla has filed a lawsuit asking a Delaware court to rule that its proposed generic of Boehringer Ingelheim’s lung disease treatment Ofev (Nintedanib) does not infringe two patents.

Cipla filed the complaint with the US District Court for the District of Delaware on Friday, requesting that the document be sealed.

In the accompanying motion to seal, Cipla explains that it has submitted an abbreviated new drug application (ANDA) to the Food and Drug Administration (FDA) seeking approval to manufacture and sell generic Nintedanib capsules.

As the complaint contains “sensitive, non-public information” related to its Anda, Cipla requested that portions of the document should be sealed.

The sensitive information includes information pertaining to “Cipla’s regulatory strategies, and confidential communications between Cipla and Boehringer”, the company claims.

The court granted the motion to seal on Monday, March 7, claiming that Cipla had “good cause” to seal. The court has now issued summons to Boehringer.

In a parallel filing, Cipla notified the  US Patent and Trademark Office that action had been filed in relation to two Boehringer patents, US patent 9,907,756 B2 and 10,105,323 B2.

Both patents are titled “Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative”.

Ofev is a blockbuster drug for Boehringer, netting €2 billion ($2.1 billion) in sales in 2020, making it the company’s second-biggest revenue-generating drug behind its type 2 diabetes treatment Jardiance (empaglflozin).

In 2020, the FDA approved Ofev for wider use to treat other lung diseases, as it was initially developed as a treatment for idiopathic pulmonary fibrosis.

Cipla has been approached for comment.

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