Patent Infringement Suit Filed Over Cystic Fibrosis Medication

A new patent infringement case was filed by Vertex Pharmaceuticals Inc. against both Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively, Lupin) on Tuesday in the District of Delaware. The claims follow Lupin’s filing of an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA) in which they seek approval to market and produce a generic version of Vertex’s KALYDECO medication.

Vertex is a biopharmaceutical company which “focuses on the pursuit of medical research to create transformative medicines for people with serious and life-threatening diseases, such as cystic fibrosis.” The defendant, Lupin, is described as a company in the business of “marketing and selling generic copies of branded pharmaceutical products.” KALYDECO is a medication designed to treat cystic fibrosis in patients over six years of age who “have one mutation in the CFTR gene that is responsive to ivacaftor potentiation.” KALYDECO is currently protected by United States Patent No. 10,646,481, or the ‘481 patent.

The ANDA submitted by Lupin, which seeks to gain approval to produce a generic version of KALYDECO, communicated Lupin’s belief that if they were to produce and market the product, they would not infringe upon any claims in the ‘481 patent. Lupin provided notice regarding the ANDA to Vertex, explaining the “factual and legal bases” behind their ANDA and also expressing their belief that the ‘481 patent would not be infringed upon.

Contrastingly to Lupin’s claims, Vertex contends that if the ANDA is to be approved and the defendants are not enjoined from patent infringement, they will be “harmed substantially and irreparably.” They are seeking favorable judgement regarding patent infringement and requesting that Lupin be enjoined from generically producing KALYDECO at least until the expiration of the ‘481 patent. Vertex also seeks litigation costs and any other relief deemed proper by the court.

Vertex is represented by Morris, Nichols, Arsht & Tunnell.