Mylan fights off Teva’s Perforomist challenge

The US District Court for the Northern District of West Virginia has upheld the validity of four patents covering Mylan’s Perforomist (formoterol fumarate) inhalation solution.

The decision yesterday, March 24, enjoins Israeli generic drugmaker Teva from making or selling its own formoterol fumarate inhalation product.

Perforomist is an inhalable solution for the long-term treatment of chronic obstructive pulmonary disease, including bronchitis and emphysema.

Mylan filed suit against Teva after it filed an Abbreviated New Drug Application seeking approval from the US Food and Drug Administration to make a generic version of Perforomist.

It said that Teva’s proposed product infringes four patents that cover “bronchodilating compositions and methods”, which are not due to expire until June 2021.

Mylan’s chief executive Heather Bresch said of the judgment: “The court’s decision to recognise the validity of the patents covering Mylan’s Perforomist Inhalation Solution not only affirms the strength of our IP on this product, but also our broader respiratory portfolio, including Mylan’s combination product currently in development.

“We are excited about the growth of our respiratory franchise and look forward to continuing to meet unmet needs in this increasingly important space.”

Teva was not immediately available for comment.