Court Prohibits GSK From Providing Generic Paxil to Mylan’s Competitor

Mylan has further cemented its win in a breach-of-contract lawsuit against GlaxoSmithKline with a court order prohibiting GSK from providing an authorized generic version of the antidepressant Paxil to Mylan’s competitor Apotex.

The U.S. District Court for the District of New Jersey ruled that supplying generic Paxil (paroxetine) to Apotex violated a March verdict that awarded Mylan $106.7 million in the contract dispute. A jury at the time decided that GSK’s entry into a generic licensing agreement with Apotex amounted to a breach of an earlier agreement inked between Mylan and GSK. 

In 2007, GSK and Mylan struck a deal settling a patent challenge against Paxil that promised Mylan generic exclusivity on the drug until 2016, barring certain exceptions.

One of the exceptions was if GSK decided to market its own generic version. Instead, in 2010 GSK settled a patent challenge with Apotex that resulted in an authorized generic licensing agreement. When Mylan sued for breach of contract, GSK countered that the first agreement allowed the company to market a generic version as it saw fit, including through a third party.

The brand manufacturer won in court initially, but on appeal a jury sided with Mylan, finding that the agreement limited GSK to marketing a generic Paxil on its own.

The $106.7 million judgment in favor of Mylan from March amounts to all of the profits the company would have made off a generic Paxil had it not been for the agreement between GSK and Apotex. With the latest ruling, Mylan may be able to collect even more money for continued loss of profits from competition, the court ruled.

Mylan praised the ruling in a statement. GSK said it was disappointed but will comply with the judge’s decision. Apotex is no longer a party to the case. — Bryan Koenig

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.