US Appeals Court reverses 2012 decision on Lovaza, clearing way for generics

Reversing a district court decision last year (The Pharma Letter May 30, 2012), the US Court of Appeals for the Federal Circuit ruled on September 12 that both Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) and Par Pharmaceuticals (NYSE: PRX) can go ahead with plans to launch generic copies of UK pharma giant GlaxoSmithKline (LSE: GSK) subsidiary Pronova's triglyceride lowerer Lovaza (omega-3-acid ethyl esters).

The drug generated second quarter 2013 sales of £309 million ($483 million), around half of which came from the USA. GSK’s shares hardly moved in morning trading on September 13, rising 0.3% to £16.24.

In its ruling, the US appeals court found that Lovaza was made "publicly accessible before the statutory bar date" and since the patent for Lovaza has expired in March this year, the drug was not longer protected from generics.