TWi launches AIDS drug generic following US court ruling

TWi Pharmaceuticals has released a generic version of the Megace ES (megestrol acetate) drug, which is used to treat certain symptoms experienced by AIDS patients, just one day after a court ruled that it did not infringe a patent owned by Par Pharmaceutical.

The release, yesterday, July 29, follows a lengthy dispute between the two companies, which started in 2011 when Par claimed that TWi’s Abbreviated New Drug Application (ANDA) to market a generic version of Megace ES infringed its patent.

Par claimed in a lawsuit filed at the US District Court for the District of Maryland that the ANDA infringed its patent number 7,101,576—titled “Nanoparticulate megestrol formulations”.

Megace ES is used to treat appetite loss, malnutrition and weight loss in AIDS patients. The US Food and Drug Administration approved TWi’s application in August 2014.

On Tuesday, July 28, the Maryland court reinstated its ruling that TWi’s ANDA application did not infringe Par’s patent. In its first decision in 2012, the district court agreed with TWi and ruled that the ‘576 patent was invalid for being obvious.

The district court’s second ruling followed a remand from the US Court of Appeals for the Federal Circuit in December 2014. The appeals court vacated the first judgment that the patent was obvious and asked the district court to conduct further analysis.

Following the re-hearing, the district court again ruled that TWi’s ANDA did not infringe the ‘576 patent.

TWi has now begun to market its Megace ES generic.

Tina Guilder, chief executive of TWi, said: “This favourable decision not only validates TWi's capability in successful patent challenges but more importantly allows TWi to fulfil its commitment to bring high-quality affordable pharmaceutical products to the patients.”

Par had not responded to a request for comment at the time of publication, but we will update the story should the company get in touch.