Appeals Court Allows Lupin Generic of ViiV HIV Drug, But Blocks Teva
A federal appeals court has upheld a lower court ruling that allowed Lupin to manufacture a generic of one of ViiV Healthcare’s HIV therapies, while blocking Teva’s ANDA of a related drug.
The U.S. Court of Appeals for the Federal Circuit offered no explanation for its decision.
Lupin may continue to market its generic version of ViiV’s Trizivir (lamivudine, abacavir and zidovudine) while Teva remains barred from marketing its generic of Epzicom (lamivudine and abacavir).
ViiV filed patent infringement lawsuits against the two ANDAs asserting the same patent, the ‘191, for both. The cases were consolidated and, in December 2013, a U.S. District Court judge for the Delaware district ruled that Teva’s ANDA infringed on the patent while Lupin’s did not.
Under the ruling, Teva is blocked from marketing a generic Epzicom until the ‘191 patent expires in March 2016.
ViiV is an independent company formed from the HIV pipelines of GlaxoSmithKline and Pfizer. The two therapies in question are both manufactured by GSK. Trizivir brought in about $55 million in sales last year, according to an SEC filing by GSK. Epzicom pulled in over $1.1 billion.
Teva declined a request for comment and ViiV did not respond to an inquiry by press time. — Bryan Koenig