GlaxoSmithKline Plc and Pfizer Inc. sued Hikma Pharmaceuticals Plc for planning to sell an injectable blood-clot treatment that the drugmakers say infringes a patent licensed by Glaxo for argatroban.
Hikma, a London-based seller of generic and branded drugs, won U.S. Food and Drug Administration approval on Jan. 5 to introduce its own version of argatroban, according to the complaint filed March 30 in federal court in Trenton, New Jersey.
Hikma plans to introduce its product “imminently,” infringing a patent that expires in 2014, according to the complaint. Glaxo, the U.K.’s biggest drugmaker, licenses the patent in the U.S. and sublicenses it to New York-based Pfizer, the world’s largest drugmaker, according to the complaint.
Unless a judge stops Hikma, Glaxo and Pfizer “will suffer substantial and irreparable injury,” according to the complaint.
A representative of Hikma, Hana Ramadan, didn’t immediately return an e-mail seeking comment on the lawsuit. Hikma, which was founded in Amman, Jordan, in 1978, has said it relies on the Middle East and North Africa for 61 percent of its revenue.
‘Expand and Strengthen’
“Argatroban will expand and strengthen our injectables product line and will help to differentiate our product portfolio in the U.S.,” Hikma Chief Executive Officer Mazen Darwazah said in a Jan. 9 statement announcing the FDA approval.
Sales of argatroban injection totaled $130 million for the 12-month period ended in November, according to the Hikma statement, which cites IMS Health.
Hikma’s argatroban injection is approved for treatment of thrombosis in adult patients with heparin-induced thrombocytopenia (HIT) and as an anticoagulant in patients at risk of HIT.
The case is GlaxoSmithKline v. Hikma Pharmaceutical Co., 12-cv-1965, U.S. District Court, District of New Jersey (Trenton). The patent can be found on the docket.