APOTEX SEEKING DECLARATORY JUDGMENT TO MARKET GENERIC ZANTAC SYRUP

Canadian drugmaker Apotex wants legal protection from patent infringement liabilities related to the manufacturing and marketing of ranitidine hydrochloride, a generic version of GlaxoSmithKline's (GSK) Zantac, according to a complaint filed in U.S. federal court last week.

Apotex is the third generic firm, behind Teva and Pharmadyne, to challenge GSK's patent covering its blockbuster anti-ulcer drug in syrup form.

According to the complaint, filed in the U.S. District Court of the Eastern District of Virginia, Apotex is seeking declaratory judgment prior to selling its own generic version of Zantac oral solution to avoid an at-risk launch.

"Only a declaratory judgment from this court can alleviate this harm and allow Apotex to obtain approval of its product and compete in the lucrative ranitidine market," the company said in court papers.

Given the potentially large risk of proceeding without resolving some of the uncertainty, the decision makes good economic sense, some legal sources say. A generic drug firm could be hit with multiple damages as well as a court injunction to halt all sales of its product if it were determined that the generic product infringed on the brand company's patent.

"A generic company can't launch or get approval without a declaratory judgment. That's the only way a subsequent filer can launch," lead attorney William Rakoczy, a partner with Rakoczy, Molino, Mazzochi, said.