A subsidiary of Bayer AG, the Germany-based pharmaceutical company, has filed suit [PDF] in federal court in Wilmington, Delaware, against Glenmark Generics, an international generic drug manufacturer, seeking to stop the Mumbai-based company from selling a generic form of a medication used to treat a skin disorder.
Glenmark applied for U.S. Food and Drug Administration approval for a generic version of Finacea, a gel use to treat the skin condition rosacea. But the Bayer subsidiaries Intendis and Intraserv said they will suffer "irreparable harm for which they have no adequate remedy at law" if Glenmark is allowed to manufacture and sell the drug before Bayer’s patent (United States Patent NO. 6,534,070, known as the ’070 patent) expires in 2018.
The lawsuit, filed under provisions of the Hatch-Waxman Act, automatically triggers a stay of final FDA approval of Glenmark’s “Abbreviated New Drug Application” (ANDA) for up to 30 months or until final resolution of the matter before the court, whichever occurs first.
According to the complaint, Glenmark sent a notice letter to Intendis and Bayer in January informing them that an ANDA had been filed with the FDA and claiming that the ANDA product “would not infringe any claims of the ‘070 patent.”
But the Bayer subsidiaries said in the complaint that the generic “is an act of infringement of one or more claims of the ‘070 patent.” They ask that the Delaware court issue a judgment and order prohibiting Glenmark from making, using, selling, or importing the generic product.
Glenmark’s application is for its own version of azeliac acid gel, which is approved for the treatment of inflammatory papules and pustules of mild to moderate rosacea —a chronic skin condition that mainly affects the face.
Glenmark said in a statement it believes it may be a “first applicant” to file an ANDA for the generic version of Finacea and may be entitled to 180 days of generic market exclusivity. This would give the company an advantage over its competitors in the generic drug space, as its product would be the only generic available during that time.
Finacea had U.S. sales of about $95 million for the 12 months ending September 30, 2012, according to data compiled by IMS Health, a provider of health-care information, Glenmark said.
Glenmark is one of several generic manufacturers that recently lost a challenge to AstraZeneca, which had its patent for cholesterol drug Crestor upheld by an appeals court until its expiration in 2016.
Calls to Bradford Badke and Michael Kahn of Ropes & Gray, who are of counsel to the Bayer subsidiaries, and to Rodger Smith II of Morris, Nichols, Arsht & Tunnel, who authored the complaint, were not immediately returned.
