Apotex faces patent infringement suit over allergy inhaler

NEW YORK Canadian generic drug maker Apotex faces a patent infringement lawsuit over its efforts to win Food and Drug Administration approval for a generic version of an allergy inhaler, according to published reports.

Bloomberg reported that Schering-Plough Corp., recently acquired by Merck & Co., was suing Apotex in the U.S. District Court for the District of New Jersey over its generic version of Nasonex (mometasone furoate monohydrate).

Under the Hatch-Waxman Act of 1984, a branded drug maker can sue a generic drug maker for patent infringement when the generic manufacturer seeks regulatory approval for its version of a drug and files a Paragraph IV certification, which asserts that its approval application does not infringe on the branded company’s patents or that the patents are unenforceable. Such a lawsuit prohibits the FDA from granting final approval to the drug for 30 months or until the generic drug maker wins the suit.