By Donald Zuhn —

On Thursday, Allergan, Inc. announced that the U.S. Court of Appeals for the Federal Circuit has affirmed judgment in favor of Allergan and Roche Palo Alto, LLC in a patent infringement suit against Apotex, Inc., Apotex Corp., and Novex Pharma ("Apotex").  As a result of this decision, Apotex will not be able to obtain FDA approval to market a generic version of Allergan’s ACULAR® (ketorolac tromethamine ophthalmic solution) product.  ACULAR® is approved for use in treating ocular itching due to seasonal allergic conjunctivitis and post-operative inflammation in patients following cataract surgery.

Last year, Apotex appealed a District Court ruling that its proposed generic product infringed Roche Palo Alto’s U.S. Patent No. 5,110,493 (which Roche licenses to Allergan), and that the ‘493 patent was a valid and enforceable.  The District Court also determined that the effective date of approval of Apotex’ Abbreviated New Drug Application (ANDA) would have to wait until after the ‘493 patent expired on May 5, 2009.