Apotex Loses in Appeal Over Generic Eye Drug
A U.S. federal appeals court has found in favor of Roche Palo Alto and Allergan in a patent infringement lawsuit against Apotex over Acular lower strength (LS), an ophthalmic drug.
Acular LS (ketorolac tromethamine) ophthalmic solution 0.4 percent is indicated for the reduction of ocular pain and burning or stinging following corneal refractive surgery.
Roche Palo Alto and Allergan, which holds the NDA for Acular LS in the U.S., brought the suit in May 2005 in the U.S. District Court for the Northern District of California after receiving notice that Apotex had filed an ANDA for a generic version of the drug with a Paragraph IV certification on the drug’s ’493 patent. The patent has pediatric exclusivity until November 2009.
The lawsuit marked the second time Apotex has been in court over an Acular product. In 2001, the drugmaker submitted an ANDA to market a generic version of regular strength Acular with a Paragraph IV certification on the drug’s ’493 patent. Roche and Allergan ultimately prevailed in that case when the court found the patent was not invalid for obviousness.
In August 2007, the plaintiffs in the Acular LS case submitted a motion for summary judgment and asked the court to bar Apotex’s unenforceability defenses as it had asserted that claim in the earlier litigation. The court agreed and ordered Apotex to pay the plaintiffs’ costs in the action.