Appeals Court Maintains Allergan Eye Drug Patent Invalidation

A federal appeals court has affirmed a lower court ruling that Allergan’s Zymar eye drop patent is invalid because the process is obvious for others to try. The decision paves the way for generic versions of the drug.

NDA holder Allergan and fellow brandmakers Senju Pharmaceutical and Kyorin Pharmaceutical argued unsuccessfully that the Delaware district court erred in finding Zymar’s (gatifloxacin) ’045 patent invalid. The patent doesn’t run out until 2019, according to the Orange Book.

In appealing the decision, the brandmakers claimed that the lower court arrived at its obviousness finding by looking at each claim in the patent individually rather than as part of a whole, as required by law. The U.S. Court of Appeals for the Federal Circuit disagreed, however, ruling Friday that the district court’s analysis was correct.

Allergan and the others first challenged the Paragraph IV ANDA against Zymar in 2011, according to the ruling in Senju Pharmaceutical v. Lupin. Lupin brought the Hatch-Waxman challenge with fellow generics maker Hi-Tech Pharmacal.

No generic version of Zymar has launched in the U.S., according to an Allergan SEC filing, although Apotex secured FDA approval in 2011 after winning its own Hatch-Waxman challenge against the drug.

Actavis, which recently acquired Allergan, did not respond to a request for comment by press time. — Bryan Koenig