Court denies bid to reclassify dry eye drug

Washington, DC-A court has ruled that FDA classification of Allergan's cyclosporine ophthalmic emulsion 0.05% (Restasis) as an antibiotic is supported by the FDA's Modernization Act of 1997. The U.S. District Court for the District of Columbia dismissed Allergan's lawsuit seeking to reclassify cyclosporine as a non-antibiotic.

Allergan brought the lawsuit in October 2003 to have the FDA reclassify and to obtain the certainty of 3 years of marketing exclusivity under the Hatch-Waxman Act.

Allergan believes the ruling will have a limited effect on the marketing of Restasis because it has a solid patent estate covering Restasis, with a use patent that does not expire until August 2009 and a formulation patent that does not expire until May 2014. Allergan said it brought the lawsuit to augment its patent estate with the certainty of 3 years of Hatch-Waxman exclusivity. Because Restasis was approved by the FDA in December 2002, however, such marketing exclusivity would have expired in December 2005.

"Allergan has spent considerable effort developing the first FDA-approved dry eye medication-Restasis-and we had hoped to have been rewarded for our technological innovation with Hatch-Waxman marketing exclusivity," said Douglas S. Ingram, Allergan's executive vice president, general counsel, and secretary. "Fortunately, Restasis has intellectual property protection through a patent estate that extends until May 2014 and thus there should be no practical need for separate Hatch-Waxman marketing exclusivity."