Allergan Loses Bid to Block Generics

Allergan Inc. lost a U.S. Supreme Court bid to force Alcon Inc. and Bausch & Lomb Inc. to stop selling generic forms of the glaucoma treatment Alphagan.

The court refused to hear Allergan’s argument that it could pursue patent-infringement claims, although it no longer has a patent for the use of Alphagan to reduce eye pressure. Alcon and Bausch & Lomb started selling their versions of the drug this year after a lower court said they could make it for that use, which was approved by the Food and Drug Administration.

Irvine-based Allergan, which also makes Botox anti-wrinkle treatments, argued that it still held two patents for another use of Alphagan to protect optic nerves, which hasn’t been approved by the FDA. Doctors often prescribe medicines for such “off-label” uses, and Allergan said it should be allowed to stop sales of generic versions because doctors may prescribe them for that use.

“Pioneer drug manufacturers simply cannot afford to make the substantial investments necessary to develop new uses of drugs if generic versions can enter the market” in the way sought by Allergan’s two rivals, the firm’s lawyers said in papers filed in Washington. “Entry of a generic almost immediately eliminates the profit margins” needed to recover research costs.

Makers of generics can sell cheaper copies of brand-name medicines once patents expire.

Alcon, the largest maker of eye-care products, and Bausch & Lomb, the third-biggest maker of contact lenses, sought FDA approval to sell a generic version of Alphagan to reduce eye pressure, the use for which Allergan’s patent had expired. The U.S. Court of Appeals for the Federal Circuit ruled in favor of Alcon and Bausch & Lomb in March.

Allergan sold $248.5 million of Alphagan worldwide in 2002, and the company said in October that sales were expected to reach as high as $265 million this year.

Alcon is based in Hunenberg, Switzerland, and Bausch & Lomb in Rochester, N.Y. Both companies said Allergan shouldn’t be able to use its patents for an unapproved use of the drug to block all generic sales when its patent for the FDA-approved use had expired.

Because drug makers are barred from promoting off-label use of medicines, Allergan still can sue for damages if it shows that the maker of a generic rival induced doctors to prescribe it for an unapproved use, lawyers for Bausch & Lomb said.

Allowing Allergan to block all generic sales of the drug would “artificially extend its patent monopoly,” Bausch & Lomb’s lawyers said in court papers.

Attorneys for Alcon, in urging the Supreme Court to deny review, said the issue wasn’t likely to recur because the FDA issued rules in June allowing companies to list only patents for FDA-approved uses of a drug in a government patent registry.