Novartis’s Alcon Wins Bid to Block Apotex’s Generic Patanol

Novartis AG’s Alcon unit won an appeals court ruling that will prevent Apotex Inc. from selling a generic version of the eye drug Patanol until a patent expires in 2015.

The U.S. Court of Appeals for the Federal Circuit in Washington today ruled that, while parts of an Alcon patent on the drug are invalid, other aspects aren’t. The ruling was posted on the court’s website.

Patanol, whose active ingredient is olopatadine hydrochloride, is used to treat allergic conjunctivitis, the most common type of allergic disease in the eye. Basel, Switzerland-based Novartis acquired the drug with its purchase of Alcon.

The ruling means the order preventing Apotex from selling generic Patanol remains in effect, Eric Althoff, a spokesman for Novartis, said in a statement. He said the company was pleased with the decision, although it’s considering its options regarding the aspects of the patent that were invalidated.

The patent, which also covers the related drug Pataday, covers the first compound to stabilize human mast cells and prevent them from triggering the allergic reactions, such as redness, itching and runny eyes, according to the lower court opinion. Mast cells exist in the body and are the primary cells involved in allergic reactions. Althoff said Alcon has other patents that protect Pataday from generic competition.

‘Long-Term Relief’

“Alcon invested many years and millions of dollars in the discovery and development of an ocular allergy product that would stabilize mast cells in the eye and provide long-term relief of the signs and symptoms of ocular allergies,” Althoff said. “Patanol and Pataday are the result of this R&D effort.”

Closely held Apotex, based in Toronto, claimed that the patent was an obvious variation of earlier inventions in the field. Officials with the company didn’t respond to a request for comment.

Circuit Judge Kimberly Moore, writing for the three-judge Federal Circuit panel, wrote that the aspects of the patent that cover a method of using olopatadine to treat conjunctivitis were obvious. The court upheld two aspects that relate to the specific concentration of the compound.

The case is Alcon Research Ltd. v. Apotex Inc., 2011-1455, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Alcon Manufacturing Ltd. v. Apotex Inc., 06cv1642, U.S. District Court for the Southern District of Indiana (Indianapolis).

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