Pfizer Inc., the world’s biggest drugmaker, faces competition to its $3 billion arthritis pill Celebrex in May after a federal judge invalidated a patent that could have delayed generic versions of the medicine.
A patent expiring in December 2015 was invalid because it wasn’t different enough from one ending in May, a federal judge in Norfolk, Virginia, said yesterday in a victory for companies including Teva Pharmaceutical Industries Ltd., Mylan Inc., and Lupin Ltd. Pfizer “will pursue all available remedies, including an immediate appeal of the court’s decision,” the company said in a statement yesterday.
Celebrex, which belongs to a class of drugs called COX-2 inhibitors, helps arthritis patients reduce pain by blocking a chemical reaction in the body that causes inflammation. The medicine had been projected to generate $2.5 billion between May and when the 2015 patent was slated to expire, according to sales estimates surveyed by Bloomberg.
“It seems likely that odds are in favor of generics launching early,” said Timothy Anderson, an analyst with Sanford C. Bernstein & Co. Pfizer’s earnings per share will be cut by 4 percent this year and 8 percent in 2015 if copycats do make it to market, he wrote in a note to clients.
“There would be little to no impact to EPS from 2016 onwards because we have already been modeling generics in late 2015,” Anderson said.
Pfizer fell 2.7 percent to $31.12 at 4:15 p.m. in New York.
Actavis Plc and Mylan said they plan to begin selling a generic Celebrex in May, as long as they get regulatory approval. Both said they may be among a limited number of companies allowed to sell the drug for the first six months, as a reward for being the first to challenge the Pfizer patent. Denise Bradley, a spokeswoman for Petach Tikva, Israel-based Teva, said the company is pleased with the decision.
Should the generic-drug companies enter the market and later lose the appeal, they could be ordered to reimburse Pfizer for any profit it loses from the low-cost competition.
An appeals court in 2008 had invalidated the patent, saying it just covers a method of administering a “therapeutically effective amount” of the compounds covered by the patent that ends in May. New York-based Pfizer asked the patent office to reissue it with modifications to work around the appeals court decision.
District Judge Arenda Wright Allen said that the modification sought by Pfizer wasn’t allowed under the law, so the Federal Circuit’s reasoning stands.
The case is G.D. Searle LLC v. Lupin Pharmaceuticals Inc., 13cv121, U.S. District Court for the Eastern District of Virginia (Norfolk).