The U.S. Court of Appeals has again ruled that Teva Pharmaceuticals Industries Ltd.’s patent for its top-selling multiple sclerosis treatment Copaxone is invalid.
A Teva spokeswoman said that the company is “committed to pursuing all legal pathways, including seeking further appellate review.”
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The decision put an end of the seven-year fight over patent protections for Copaxone, and opened a way for the company rivals to launch their generic version.
In January, the U.S. Supreme Court said the appeals court took the wrong approach in its original decision to cancel the patent.
The extended litigation has benefited Teva, which has been able to continue to sell Copaxone without competition from other manufacturers that would offer steep discounts for their generic versions, Reuters report
The drug makers been developing generic forms of Copaxone are Novartis AG’s Sandoz unit and Momenta Pharmaceuticals Inc , Mylan Inc and Natco Pharma Ltd.
Teva’s patent covered a method of manufacturing the drug. The Federal Circuit said on Thursday that under the high court’s latest standards for determining when a patent is too vague to deserve legal protection, the Teva patent is indefinite, says Reuters reporters.
Teva “has failed to inform with reasonable certainty those skilled in the art about the scope of the invention, ” the court said.
Teva had sued Sandoz and Mylan in 2008 and 2009 in federal court in New York for patent infringement over their Copaxone copycat versions.
Central to the case was how the district judge interpreted a specific term in a key patent for the drug. The appeals court did not accept that interpretation and invalidated the patent, Reuters report.
The Supreme Court said the Federal Circuit should have deferred to the district judge unless there is evidence of “clear error, ” sending the case back down.
But, the appeals court on Thursday found the patent is still indefinite.
Teva is in the process of take over battle f Mylan, while Mylan itself has made effort to buy Perrigo Co.
Mylan CEO Heather Bresch said, “We have stated all along that the ‘808 patent on Copaxone is invalid and are gratified that the Federal Circuit Court of Appeals has agreed and put this matter to rest. We continue to remain very confident in our application for our generic version of Copaxone and look forward to bringing our product to market upon approval from the U.S. Food and Drug Administration.
“Further, we believe this ruling underscores concerns with Teva’s ongoing financial prospects, as Teva’s Copaxone franchise has historically been its largest and most significant revenue driver.”
Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced:
“We are very pleased with the Federal Circuit’s decision to declare Teva’s manufacturing process patent invalid once again, ” said Craig Wheeler, President and Chief Executive Officer of Momenta. “We look forward to providing patients with a more affordable generic alternative for the treatment of multiple sclerosis.”