Court rejects rivals' motion to void patents on Teva's Copaxone

Teva Pharmaceutical Industries won an important victory yesterday in its battle to defend its patents for its multiple sclerosis drug Copaxone. Judge Barbara Jones of the U.S. District Court for the Southern District of New York denied a motion for summary judgment filed by Sandoz and Momenta Pharmaceuticals to invalidate the patents.

Sandoz and Momenta had claimed that Teva's patents were invalid because they did not include an exact molecular weight for the drug, so there was no need for a trial on patent infringement.

	A needle of Copaxone, safe from generic competition, for now.
	Photo by: Ofer Vaknin

Teva sued its two competitors in August 2008 claiming patent infringement after Sandoz and Momenta submitted a request to produce a generic version of Copaxone. Teva said its Copaxone patents were valid through 2014.

Copaxone is Teva's flagship drug, providing more than 20% of its revenues in the second quarter of 2010. Analysts estimate that it accounts for between 25% and 30% of Teva's profits. Copaxone sales grew 13% in the second quarter to $773 million amid a 21% sales increase in the United States. Teva is the world's largest generic drug manufacturer.

But the battle is still far from over. Judge Jones ruled that a full trial would have to be held on whether the patents are valid and specific enough. The court has yet to set a date.

Ronny Gal, a pharmaceutical analyst at Sanford Bernstein, said the trial will probably be held in the second half of 2011, so it is likely that any generic rivals to Copaxone will not be approved before mid-2012.

Even if Sandoz and Momenta receive U.S. Food and Drug Administration approval for a generic version, the court may issue a restraining order against them until the suit is settled, said Gal.

In any case, Sandoz and Momenta have two sets of hurdles facing them: The patent suit and the FDA approval process. But that doesn't mean Teva will have an easy time defending its Copaxone patents. Gal said Teva is exposed to claims that its patents are trivial because they are based on previous research, but the judge did not comment on such a possibility.

Teva said it was pleased with the decision and would continue to vigorously defend its Copaxone patents.

Teva stock were up by 2.3% in late trading in New York.