25 September 2013Americas

Teva holds on to Azilect exclusivity

The US District Court for the District of New Jersey has found in favour of Teva Pharmaceutical Industries Ltd in its patent infringement case with Mylan over Parkinson’s disease drug Azilect.

The patent at suit, 5,453,446, covers use of the R-enantiomers of N-propargyl 1-aminoindan compounds. The novel compound was found to be useful in the treatment of Parkinson’s disease, memory disorders and dementia.

In a statement, Teva said it anticipates the court will enter judgment that prevents Mylan from launching a generic version of Azilect before Teva’s patent expires in 2017.

Teva launched the suit in October 2010, shortly after Mylan filed an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of the drug. Mylan countersued, claiming the patent was invalid and unenforceable.

Teva filed similar lawsuits against Watson and Orchid in the same month of 2010, as well as other suits with Apotex in May 2011 and Sandoz in April 2012. It reached settlement agreements with Watson, Apotex and Orchid earlier this year.

Teva said it was pleased with the ruling, which “further confirms the strength of Teva’s Azilect IP rights.”

Joseph O’Malley, co-chair of the IP practice at Paul Hastings in New York, said "the decision shows, if anything, how much Mylan and Teva do not get along."

When Mylan develops a branded product, like with respiratory drug Perforomist, then Teva will challenge it, and vice versa, he added.

“Most of the generics had the good sense to settle their validity challenge against Teva’s patent.

Mylan continued with an obviousness challenge that was flawed on many levels,” he said.

“Many patents covering a single enantiomer survive obviousness challenges even when the racemate (which includes the enantiomer) is in the prior art as an effective treatment for the indication at issue.  Here, there was no such racemate patent.

“There was only a hint in the prior art that the racemate molecule could be an effective treatment for Parkinson’s, among many other arguably more promising candidates.

“Mylan’s obviousness position, based as it was on impermissible hindsight, was a stretch, at best,” he said.

Azilect launched in the US 2006. According to Zacks Investment Research, it posted sales of $420 million in 2012.

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