Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has filed a patent infringement lawsuit against Canadian drug development company Apotex Inc. with the US District Court for the District of New Jersey. The lawsuit was filed after Apotex applied to the US Food and Drug Administration (FDA) to market a generic version of Azilect, Teva's brand treatment for Parkinson's disease.
Azilect had $318 million in sales in 2010, and $90 million in sales in the first quarter of 2011. Teva's statement of claim says that Azilect's US patents are valid through February 2017. The US patents were granted in 1995 to Azilect's inventors, and Teva now owns the rights to the drug under an agreement with the Technion - Israel Institute of Technology.
Apotex is not the first company that Teva has sued for infringing its Azilect patent. Eight months ago, it sued Watson Pharmaceuticals Inc. (NYSE: WPI), Mylan Inc. (NYSE: MYL), and India's Orchid Chemicals & Pharmaceuticals Ltd. (BSE: 524372), after they submitted generic versions of the drug to the FDA for approval. Under US law, the defendants cannot market their versions of a drug until a certain period has passed, which in the case of these three companies is November 2013, unless the court rules in their favor beforehand.
It can therefore be said that a launch of generic Azilect is still far off.
In June 2008, Teva announced that the clinical trial of Azilect achieved all its endpoints, and that it can delay the development of Parkinson's disease. All current Parkinson's treatments, including Azilect, only treat symptoms of the disease. On the basis of the study's results, Teva asked to change Azilect's indication. If and when the application is approved, Azilect will become the first drug approved for delaying Parkinson's, which could boost the drug's sales. The FDA has yet approved the change.
Teva's share price fell 0.2% in premarket trading to $48.93, giving a market cap of $46 billion, but rose 0.1% by mid-afternoon on the TASE to NIS 167.20.
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