In a setback to Hyderabad-based Natco Pharma, the Israeli drug giant Teva Pharma claims to have won the first round of patent battle over the blockbuster multiple sclerosis drug Copaxone (Glatiramer Aceatte) in the United States. Teva Pharma said on Monday that the US District Court for the Southern District of New York has issued a favourable set of claim construction rulings in the company?s patent infringement lawsuit against Natco and US generic giant Mylan along with Novartis?s generic arm Sandoz and Momenta Pharma. The drug clocked annual sales of $2.2 billion in the US and worldwide revenue from the product exceeded $3 billion in 2010.
?How this case pans out for Natco in US would have a very important bearing on the generic drug maker?s potential US fortunes, considering the drug garners revenue worth multiple billions and is still growing decently over such a high base, and the generic opportunity is officially being chased by only two set of players, so the fragmentation of market share would be limited, if Natco manages the opportunity. Also, the technology behind the drug remained quite difficult to crack for a long time,? an analyst said.
The drug is equally important for Teva, as the brand accounts for over 20% of its annual revenue (in 2010). However, the final rulings of the court would become clear only once the trial starts early September.
?It is premature to comment on this matter and as it is subjudice and the trial is beginning in the next eight days,? a Natco spokesperson told FE.
Interestingly, the drug maker is also fighting a legal battle with Teva in the Delhi High Court on the same drug. This follows a development in 2009 in which Natco scored a major victory against Teva by successfully blocking its patent application for the MS drug in India and the patent office here refused to grant a patent to Teva for the drug. By then, Natco had successfully commercialised a generic version of the MS drug in the Indian market as well the Ukraine. For many other regulated markets of US, Europe, Australia, New Zealand, Japan and Canada, it has tied up with US generic giant Mylan to market and distribute the drug.