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HYDERABAD-based Matrix Laboratories has taken Israeli pharma major Teva head on by filing an application challenging a process patent used to make Teva’s blockbuster drug Copaxone, used in the treatment of multiple sclerosis. The process patent in question relates to a method of manufacturing copolymer-1. Copaxone is Teva’s best-selling drug and contributes to a fifth of the company’s annual revenue of over $11 billion.

   Matrix Labs wants the patent revoked on the grounds that it is wrongly patented, does not involve any inventive step and that it does not disclose the best mode of performing the invention. Neither Matrix Labs nor Teva responded to email queries.

   The application was filed by Matrix under Section 64 of the Patents Act, 1970, for revocation of a patent granted to Yeda Research and Development. The respondents to the case include the patent holder Yeda and Teva, which is the exclusive licensee.

   While the application was filed in April, Teva’s counsel sought a threemonth extension last month to reply. So, the case is likely to come up in September at the Intellectual Property Appellate Board (IPAB) in Chennai.

Industry experts say that if Matrix Labs wins, it could eat into Teva’s revenues as the former will be able to make a generic version of Copaxone and market it through its parent Mylan in US.

In what was then the biggest deal in the Indian pharma space, Mylan picked up 71.5% in India’s drug ingredients maker, Matrix Laboratories, for Rs 3,680 crore ($736) million in 2006.

“The case would certainly benefit Matrix if the verdict tilts in its favour as it could make and market the cornerstone drug in all major markets. But on the flip side, Teva’s revenues will take a beating only if more such generic companies begin supplying the drug as Teva is the market leader,” said Sarabhjit Kaur Nangra, research head, Angel Broking.

The ramifications could be greater if the judgment fails to defend the monopoly interests of Teva, as it would question the patentability standards and the common good manufacturing practices (CGMP) used by the innovator company, the analyst added.

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