The Hindu Business Line : Wockhardt opposes Roche patent on Pegasys

Mumbai March 29 The country's first product patent, granted in the amended patent regime to Swiss pharmaceutical company Roche on its Hepatitis C drug Pegasys, has been opposed. Mumbai-based drug maker Wockhardt has opposed the product patent on Pegasys at the Indian Patent Office.

Wockhardt's opposition to the product patent on Pegasys could well be the country's first post-grant opposition, said a patent lawyer familiar with the development. Roche had received a product patent on Pegasys in March last year.

By filing a post-grant opposition, drug companies are not just protecting their turf, but also putting to test provisions provided in the Patent Amendment Act 2005.

Patent regime

The Roche's Managing Director in India, Dr G.L. Telang, told Business Line that the product patent on Pegasys belongs to Hoffmann-La Roche and the company would respond to the opposition.

The procedures of the post-grant opposition would possibly play out at the Chennai patent office, where the patent had possibly been issued, a patent lawyer said.

The little more than two-year-old product patent regime has been seeing drug companies file pre-grant oppositions, where the patent applications are opposed before the grant of a patent. The new product-patent regime allows for both forms of opposition, a patent lawyer said.

Explaining the procedure, the lawyer said that a drug company had to oppose a product patent that was granted, within 12 months from the date of publication of the patent. The company granted a patent, Roche in this case, will be given three months to respond.

About Pegasys

Pegasys is the brand name under which Roche sells Pegylated interferon alfa-2a. The drug involves a technology that reduces the frequency of injections that a patient has to take to one a week, as compared to the earlier practice of three a week.

Pegasys was launched in India in 2003 and the cost to a patient is about Rs 2.25 lakh for six months. Explaining the pricing, Dr Telang had said when the patent was granted last year that the total cost included the cost of therapy, testing, monitoring and follow-up, besides the cost of the drug itself. Ribavirin, another medicine used in some cases with Pegasys, is also bundled into this package, he added.

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