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IPAB invalidates India’s First Pharma Product Patent

A recent post-grant opposition proceeding brought forth by Sankalp Rehabilitation Trust (a Non-Government Organization) against F. HOFFMANN-LA ROCHE AG and the Assistant Controller of Patents & Designs before the Intellectual Property Appellate Board (IPAB), resulted in invalidation of India's first pharmaceutical product patent ‘Pegasys’ inter alia on the grounds of obviousness.

The order steered clear the definition of "a person interested" and stated that the parties injured from the grant of a patent are not limited to the manufacturers or the sellers of medicines protected by the patent, but also the patients or those in need of the medicine are also interested parties in such instances. Since patents are not merely private rights, they harness a significant "public interest" dimension as well.

The well reasoned order while going to the root of obviousness and heavily relying on the observation made in KSR v. Teleflex, stated that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. Use of conventional methods apart from obtaining results that were predictable and not surprising rendered Roche’s patent obvious over the cited prior arts.

In respect of the controversial Section 3(d) of the Indian Patents Act, 1970, the observation made in the case of Novartis-Gleevec was reiterated, stating that the burden of proof to prove therapeutic efficacy lies on the patentee while in the present case, Roche did not discharge the burden of proof in determining the invention to be a new class of PEG derivative of interferon.

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