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The Intellectual Property Apellate Board (IPAB) today set aside the grant of patent to Swiss drug major Hoffmann-La Roche's Pegasys, a drug used for the treatment of Hepatitis C, by the Indian Patent Office (IPO). The order comes following an appeal filed by a Mumbai-based community based non-prifit organisation, The Sankal Rehabilitation Trust, challenging the rejection of its post-grant opposition by the IPO.
The appeal was against a decision the IPO delivered in March 2009, which rejected the Trust's post-grant opposition against the grant of patent for Pegasys (Peg-Interferon α2a). The appeal is allowed through the IPAB order now. It is to be noted that the IPO has granted Patent for Pegasys with Patent Number 198952 on February 21, 2006.
The Corum comprising Justice Prabha Sridevan, chairman of IPAB and the Technical Member (Patents), D S Parmar, ordered, "In the end, the invention is held to be obvious. The appeal is allowed and the grant of Patent No.198952 is set aside."
Analysing the claims of the company, with the scientific background, the Board said that the controller has erred in citing some of the specifications in the formula as a difference. Concluding on the obviousness of the invention, the Board said that, "If the results were predictable then there is no surprise. Definitely the prior arts above mentioned and in particular, Monfardini render the invention obvious."
The Trust, earlier in its post-grant opposition petition filed with the Controller of Patents, the Patent Office, said that the patent is related to a chemical modification of interferon, a naturally occurring protein produced by the body which is identified to have antiviral and antiproliferative activity. In particular, interferon has been shown to be effective against the hepatitis-C virus (HCV), which if not treated, would lead to liver cirrhosis, liver failure and liver cancer, it said.
However, the attack of the appellant (The Sankalp Rehabilitation Trust) on novelty was rejected by the Board, stating that to defeat novelty, the appellant should show that an earlier document , disclosed all that the patentee is seeking to patent. And that each limitation of the claimed invention is found in a single prior art reference. The appellant has not done this.
The case is not only important since it gives access to pegylated interferon to the patients, but also it determines whether non-governmental organisations (NGOs) or community-based organisations can file a post-grant opposition or revocation petition challenging the grant of a patent in India, according to a counsel appeared in the IPAB for the Trust.
The company raised a preliminary objection regarding the locus standi of the appellant as not being a ‘person interested’. The Board ordered that, "Further public interest is a persistent presence in intellectual property law and will not melt into thin air, nor dissolve. We therefore hold that the appellant who works for a community which needs the medicine is definitely a ‘person interested” The locus standi objection is rejected."
The Trust filed an opposition to challenge the grant of patent to Pegasys, in May 2007, arguing that the technology of combining interferon and other biologically active proteins with PEG has been known for many years and could not fit to the condition under the law that the patent could only be allowed to inventions that are new and involve an inventive step.
Mumbai-based Wockhardt, had also filed a post-grant opposition against the patent granted to Pegasys, which was also rejected by the Indian Patent Office.
In its order on March 2009, the IPO rejected the post-grant opposition filed by Sankalp against the grant of Roche's patent for Pegasys, added reports.
