The Patent Office has begun the hearing of Pegasys, India’s first product patent under the new Patent Act, which had been granted to Roche India, the Indian branch of the Swiss Hoffman La Roche, and then subsequently received one of India’s first post-grant opposition in March last year.
About Pegasys
Pegasys, or Pegylated interferon alfa-2a as it is also known as, is a drug which is used to treat Hepatitis C. The prescribed six-month course of treatment used to cost about Rs 4.36 lakh (available at a discounted price of Rs 3,14,496). It is to be taken in combination with Ribavarin, which costs another Rs 47,160. The drugs, prices of which have since dropped substantially, however, still cost Rs 2.25 lakh for a 6-month treatment course. As opposed to the earlier practice of having the dosages spread out over 3 injections a week, this drug involved a technology which reduced the required frequency to once a week.
The Challenge
The Patent Act allows for both pre-grant opposition as well as post-grant opposition where the drug company has to oppose the granted product patent within 12 months from the date of publication.
Sankalp Rehabilitation Trust, a Mumbai-based NGO that works with drug users, joined Wockhardt (which had filed its opposition 2 months prior) in its opposition of the patent at the Chennai Patent where Assistant controller of patents heard the post-grant opposition. It was argued that the claimed invention, the branched pegylated form of interferon alfa 2a did not satisfy the patentability criteria under Indian law as Pegasys involves combining interferon with polyethelyene glycol (PEG) which helps the interferon to remain in the bloodstream, and also that the technology of combining interferon and other biologically active proteins with PEG had been known for years prior to Pegasys patent. In light of this, the counsel put forward that there was no inventive step and was obvious to a person skilled in the art. Further, they alleged that Roche’s ‘invention’ is at most a ‘mere admixture’ of known substances and thus not patentable under section 3(e) of the Patents Act 1970, and is just a ‘new form of a known substance’ and not patentable under section 3(d) of the Act.
In response to Roche’s questioning of Sankalp’s locus to file, Sankalp pointed out that a public interest group was a ‘person interested’ and as such was allowed to file under law. Roche also argued that the documents which were relied upon, spoke of pegylation as enzymes and that as interferon was not an enzyme, these documents could not be used to object to the novelty and
inventive step involved in the pegylation of interferons. This was countered by Sankalp stating that pegylation was known to protein chemistry generally and was not specific to enzymes.
The parties had until September 25th to file their written submissions.
Implications
Though other generic copies of the drug are already being marketed in the country, the amended Patent Act does not require companies which have made substantial investments in products which were released prior to January 2005 to stop the manufacturing of their products. Despite competition from Indian companies such as Wockhardt, Shanta Biotechnics and Bharat Biotech, Roche managed to stick on to its pre-grant prices. Factors such as this along with the several pre-grant oppositions that big pharmaceuticals have been facing, post-grant oppositions such as this will probably keep other multinationals on their toes and will probably make the already cautious drug companies even more wary of the products they introduce in the future.
Or in alternative…
In the meanwhile, 2 scientists, back in the beginning of 2007, claimed to have ‘invented around’ the patent. Claiming to have cured Hepatitis C, British Scientists Shaunak and Brocchini claimed to have used the basic molecular structure of pegylated interferon, (the very same patented by Roche Pharmaceuticals).
The ultimate aim in doing all of this is to provide access to the drug to impoverished nations, at affordable rates to treat Hepatitis C, whether produced by the La Roche or through alternative means by different scientists. SpicyIP only hopes that this hearing is completed as speedily as possible, to help provide quicker access of the drug to those in need of such treatment.
