Roche’s Pegasus patent invalidated in India

08-Nov-2012

On 2 November 2012, the Indian Intellectual Property Appellate Board (IPAB) handed down a decision invalidating Indian patent no.198952 in the name of Swiss pharmaceuticals manufacturer F.HOFFMANN-LA ROCHE AG.  The revoked patent seeks to protect Pegasys (Pegylated Interferon Alfa-2a), a drug used to treat Hepatitis C. 

It is a significant case for various reasons. The patent is India’s first granted pharmaceutical product patent and first post grant opposition case.  It is also a case that has raised issues relating generally to the pricing and accessibility of pharmaceuticals.  Specifically, the drug costs INR 436,000 (approximately A$7,830) for a six month treatment, and is usually taken in combination with Ribavarin costing an additional INR 47,160 (approximately A$850). For this reason the appellant Sankalp Rehabilitation Trust, a patient group, opposed the grant of the patent.

IPAB’s decision is limited to the question of patentability.  The decision invalidates the patent because (a) it is considered to be obvious, and (b) it fails under section 3(d) of the Indian Patent’s Act. 

Section 3(d) states that “the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant” is not an invention under the Act.

The IPAB provides the following explanation which is the core of their finding, in relation to

(a) obviousness

            “Once the Court has the facts, it has to put the clock back to the date of the invention and see if the 
            ordinary man would have found it obvious to put this invention together. In the present case, 
            Interferon had already been used to treat hepatitis C. There were problems in the use of this protein 
            as such. Pegylation (PEG) was known from 1970s and the pegylation of proteins was known to 
            improve the activity of the proteins. There was intense activity in the field of PEG chemistry and the 
            person skilled in the art will be acquainted with it, if not directly involved in it. Linear conjugates of 
            Protein showed improvement over unconjugated protein.

            ...The Person of Skill In The art takes a look at Monfardini and also at the other exhibits. He knows 
            that the activity of Interferon has to be improved for Hepatitis C cases. He knows that linear 
            pegylation will improve it a bit. He knows that branched pegylation has shown marked improvement 
            over linear conjugates in the case of superoxide dismutase and three enzymes. He is confident that 
            branched PEGylation of Interferon will work; it has worked in Monfardini with enzymes. Monfardini 
            gives him the structure on a platter. He also knows that he can work with molecular weight range of 
            5000-40,000 Daltons to strike oil. He has reason to believe that higher may be better. Why would 
            [he] not be willing to make trial and error experiments and see if it works as Synthon said?”

(b) section 3(d)

            “...The examples in the Complete Specification show improvement over unconjugated interferon, 
            but the inventor claims surprising activity when compared to other conjugated interferon which is not 
            shown. Hence the evidence for the “surprising activity “is not adequate. The authors must present 
            themselves as witnesses either in person or through proof affidavits for only then the evidence can 
            be admitted.

Finally, the decision states that patient groups, such as the appellant, are certainly “persons interested” under the meaning of the Act because patents have a significant “public interest” dimension.  Accordingly, they may oppose a granted patent under the provisions of the Act.

The decision may be further appealed.  The decision is another blow to overseas pharmaceutical patent holders in India after grant of a compulsory license to Natco (generic manufacturer) earlier this year.

Shriraj Takle