Update: Indian Patent Office hears post-grant opposition on Pegasys

[Guest guest]

INDIAN PATENT OFFICE HEARS POST-GRANT OPPOSITION ON PEGAYS

9 September 2008. The Assistant Controller of Patents at the Chennai Patent Office, India, yesterday heard a post-grant opposition filed by Sankalp Rehabilitation Trust against the grant of a patent to F. Hoffmann La Roche AG (Roche) for Pegasys, a drug used to treat Hepatitis C.

This was the first hearing on a post-grant opposition filed by a public health group. The Indian Patent Office had granted a patent to Roche in 2006 for Pegasys. Patients with chronic Hepatitis C need a six-month course of treatment of Pegasys (pegylated interferon alfa2a), which costs about Rs. 4,36,000 (available at a discounted price of Rs. 3,14,496). Pegasys is to be taken in combination with Ribavarin, which costs Rs. 47,160.

In May 2007, Sankalp Rehabilitation Trust, a Mumbai-based NGO that works with drug users, filed a post-grant opposition against the grant. Injecting drug users are particularly vulnerable to infection with Hepatitis C. It is estimated that about 92% of adult Indian injecting drug users are infected with Hepatitis C virus. Hepatitis-C is also a major co-infection that affects persons living with HIV. In fact, a study estimates that about 92% of PLHIV in the North-East have HIV-Hepatitis C co-infection. Because the drugs are so highly priced, patients with chronic Hepatitis C, who require treatment, are unable to afford it. The irony is that while PLHIV in the North East access free first line antiretrovirals through the government roll-out, they are dying because they cannot get themselves treated for Hepatitis-C. As Ajitshwor, a Manipur-based INP+ member noted, " I know that I will not die of AIDS...what is going to kill me is hepatitis C. "

Mr. Anand Grover, counsel for Sankalp Rehabilitation Trust, argued that the claimed invention, Pegasys—the branched pegylated form of interferon alfa 2a—did not satisfy the patentability criteria under Indian law. He argued that Roche's patent for Pegasys involves combining interferon—a naturally occurring protein with antiviral effects that has been known for years—with a structure called polyethelyene glycol (PEG), an inert substance that helps to prevent the interferon from being broken down by the body, thus allowing it to remain in the bloodstream longer. This technology of combining interferon and other biologically active proteins with PEG had also been known for years prior to this patent. In fact, the technology embodied in Roche's patent is essentially identical to that disclosed in an academic paper that was published a year prior to the filing of Roche's patent application. Therefore, all Roche did was apply what was already known to interferon alfa 2a. Mr. Anand Grover said that, in light of this, the invention was not new and, in the alternative, also was obvious to the person skilled in the art and lacked inventive step. He further argued that Roche had also failed to satisfy section 3(d) of the Patents Act, which requires a showing of enhanced efficacy. He pointed out that admittedly, pegylated interferons were known substances at the time of the application. However, Roche did not provide data to show that the claimed invention was significantly more efficacious than other pegylated interferons. He said that the limited data provided by Roche to show enhanced efficacy was not adequately proved as required by law and further was not conclusive for all human cell lines. Raising another ground, Mr. Anand Grover argued that pegylated interferon was merely an admixture of known substances, with no showing of synergistic effect, and therefore failed to satisfy section 3(e) of the Patents Act.

Responding to this, Mr. Guru Natraj, counsel appearing for Roche, first questioned the standing of Sankalp Rehabilitation Trust to file a post-grant opposition. He claimed that under the law, only a " person interested " could file a post-grant opposition and Sankalp Rehabilitation Trust did not satisfy this criterion. He then argued that the burden of proving the invalidity of the patent was on the opponent, and it was not for Roche to prove that its patent was valid. Responding to the documents cited by Mr. Anand Grover, Mr. Guru Natraj attempted to distinguish them and claimed that they taught pegylation of 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. He added that the documents, in fact, taught away from using pegylated interferon of the higher molecular weights claimed by Roche. He argued that none of the documents cited by Mr. Anand Grover disclosed all the elements of the branched pegylated interferon of a particular molecular weight that Roche was claiming. Mr. Guru Natraj further argued that the patent satisfied the " technical advance " requirement of inventive step because Pegasys was more efficacious.

Rejoining to the arguments, Mr. Anand Grover argued that the question of standing of Sankalp Rehabilitation Trust had not been raised earlier. In any event, he relied upon a decision of the Delhi High Court to show that a public interest group was a " person interested " as required under law. On the issue of burden of proof, Mr. Anand Grover relied on a judgment of the Supreme Court to show that the burden of proving inventive step was on the patent holder, Roche in this instance. He pointed out that pegylation of biologically active molecules, including various proteins, enzymes and hormones, was known to produce certain desirable effects and that it could not be said that pegylation of proteins such as interferon alfa 2a was unknown. Responding to the proving of " technical advance " , Mr. Anand Grover said that " technical advance " and obviousness are components of the inventive step requirement and ought not to be conflated with the requirement of showing of efficacy under section 3(d) of the Patents Act.

The parties have been given until 25 September 2008 to file their written submissions.

Today, the Patent Office will be hearing a post-grant opposition filed by Wockhardt against the same patent.

After the hearings conclude, the Patent Office will decide whether Roche's patent is valid or whether it should be amended or revoked.

Further details relating to the Pegasys opposition will be made available on our website (www.lawyerscollective.org) shortly.

In solidarity,

Lawyers Collective HIV/AIDS Unit