INDIAN PATENT OFFICE REJECTS POST-GRANT OPPOSITION ON PEGASYS

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INDIAN

PATENT OFFICE REJECTS POST-GRANT OPPOSITION ON PEGASYS

14 April

2009

In a setback to public health groups, the Indian Patent

Office has rejected the post grant opposition filed by Sankalp Rehabilitation

Trust against the grant of patent to F Hoffmann-La Roche AG (Roche) for Pegasys

(pegylated interferon alfa2a), a key drug used to treat Hepatitis C.

In 2006, the Indian

Patent Office granted a patent to Roche for Pegasys. The Patent grants a

monopoly to Roche, to market pegylated interferon alfa2a. Patients with

chronic Hepatitis C, who need a six-month course of treatment of pegylated

interferon alfa2a, have to purchase it at a cost of approximately Rs. 4, 36,000

[8,752.38 USD](available at a discounted price of Rs. 3, 14,496 or 6,313.28 USD).

Again, Pegasys has to be taken in combination with Ribavarin, which alone costs

Rs. 47,160 [946.70 USD].

In May 2007, Sankalp

Rehabilitation Trust, a Mumbai-based NGO that works with drug users, filed a

post grant opposition to challenge the patent.

Roche’s patent for

Pegasys involves combining interferon alfa2a – a naturally occurring

protein with known antiviral effects – with a structure called

polyethelyene glycol (PEG), a known inert substance that prevents 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 Roche’s

claim for the patent.

Sankalp argued in its

opposition that the patent was wrongly granted because given the existing knowledge

at the time Roche filed its patent application, the “invention”

that Roche was claiming was neither new nor inventive. Sankalp also urged that

the pegylated form of interferon claimed by Roche is only a “new form of

a known substance” without increased efficacy as compared to other known

interferon conjugates and therefore is not patentable under section 3(d) of the

Patents Act

Wockhardt, an Indian

company, had also filed a post-grant opposition against the patent granted to

Pegasys.

Under the Indian law, an

Opposition Board was constituted. It appears that the Opposition Board, after

reviewing the oppositions and the evidence on record, concluded that the

“invention” claimed in the patent ought to be revoked. The

Opposition Board found that in light of certain prior art documents cited by

Wockhardt, the claimed invention of conjugating interferon alfa2a with PEG was

not new. It further found that given the knowledge available through the

documents cited by Sankalp and Wockhardt, any person skilled in the art could

contemplate the structure of pegylated interferon and the process of preparing

the same. Regarding the objection under section 3(d) of the Patents Act, 1970,

the Opposition Board found that Roche had not proved an increase in efficacy

over the known substances.

Thereafter, a hearing was

held on 8–9 September 2008 before Mr. T. V. Madhusudhan, the Assistant

Controller of Patents and Designs.

In a decision delivered on

17 March 2009, the Patent Office dismissed the oppositions and upheld the grant

of patent to Roche.

Disagreeing with the

recommendations of the Opposition Board, Mr. T. V. Madhusudhan held that the

documents cited by the Opponents did not destroy the novelty or inventive step

of the particular high molecular weight of pegylated interferon claimed by

Roche. He further held the increased antiproliferative activity and decreased

antiviral activity of pegylated interferon shown through experiments by Roche

constituted an enhancement in therapeutic efficacy and therefore section 3(d)

was satisfied.

While dealing with the

question of the standing of Sankalp to file a post-grant opposition, the Patent

Office left the question open as Roche raised this objection only at the time

of hearing.

The decision of the

Patent Office rejecting the post-grant opposition can be downloaded from our

website (www.lawyerscollective.org).

In solidarity,

Lawyers Collective

HIV/AIDS Unit