Opposition filed against patent on key Hep C drug

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Dear Friends,

On 18 May, the Sankalp Rehabilitation Trust, an organisation that provides

treatment and rehabilitation support for injecting drug users, filed a

post-grant opposition against Roche's patent for the hepatitis-C drug

peg-interferon á2a, marketed by Roche as Pegasys.

The patent for Pegasys was the first product patent granted in India under the

new TRIPS-mandated product patent regime, and is only available from Roche at

the price of Rs 2.25 lakh (US$ 5,625) for a 6-month course. In the hope that an

absence of patent protection will spur generic competition to bring down the

price of this much-needed drug, Sankalp decided to file an opposition against

Pegasys.

Hepatitis-C represents a huge public health problem in India. An

estimated 12.5 million people in India are infected with the hepatitis-C virus

(HCV). Left untreated, hepatitis-C can lead to liver cirrhosis, liver cancer or

liver failure. Hepatitis-C is especially pernicious for those co-infected with

HIV, as several studies have shown that HIV-HCV co-infection leads to increased

rates of disease progression. Injecting drug users are especially vulnerable to

HIV-HCV co-infection.

For instance, a study in the Northeastern state of Manipur reported HIV-HCV

co-infection rates as high as 93% among injecting drug users. However, due in

part to its high cost, hepatitis-C treatment is not available in government

hospitals.

Indeed, we have been told that treatment programmes are not even bothering to

screen for HCV due to the unavailability of treatment.

Roche'2s 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.

The opposition to the patent for Pegasys was based on these grounds.

Patent protection is only granted to inventions that are new and involve an

inventive step. Sankalp has argued in its opposition that the patent was

wrongly granted, because given the state of the existing knowledge at the time

of the grant of patent, the " invention " that Roche was claiming was neither new

nor inventive. Rather, Sankalp has argued, the patent is an attempt to obtain a

monopoly over technology that existed in the public domain.

Sankalp has also invoked some legal provisions that are unique to

Indian patent law, including the assertion that Roche's alleged " invention " is

at most a " mere admixture " of known substances and unpatentable under section

3(e) of the Patents Act, and that it is just a " new form of a known substance "

and not patentable under section 3(d) of the Act.

A copy of the opposition can be found at our website:

www.lawyerscollective.org

Feel free to contact us with any questions.

In Solidarity,

Lawyers Collective HIV/AIDS Unit

Lawyers Collective HIV/AIDS Unit

63/2, 1st Floor, Masjid Road,

Jangpura,

New Delhi - 110014

Phone - 011-24377101, 24377102, 24372237

Fax - 011-24372236

E-mail - aidslaw1@...