Help Stop Pegasys from Monopolizing Hep-C Drugs in India

April 14, 2010 12:36 pm

Sankalp Rehabilitation Trust is presently involved in a case to ensure that people have access to treatment for Hepatitis-C. The drug in question is Peg-Interferon α2a, marketed by Swiss global health-care company La Roche Limited as 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, it can lead to other complications such as liver cirrhosis, liver cancer, or liver failure. Those who suffer from an HIV-HCV co-infection have an increased rate of disease progression. Injecting drug users are especially vulnerable to co-infection; figures from Manipur show a high co-infection rate of up to 93% among injecting drug users. However, partly due to its high cost, treatment for HCV is not available in government hospitals in India. Thus, an ironic tragedy unfolds—people living with HIV are able to obtain treatment for HIV, but are dying because of their HCV-related complications.

In 2006, the Indian Patent Office granted a patent to Roche for Pegasys, the first product patent for pharmaceuticals granted in India under the new World Trade Organization Intellectual Property Agreement, which essentially grants a monopoly to Roche. Patients with chronic HCV, who need a six-month course of treatment of Peg-Interferon α2a, must purchase it at a cost of approximately Rs. 4, 36,000 [8,752.38 USD] (sometimes available at a discounted price of Rs. 3,14,496 or 6,313.28 USD). Again, Pegasys has to be taken in combination with anti-viral drug Ribavirin, which alone costs Rs. 47,160 [946.70 USD].

As we know, a patent grants a monopoly to the patent holder to prevent others from making or selling the same drug without its permission. If there is no patent, other companies can make and sell the drug. The resulting competition helps lower the prices of drugs, as has been clearly shown by the falling prices of HIV drugs.

Therefore, in May 2007, Sankalp filed an opposition to challenge the grant of patent to Pegasys. Wockhardt, an Indian company, had also filed a post-grant opposition against the patent granted to Pegasys.

Roche’s patent for Pegasys involves combining interferon – a naturally occurring protein which has been known for several years to be effective against HCV – with a structure called polyethelyene glycol (PEG), an inert substance. PEG helps to prevent the interferon from being broken down immediately by the body and thus allows it to remain in the bloodstream longer. This technology of combining interferon and other biologically active proteins with PEG had also been known for many years.

Under the law, a patent can only be granted to inventions that are new and involve an “inventive step.” Sankalp argued that the patent was wrongly granted as Roche’s “invention;” in fact, combining interferon with PEG was neither new nor inventive. Sankalp also opposed the patent based on other public health safeguards, which disallow patenting of “mere admixture” of known substances and patenting of a “new form of a known substance” without increased efficacy.

In a decision delivered in March 2009, the Indian Patent Office rejected the post-grant opposition filed by Sankalp against the grant of Roche’s patent for Pegasys.

The patent case has not yet been settled, and Sankalp continues to work to end Roche’s monopoly, decrease pricing of HCV medicines, so that we can provide affordable and necessary treatment for their clients.