Generic competition likely to bring down its price

The Sankalp Rehabilitation Trust hopes that the absence of a patent barrier would spur generic competition to bring down the price of the much-needed pegylated interferon alfa-2a (Pegasys), a medicine used to treat Hepatitis C, bringing relief to people suffering from the disease. The Trust provides treatment to, and rehabilitation support, for injecting drug users (IDUs).

The Trust had challenged the award of patent of the drug to F. Hoffmann-La Roche A.G. (Roche) based on which the Intellectual Property Appellate Board (IPAB) in India revoked the patent on Friday. It also held that a patients’ group can challenge the validity of granted patents.

Director of Sankalp Rehabilitation Trust Eldred Tellis hopes that the government would now take concrete steps to start providing access to this medicine. “It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine,” he said.

The patent, granted to Roche in 2006, was the first product patent on a medicine in India under the new Trips-mandated product patent regime for medicines. The patent granted a monopoly to Roche to market pegylated interferon alfa2a. Patients with chronic Hepatitis C, who need a six-month course of treatment of Roche’s product, have to purchase it at a cost of approximately Rs. 4,36,000 (available at a discounted price of Rs. 3,14,496). Again, it has to be taken in combination with ribavarin, which alone costs Rs. 47,160.

Concerned about the impact of this patent on access to medicines, Sankalp filed a post-grant opposition challenging the grant of the patent with technical and legal aid from Lawyers Collective HIV/AIDS Unit.

Anand Grover, senior counsel and Director of Lawyers Collective HIV/AIDS Unit, who appeared for Sankalp in this matter, said: “This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis C, both in India and globally, will benefit. It is also historic because this was the first-ever product patent granted on a medicine in India since 1970.”

Hepatitis C represents a huge public health problem in India and globally. An estimated 10 to 12 million people in India, including 50 per cent of IDUs nationally and 90 per cent of IDUs in north-east India, are infected with Hepatitis C virus (HCV). Left untreated, Hepatitis C can lead to liver cirrhosis, cancer and liver failure. Hepatitis C is especially of concern for those co-infected with HIV, as several studies have shown that HIV-HCV co-infection leads to increased rates of disease progression. IDUs are especially vulnerable to HIV-HCV co-infection with HIV-HCV co-infection rates as high as 93 per cent among IDUs in Manipur. However, unlike both first- and second-line HIV treatment, which is available to all people living with HIV who need it, Hepatitis C treatment is not available in government hospitals largely due to its high cost. Treatment programmes do not even bother to screen patients for HCV due to the unavailability of treatment.

Despite Sankalp’s case that Roche’s claims did not satisfy the patentability requirements under Indian law, in 2009, the Patent Office rejected the post-grant opposition filed by Sankalp and an Indian company and upheld the validity of Roche’s patent. Sankalp then filed an appeal before the IPAB challenging this decision.

Mr. Grover said, “We are happy that the IPAB has recognised the element of public interest in setting aside undeserving patents and held that patients’ groups, who are directly impacted by patents on medicines, can challenge granted patents. This will be of import as concerned patients’ groups will now have better clarity in challenging patents on medicines for HIV, cancer and other diseases.”

Setting aside the patent, the IPAB held that Roche has not provided any evidence, in the specification or even otherwise, to prove that pegylated interferon has enhanced efficacy. The IPAB, however, held that Roche’s claims were novel.