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India revokes Roche's Pegasys patent after patient group challenge

Company becomes latest in big pharma to see intellectual property overturned

Roche Pegasys (peginterferon alfa-2a) 

Another month goes by, and another big name pharma brand loses patent protection in India. This time Roche's hepatitis C drug Pegasys is the product to see its intellectual property overturned.

India's Intellectual Property Appellate Board (IPAB) revoked the patent on Pegasys (peginterferon alfa-2a) on the grounds of 'obviousness' and because Roche had failed to show it was more efficacious than its older, non-pegylated version of the drug.

The case is particularly notable because Pegasys was the first pharmaceutical product to be granted protection under India's patent law, which was introduced in 2005. 

Pegasys was brought into the firing line after an opposition to its patent was filed by Sankalp Rehabilitation Trust, a community-based patient organisation that provides care and treatment for injecting drug users, who are vulnerable to infection with the hepatitis C virus.

The latest turn in the case comes after Roche's patent on Pegasys was previously upheld by the Indian Patent Office after challenges from Sankalp and Indian drugmaker Wockhardt. Roche has the right to appeal the IPAB's decision, but as not yet said whether it will do so.

On the obviousness point, the IPAB concluded that interferon alfa was already an established treatment for hepatitis C, while the use of pegylation to improve the activity of protein-based drugs had been recognised since the 1970s. That meant that a person 'skilled in the art' could have predicted the claims made by the patent. 

Meanwhile, with regards to the requirement for increased efficacy - which is enshrined in Section 3(d) of India's 1970 patent act - the IPAB said: "We find that the respondent has not discharged the burden of proof."

The ruling is also significant because it specifies for the first time that a patient group is considered to be an interested party in patent opposition cases, raising the possibility of additional patent challenges in future.

"In India [Pegasys] is currently unavailable in the public healthcare system and unaffordable in the private sector," according to Medecins sans Frontieres, which notes that Roche is selling the drug at around $247 per vial.

IPAB documents indicate that a treatment course with Pegasys costs around 438,000 rupees (about $8,000), although it can be obtained at a discounted price of around 315,000 rupees, with another 47,000 rupees needed for oral ribavirin that is administered alongside Roche's drug.

The latest case comes after a flurry of defeats for pharma multinationals in IP disputes in India and elsewhere. 

Last month India revoked Pfizer's patent on cancer drug Sutent (sunitinib), while Indonesia broke several patents on HIV and hepatitis C drugs sold by Merck & Co, Gilead, Abbott Laboratories and Bristol-Myers Squibb.

In September Bayer failed in a bid to overturn a compulsory license which removed patent protection for its Nexavar (sorafenib) product. Just prior to that, Roche had lost a four-year legal dispute with Cipla over patent rights to Tarceva (erlotinib).

6th November 2012

From: Sales, Regulatory

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