Major setback for scaling up Hepatitis C (Hep C or HCV) treatment

Major setback for scaling up Hepatitis C (Hep C or HCV) treatment

The Indian Patent Office has rejected a post-grant opposition filed against the grant of patent to drugs that are used for Hepatitis C (Hep C or HCV) treatment.

A Mumbai-based non-governmental organization, Sankalp Rehabilitation Trust, had filed this post-grant opposition against the grant of patent to F-Hoffmann-La Roche AG (Roche) for Pegasys (pegylated interferon alfa 2a) - a key drug used to treat HCV.

Hepatitis C is a blood-borne, infectious, viral disease that is caused by the hepatitis C virus (HCV). The infection can cause liver inflammation that is often asymptomatic, but chronic hepatitis can lead to cirrhosis and liver cancer. HCV transmission occurs when traces of blood from an infected person enter the body of a HCV-negative person. Like HIV, HCV is spread through sharing injection equipment, through needle stick or other sharps injuries, or less frequently from infected mothers to their babies.

HCV transmission rates are higher than that of HIV, and the condition is often more severe in drug users. People who share injection equipment are vulnerable to HCV and HIV infection, and in many places co-infection is not common.

Greater awareness about hepatitis C, more investment of resources, cheaper diagnostic and treatment services, and improved hepatitis-related treatment literacy, are all urgently needed by people co-infected with the hepatitis C virus and HIV.

"Hepatitis C treatment is mostly left out since AIDS activists are so focused on ARVs [antiretroviral drugs] or other prevention and treatment services," had said Umesh Sharma, in 2006, who had then completed a course of hepatitis C treatment.

The treatment for HCV was already very expensive - costing on average approximately US$250 per week. Interferon injections are given weekly, in addition to ribavirin tablets.With rejection of post-grant oppostion to granting of patent to pegasys (HCV drug), the monopoly will further exacerbate access, availability and affordability to HCV treatment.

The Lawyers' Collective in a posting on International Treatment Preparedness Coalition (ITPC) had said that In 2006, the Indian Patent Office had 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 [USD 8,752.38 ] (available at a discounted price of Rs. 3, 14,496 or USD 6,313.28 ). Again, Pegasys has to be taken in combination with Ribavarin, which alone costs Rs. 47,160 [USD 946.70 ].

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, says the Lawyers' Collective posting.

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.

However, in a decision delivered on 17 March 2009, the Indian Patent Office dismissed the oppositions and upheld the grant of patent to Roche.

The impact of this decision is likely to be grim - with worsening access, availability and affordability of HCV treatment for those who need it most. Hope it gets reversed before it is too late.

- Bobby Ramakant

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