Indian Patent Office

Indian Patent Office, LONDON: ‘Medicins Sans Frontieres’, an international medical humanitarian group, today welcomed India’s decision to reject a patent granted to Swiss drug multinational Roche for its AIDS related drug Valganciclovir.



Valganciclovir (Valcyte) is an important drug for the treatment of severe eye infection that people living with HIV (the AIDS virus) are susceptible to. It is also used in treatment and prevention of infections caused by cytomegalovirus (CMV) in organ transplant patients.

“Roche was attempting to patent a new form of a drug that was really invented in the 1980s,” said Leena Menghaney, project manager of the MSF Campaign for Access to Essential Medicines in India.

“This decision shows that Section 3(d) of India’s Patents Act, which prevents companies from filing unjustified patents, is working. Equally importantly, the Patent Office also found separately that the patent claims were obvious and therefore not patentable,” she said.

“This is one victory for access to medicines, but we have to be careful not to lose an even bigger fight,” she added.

Medicins Sans Frontieres(MSF) or Doctors Without Borders, a Geneva-based non-governmental organisation, best known for its projects in war-torn regions and developing countries facing endemic disease.

The decision on April 30 ended one of the toughest patent battles between Roche, Indian generic drug makers and groups of patients.

To date, the price of valganciclovir is prohibitively expensive – Roche markets the drugs for up to 382,245 (USD 8,500) for a four-month treatment course in high-income countries.

In India, the Roche price for a standard protocol is about Rs 267,523 (USD 5,950) for a four-month treatment course and Rs 1,040 for each 450 mg tablet while generic equivalents are available at a fourth of its cost.

The Chennai office rejected the patent claim primarily on the grounds that valganciclovir lacked the novelty that merits protection.

In December 2006, MSF approached Roche for a discount, but even the “discounted” price was so high that some MSF AIDS projects opted out of providing this treatment for CMV.

Through this decision, the Indian Patent Office has also confirmed the right of patients groups to oppose a patent after it has been granted, a matter on which Roche claimed there was ambiguity.

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