Essential Medicines News

Médecins Sans Frontières (Doctors Without Borders), as part of its Campaign for Access to Essential Medicines, is asking pharmaceutical company Novartis to drop its legal challenge to India’s patent law. Novartis is suing after the country rejected the patent application for the company’s Glivec. MSF has launched a petition to pressure Novartis to drop the case.

The press release states that Indian law provides effective access to essential medicines, but this challenge could weaken the effectiveness of that regime. In particular,

The company is challenging a key public health safeguard enshrined within India’s Patents Act that aims to restrict the granting of trivial patents. If Novartis gets its way, it could mean that essential drugs are more likely to be patented in India, thereby restricting generic production and keeping prices for newer medicines high.

The press release compares the situation to South Africa in 2001:

Novartis was one of the 39 companies that took the South African government to court over five years ago in an effort to prevent the government from importing cheaper AIDS medicines.

“It feels like we’re back in South Africa in 2001,” said Dr. Tido von Schoen-Angerer, of MSF’s Campaign for Access to Essential Medicines. “Just like five years ago, Novartis with its legal actions is trying to stand in the way of people’s right to access the medicines they need.”

MSF has also posted a Q&A and a timeline on the issue.

Novartis has responded by posting their perspective in a document on their Web site. The document notes that Glivec (also known as Gleevec), the cancer drug imatinib mesylate, is patented in other countries. However, Indian patent examiners rejected the application for Glivec, resulting in Novartis’ challenge.

Novartis’ suit seeks to weaken the Indian standard on patentability. MSF counters the strict standard is designed to protect public health and therefore within India’s rights under the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights treaty. MSF points to the 2001 Doha Declaration, which states that TRIPS

…can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.

On pricing, MSF says that

In other countries where Novartis has obtained a patent, Gleevec is sold at $2,600 per patient per month. In India, generic versions of Gleevec are available for less than $200 per patient per month.

On the other hand, the Novartis document notes that the company

…provides Glivec totally free of charge to over 6,500 patients (99% of all patients receiving the medicine) as part of our Glivec International Patient Assistance Program (GIPAP). Therefore only 1% of patients pay for their treatment. Worldwide, we provide Glivec free of charge to more than 17,000 patients in 83 countries. On the other hand, the generic versions of Glivec in India are priced at approximately 4.5 times the average annual income, putting them out of reach for most patients needing Glivec in India. Clearly, generics do not, and will not sufficiently address the need for access to Glivec, or other life saving medicines in India.

Novartis also has a site for their Glivec patient assistance program.