TAG supports opposition of Sanofi TB drug patents in India

Treatment Action Group ( TAG), a US-based organisation focused on research of diseases such as HIV/AIDS and tuberculosis (TB), has applauded an opposition that aims to block Sanofi from patenting a new TB drug in India.

On December 5, TAG issued a statement of support for a TB survivor, Ganesh Acharya and Delhi Network of Positive People (DNPP), saying that the drugs being claimed by Sanofi are “public goods”.

The oppositions, submitted on November 5 at the Indian Patent Office in Kolkata, are against two patents applied-for by Sanofi.

The first patent, titled “Pre-grant opposition of patent titled Anti-tuberculosis stable pharmaceutical composition in the form of a coated tablet comprising of granules of isoniazid and granules of rifapentine and its process of preparation” covers a new TB treatment.

The second patent covers a water-dispersible formulation for young children.

Isoniazid and rifapentine have separately been approved and on the market since 1952 and 1998, respectively. Sanofi’s patent application covers a tablet which combines both drugs.

According to World Health Organization’s 2017 Global TB Report, nearly 2.8 million people fell ill with TB in India, which alone accounted for nearly a quarter of the world's TB burden. Around 435,000 people lost their lives to TB that same year.

In their opposition, Acharya and DNPP said claims 1-8 of the patent were not novel, and had already been published in prior art.

Additionally, they said the claims of the patent were obvious and lacks an inventive step, by simply combining two existing drugs.

The opposition said such patent claims will block Indian generic manufacturers from entering the market, and will allow the French pharma company to control the market for TB therapies.

TAG’s TB project co-director, Mike Frick, said Sanofi’s filing shows that the “patent system is broken”.

“Rifapentine and isoniazid are public goods. Sanofi is not the innovator behind rifapentine, but instead the beneficiary of public funding,” he said.

“The idea that the company is now seeking monopoly control over the combination of two-decades-old medicines in the public domain shows that the patent system is broken; the idea of patents on combinations of medicines should be opposed,” Frick added.

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