India’s Patent Laws Threaten Public Health, U.K. Experts

Pending cases against India’s patent laws threaten public health and misinterpret international IP agreements, say two public health experts from the U.K.

AsianScientist (Oct. 1, 2012) – Pending cases against India’s patent laws threaten public health and misinterpret international intellectual property (IP) agreements, say two public health experts from the U.K.

In The Lancet report, Peter Roderick and Allyson Pollock from Queen Mary, University of London, U.K. highlight the incompatibilities of international patent laws with India’s, based on its legal battles with the pharmaceutical giants Bayer and Novartis.

Tapping the growth of the Indian drug market by pharmaceutical companies requires protection of their IP, they say.

However, copy-cat drugs make up 90 percent of India’s thriving generics industry. After India joined the World Trade Organization, it had to acknowledge the importance of protecting IP, in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Despite this, India’s patent system still protects its domestic market and pharmaceutical generics manufacturers. The authors name two examples: the first being Section 3(d) of the Indian Patent Act which prevents companies from owning additional secondary patents for drugs that do not demonstrate enhanced efficacy. This clause prohibits companies from making minor changes to drugs they already own the patents on, stopping them from extending the lifespan of their existing patents.

Another example given by the authors is compulsory licensing, which allows countries to force a company to license a patented drug to a generic pharmaceutical manufacturer, so it can produce drugs for its domestic market at a lower price and cost to the patients.

The authors next highlight two important cases: the first on Bayer, which is seeking to overturn a compulsory license for its kidney and liver cancer drug, Nexavar (Sorafenib); and the second on Novartis, which is seeking to obtain an Indian patent on its chronic myeloid leukemia drug, Glivec (Imatinib).

In 2008, Bayer obtained an Indian patent for Nexavar, allowing them to import and launch the drug in India. But in 2010, generics manufacturer Cipla began making and selling a generic version there. Patients buying the drug from Bayer paid about ten times more than those who purchased it from Cipla. Cipla sold approximately ten times as many boxes of Nexavar than Bayer, suggesting that lowered drug costs allowed for easier public accessibility.

Another generics manufacturer Nato recently received India’s first compulsory license to manufacture and sell Nexavar, a move that has been deemed as the “most egregious” example of anti-TRIPS behavior by the Obama administration.

In the case of Glivec, the authors describe how Novartis was refused an Indian patent in 2006, based on Section 3(d) of the Indian Patents Act. India claimed it was an unpatentable modification of the existing drug Imatinib which did not result in improved efficacy. However, Novartis insisted this was essential for better absorption of Glivec, subsequently leading to improved efficacy.

Novartis has since been trying to challenge this decision, with another hearing at the Indian Supreme Court that started on September 11 this year. The authors believe that this legal battle will have important repercussions as this law has not been applied consistently, especially when defining what constitutes enhanced “efficacy.”

All these issues have arisen as India is set to negotiate a Free Trade Agreement with the European Union, which may extend patent protection in India beyond its original obligations.

The authors say that Bayer and Novartis are “seeking to undermine public health considerations aimed at improving access and therapeutic advantage,” and India’s response to the challenges of balancing international IP protection obligations and domestic needs will provide a “useful example for low-income and middle-income countries worldwide”.

The article can be found at: Roderick P et al. (2012) India’s patent laws under pressure.

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Sarah has a PhD degree in biomedical sciences. She hops on a plane or dive boat every chance she gets, and firmly believes that “one’s destination is never a place, but a new way of seeing things.”

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