Sunday, February 3, 2013

Emerging Countries Take Note: Big Pharma's Losing Patent Battles In India

Techdirt has followed the history of major drug kidneys and liver cancer marketed under the name Nexavar since March, when India was granted a compulsory license for the first time since recovering pharmaceutical patents. Of course, the patent holder, Bayer, defended, and an appeal against this decision. Now we learn that the Intellectual Property Watch Bayer lost:

last Friday (September 14), the property Chennai based Intellectual Appeal Board (IPAB), which is responsible for hearing appeals of patent applications has rejected a request by German pharmaceutical group Bayer more AG, seeking a stay on the controller order of compulsory licensing Indian Patent (CL) for the Indian generic drug maker Natco Pharma Limited, a drug used to treat kidney cancer and liver.

Bayer is quite possible to try to appeal to a higher court, but what is remarkable is that this is only one case several large pharmaceutical companies in India right now. For example, the Delhi High Court ruled that Roche's patent medicine against cancer Tarceva was valid, but that the generic does not infringe on that, because it was only a variant of sale drugs. Another case concerns drug against blood cancer Gleevec, sold as Glivec in India, including the manufacturer, Novartis, fights refusal of India to grant a patent. Here is the context:

centers of legal disputes in the case of Glivec to a provision of the Indian Patent Act of 2005, referred to in Section 3 (d), which states that "the mere discovery of a new form of a known substance which does not result in the improvement of the known efficacy of the substance or the mere discovery of a new property or new use for a known substance or the mere use of a process, machine or apparatus unless known knows the outcome of the process of a new product or employs at least one new reactant. "The dispute highlights a fundamental question: what is an" invention "? Or, more specifically, how innovation is necessary to obtain a patent in India

Novartis says it is fighting for more money, but to get their "honor." What this means is that it is likely to establish the principle that patents can provide new forms of drugs, but do not provide improvement over previous versions. If you lose if Gleevec / Glivec, which could have serious consequences for future patent applications by the company in India.



More generally, the current round of high-profile cases of drug patents could have important knock-on effects in other areas. Western pharmaceutical companies are probably afraid that his recent failures in India for some patents or block local generic manufacturers could be replicated elsewhere as emerging awaken the flexibilities contained in the TRIPS Agreement that India is booming. Intellectual Property Watch The article mentions three countries are already considering this - Botswana, South Africa and Swaziland.


An article published in the prestigious medical journal The Lancet recognizes that the growing success of India might well encourage other
trying to limit compulsory licenses and to avoid testing efficiency products, Bayer and Novartis case trying to undermine public health considerations to improve access and therapeutic benefit. The TRIPS Agreement does not limit the grounds on which compulsory licenses may be granted, and does not prevent patent applicants must demonstrate greater effectiveness in their so-called new inventions and useful. There are many challenges to access and rational use of medicines in India, but the provisions of the patent laws of the country, if it is larger and properly implemented, should help, not hinder access. Laws of India and experience could provide a useful example for low-income countries around the world and middle income countries.
watch this space.
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