India rejects Novartis cancer-drug patent
NEW DELHI, April 1 - RAPSI. In a judgment released Monday, the Supreme Court of India refused to extend patent protection for Novartis cancer drug Glivec. The court noted that it was stretched between the policy goals of protecting the pioneering of new medicine and promoting public health.
With regard to the former concern, the judgment noted: “The Court was urged to strike a balance between the need to promote research and development in science and technology and to keep private monopoly [at a minimum]…”
With regard to the latter, a plethora of concerns were noted: “Arguments were made about India’s obligation to faithfully comply with its commitments under international treaties and counter arguments were made to protect India’s status as ‘the pharmacy of the world’… and the Court was also reminded that an error of judgment by it will put life-saving drugs beyond the reach of the multitude of ailing humanity not only in this country but in many developing and under-developed countries, dependent on generic drugs from India.”
Under Indian law, a product cannot qualify as an invention for patent purposes unless it can be proven, among other things, that it would improve the “efficacy” of a known substance.
According to the law, as quoted by the judgment, “The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance… [does not constitute an invention within the meaning of the law].”
The court read this requirement to mean “therapeutic efficacy.”
It found that under a variety of different tests and theories that the drug’s properties, “may be otherwise beneficial but these properties cannot even be taken into account… since these properties have nothing to do with therapeutic efficacy.”
In a statement released on the heels of the judgment, Novartis claimed that the judgment would discourage pharmaceutical innovation in India.
Speaking on behalf of the company, Vice Chairman and Managing Director of Novartis India Limited Ranjit Shahani said: "Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs… We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options."