A detailed summary of the case: http://thedemandingmistress.blogspot.in/2013/04/link-to-novartis-judgment-of-supreme.html
In a long-standing battle between Novartis, one of the biggest pharmaceuticals in the world and the Cancer patients Aid Association, the Supreme Court dealt Novartis a huge blow by ruling against it. While Novartis has suggested that the judgement will reflect on their future activity in and related to India, Indian Pharma and activists around the world have lauded the judgement.
Novartis has for long manufactured Glivec, a drug used in the treatment of certain forms of leukaemia with good results. The case dealt with the patent application of a modified form of Glivec. While Novartis argued that the modification being significantly different should be granted a different patent, the Controller of Patents relied on section 3(d) of the Patents Act to refuse the patent. Section 3(d) reads:
3. What are not inventions. The following are not inventions within the meaning of this Act,-
(d) 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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
Explanation : For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy;
The Supreme Court decided that the new drug was not substantially different from Glivec with respect to efficacy and hence the patent could not be granted.
The judgement comes as a huge relief to the various cancer patients in the country who are dependent on the drug and also to the Generic medicine industry in India as a whole. There are two other cases, of matter related to drugs produced by Roche and Pfizer pending in the Supreme Court of India and the judgement will immensely influence those judgements. Effectively the judgment has upheld the objective behind section 3(d), which was to stop Evergreening, a practice common in the US and Europe. Evergreening is when Pharmaceuticals patent slightly modified medicines to continue their exclusive hold on a market. The practice results in the medicines for several diseases being very highly priced causing immense difficulty to people in developing and less developed countries. India exports Generic drugs to a whole lot of Asian and African countries and the judgement will also be a boon for patients in such countries.
Novartis has claimed that the judgment would reflect poorly on India as an investment destination for pharmaceuticals and have also claimed that it will deter Novartis from not only researching in India, but also releasing new drugs, thus creating a anti-growth drug environment in the country.
As a state that cannot by itself successfully deal with the health of its citizens, and as a country on which other such states are dependent, it was essential that the Supreme Court rejected Novartis’ patent. The judgement will help curb evergreening and make expensive drugs accessible to more people around the world.
 The generic Glivec costs significantly less (one thenth) than the Novartis product. The same is the case with all other generic drugs.
- India’s Supreme Court rejects Novartis’ right to patent new version of cancer drug (foxnews.com)
- SC decision on Novartis to benefit poor patients: Pharma companies (thehindu.com)
- India to rule on Novartis patent (bbc.co.uk)
- Landmark verdict gives big boost to cancer patients (thehindu.com)
- #India- SC rejects Novartis’s patent plea for cancer drug Glivec #goodnews (kractivist.wordpress.com)
- SC rejects Novartis’ patent plea for cancer drug Glivec (thehindu.com)