Evergreening involves the process by which the innovators of a certain idea keep their products updated as they intend to increase the life of the patent term beyond the 20 years as permissible by law so as to enjoy the benefits for a much longer time. This can have adverse consequences welfare as there is a clash of interest which occurs between the pharmaceutical companies and public interest. This can be illustrated by taking into consideration the Novatis case. Chronic myeloid leukemia is a type of blood cancer and India reports almost 30,000 cases of this disease every year. Novarits had introduced Glivec (imatinib mesylate) in 2001 in India, which was a drug useful in remission in over 90% of CML patients. Interestingly the one produced
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If a patent was granted to Novartis this would place a restriction on the existing Indian companies to produce this drug and makes it inaccessible to certain sections of the population who might be in dire need of it. But there is a ray of hope considering the decision of the Chennai High Court in the Novartis case. India’s Parliament had amended the Indian Patents Act, 1970 in 2005 where one of the important aspects was that medicines could be patented in India. But Section 3(d) of the Indian Patents Act says that “(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. …show more content…
The High Court had looked into this conflict and felt that municipal law prevails over international law and moreover international treaties are not directly enforceable in India. The second ground fro contention was rejected by providing transparency to the meaning of “efficacy” which was said to be the ability to produce a desired result. The test of efficacy is a combination of three vitals factors such as the function, utility and purpose of the product under consideration. When we take the example of medicines which claim to cure diseases, the test of efficacy can be that of ‘therapeutic efficacy’. Keeping this in mind if we take the Novartis’ application for patent application for a variation in their product, it did not conform to the standard to Section 3(d) of the Indian Patents Act, 1970 and did not have any enhanced therapeutic efficacy. Interestingly even the Supreme Court had upheld the observation of the High Court and the Indian Patents office which had rejected the patent application which was filed by the
If a patent was granted to Novartis this would place a restriction on the existing Indian companies to produce this drug and makes it inaccessible to certain sections of the population who might be in dire need of it. But there is a ray of hope considering the decision of the Chennai High Court in the Novartis case. India’s Parliament had amended the Indian Patents Act, 1970 in 2005 where one of the important aspects was that medicines could be patented in India. But Section 3(d) of the Indian Patents Act says that “(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. …show more content…
The High Court had looked into this conflict and felt that municipal law prevails over international law and moreover international treaties are not directly enforceable in India. The second ground fro contention was rejected by providing transparency to the meaning of “efficacy” which was said to be the ability to produce a desired result. The test of efficacy is a combination of three vitals factors such as the function, utility and purpose of the product under consideration. When we take the example of medicines which claim to cure diseases, the test of efficacy can be that of ‘therapeutic efficacy’. Keeping this in mind if we take the Novartis’ application for patent application for a variation in their product, it did not conform to the standard to Section 3(d) of the Indian Patents Act, 1970 and did not have any enhanced therapeutic efficacy. Interestingly even the Supreme Court had upheld the observation of the High Court and the Indian Patents office which had rejected the patent application which was filed by the