‘Evergreening of Patents’ and history in India

A short note

In “Evergreening- A controversial issue in Pharma Milieu” by Glenmark pharmaceuticals, evergreening is defined as “ways to take undue advantage of law and associated regulatory processes to extend IP monopoly over important drugs by filing disguised/artful patents on patent protected inventions before expiry of parent patent” (Bansal, Sahu et al., 2009). In pharmaceuticals, with slight variations in old inventions, new inventions are claimed which is called evergreening of patents. These inventions do not provide therapeutic efficacy rather aid company’s economic advantage as this retains market dominance of the said company which is easier than creating a patent again.

To curb the issue of evergreening, Patent Act, 1970 was amended in 2005 to introduce section 3(d) which specifically disregards derivates, salts and such trivial changes as inventions. This principle was developed in Novartis Ag v UOI.

A free base medicine Imatinib got patented in USA in 1993, however when applied in India, it was rejected as prior 1995, India did not provide pharmaceutical patents. In 1997, Novartis filed a patent application for ‘Glivec’ an anti-cancer drug, used to treat Chronic Myeloid Leukaemia (CML) and Gastrointestinal Stromal Tumours (GIST). The invention was from beta crystalline salt from imatinib mesylate of free base imatinib. The patent application was refused by Madras patent Office in 2006 on the grounds that under section 3(d) there is no major difference in “therapeutic effficacy” between imatinib and glivec and the former was already patented.

As a result, Novartis appealed in Madras High Court against the denial by patents office madras and claiming that section 3(d) is not in compliance with trips, its vague and arbitrary and violates article 14 of constitution. High court denied jurisdiction which lead to petition in IPAB and finally in supreme court. The courts held thst the substance always existed in amorphous form and thus the product has to qualify the test under section 3(d) of the Act. It was contented by Novartis that the physio-chemical properties of polymorph form of imatinib which has better thermodynamics stability and lower hygroscopicity which improves efficacy.  The courts rejected this contention for patents the efficacy should be “therapeutic efficacy”. 

The positive affect of evergreening is the affordability by poor for if the monopoly is established then the affordability of poor will reduce that too on life saving drugs, along with which it keeps at bay the common drugs price for common people in underdeveloped and developing countries. However, it seems that India’s patent law for preventing evergreening is overreaching for if a drug is better in ways of cost efficiency or reduced side effects or increased adherence then though the drug would be beneficial for the people and still won’t be patented, discouraging further such research and developments. No molecule merely presented differently shall be allowed patent but even the slightest research and development counts and should be appreciated. 

One alterative solution to this problem of evergreening is compulsory licencing where a non-patent holder is provided with the drug manufacturing order tot make it reachable to the poor. Secondly to uplift the poor, government should ensure health facilities to all, especially access to crucial life saving drugs. Models of USA or Australia can be referred for improvised patent laws which would be mutually beneficial for all; people, government and the researchers. 

Aishwarya Says:

I have always been against Glorifying Over Work and therefore, in the year 2021, I have decided to launch this campaign “Balancing Life”and talk about this wrong practice, that we have been following since last few years. I will be talking to and interviewing around 1 lakh people in the coming 2021 and publish their interview regarding their opinion on glamourising Over Work.

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