Written by: Excelon IP
Ever since the inception of Trade-Related Aspects of Intellectual Property Rights (TRIPS) in India’s IP framework, there has been a balance in the interest of patent owner and importance of public interest with the implementation of the scope of patentability and compulsory licenses, respectively. Let’s see how convincing this statement is.
Section 3 of Indian Patent Act deals with the inventions which are restrained from being patented and one of the subsections of this provision i.e. section 3(d) doesn’t allow the minor modifications of known substances. It specifically states that “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. This is further explained as: “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”.
Before one could think about the different perspectives of this dice called section 3(d), let us first interpret what the above statement has to say and in order to do that, two terminologies named “Discovery” and “Efficacy” need to be clarified. Discovery means the finding of something which already existed somewhere but was unnoticed until its finding. Therefore, one cannot claim this discovery as an Invention and seek a patent for the same. New form or new use or new property of a known substance or new use of the known process is considered to be just a modification or amendment of known substance and they exhibit the equivalent function as the known one. But here a condition is applied which explicitly says that even if it is a modification to what is already known, it should be superior with respect to the efficacy to get qualified as a patentable matter.
Since the provision is silent about what the efficacy stands for, the Novartis v/s Union of India case, almost known to everyone belonging to the IP fraternity, throws light on the exact meaning of efficacy. When Novartis tried to register a patent for a beta crystalline form of imatinib mesylate (Gleevec), it was rejected by Madras Patent Office citing that it is merely an amended version or one can say polymorph of imatinib mesylate. Unsatisfied with the decision of the patent office, Novartis went for filing a petition to IPAB, Madras High Court and lastly to the Supreme Court. Agreeing with the decision made by IPAB and High court, Supreme Court further elaborated the word efficacy, saying the modified version should be of increased therapeutic efficacy and should be proven more safe and effective as compared to the existing molecule, which Novartis failed to prove. Apart from having physical properties of enhanced quality, if those physical properties don’t have to do anything with enhanced therapeutic efficacy then the invention is covered in the ambit of section 3(d) and the patent cannot be issued for it.
If there wasn’t an existence of this act, some pharmaceutical giants would have leveraged this opportunity of extending the protection of the blockbuster molecule by filing patents of its modified version. For instance, if the decision was made in favour of Novartis, the annual cost of Rs. 1,500,000 for the medicine would still have been persisted by constraining the generic entry which cost just Rs. 10,000 annually. Considering the fact that India is a developing country and it has a number of people living in extreme poverty, the easy access of life-saving medicine ought to be given by precluding the ever-greening of patents and allowing the availability of generic manufacturers in the market.
However, demonstrating the efficacy data through clinical studies of the modified invention and if doing so can justify the superiority of the invention, then the patents definitely get the green signal from the controller. For instance, patent 201928027472 owned by Glenmark Pharmaceuticals for the combination of Remogliflozin and Metformin was alleged to be non-patentable by the controller under section 3(d) of IPA, 1970. But after the applicant presented various studies to evaluate the safety & efficacy of the said combination in subjects with Type-2 diabetes mellitus, the patent was given a grant recently in March 2020.
One more perspective to this act is, even if the modified molecule is therapeutic effective than its parent molecule, proving it can be a challenging task because the patents are filed at the initial stage of drug discovery and the safety and efficacy data can only be gathered after conducting clinical trials. Proving the therapeutic efficacy every time may not be possible thus a rejection of the issuance of such application may discourage solutions achieved through deep research of existing concepts as patents are kind of incentives/reward which help the inventor recoup the cost he put for the research and development.
Section 3(d) is considered to be toughest to overcome especially by foreign organizations and they always seek easing of IP legislation of India for the allowance of incremental innovations. This provision stifles the inventions involving new therapeutic indication of an existing drug. In this case, one cannot call it an evergreening of a patent or an attempt to extend the life of a patent because a lot of research and funding goes into finding the alternative indication and reimbursement has to be made to such inventions. Here, the provision doesn’t actually seem to be fair when it comes to the interest of the patent owner.
So section 3(d), Boon or a bane, indeed hard to describe!