K&S Partners, the Intellectual Property Attorneys, is of the view that the grant of a patent has no direct correlation to access life-saving medicines. The observation is based on the recent Indian Patent Office (IPO) granting a patent for PCV13 (Prevnar13) which claims to provide protection against 13 strains of the Streptococcus Pneumoniae by rejecting two oppositions filed by Panacea Biotech and MSF India.
The patent office observed that the argument by the opponents that inclusion of serotype in a vaccine formulation as being a ‘simple arithmetic progression’ is nothing but a speculation in hindsight.
A skilled person would be aware of various issues faced in multivalent conjugate vaccine formulations namely: Carrier induced epitope suppression, Antigen competition, Immune interference, and Epitopic load. Thus, he would never take a risk of increasing these serotypes and increasing the epitopic load. On the contrary, PCV13 claims a higher 13 valent vaccine that not only increased the coverage from 9 to 13 but was also successful in including serotype 6A, 19A and serotype 3 in addition to 7F and thus same is novel and inventive. It is interesting to note herein the opponents never took the ground of applicability of Section 3(d), said Amrish Tiwari and Saurabh Anand, Patent Attorneys, K&S Partners.
However, the common argument taken almost every time that grant of a patent can directly affect access to life-saving medicines always overlooks the existing provisions of the Patents Act like compulsory licenses, they added.
In April 2013, Supreme Court interpreted the term ‘efficacy’ as ‘therapeutic efficacy’, which resulted into more stringent examination by the IPO under Section 3(d). For instance, applications for Tosylate salt of Sorafenib and Xtandi were rejected by the IPO citing lack of ‘therapeutic efficacy’ as one of the major reasons.
However, time and again Courts have clarified that the purpose of Section 3(d) is to encourage incremental innovation in pharmaceuticals as it lays down a threshold for what subject matter would qualify as the ‘same’ or ‘known’ substance and what would qualify as a ‘new’ substance, stated Tiwari and Anand.
“Thus, in relation to pharmaceutical products, section 3(d) would only be applicable if there is a ‘known substance’ and in cases where an innovator company has come up with a novel and inventive product/process, same is outside the purview of Section 3(d). As per the Indian Patents law, Section 3(d) does not apply to all pharmaceutical and chemical inventions, and in particular does not apply to new chemical entities (NCE). Section 3(d) was designed to make a higher bar of innovation for patentability of new salts, esters, polymorphs etc. unless they differ significantly in properties with regard to efficacy, to avoid alterations being made to the form of such substances and thus extending market exclusivity of known substances,” they said.
In addition to it, innovator companies are also devising new strategies like licensing with domestic players in India, which not only reduces the additional cost but is also making the same available to larger scale of public for example Gilead, Novartis in recent years. Thus, an overall approach, not only by the Companies, but also by the Government in the form of various health schemes, insurances, is required to be considered for life saving drugs. It is high time to refrain from a singular point of attack on the existing patent system and devise a mechanism which is not only conducive for perpetual R&D along with maintaining public health and accessibility, noted Tiwari and Anand.