Impact of TRIPS on Generic Pharmaceuticals in India - A Research Endeavor in Delhi

Impact of TRIPS on Generic Pharmaceuticals in India - A Research Endeavor in Delhi

I am currently working at the Human Rights Law Network, located in Delhi, India. My experience here has been just phenomenal. I am extremely excited to share with all of you what I learn during my tenure at HRLN.

Upon arriving, I attended the HIV/AIDS Conference, initiated and organized by HRLN. My involvement in the conference sparked anger, passion and hunger, emotional elements advocated during teachings to initiate change. It was strikingly apparent that access to ARV medication for treatment of HIV/AIDS is a prevalent field pertaining to human rights and patent law. It is a field in desperate need of activist support within India. What was even more surprising was the immense role patent law is playing in limiting access to these life saving drugs. During group discussions conducted by Colin Gonsalves, founder of HRLN, it was saddening to become aware there is a lack of action being undertaken to spark Public Interest Litigation (PIL.) It became crystal clear to me during these discussions what I would like to achieve during my tenure at HRLN. I have been recently granted permission to compose a circulatory booklet, that would distill complex knowledge regarding Indian patent law and spark action for increasing access to ARV medication for the treatment of HIV/AIDS. My hope is that after reading this booklet, HRLN employees will undertake litigation due to being informed. By maintaining a comprehensive understanding of patent law, they may file pre-grant oppositions against patent applications for ARV medications. Patent applications for ARV medications, since India ratified TRIPS are often simple modifications or combinations of existing drugs. Terrains that will be investigated comprise of adequacy of current patent law, suggested reform, and possible international benchmarks which could be incorporated, while taking into consideration cultural and modern norms. To attain these goals, extensive field work and research will have to be undertaken.

Some Background Information

Review and reform of the 1970 Patent Act became an extensive undertaking within India from the beginning of 1995. Amendments were made to become compliant with standards maintained by the WTO and ratifying TRIPS. The most significant difference due to amendments is that both drug processes and products can now be patented in India. Utilizing the 1970 Patent Act, only pharmaceutical drug processes could be patented, which allowed generic manufacturers to simply reverse engineer drugs. They would provide these drugs to both domestic and international markets for substantially lower prices. The ability to mass produce generic pharmaceuticals, due to the non-existence of pharmaceutical product patentability, helped create the current generic industry which is renowned internationally. However, by becoming TRIPS compliant and allow product patents, many fear the ramifications towards the industry will be significant.

These changes also resulted in the current form of s.3(d) within the Patent Act. This section has been deemed the “efficacy standard.” Based on recent case law, this provision disallows the granting of patentability towards mild modifications or combinations of existing patented drugs. This was demonstrated in the denied patent application for Glivec by Novartis. The initial establishment of this high threshold limits the ability of pharmaceutical manufacturers to undertake simple modifications or combinations of drugs and then then attain patentability. There have been PIL’s introduced in India courts by multinational pharmaceuticals regarding the constitutionality of this provision. However, the outcomes have yet to lower the threshold. Despite these recent positive outcomes, there is still fear that a case may eventually lower the standard. Another prevalent problem is the lack of a definition for the “efficacy” standard, which would allow the establishment of a bright line for threshold purposes. Right now, there is a “therapeutic” standard being maintained to decipher the definition. This means there must be a more beneficial outcome for the new drug in comparison to the older one. Despite the therapeutic standard, it is quite obvious that more clarity is needed. The lack of flexibility and clarity within this provision could result in ramifications on the generic pharmaceutical industry not only for India but on a global scale as well.

We are well aware that India, through its recent ratification of the TRIPS agreement, which stands for Trade Related Intellectual Property Rights, is now participating in a globalized legal pluralist landscape. Initial impressions resulted in governing bodies in India thinking acceptance was necessitated for economic prosperity and protection. However this may not be the case. India, who was once deemed a leading manufacturer of generic pharmaceutical drugs, is now restricted by patent law and can no longer simply reverse engineer drugs. This will disallow provision of low cost drugs to developing countries, including itself. The 1970 Patent Act was providing positive results towards access and even economic prosperity prompting one to question the substantial changes. Case law is still lacking regarding s.3 of the Patent Act which outlines patentability guidelines and many still fear mild modifications and combinations could still achieve patent protection during coming years. This will further impact the generic industry, since they cannot produce drugs which receive patent protection. Another issue I intend to cover, which is within TRIPS, is the granting of compulsory licenses as a possible solution.

Overall, the amendments can be deemed a double edged sword. Product and process patentability for pharmaceuticals, disallow generic manufacturers to simple reverse engineer drugs. However, based on recent case law, it disallows pharmaceuticals companies from attaining patents on simple modifications or combinations. Overall, changes and clarity still needs to be achieved. I will write again soon to provide you with some of my findings from field research undertaken and experiences.