EVOLUTION OF PHARMACEUTICAL INDUSTRY:
The Indian pharmaceutical industry has tremendously evolved over the decades from being dependent upon other multinational companies for imports of medicine and medical tools to becoming an influential contributor to the global market. In 1969, the Indian pharmaceutical industry had a 5% share of the market and the global pharmaceutical companies had 95% but, by 2020 this situation was reversed by the Indian pharmaceutical industry owning 85% shares in the market and global players with only 15% in hand. Today India not only has the capability but also the resources of producing high-quality generic medicine that is being sold around the global market.
With such an impressive growth rate multiple MNC’s have penetrated the Indian Pharmaceutical industry, fifteen out of twenty pharmaceutical companies in the world have a presence in India today, majorly consisting of privately-owned companies by Indians who now dominate over a substantial share in the domestic market due to elements like favourable governmental policies and limited competition from MNC’s. Today India alone contributes 20% by value to the global generics market and on top of it, is contributing 40% to the US drugs.
Before 2005 the pharmaceutical companies feared the transition from process patent to product patents under the TRIPS agreement as it could have resulted in closing multiple companies but over the years new amendments and new situations have brought new challenges and opportunities for the industry.
PHARMACEUTICAL IP CHALLENGES:
- In the year 2016, the Government of India brought major changes in the IPR policy of the country with seven objectives, without bringing any amendments to the already laid provision of the Indian Patent Act of 1970, stating that the laws complied with the minimum protection standard of Intellectual property set by the TRIPS agreement despite receiving constant recommendations from various key players around the globe like the USA.
- Section 3(d) of the Indian Patent Act, 1970 states “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’ is not an invention, and hence cannot be patentable” as per the interpretation of the court in the case of Novartis A.G v. UOI (2016) 6 SCC 1 which raised multiple doubts and debates across the minds of professionals, as a product is granted a patent for 20 years in India and once the patent expires other companies could manufacture the same product at a cheaper price. Usually, the pharmaceutical companies try to evergreen their patent by slightly modifying their products from original ones, but the laws in India have set up much more stringent conditions for obtaining it.
- Another challenge faced by India is due to the concept of compulsory licensing which finds it legitimacy in the TRIPS agreement and is also provided in section 84 of the said act, by the virtue of this section the government can legalize a third party to produce a product by fulfilling certain conditions without even taking the consent of the patent owner or holder. This is widely used by countries across the globe in their pharmaceutical industry for the production of medicines but is not being used by India such efficiently as it daunts the investiture by companies in R&D and stops them from making innovations.
- While trademark laws also raise certain concerns with regards to generic drugs which are is time to time considered to be synonymous for non-brand drugs, so it becomes quite prominent to state that generic products which are patented or whose patents have expired may also be sold under trademark and at times may command a high price despite the competition from bioequivalent products.
- The protection of the undisclosed information which is also termed as trade secrets (including formulas, information, program, devices, methods, techniques, or process ) is the least familiar and acknowledged aspect of IPR among the people. Laws relating to all forms of IPR prevail in India but there is no separate or distinguished law for securing the trade secrets and hence India still fails to protect such a vital part of any creation and innovation. It, therefore, requires immediate action by the lawmakers.
PHARMACEUTICAL IP OPPORTUNITIES:
- The National IPR policy of 2016 has enabled compulsory licensing with restrictions in case of public health emergencies which is going to play a key role during the COVID-19 pandemic, and this policy has been laid in compliance with the guidelines of WTO.
- For the smooth functioning and better implementation of the IPR policy, the government has initiated to build cells in every government department and state departments to coordinate with DIPP which now would enable to foster creativity and innovation along with promoting and encouraging entrepreneurs.
- On one hand, the COVID-19 pandemic has lead Indian Council of Medical Research (ICMR) to partner with WHO on the global solidarity trial to discover the vaccine, on the other hand, the Cancer Patients Aid Association (CPAA) is urging the government to revoke the patent granted to Gilead on Remdesivir compound as it is against the public interest.
The year 2015 to 2020 has brought some major additions to the IPR laws for the pharmaceutical industry in India, with the recent situation of pandemic they might witness multiple other changes in the policies and laws, but so far India is trying its best to maintain its policy according to the International norms for a global acceptances and for improving the domestic conditions. The pandemic has truly expanded the ability of the industry which is supplying multiple essential drugs and other commodities across the globe to overcome the situation at hand. The national policy too brought in multiple positive changes and has contributed toward the growth and development of the industry.
- Lakshay Kawatra and Vishal Choudhary . The Dichotomy Of IPR Protection And Social Welfare- An Analysis Of The Indian Patents Act With Respect To The Pharmaceutical Industry, 24 January, 2020; https://www.mondaq.com/india/patent/886878/the-dichotomy-of-ipr-protection-and-social- welfare-an-analysis-of-the-Indian-patents-act-with-respect-to-the-pharmaceutical-industry?signup=true
- Jena, Saswati & Katual, Manoj & Jena, Shubhashree & Sl, Harikumar. (2017). INNOVATION IN PHARMA SECTOR: THE IMPACT OF IPR (PRODUCT PATENT) IN INDIAN SCENARIO: AN OVERVIEW. https://www.researchgate.net/publication/318653820_INNOVATION_IN_PHARMA_SECTOR_THE_IMPACT_OF_IPR_PRODUCT_PATENT_IN_INDIAN_SCENARIO_AN_OVERVIEW
- Pradeep Kumar Kamal. India’s New Medical Device Regulation, 11 July 2019: https://www.mondaq.com/india/life-sciences-biotechnology-nanotechnology/824468/india39s-new-medical-device-regulations