• The Law Gazette

Public Health & IP Laws: Patent Protection Waiver & Its Implications on Indian Pharmaceutical Sector

Intellectual Property (IP) is defined [i] as the intangible creation of the human intellect which primarily encompasses copyrights, patents, and trademarks. The purpose of IP laws is to encourage innovations and creations. After the emergence of the COVID-19 pandemic, as vaccines slowly began to be developed by various nations, there arose a tussle between providing easy access to vaccines in public health interest and securing patent protection for such vaccines. In such a situation, the US government recently decided to put an application before the WTO to waive off IP protection for easy access to vaccines for the citizens.


WHAT ARE IP RIGHTS?

Intellectual Property (IP) Rights are the rights[ii] granted to individuals over their inventions, granting the creator an exclusive right to utilise his or her creation for a set period of time. Since at least 500 BC[iii], when a state in Greece awarded one-year protection to creators of ‘a new refinement in luxury’, intellectual property rights have been a driving factor behind innovation and creation. In India, the Patent Rights[iv] were introduced for the first time in 1856 and the Patent Act was passed in 1970. To further the aim of IP right protection, India became a signatory to the Paris Convention for the Protection of Industrial Property 1883, and the Patent Cooperation Treaty 1970 in 1998[v].


Any invention that meets the requirements of newness, and usefulness can be the subject of a patent under the Patents Act. India became a part of WTO and in 1995[vi], the TRIPS Agreement came into force. The TRIPS agreement was a set of guidelines to be followed by the member states of WTO in the field of Intellectual Property Rights. As a result of this development, India, as a WTO member, was required to give up[vii] some of its long-held IP positions in order to comply with the TRIPS Agreement's new requirements. This demanded from India to restructure its patent laws and include the pharmaceutical sector under the ambit of Patent laws which was previously excluded[viii].


The problem arose when India failed to comply with such guidelines and failed to grant the patent rights to pharmaceutical products, putting itself under the Priority Watch List[ix] of the USA. This was further complicated by the Indian government’s price capping[x] policy on the pharmaceutical products for greater access to healthcare for all. This government intervention led to dissatisfaction of the inventors of pharmaceutical products to innovate. Along with this, the low spending on the health sector by the government (about 1% of GDP[xi]) further aggravated the discontent. This led pharmaceutical industries[xii] to focus more on generic drug[xiii] production and profiting from consumer/patient’s overhead expenses, hospitalisation costs, and so on. The system, in some way or the other, harmed both inventors and consumers.


PRESENT IMPLICATIONS

As the covid cases surged, the Biden administration came up with the proposal[xiv] to waive the IP protection of the vaccines for timely and affordable access and to scale-up research in the field, which is further supported by over 100 countries . This is a welcome change on the face of rising Covid cases as it would ensure timely access to vaccines. However, the waiver of IP rights has led to a series of problems.


The digitalization of the vaccine registration process made vaccines inaccessible for 2/3rd of the rural population who are still without any internet connection[xv]. Moreover, the government has provided free vaccination only to front-line workers and those above 45 years old[xvi]. Therefore, Indians between 18–45 years old had to purchase vaccines from private facilities whose prices ranged from almost 12 USD for Covishield vaccine and 17 USD for Covaxin[xvii]. This has created a rich-poor gap questioning the motive behind relaxation of IP rights in vaccines. The opening up of the private market has shifted the burden of vaccination to the public. Furthermore, the instances of fake vaccination have raised an alarm among people doubting the efficiency of the vaccines.


In Glenmark Pharmaceuticals Ltd. vs. Curetech Skincare and Anr, the Bombay High Court held that ‘Drugs are not Sweets’[xviii]. Understanding the essence of the judgement, we can infer the heaviness of responsibility and care that pharmaceutical industries have to exercise pertaining to medicines. Interestingly, if the IP laws in relation to pharmaceutical products are not implemented, the credible threat of punishment does not work in the mind of pharmaceutical industrialists leading them to deteriorate the quality of the drugs for profit maximization. The proposal of waiver of patent restrictions on vaccines have resulted in a proliferation of scammers giving fake vaccines to thousands of citizens[xix]. This is due to the lack of implementation of IP rights which would have restricted the producers to a limited and guaranteed few. The waiver might also lead us to question whether in the coming future, IP rights for pharmaceutical products would really be implemented or not.


FUTURE IMPLICATIONS & SUGGESTIONS

Although the proposal for waiver of Patent rights in the face of a global crisis looks promising as it gives us a few much needed short term reliefs, its implications and effects in the long run puts the very basis of public health as well as IP Laws into deep waters. The lifting of patent protection during an emergency might lower the prices and make such intellectual property easily accessible, but in the long run it can discourage investors as well as innovators to develop new intellectual goods. For example, innovators in the pharmaceutical sector might refrain from coming up with medicines for incurable diseases if such dangerous precedents of patent waiver is set.

Speaking strictly in the Indian context, where government regulations aren’t strong enough, such waiver of Patent protection might lead to illegal production of drugs in huge numbers leading to the depreciation of overall public health. Also, such waiver leading to lack of innovation will prevent India from being self-sufficient which is a long aspired national goal.


One measure can be bringing in strong regulatory measures to control illegal production of drugs after the patent protection is lifted in emergency situations of supply shortage. The drugs won’t be subject to approval from the patent owner at each stage but instead the Government can take action to set up task forces in order to overlook the functioning of various private organisations and institutions producing such drugs to meet the demand. Further, the original innovators can be given Governmental grants to make up for the loss they incurred from the waiver of patent rights. Alternatively, instead of completely waiving off the patent rights, the licensing process can be made faster to grant every private organization the access to reproduce such patented drugs.


CONCLUSION

Therefore, coming to a conclusion based on a myopic analysis of Patent Protection waiver due to its immediate result will not be rational. Rather, importance must be given to future implications of such decisions in order to formulate better action plans to handle such situations along with maintaining a balance between intellectual property protection and public health interests.


ENDNOTES [i]What are intellectual property rights?, World Trade Organization https://www.wto.org/english/tratop_e/trips_e/intel1_e.htm (last visited September 8, 2021). [ii]Legal Information Institute, Intellectual Property, Cornell Law School https://www.law.cornell.edu/wex/intellectual_property (last visited September 8, 2021). [iii]Rohan Seth, Contemporary and Upcoming Issues in the Field of Intellectual Property Rights, The Peninsula Foundation https://www.thepeninsula.org.in/2020/09/10/contemporary-and-upcoming-issues-in-the-field-of-intellectual-property-rights/ (last visited September 8, 2021). [iv] Nilesh Zacharias and Sandeep Farias, India: Patents And The Indian Pharmaceutical Industry, Mondaq https://www.mondaq.com/india/patent/865888/patents-and-the-indian-pharmaceutical-industry(last visited September 8, 2021). [v] WIPO Media Center, India Accedes to the Paris Convention and the Patent Cooperation Treaty (PCT), World Intellectual Property Organisation (September 8, 1998) https://www.wipo.int/pressroom/en/prdocs/1998/wipo_upd_1998_32.html(last visited September 8, 2021). [vi]Juan He, Innovation, Economic Development, and Intellectual Property in India and China. ARCIALA Series on Intellectual Assets and Law in Asia (KC Liu & U. Racherla eds, Springer, Singapore) https://doi.org/10.1007/978-981-13-8102-7_11 (last visited September 8, 2021). [vii]Id. [viii]Nilesh, supra note iv. [ix]PTI, IP protection: US puts India on Priority Watch List, The Indian Express (September 8, 2021) https://indianexpress.com/article/india/ip-protection-us-puts-india-on-priority-watch-list-7297579/ (last visited September 8, 2021). [x] Seth, supra note iii. [xi]Reuters, India doubles healthcare spending, opens up insurance in "get well soon" budget, The Economic Times (February 01, 2021) https://economictimes.indiatimes.com/news/economy/policy/india-doubles-healthcare-spending-opens-up-insurance-in-get-well-soon-budget/articleshow/80629478.cms?from=mdr (last visited September 8, 2021). [xii] Seth, supra note iii. [xiii] Yağmur Karahan, Turkey: Evaluation Of Generic Drug Concept Within The Scope Of The Patent System And Competition Law, Mondaq (03 May, 2021) https://www.mondaq.com/turkey/patent/1064204/evaluation-of-generic-drug-concept-within-the-scope-of-the-patent-system-and-competition-law(last visited September 8, 2021). [xiv] Kirtika Suneja, US to support India-SA patent protection waiver proposal for easy vax access, The Economic Times (6 May, 2021) https://economictimes.indiatimes.com/news/international/world-news/us-announces-support-for-covid-19-vaccine-patent-waiver-as-proposed-by-india-south-africa/articleshow/82422977.cms(last visited September 8, 2021). [xv] Rezwan, India's free Covid vaccination drive faces hurdles in supply, hesitancy, Business Standard (July 2, 2021) https://www.business-standard.com/article/current-affairs/in-indian-govt-free-vaccine-program-challenge-is-reaching-vulnerable-people-121070200444_1.html (last visited on September 8, 2021). [xvi]Rezwan, supra note xv. [xvii]Id. [xviii] Glenmark Pharmaceuticals Ltd. v. Curetech Skincare & Ors., 2018 (76) PTC 114 (Bom). [xix] Sushmita Pathak, Thousands Given Fake Vaccines Through Scam In India, NPR (July 9, 2021), https://www.npr.org/2021/07/09/1014512227/thousands-given-fake-vaccines-through-scam-in-india (last visited on September 8, 2021).


ABOUT THE AUTHOR

This blog has been authored by Srijeeta Chakraborty & Tridib Mandal, who are 2nd Year B.A., LL.B. (Hons.) students at West Bengal National University of Juridical Sciences, Kolkata.



[PUBLICATION NO. TLG_BLOG_21_16]