By, Neeraja Seshadri, Amala Govindarajan
The coronavirus pandemic has sparked a global debate about whether the patent rights of pharmaceutical companies will prevent life-saving drugs and vaccines from being accessible to countries worldwide.[i] The question has also come up about what policy national governments can adopt to abate such a crisis if it should occur. India is in a unique position in this regard due to the important global position it occupies due to the stronghold of the Indian generic drug companies. Due to the large scale demand for generic drugs manufactured in India, any drug or vaccine that can be used for the treatment of coronavirus disease has the potential to result in a patent dispute in the country. In this context, on 9th April 2020, the Cancer Patients Aid Association (CPAA) wrote a letter to the Health Ministry and the Pharma Ministry seeking for the Central Government to revoke the patent granted to Gilead Life Science’s drug Remdesivir[ii] on 18th February 2020 (Application No. 201727012821).[iii] In its letter, the CPAA states that under Section 66 of the Patent Act, 1970,[iv] the patent must be revoked on the ground of public interest.[v]
Apart from Remdesivir, other drugs like Favilavir and ChAdOx1 nCoV-19 vaccine by the University of Oxford[vi] have also come up in this context and there exists a legal conundrum around the viability of granting patents considering the state of affairs.
Section 66 of the Patent Act, 1970 deals with the revocation of the patent in the public interest. The criteria for revocation of patents under this provision are that a patent must be prejudicial to the public interest or mischievous to the State. This provision has been invoked by the Indian Government in two instances. The first instance of revocation was Agracetus’s Patent, Indian Patent Number 168950, titled “A method of producing transformed Cotton Cells by tissue culture.”[vii] Agracetus, a US-based company, was granted a process patent for genetically engineered cotton cell lines. In 1994, the patent granted was revoked in the interest of farmers’ rights by the Government. It was observed that due to the significance of this crop in the Indian economy, monopoly rights in the form of a patent would prove to be counterproductive.
The second instance of revocation was Avesthagen’s Patent, Indian Patent Number 252093, titled “synergistic ayurvedic/ functional food bioactive composition.”[viii] The patent was granted for a composition comprising of jamun, lavangpatti, neem, and chundun for the treatment of diabetes. The patent was revoked by the Government of India in 2012 on the ground that it was prejudicial to the public as it already existed in the public domain in the Traditional Knowledge Digital Library. The contention that the combination of the components is an aggressive medication was not accepted by the Government of India. It further rejected the contention that this composition was novel.
The legal conundrum in the case of revocation of the patent of the Remdisivir drug primarily arises as a result of ambiguity surrounding the Section 66 of the Patent Act, 1970 due to inadequate legal literature and the existing alternative solution of compulsory licensing under the provisions of this legislation. The concept of Intellectual Property primarily revolves around creating a conducive environment for creativity and innovation through incentivization.[ix] It also aims at striking an optimum balance between public interest and interest of innovators. It is important to evaluate the revocation of patents in this light to conclude that when there exists an alternative mechanism to ensure that the public interest is tended to, such an option must be resorted to ensure the protection of the innovator as well as the public at large. In the first two instances of revocation of patents, there was no other tenable alternative solution. However, while dealing with pharmaceutical drugs, the legislation provides for Compulsory Licensing as an alternative to revocation of Patents under Section 84 of the Patents Act, 1970.[x] An interested person can apply to the Indian Patent Office to grant a compulsory license for the patented drug, even without the consent of the patent holder, on any of these three grounds –
- That the patentee is unable to satisfy the reasonable requirements of the public with respect to the patented product; or
- That the patentee has not made the patented invention available at a reasonably affordable price; or
- That the patented invention has not worked in India
In the backdrop of the coronavirus pandemic, the first ground of the patentee not being able to satisfy the reasonable requirements of the public would be the most suitable. Since the CPAA letter in April 2020, some new developments have taken place. Gilead has issued voluntary licenses to four generic drug manufacturers operating in India namely Noida-based Jubilant Life Sciences Ltd, Mumbai-headquartered Cipla Ltd, Hyderabad-based Hetero Labs Ltd and the US-based company Mylan NV.[xi] However, keeping in mind the sheer magnitude of the crisis where the demand for the Remdesivir drug and other potential other drugs and vaccines runs in millions, it is entirely possible that voluntary licenses granted would be insufficient.[xii] In such an instance, the Government can always resort to compulsory licensing. Under Indian patent law, a compulsory license can only be granted after a period of 3 years from the granting of the patent. However, under Section 92 of the Patent Act, 1970,[xiii] the Government is empowered to grant a compulsory license in the times of a national emergency or other extreme circumstances even if the mandatory three-year period has not expired. The coronavirus pandemic is an unprecedented challenge and it certainly falls under the category of a dire emergency. In light of the same, compulsory licensing presents itself as a far more feasible solution than that of revocation under Section 66 of the Patents Act, 1970.
[i] K.M. Gopakumar and Prathibha Sivasubramanian, Drugs That Could Be Used to Beat COVID-19 Have Another Barrier – Patents, The Wire (Jun. 15, 2020, 8:00 PM), https://thewire.in/law/remdesivir-favipravir-covid-19-patents-indian-patents-act-ustr.
[ii] Cancer Patient Aid Association, https://cancer.org.in/images/CPAA-Rev-of-Patent-2020.pdf (last visited Jun. 15,2020).
[iii] Indian Patents Advanced Search System, http://ipindiaservices.gov.in/PatentSearch/PatentSearch//ViewApplicationStatus (last visited Jun. 15,2020).
[iv] The Patents Act, 1970, § 66, No. 39, Acts of Parliament, 1970 (India).
[v] Namratha Murugeshan, Govt Urged to Revoke Patent for Gilead’s Potential Anti-COVID19 Drug Remdesivir, Spicy IP (Jun. 15, 2020, 8:21 PM),https://spicyip.com/2020/04/govt-urged-to-revoke-patent-for-gileads-potential-anti-covid19-drug-remdesivir.html.
[vi] Praveen Duddu, Coronavirus treatment: Vaccines/drugs in the pipeline for COVID-19, Clinical Trial Arena (Jun. 15, 2020, 8:22 PM),https://www.clinicaltrialsarena.com/analysis/coronavirus-mers-cov-drugs/.
[vii] Prabuddha Ganguli, Intellectual Property Rights: Unleashing the Knowledge Economy, 160 (TATA McGraw Hill Publishing Company Ltd. 2001).
[viii] Prashant Reddy, Govt. of India follows up on SpicyIP reporting – revokes Avesthagen patent – first Indian victory for TKDL, Spicy IP (Jun. 15, 2020, 8:21 PM), https://spicyip.com/2012/10/govt-of-india-follows-up-on-spicyip.html.
[x] The Patents Act, 1970, § 84, No. 39, Acts of Parliament, 1970 (India).
[xi] Leroy Lero, Gilead gives royalty-free licences for remdesivir to Cipla, Jubilant Life, three others, Live Mint (Jun. 15, 2020, 8:31 PM), https://www.livemint.com/companies/news/gilead-gives-royalty-free-licences-for-remdesivir-to-cipla-jubilant-life-three-others-11589309431007.html.
[xii]Aditya Gupta, Patents and Covid-19: Strategies for patentees, generics and the Indian Government, Lexology (Jun. 15, 2020, 8:33 PM), https://www.lexology.com/library/detail.aspx?g=a58d8434-90b7-43fc-ae80-ee66a85383a0
[xiii] The Patents Act, 1970, § 92, No. 39, Acts of Parliament, 1970 (India).