Chaos has set in. The Indian health care system has crumbled! We the citizenry are as much to blame for the current chaos as governmental lax and indolent response. While the citizenry has moved from vaccine hesitancy to vaccine hankering; the government has moved from vaccine opulence to vaccine sparsity. In all this chaos the role of vaccines in mitigating fatality has been recognised and endorsed world-over with more and more anti-vaxers jumping ships onto the vaccination camp.
This need for large number of vaccines has triggered the debate on licensing vaccine patents to developing countries to enable diffusion of knowledge to increase vaccine production capacities. One of the mechanisms floated around is by issuing compulsory patent licenses. Now, can India issue compulsory licenses? The answer is no and yes. No, because compulsory licenses are issued to inventions which have been granted patent rights. In case of COVID patents, many inventions are new and the respective patents have not yet been filed in India. The answer is yes, because Indian government still has powers to license inventions for its use, though the respective royalties would have to be negotiated with patent holders.
India and South Africa floated the idea of intellectual property wavier or TRIPS wavier (Trade-Related Aspects of Intellectual Property Rights) at World trade Organization (WTO) last year. This was initially opposed by European Union and United States of America however the present dire need to increase vaccine production has now mellowed their stance on transfer of intellectual property rights. But there are still legal bottlenecks in our national patent legislation which must be deliberated upon to enable local pharmaceutical industries to produce vaccines.
Compulsory licenses envisaged under the section 84, 92 of The Patents Act -1970 (TPA) are seen as the legal tools available to broaden vaccine manufacturing capacity by granting patent licenses to Indian manufacturers. However, a cursory reading of the said provision brings forth the futile assertions made with regards to compulsory licensing.
Section 84: Compulsory licences. (1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:- 1) that the reasonable requirements of the public with respect to the patented invention have not been satisfied.
Section 92. Special provision for compulsory licences on notifications by Central Government–(1) If the Central Government is satisfied, in respect of any patent in force in circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use, that it is necessary that compulsory licenses should be granted at any time after the sealing thereof to work the invention..
The legislation explicitly states that compulsory licenses can be issued post 3 years of the grant of the said patents. If we solely consider the case of Oxford/Astra Zeneca vaccine patents, the patents concerned are WO2012172277 which India granted a patent in the year 2019 and other patent application (WO2018215766A1) had been filed internationally in the year 2017 under Patent Cooperation Treaty (PCT) with India as one of the many designated states and has still not entered the Indian national phase.
Any international patent (PCT) application has two phases 1. an international phase and the other 2. national phase. International phase consists of the patent application being initially searched and examined for its novelty. Once searched and examined which takes up to 30 months for the date of filing the patent application, the owner can bring forth the said patent into the national phase where the Indian Patent Office grants the patent to the owner. Compulsory license does seem to be an ineffective tool to address the current crisis.
Though compulsory license may be ineffective, the central government has another tool in its tool kit. Section 100 (1) of TPA empowers the central government to use any invention for its purposes. Bombay high court in Garware-Wall Ropes Ltd. vs A.I. Chopra And Anr. expounding on Section 100 has laid down that that the central government can use its powers u/s 100 to grant patent utilization licenses to third parties subject to payment of royalties to the patentee.
Sec 100. Power of Central Government to use inventions for purposes of Government. -(1) Notwithstanding anything contained in this Act, at any time after an application for a patent has been filed at the patent office or a patent has been granted, the Central Government and any person authorised in writing by it, may use the invention for the purposes of Government in accordance with the provisions of this Chapter.
Section 100 does provide the necessary legal framework of issuing licenses to patent applications and granted patents; however, if patent applications have not entered the Indian national phase or have not yet been filed in India, there seems to be a gaping hole in the legislation which further has to be deliberated upon.
Finally, it must be kept in mind that patents are a small cog of the whole process of vaccine production. Technology and knowledge transfer, logistics, physical infrastructure are far bigger hurdles to cross over than brawl over intellectual property licenses. Rather than wait for TRIPS wavier and building capacities, central and state governments should follow the Israeli model of ordering vast number of vaccines and negotiating an agreement with vaccine producers at the earliest. Israel bartered citizens anonymised health data for vaccines with Pfizer to enrich and provide valuable feedbacks for faster and dynamic vaccine development. Though data sharing and indemnity protection to vaccine producers are critical concerns which might backbite the government in the future, individual state leaders should show courage and implement risky and innovative solutions in a localized manner.
A proactive stand to increase the base of vaccine manufactures by providing them confidence and trust as equal partners by incentivizing them should be the objective of governments rather than while away time in sluggish bureaucratic overtures.