Rahul Khullar
With the World Health Organization (WHO) declaring B.1.617 (first originated in India) variant as “Variant of Global Concern” and India witnessing an unprecedented rise in SARS COV-2 infections, one piece of advice that is being given to us from governments and medical experts is to shun ‘vaccine hesitancy’ and get inoculated as soon as possible to break the chain of transmission. It is deplorable that India being the largest manufacturer of vaccines globally, is not having enough doses to meet its domestic ends at the pace as thought out by the government at the commencement of the inoculation drive. Perhaps domestically, it might be due to policy paralysis, but internationally this shortage is due to the provision of ‘Intellectual Property Rights (IPRs). IPRs are of many types, but the most well known are copyrights, patents, trademarks and trade secrets. Today’s topic concerns patents and their waiver. Patents under TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement of WTO (World Trade Organisation) provides the patent owner (Patentee) the legit means to prevent others from making, using or selling his/her invention for a limited period (usually 20 years). For instance, the AZD1222 vaccine co-developed by Oxford &Astrazeneca and patented by the duo. It is being manufactured by Serum Institute Of India (SII) under the name of Covishield. SII can manufacture it because patentees (Oxford &Astrazeneca) did a mutual agreement with SII and gave it a ‘Voluntary License’ with all the requisite expertise to produce Covishield jabs. In return, SII has to pay a royalty to the patentees (Oxford & AstraZeneca). In SII’s case, the royalty is 50% on net sales. If it’s selling a vial of Covishield at Rs.300, Rs.150 out of it would be paid to Oxford and AstraZeneca as royalty. This is due to the patents that in India, out of 3000 pharma companies with a strong network of over 10,500 manufacturing facilities, only two companies (Serum Institute Of India & Bharat Biotech International Ltd.) are presently manufacturing Covid-19 vaccines. The majority of the manufacturing capacities of Indian Pharmas are being disused, and the onus of inoculating 136.64 crore Indian citizens and providing commercial vaccine shipments internationally have been left over to these two companies overstraining them and creating a supply deficit. This duopoly is also not letting the price of the vaccines drop as they don’t have substantial competitors in the market.
India-South Africa Waiver Proposal
On 2nd October 2020, sensing the exigency for a patent waiver, India and South Africa representing developing and low-income nations, pioneered the proposal of a waiver from certain provisions of the Trade-Related Aspects Of Intellectual Property Rights (TRIPS) agreement at the World Trade Organisation (WTO). The duo demanded that the WTO members should work unanimously to ensure that IPR such as patents, copyrights and industrial designs do not impede the timely access to affordable medical products, including vaccines and medicines essential to combat COVID-19. Many countries at that time were divided in their opinions, with the United States of America and the European Union (EU) being the primary opponents to the waiver proposal. But recently, Biden’s administration, despite earlier vacillation, came in strong support of the waiver. As the west follows the USA, many changed their stances, like the EU and France from earlier being opposed to now a supporter of the proposal barring certain exceptions like Germany, which opposes the patent waiver on the grounds that it would disincentivize the pharmaceutical industry and will halt further medical innovations. But pragmatically, this is not the case as the waiver proposed is a temporary one (until the pandemic ends) and not of a permanent nature. Amid this challenging situation, public health is sacrosanct and of paramount importance. We cannot endanger humanity over trivia financial losses of pharmaceutical giants. However, such a waiver can only be enforced if the final proposal, which will have to be reworked through discussion, is accepted by all the members of WTO given the consensus-based nature of the WTO.
Patent Waiver Not A Panacea
There are many bottlenecks in the process of expeditious vaccine manufacturing rather than merely waiving off the patents. We need to understand that waving off the patents and sharing the vaccine recipe and technological know-how are two different things. Even if patents are waived off, then also the other generic manufacturers would take substantial time to develop a new vaccine because patent waivers stipulate that anyone can produce a patented product without facing any legal suit from the patentee however it does not compel the patentee to disclose its trade secrets, technological know-how, and product recipe. Therefore ,to produce a patented vaccine, the generic manufacturers will need first to understand its composition, do reverse engineering, run the clinical trials from scratch and at last need to get regulatory approval as well, which is a rigmarole and would not serve the dire need of ramping up the vaccine and other Covid-19 related production at this critical stage.
Uncertainties and Alternatives
Despite the USA supporting the patent waiver, no one knows how long it will take for the WTO member states to reach a consensus given the complexity of the member states’ issues and diversified opinions. At this time of public health emergency, we cannot afford to wait for a consensus to reach this will cost us many dear lives.
The alternatives are, firstly, to issue Compulsory Licences (CLs) to generic manufacturers by paying a reasonable royalty to the patentee. This is one of the flexibility provided to all the WTO member States in the field of patent protection included in the WTO’s agreement on intellectual property- the TRIPS agreement. Under it, the government allows someone else to produce a patented product without the patentee’s consent or plans to use the patent-protected invention itself.
In the case of India, we also have section 92 of The Patent Act Of 1970 as well which empowers the central government to issue compulsory licences under three conditions:
* There must be a national emergency
* The requirement must be highly urgent.
* Should be for public non-commercial use.
A lethal virus killing 4000+ people a day does qualify for all three. So theoretically, India can do this. In this way, India can circumvent the patent barriers and provide impetus to the vaccine and other Covid related diagnostic productions. But here also, the problem is the same as with patent waiver. The patentee cannot be compelled to share the trade secrets or technological know-how so still, it will take substantial time to produce a generic vaccine if we make it via reverse engineering. But this is in the hands of the nations to issue compulsory licenses, unlike patent waivers where WTO’s member states have to decide unanimously. As everyone is uncertain about the endgame of the pandemic, so governments should not delay any further in using such legit flexibilities. India, which is facing the dual threats of the virus and post virus recovery fungal infection, Mucormycosis aka Black fungus which has now been declared as an epidemic in many states and UTs, with its patented medicine viz. Amphotericin B running short of supply, Indian Government should not delay any further in invoking section 92 of The Patent Act Of 1970, i.e.’Compulsory Licensing’ and empower its credible pharmaceutical companies to produce generic drugs in abundance so that we could prevent any further deadly Covid waves. Invoking this provision will not only suffice the supply deficit but also help bring down the cost of such vaccines and medicines drastically. Although if we would have done it earlier, we could have saved many precious lives from this catastrophic second wave of Covid-19. But it’s never too late. We should invoke it right away.
Secondly, to effectively use the provision of compulsory licensing in bringing the present ongoing crisis under control, nations must insist their respective patentees of Covid vaccines and other Covid related drugs to share their technological know-how, expertise and trade secrets with the world so that production could be ramped up. There must not remain any ‘vaccine inequity’ which could impede our target of achieving 80% global ‘Herd Immunity to end this pandemic.As India pioneered for TRIPS waiver at WTO last year, it must also pioneer by giving away the IPR and related expertise of its own indigenously produced ‘COVAXIN’ vaccine. This will help India set a precedent in front of the International community so that the world could follow in India’s footsteps.
(The author is a Geopolitical Analyst)
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