Break The Barrier
BREAK THE BARRIER
Ever since the Biden administration announced support for a patent waiver - as late as 5 May, there has been quite a flutter on this side of the camp. What is this all about? Let's explore.
As we all know, India being a member of the WTO, amended its patent and other IP laws in order to conform to TRIPS requirements. This overhauled the process-only patent regime for drugs and introduced product plus process patents with a life of 20 years.
As a consequence, drugs and vaccines that are crucial for managing the COVID-19 pandemic are caught in the patent stranglehold, limiting their availability and accessibility to a handful few - either the patentees or their chosen licensees. Third parties out of the fray, coupled with an explosion in the number of COVID positive cases has led to an acute shortage of medicines, forcing us to rely on imports, and re-examine whether patents and medicines should be filtered through the public interest angle for now. The obvious and only solution to end the disaster quickly is to expand the manufacturing base and make available all the drugs and vaccines in large numbers so that every citizen is armed and ready to combat this deadly virus.
It is in this context that in around October 2020, India and South Africa had proposed to the WTO that the implementation or enforcement of IP rights be suspended/waived for the period of the pandemic. Because the TRIPS mechanism is consensual, India and South Africa need the consent of 164 countries before a resolution can be passed by the TRIPS Council. The debate is on. While the US appears to support the waiver, there is dissent from the developed world including from Europe, Japan, etc.
What are the patent barriers?
We have following vaccines for now:
1. Covaxin – which has been jointly developed by Bharat Biotech with the aid of the Indian Council of Medical Research (ICMR) and the National Institute of Virology. It is based on an inactivated virus, which uses common technology platforms. As per public domain resources, the patent is pending.
2. Covishield – which is sub-licensed to Serum Institute of India (SII) by AstraZeneca; it has been developed by Oxford University who granted an exclusive licence to Astra. There are two granted patents and two pending applications.
3. Sputnik V – developed by Gamaleya Research Institute of Epidemiology and Microbiology in Russia. It is an adenovirus-based vaccine. No patents/applications could be located - it may follow a licensing model.
4. Covavax - developed by Novavax, a US-based company, is a protein-based Covid-vaccine. It is learnt that SII has acquired the license rights to this vaccine for supply in India; there are pending applications protecting this vaccine's composition.
5. J&J vaccine - this is also an adenovirus-based vaccine developed by Johnson & Johnson. It is based on technology similar to Sputnik V or that of Astra. Biological E is believed to have the licence to produce the product. The IP landscape around this is not fully open to the public.
6. Pfizer-Moderna - this is an mRNA-based vaccine – not yet approved in India. There are pending applications protecting this vaccine's composition and the technology platform.
As of now, only Covaxin and Covishield are approved for use in India. The rest are at various stages of being approved. Thus, except for Covishield, there is no immediate patent barrier for manufacturing these vaccines. As for Sputnik V, royalty-free licences are being granted. Moderna had earlier declared that they would not be pressing their rights in the vaccine. If they abide by that commitment, it would ease the IP burden.
Despite having a long history of developing and providing vaccine to the entire country through various means, our reaction to the Covid-19 pandemic has been incomprehensively relaxed. India has currently vaccinated less than 11 per cent of its population (10.13 per cent as of 15 May 2020), which is among the lowest in the world.
Though vaccine approvals came as early as 21 January, chaotic planning coupled with an overdose of vaccine diplomacy has deprived us of a golden opportunity of achieving herd immunity quickly.
Let's be clear: when it comes to the manufacture of vaccines, unlike synthetic drugs, the regulatory approval path is quite arduous and even if an abbreviated path is followed, it would take at least six to eight months for any approval to come through optimistically. Apart from this, the raw materials for a vaccine such as adjuvants, cell culture media, cell lines, etc. are important from various countries including the United States. Though some of the export bans have been lifted, the issue of access to technology in the form of cell lines, etc. still remains a challenge.
Therefore, though the attractive proposition of IP waiver is in the works, and even if a deal is struck by tomorrow, we have a lot of homework to do before we unlock the secret to the vaccine recipe and the citizens can avail its benefit with a generic vaccine. But, yes, the IP waiver would encourage generic companies to make investments without the fear of being sued and dragged into prolonged litigations, and perhaps, before the anticipated third wave, one may have just enough vaccines.
The IP waiver would also enable hundreds of entities in India to manufacture small synthetic molecules which are often in short supply. Ramdesivir, favipiravir, apixaban, molnupiravir, baricitinib, hydroxychloroquine, lopinavir, and interferon beta-1a are drugs used for the treatment of Covid-19 at various stages and found to be in short supply. These are produced by a handful of licensees and clearly, there is no solution other than to urgently ramp up the production of these drugs and make them available on large scale through reliable sources.
When faced with a mammoth problem of the kind that we have, a compulsory licence comes across as an immediate answer. Is that the only option?
The Patents Act, 1970 offers several solutions, some of which can be implemented immediately.
a) Section 47 read with section 100: Use of patented inventions by the Government – either though self-manufactured or through imports; as per these provisions, the Government may import the patented drug/vaccine and/or authorise any number of companies to manufacture the drugs/vaccines for use of the Government, i.e. through Government or its authorised channels. The Patentee would be given a certain compensation, but there is no need for the Government to engage in long debates before such steps are taken. In other words, Government can engage in contract manufacturing of the drugs/vaccines through third parties right away.
b) Section 92, 92A: The Government under these provisions is empowered in cases of 'national emergency' or 'extreme urgency' or 'public health crisis' to issue a notification that it is satisfied that such circumstances of urgency exist, necessitating the issuance of compulsory licence and then invite applications from interested parties for the manufacture of the drugs in question.
There is no limit to the number of drugs that can be covered under such notification. All the terms, including royalty and the terms of the licence, would be settled by the Controller of Patents. Of course, it can be challenged at different levels in the High Court by way of writ and other means. This option can also be exercised, provided the steps of this provision are followed.
Russia for instance has already issued a compulsory licence using provisions similar to Section 100 for remdesivir to a company called Pharmasyntez. Gilead has retaliated with a lawsuit filed against the Russian Government.
c) Voluntary licences: Government should intervene and proactively encourage innovators to grant voluntary licences to as many companies for a limited-term so that technology is available and production can be ramped up. This, of course, coupled with an assurance of fast track regulatory approval be it of vaccine or drug.
Thus, India should use all the flexibilities within the current Patents Act and throw open the manufacture of the important drugs and vaccines used for Covid treatment to as many manufacturers as would be ready and willing to take up this not-so-daunting task. Given that, the Delhi High Court in the case of Rakesh Malhotra v Union of India as well the Supreme Court In Re: Distribution of Essential supplies & services during the pandemic case, has directed the Government to consider the use of such tools, there is hardly any justification for any further inaction or pussy-footing on this issue.
The argument of big pharma companies that they would be 'disincentivised' from further research, that it would give away confidential information, that some countries demanding access are so far behind that it is impossible to play catch up, are common oft-repeated narratives, all without merit.
Covishield and Covaxin are both outcomes of public-funded research; hence the public has a right to the fruits of the research. To say that our scientists are "far behind" technologically is a story of the past. In today's world, the globe is one. Technology pervades and reaches everywhere, perhaps technical know-how may be limited; but even that limitation is not impossible to overcome.
The right to life and liberty, right to good health, right to medicines should not remain platitudes that adorn statute books. What good are sections and rules, if not implemented at the right time for the right causes.
The 'pharmacy of the world' must live up to its reputation – by harnessing and unleashing the potential of its pharma companies to come to the aid of a grieving and pained India.
Disclaimer – The views expressed in this article are the personal views of the author and are purely informative in nature.