If right to knowledge is the panacea—then is it right to say that if we remove the legal and institutional barriers between those who could access the world’s research and those who couldn’t, then everything else would fall into place?
In this day and age, such is the quagmire the stakeholders are stuck in. These are trying, stressful, and uncertain times, even for the optimist. As the number of confirmed cases of COVID-19 rise and hospitals begin to fill, the need for medicine and medical supplies is at the forefront of everyone’s mind. The search is on for rapid and innovative solutions. In the absence of any vaccines to prevent COVID-19, there are many clinical trials (CTs) taking place to find a treatment. These CTs are mainly focusing on either re-purposing or repositioning the existing molecules. But what if that brilliant solution treads on a patent?
The India’s Tale
WHO has published a landscape of therapeutics which could be used for treating COVID-19, and some of them are undergoing CTs as well. Generally speaking, patents are not a concern when it comes to old molecules under CTs because these molecules are already out of patent protection.
However, a few of these molecules are still under patent protection in many countries. Two in particular – Remdesivir and Favipiravir – are under patent protection in India. Two health advocacy groups have written to the Indian government asking it to rescind patents given to Gilead Sciences for the drug Remdesivir which is believed to be the most promising drug used for treatment against COVID 19, so it can be distributed more fairly to corona virus patients around the world, particularly in poorer nations. Desperate times call for desperate measures, it would be interesting to see if the Indian Government will have to resort to using its powers, under the Patents Act, 1970, to effectively balance its responsibility of protecting public health with a patentee’s exclusivity rights.
The Global Moves
Responding to the patent barriers, a few countries like Israel and Chile have issued compulsory licenses to allow a generic company to produce or use the patented medicine/invention without the permission of the patent holder. Germany even amended its patent law to facilitate the quick issuance of compulsory licenses, while Canadian government has legislated a “fast-track” to authorising use of patented products by the government or other person in this trying time. To clearly understand this Canadian scenario imagine: Company X struggles to supply hospitals with medical equipment. Company Y enters the picture and reverse engineers the original piece of equipment, finding a new way to make it using a faster process. But Company X has a patent on the medical equipment, granting them an exclusive right to make, use, and sell it. Can Company X sue Company Y? Now while Company X does have the right to sue Company Y, the Canadian government can now stop that lawsuit in its tracks and step in to authorise use of the patented invention by Company Y and instead of protracted licensing negotiations between the patentee and new manufacturers, the government can step in to authorise that use. Moreover, the third world nations aren’t keeping behind; the national assembly of Ecuador has passed a resolution empowering the health minister to issue these licenses. Costa Rica’s government recently called on the WHO to establish a voluntary pool of IP rights for Covid-19 treatments, which would allow multiple manufacturers to supply new drugs and diagnostics at more affordable prices.
Way Forward
Creating impediments through exclusivity claims in the wake of pandemic will result in dividing countries, corporations and international organisations. This will not benefit patients and the world as a whole. If patent owners create hindrances on the strength of patent rights, the world will start detesting patents and that is not the situation IP owners ought to be in. Under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) regime there are several tools such as compulsory licensing, patent pooling which are available to ensure access to medicines. However, beyond the laws, society needs to respect innovation. To protect sanctity and integrity of patent systems, and in order to ensure that an an anti-IP sentiment is not generated globally, answers need to be found within the existing regime. Plausible methods by which aggregation and dissemination of innovative products can be ensured are as here in under:
Patent pools : It is defined as an agreement between two or more patent owners to license one or more of their patents to one another or to third parties. Often, patent pools are associated with complex technologies that require complementary patents in order to provide efficient technical solutions. They’re said to have positive effects on competition and innovation. By sharing intellectual property assets, companies may develop new products and reduce their transaction costs. Historically, patent pools have been concentrated in Europe and the United States, nevertheless recently Asian companies have increased their participation in patent pools given their growing role in technological innovation. Such pools are usually managed by a central agency. Patents which become the part of the pool are readily made available for licensing. Some pools even publish the royalty rates payable for such licences. Anyone who wishes to obtain a licence Will be able to approach the pool, agree to the terms, and begin to manufacture and sell the products. Presently a more fruitful endeavour would be to create a global pool of COVID-19 related innovations, in respect of vaccines and medicines and this could be managed by a trust worthy international organisation. Even if the royalties are at a minimum level, the revenues would still be in billions of dollars owing to the large swathes of the population affected by the pandemic, who will need to be administered by these products. Combating the crisis and earning collectively is the need of the hour. Moreover, pooling of patents is in line with the Doha Declaration on Public Health which is a part of TRIPS agreement, which recognises the need for taking measures to ‘protect public health’ and promote ‘access to medicines’.
Compulsory licensing or Revocation : Covid-19 has without a doubt initiated a new IP saga. But how well do relevant exceptions in the patent system, such as compulsory licenses really work in such extraordinary circumstances? Compulsory Licensing is an involuntary contract between an unwilling seller (patentee) and a willing buyer (licensee), which is enforced by the State i.e. when the Government allows a third party to manufacture and sell a patented product without the consent of the patentee. Indian patent law ( The Indian Patent Act, 1970 hereinafter IPA) has several mechanisms to deal with potential abuse of the patent system as well as to ensure affordable access to medicines and public health facilities. Among these are the provisions relating to compulsory licensing upon a notification by the central government (section 92, IPA) and the provision for revocation on ground of prejudice to the public (section 66, IPA). Both these provisions come into play only after the patent has been granted.
The first provision, for compulsory license on a notification by the Indian government (section 92, IPA) is influenced heavily by the Doha Declaration. This provision is very different from the general compulsory licensing mechanism (section 84, IPA) in India wherein a potential applicant has to wait for at least three years before applying for a compulsory license and is additionally required to first attempt to negotiate a voluntary license with the patentee. Under section 92 IPA,, however, all that is required is that the Indian government should bring a notification in the official gazette, any time after sealing of the patent, declaring that compulsory licenses should be granted thereon. This can be done by the central government under the following circumstances, (1) National emergency, (2) Other circumstances of extreme urgency and (3) Public non-commercial use. Once such a notification is there, any person interested (which is a competitor or a generic manufacturer) can apply to the Controller of Patents and the Controller will have to grant the compulsory license.
The second provision allows the Indian government to revoke a patent if the same is “generally prejudicial to the public” (section 66, IPA). Here, the central government will have to hear the patentee before declaring the patent as revoked. It can, perhaps, be argued that any patent that reduces access to medicines during a pandemic is prejudicial to the public. This provision is different from the usual revocation provision (section 64, IPA) because it brings in elements of public interest and of what qualifies as prejudicial to the public. Therefore, this section is not dependent on the inherent strength or weakness of the patent itself. For a usual revocation, inter-alia, lack of novelty, inventive step, and industrial applicability is required to be proven. But this is not the case with revocation under section 66, IPA.
In once and for all
With the arrival of Covid-19, it is now painfully obvious that such monopolisation comes at the cost of human lives. Pandemics need avant-garde solutions. Governments and international organisations need to arrive at consensus in advance to ensure that the system is ready. Monopoly control over the technology used in testing for the virus has hampered the rapid roll out of more testing kits, just as 3M’s umpteen patents mentioning “respirator” or “N95” have made it more difficult for new producers to manufacture medical- grade face masks at scale. Following the words of Wilson Luna ‘A decision is only made once it is followed by immediate and massive action’, it is imperative at a time like this that no monopoly rights be granted, so that more manufacturers can produce the drugs and essential medical equipment to be made available to all the people who need it, at affordable costs. It should be noted here that social and economic welfare as well as the protection of public health are important goals that are recognised by TRIPS as well ( Article 7 & Article 8 ). Finally, it will be interesting to see how the government and the stakeholders react to such crisis and how they use the flexibility under the patent system or how they react to the deterrent effect of such flexibility, in India and elsewhere.
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