The COVID-19 surge is getting worse. The Union Health Ministry, via its revised Protocol, has recommended Remdesivir. This is an antiviral drug that is a possibly effective treatment for COVID-19. The greatest tussle is always between affordability and accessibility. Should the public Health get priority over patent protection in the present scenario? Since Remdesivir is an effective treatment against COVID-19, should its patent be revoked?
Understanding the Issue
On April 9, 2020, the Cancer Patients Aid Association wrote a letter to the Union Health Ministry. In it, they demanded patent revocation for Remdesivir. The application claimed revocation on the grounds of public interest under Section 66 of the Patents Act, 1970. The application stated that the patent lacks novelty and an inventive step. Both are grounds for post-grant opposition. The previous judgments which invoked Section 66 were on different grounds. One was that the patent was prejudicial to farmers’ rights. Another was that it formed a part of traditional knowledge.
Revoking Remdesivir patent could enervate the patent framework in India. Possible alternatives to the revocation are compulsory licensing and a patent pool. Compulsory licensing has worked well in Italy. Nevertheless, four pharma companies have signed voluntary licensing agreements with Gilead Sciences. Gilead Sciences Inc. is the original drug manufacturer for Remdesivir. This trend suggests that India does not want to indulge in unnecessary politics.
The fight over patent ownership gets intensified if one looks at the Cell Research Paper. This paper has suggested Remdesivir as an effective drug against COVID-19. Seven scientists from Wuhan and three from Beijing are responsible for writing it. Wuhan Institute of Virology has also applied for a patent for Remdesivir. This application was on the basis of second medical use. Chinese Patent law permits this kind of use. Criticising this tussle is not the way out because Remdesivir was a public-funded drug.
Further, Sanofi’s Plaquenil (earlier used for SARS) has also treated a Japanese patient. Other drugs have also proved useful. However, no drug is a sure treatment against COVID-19. In such a scenario, should grant of a patent be prioritised over public health?
Nevertheless, if patentability is not that important, will COVID-19 render patent law sterile? The best possible alternative is to pay heed to public Health. Even so, patent protection is also necessary.
Compulsory Licensing: An Alternative to Section 66
Compulsory licensing has proven to be an alternative to revocation of patents. The revocation of patents could be susceptible to controversies. Italy has adopted a compulsory licensing model. With fixation of a reasonable royalty, compulsory licensing can bring the required equilibrium. At this stage, where public Health is of exemplary importance, this model can take care of the clash. Countries like Israel and Ecuador have also implemented this model.
With a stark rise in demand, the affordability of medicines is another challenge. The public health criterion makes it essential to make drugs affordable. This alternative is best for countries which are cash-stripped. In Indian Patent Law, a precondition to this is a government notification. At times, due to political pressures, governments are not in a position to grant these.
Does India have Requisite Know- How?
Certain technical limitations exist with breaking patents. Extensive know-how is a prerequisite when it comes to patents. Where public health is at stake, Sections 92, 101, and 103 should be exercised with caution. For medical technologies, it may be a hassle. India’s pharmaceutical know-how is quite weighty. Bulk procurement and technology transfer agreements could also be helpful.
Right to Health (Rth) Framework for Patent Policy
Access to medical aid is well within the realms of Right to Health under Article 21 of the Constitution. The Government also has positive obligations towards securing RtH of the patients. Provisions of masks, sanitisers, hazmat suits all fall under its duty, especially in cases of non-affordability or unavailability. Securing public Health at the cost of patent infringement could be fine. However, the reverse could render patent law hollow.
This approach is also enshrined in General Comment No. 14 of ICESCR. Paragraph 37 of the comment notes that state parties should take positive steps. These steps should be towards securing the Right to Health. Moreover, this framework should be the basis for patent law. As innovation is of no use unless put to public usage.
Costa Rica had suggested patent pooling on the pillars of solidarity and collaboration. Unbiased access to medicines and other COVID-19 related technology is of utmost importance. Patent pooling will create a platform for pooling data. It will also pool knowledge, and patents to deliver health goods. To ensure affordability and accessibility, this information will be accessible to all. Patent pooling can act as a game-changer. It could bring in efficiency and improve collaboration. It will also help lessen transactional costs. The voluntary nature of patent pooling enables governments to give incentives. These may be tax breaks and providing R& D support to companies. In these times, pharma companies should develop a collaborative aptitude.
Due to accessibility concerns, patients have also started importing Remdesivir from Bangladesh. Bangladesh can manufacture the same due to its exemption from TRIPS. The Drugs Controller General of India is still awaiting test results. Post this, they will issue approval to the Bangladeshi companies.
However, the affordability concerns cannot abate by importing at individual levels. Right to Health is a fundamental right and available to all. The RtH framework is a must in these trying times.
According to Ms Harshada Wadkar, a Senior Associate at Lex Orbis:
“Due to the global pandemic, the Government enforced a countrywide lockdown in March. Since then, IP offices are functioning remotely. Notices for extension are also issued. Along with the extension of deadlines, policy guidelines are also required. Fast-tracking of applications providing a particular solution can also be inspiring.”
Accordingly, practical measures and the RtH framework will strengthen the patent fabric.
Conclusion and Recommendations
The pandemic has resulted in patent battles. Concerns of patent protection while ensuring public Health have increased. As the virus spreads, countries facing a financial crunch must look for alternatives. Patent law would remain hollow if not used for public welfare. The Right to Health framework is the best patent policy.
Patent pooling through international collaboration can also prove to be useful. PPP patent pooling is also an effective way. Doha Declaration under TRIPS promotes patent pooling. Also, Seagate technology has signed a Pledge. This Pledge is the Open COVID Pledge. Under this, it provides free access to its patent technology for diagnosis. Seagate has also announced the’Data4Good’ program. This enables employees to contribute their skills and expertise.
Another plausible solution could be a patent buy out. This is when the Government acquires the patent and gives it out in the public domain. A system of auction can help reach a fair price. The Government pays the highest bid. Also, a mark-up will incentivise the technology for a social cause. Patent experts are also required to figure out the authenticated patents. This will avoid low-quality patents.
This way, patents can get secured without any compromise on public Health.
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