This article is written by Amritesh Panda, a student of Symbiosis Law School, Pune
After the Trump administration endorsed Gilead Science’s remdesivir as an emergency drug for treating COVID-19, countries rushed to stock it. Gilead has authorized four Indian and one Pakistani firm to manufacture remdesivir. The demand for this ‘experimental’ drug has outstripped the supply, meaning its price will remain high. Two health groups have written to India, the world’s biggest generics producer, to invoke its compulsory licensing law to revoke the American firm’s patent on remdesivir. However, it’s not an easy decision to make.
In the absence of any vaccines to prevent COVID-19, there are many clinical trials (CT) taking place to find a treatment. These CTs are mainly focusing on either repurposing or repositioning the existing molecules. 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. The generic availability of these medicines can facilitate compassionate use and Clinical trials in India without depending on supply from the patent holders.
This article endeavors to assess from a legal standpoint, the various alternative approaches that have been available to pharmaceutical giants, the Government of India and other potential stakeholders to ensure affordable access of Remdesivir and other potential COVID-19 drugs.
Are there any potential COVID-19 drugs?
Remdesivir is believed to be the most promising drug which can be used for treatment against COVID 19. It is a broad-spectrum antiviral drug, which is currently undergoing clinical trials in China and many other countries.
The drug works by inhibiting the virus’s ability to replicate itself inside cells. This indicates that the drug would effective even when a person is in the initial stage of infection and the virus is still reproducing in the upper respiratory tract.
Though it has not shown any efficacy against Ebola, lab and animal studies show have shown that this drug works against SARS and MERS as well, two other respiratory illnesses brought on by coronavirus infections and which are more lethal but less transmissible than the new coronavirus. This medicine is part of the WHO-sponsored multilocational “mega” CT.
Dr. Anthony Fauci, who runs the National Institute for Allergy and Infectious Diseases(NIAID) said on April 29: “The data shows remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.” He said the results proved a drug can block this virus and were “opening the door to the fact that we now have the capability of treating” patients. By and large, this was good news, but there was a caveat- the data were based only on a preliminary analysis. Rather than release all the data, the National Institute of Health, which sponsored the study, issued a press release saying a forthcoming report would have “more comprehensive data”.
There are also a number of promising drugs like Favipiravir, Ritonavir/lopinavir, and interferon-beta, where some are in the initial stage of testing and require more comprehensive analysis in order to include in the treatment regimen.
How Patent laws can be a barrier in the availability of these drugs?
Drug patents in India are an important issue as many large global pharmaceutical firms depend on India’s generic drug- makers to manufacture and sell a cheaper version of critical drugs to them. Gilead a pharmaceutical company, has three patents in India for remdesivir stem from 2009 when the drug was in development to treat Ebola.
Two health advocacy groups have written to the Indian government asking it to cancel patents given to Gilead sciences for the drug remdesivir so it can be distributed more fairly to coronavirus patients around the world, particularly in poorer nations.
Patents on these chemical compounds have many ramifications for India. Though the Indian Patents Act allows the use of these patented medicines for research and development (R&D) purposes. Further, Section 107 of the Patents Act allows anyone to produce, use, and even market the patented medicine without the permission of the patent holder for obtaining regulatory approvals. Thus, Indian generic companies and research institutes are free to produce and use these patented medicines during CTs. But the production use and marketing cannot be done once the regulatory authority provides marketing approval. In reality, these provisions would be of little use because the private sector companies will not make any investment unless there is a guarantee to market in the future.
What steps can Indian generic companies or the Indian Government take if they wish to launch a drug which proves to be effective in the treatment of COVID-19 without a license from the patentee?
- The first option is the compulsory license provision under Section 84 of the Patent Act. Under Section 84, any person, after three years from the date of grant of that patent, can make an application for grant of a compulsory license, on any of the following grounds:
- The reasonable requirements of the public with respect to the patented invention have not been satisfied;
- The patented invention is not available to the public at a reasonably affordable price.
- The patented invention has not worked in the territory of India.
The Section 84 option is not available for Remdesivir because the date of the patent grant is in 2020. Any application for a compulsory license before three years from the date of the grant is not possible under Section 84. In the case of Favipiravir, a compulsory license application can be made after failure to obtain a voluntary license in a reasonable period.
Though the Patents Act says the “reasonable period shall be construed as a period not ordinarily exceeding six months”, in the current situation, six months is a long period. Further, the issuance of a compulsory license requires hearing of the patent holder and it can delay the issuance of the license. The threat of litigation also make the generic companies to distance from using Section 84 in the case of Favipiravir. Therefore, a compulsory license under Section 84 would be unfeasible.
- The second option is under Section 92 (3) – in case of a national emergency or circumstances of extreme urgency, public noncommercial use arises during a public health emergency or during a public health crisis, like an epidemic. At this time, the controller of patents has the discretion to grant a compulsory license even without hearing the patent holder. In such circumstances, the applicant does not need to make any attempt to obtain a voluntary license. The precondition to seek a compulsory license is a government notification saying it is necessary to issue a compulsory license.
- The third option is that the government should issue a government issue license on a patent under Section 100. Under this provision, the government directly uses or authorizes a private company to make use of the patents. Furthermore, Section 100 of the Patent Act provides for the Central government to grant specific companies authorization to use any patents or applications pending grant of patent for the “purpose of government”.
- Lastly, and the fourth option is that the Central government, under Section 102 of the Patent Act, may simply acquire the patents in question along with their stockpile. Upon the Gazette Notification, much like a notification for land acquisition, the invention (product) or patent and all rights in respect of the invention or patent shall stand transferred to and be vested in the Centre. Such an acquisition would be immediate. Similar to the provisions of Section 100, if the Central government is unable to reach an agreement with the Patent Owner with respect to the quantum of royalties, a reference under Section 103 may be made to the High Court to fix the quantum of royalties.
India is not only a chief exporter of drugs but also the primary producer of drugs for its own population. India is among a few countries in the world where generic drug manufactures control a large share of the domestic pharmaceutical market than big MNCs but the biggest test of India’s commitment to ensure the affordability of life-saving drugs is this global pandemic, which has exposed global inequalities in access to medicine and healthcare. The human race is facing a severe threat and people around the world are anxious to get their hands on a treatment even if tentative- till the vaccine arrives.
- Section 84,100,102,103and 107 in The Patents Act, 1970