COVID-19 more commonly known as the Corona Virus Disease, 2019 has taken the world by storm. It is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). First identified in late 2019 in the capital city of Hubia, Wuhan, China and has spread globally which lead the World Health Organization to classify COVID-19 as a pandemic on March 11, 2020 and declared the outbreak as a “public health emergency” of international concern. This forced the governments of various countries, including India to take emergency measures and imposing lock downs of all social, commercial, industrial activities.
Scientists are laboriously working towards finding a cure for this pernicious and ostensibly incurable disease. WHO claims that a vaccine for this virus would be available publicly by 2021 (18 months). This long period is due to critical factors like determining the characteristic of the current virus, pre-clinical testing of the potential vaccines and other factors like mutation of the virus for production of vaccines.
Importance of Intellectual Property in relation to Public Health
From a Public health standpoint, the most relevant form of Intellectual property is Patents. The Public Health, Innovation and Intellectual Property (PHI) Team, incorporated by WHO is responsible for promoting innovation in the discovery, development, production and delivery of essential health technologies. Hence, IP plays an important role in facilitating and promoting R&D. As we all are aware the process of registration and grant of patents for medicines and medical processes are tedious and long running, but once granted, the applicant enjoys the rights and royalties for over 20 years from the date of application. One of the major concerns of the Government is the availability and access of such patented essential drugs to the public at large which usually aren’t pocket friendly. The question also arises that can the Government revoke a Patent to supply such medications during the time national emergency such as a pandemic? At the time of crisis or an emergency, like the one world is facing right now, the most obvious viewpoint would be to do away with patent rights related to life saving innovations. The Patent Act, 1970 (hereinafter referred to as the Act) have adopted and formulated certain section pertaining to such circumstances in India which we shall discuss.
Drugs for treatment of COVID-19
Remdesivir and Favipiravir are the two prominent drugs which are being evaluated for possible treatment of COVID-19. US based Gilead Sciences Inc. has patented Remdesivir and have also received a grant in the US as well as In India. Remdesivir is believed to be the most promising drug which can be used for treatment against COVID 19 and USFDA has given Emergency Use Authorization to Remdesivir. Though there is no efficacy of this drug against Ebola, lab and animal studies have of Remdesivir has shown its efficacy against SARS and MERS which are the two known respiratory illnesses brought on by coronavirus infection. Few pharmaceutical companies in India namely Cipla, Hetero Labs, Jubilant Life sciences and Dutch firm Mylan have signed licensing agreements with Gilead to manufacture generic versions of Remdesivir. The licensing agreements will allow the companies to receive technology transfer of the manufacturing process for Remdesivir from Gilead which will aid them to scale up production more quickly.
Remdesivir being a patented product is facing some criticism in India. Recently, a Mumbai-based civil society organisation Cancer Patent Aid Association (CPAA) had written to the government demanding the revocation of the patents on Remdesivir, citing that it does not meet the novelty and inventive step criteria as per Indian standards. The experimental drug, however, has a couple of undisputed patents also in India.
Favipiravir was developed by the Fujifilm Toyama Chemical Corporation, and it is being manufactured by Zhejiang Hisun Pharmaceuticals as per a licensing agreement with Fujifilm. Favipiravir can reportedly treat RNA viruses, like SARS-CoV-2. However, the drug shows less efficacy in patients with severe symptoms. China has used Favipiravir for treating patients in Shenzhen who had tested positive for COVID-19 and have found positive results. Glenmark Pharmaceuticals Limited is the first company in India which has entered phase 3 of the clinical trials of Favipiravir. Glenmark is evaluating safety and efficacy of the Favipiravir in Covid-19 patients in India. Favipiravir, if commercialized, will be marketed under the brand name ‘FabiFlu®’ in India. Drug prepared by Glenmark is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark is estimating that the study will be completed by July/ August 2020.
Global Scenario: Patents
The German government has enacted few amendments to the German Act on the Prevention and Control of Infectious Diseases in Humans in wake of the rise of Covid-19, which may have an impact on patents as well. As per the changes in the law, the federal ministry, in an ‘epidemic situation’ would be authorized to use an invention relating to medicines, narcotics, active substances, starting and auxiliary materials, medical devices, laboratory diagnostics, aids, items of personal protective equipment and products for disinfection in the interest of public welfare or in the interest of the security of the Federal Republic of Germany as per section 13 (1) of the German Patent Act.
Section 13(1) of the German Patent Act is a provision which has apparently never been used after 1945 and which in its current form reads as follows: “The patent shall have no effect in a case where the Federal Government orders that the invention is to be used in the interest of public welfare. Further, it shall not extend to a use of the invention which is ordered in the interest of the security of the Federal Republic of Germany by the competent highest federal authority or by subordinate authority acting on its instructions”.
Recently it was reported that Swiss multinational Roche, world’s leading diagnostic kit maker, was accused by the politicians in the UK and Netherlands of withholding the chemical formulae for a reagent, a buffer used in its polymerase chain reaction-based test for COVID-19. Roche was blamed for its inability to supply sufficient volumes of this reagent as one of the reasons for delay in the scaling up coronavirus tests in their respective countries. However, it was apparent that the politicians wanted Roche to share the chemical formula so that it can be produced locally.
The Executive Director of developing world centric think tank South Centre, Carlos Correa, has appealed to global organisations like World Health Organisation (WHO), World Trade Organization (WTO) and World Intellectual Property Organisation (WIPO) that they should support WTO member countries, which are planning on invoking the ‘security exception’ under Article 73 of the Agreement on Trade-related Intellectual Property Rights (TRIPS) Agreement, in order to take necessary actions for the protection of its essential public interests in the wake of COVID-19. He has also pointed out that the use of this exception will be fully justified to procure medical products and devices or to use the technologies to manufacture them as necessary to address the current health emergency. In an open letter to the heads of WHO, WTO and WIPO, Correa appealed that the executives in their official capacities, should support developing and other countries, as they may need, to make use of Article 73(b) of the TRIPS Agreement to suspend the enforcement of any intellectual property right that may pose an obstacle to the procurement or local manufacturing of the products and devices necessary to protect their public health. Article 73 of the TRIPS agreement relates to Security Exceptions and it read as follows:
“Nothing in this Agreement shall be construed:
(a) to require a Member to furnish any information the disclosure of which it considers contrary to its essential security interests; or
(b) to prevent a Member from taking any action which it considers necessary for the protection of its essential security interests;
(i) relating to fissionable materials or the materials from which they are derived;
(ii) relating to the traffic in arms, ammunition and implements of war and to such traffic in other goods and materials as is carried on directly or indirectly for the purpose of supplying a military establishment;
(iii) taken in time of war or other emergency in international relations; or
(c) to prevent a Member from taking any action in pursuance of its obligations under the United Nations Charter for the maintenance of international peace and security.”
Evidently, Article 73(b) authorizes member countries to take appropriate measures with respect to Intellectual property right with a view to safeguard public health.
In order to remove the patent barriers, a few countries like Israel and Chile have issued compulsory licenses to a generic company to manufacture or utilize patented medicine/invention without the permission of the patent holder. As mentioned earlier, Germany even amended its patent law to facilitate the quick issuance of compulsory licenses, while Canada is on its way to do the same. Further, a resolution was passed by the national assembly of Ecuador which empowers the health minister to issue these licenses.
Revocation of a Patent
In India Section 66 of the Indian Patent Act, 1970 empowers the Central Government, to revoke any patent granted by the Indian Patent Office if the said patent is prejudicial to public interest. Section 66 reads as “Where the Central Government is of opinion that a patent or the mode in which it is exercised is mischievous to the State or generally prejudicial to the public, it may, after giving the patentee an opportunity to be heard, make a declaration to that effect in the Official Gazette and thereupon the patent shall be deemed to be revoked.”
Though the Central Government has the power to revoke a patent for national emergencies subject to public interest, it has used its power only in two cases so far for the following cases
1. Agracetus’s Patent
Agracetus was a US based company which through its US patent application number 919 Cal 87 filed an application in India under the number 168950 titled “A method of producing transformed Cotton Cells by tissue culture”. The government observed that the patent would affect the farmers and the cotton industry which would eventually result in negative ramifications on the Indian Economy and thus the patent was revoked by invoking provisions under Section 66 of the Act.
2. Avesthagen’s Patent
Avesthagen, an Indian company had obtained a Patent on alleged traditional knowledge titled “synergistic ayurvedic/ functional food bioactive composition” with application no. 1076/CHE/2007. The patented invention was used for the treatment of diabetes, composed of 3 herbal composition jamun, lavangpatti and chundun. The patent was initially filed in the EPO (status to which was objected) which was challenged by TKDL, but Indian equivalent was not opposed. Subsequently, the Ministry of Commerce and Industry through TKLD revoked the patent under Section 66 via its notification of November 7, 2012.
In both situations the Government made sure that such revocation was for the interest of public at large and the same is not endangered due to grant of such patents. No cases of revoking a patent by the government during national emergency for drugs and medicines have been filed but there are other provisions in which the Government may utilise, manufacture and use such patents. A reference of the same is made below.
Conditional grant of patent [Section 47]: This empowers the Government to import, make, use or distribute any patent with respect to any medicine or drug for its own purpose or for public health distribution.
Grant of compulsory licence [Sections 82 to 94]: Chapter XVI deals with the general principles and circumstances for grant of compulsory licences in order to protect public interest particularly public health and nutrition. These provisions check the abuse of patent rights. They can be invoked if the reasonable requirements of the public with respect to patented inventions have not been satisfied, and the patented invention is not available for public at a reasonably affordable price, and if the patented invention is not worked in the territory of India. Section 92 provides for action in case of national emergency, extreme urgency and public non-commercial use, and can be invoked without the grace period of 3 years from grant of patent. In India, the first compulsory license was granted to Natco Pharma on March 2012 for drug named Nexavar used for the treatment of Liver and Kidney Cancer patented by the German Drug maker Bayer AG.
Use of invention for the purpose of Government [Sections 99-101]: These complements Section 47.
Acquisition of invention and patent for public purpose [Section 102]: This empowers the Government to acquire a patent to meet national requirements.
Bolar provision [Section 107 (A) (a)]: This facilitates production and marketing of patented products immediately after expiry of term of patent protection by permitting preparatory action by non-patentees during life of patent.
Parallel import [Section 107(A) (b)]: This provides for import so that patented product can become available at the lowest international price.
Although the Act confers the power on the Government of India to invoke above discussed provisions during national emergencies, it fails to specify the scope and ambit of such powers exercised by the Authorities. The modes of revocation or detailed factors amounting to revocation are not specified in the Act which may lead to judicial conflict or confusion. Further, Compulsory Licensing having requirement of public non-commercial use, lacks to interpret whether it is inclusive of national emergencies or is an individual criterion. In India, by taking advantage of the provisions under the Patent Act and TRIPS agreement, the government will be able to take proper measure to safeguard public health by utilizing lifesaving patent protected medicines, without the fear of facing international pressure to enforce patent rights.