Discerning Relationship of Patents and COVID-19

The shockwave of corona seems to underscore the imperative obligation of securing intellectual property rights especially patents. This is evident from the fact that, in January of 2020, Chinese researchers at the Wuhan Institute of Virology filed a patent with the use of Remdesivir an antiviral drug, to treat COVID-19. Ironically, it was not Wuhan Institute of Virology that developed the Remdesivir. It was rather developed by a USA based pharmaceutical company – Gilead Sciences Inc. The Patent covering remdesivir in India is protected with the patent number IN332280 granted on February 18, 2020. Similarly, patent applications for this celebrity antiviral drug (currently in phase-3 of trials) were filed with all major IP offices. The Remdesivir was originally developed to treat Ebola but in early 2020, and the efforts to understand its activity against COVID-19 virus started in early 2020. 

Government of India, Science and Technology Minister, Dr.Harsh Vardhan said that “The Hyderabad based Indian Institute of Chemical Technology (CSIR-IICT) has synthesized the key starting materials for Remdesivir, in a first step to develop the active pharmaceutical ingredient.” The Indian Patent regime does not obstruct any specifics to use the patent and conduct trials for R&D purpose. 

The Indian Patent Act, 1970 very delicately handled the patentee right and the interest of society. The Indian Patent Act pumped a silver lining provision for the US$19.14 billion worth of the generic pharma industry in India by introducing a “bolar exemption” provision through the section 107A. Bolar exemption is a defence strategy of the generic pharma industry against the patent infringement suit. This provides the pharma companies to conduct research and trials on the patented pharmaceutical drug even before the patent expires, assisting in the early launch of generic versions of the drug once the drug's patent period expires. The strategy proves out to be of greater mileage in the fierce generic pharma industry. 

In the current scenario, it is quite apparent that the Indian government may request the Gilead Sciences to grant a voluntary license to generic pharma countries for mass production of the drug. Alternatively, there are provisions under Chapter XVI of the Indian Patent Act, 1970 to introduce compulsory license under Sections 84 and 92 of the Patent Act. Section 84 (1) of the Patents Act recites, 

“At any time after the expiration of three years from the date of the 170 [grant] of a patent, any person interested may make an application to the Controller for grant of a compulsory license on patent on any of the following grounds, namely:- 

(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or 

(b) that the patented invention is not available to the public at a reasonably affordable price, or 

(c) that the patented invention is not worked in the territory of India.” 

The provision of ‘expiration of three years from the date of the grant….’ seems to be a defense for the innovator company, not until the section 92A(1) of the Act kicks in which resorts to powers conferred with the central government to issue compulsory licenses any time after the grant in circumstances of national emergency or circumstances of extreme urgency.  

India is not the only country sending chills along the spines of innovative companies with such provisions. Along similar lines, many countries like Canada, Germany are enacting procedures to circumvent the patents right by the government in the interest of public welfare and issue a compulsory license. 

Another drug in the race of clinical trials is Favipiravir, a broad-spectrum inhibitor of viral RNA polymerase developed by the Fujifilm Toyama Chemical corporation. Favipiravir is effective against a wide range of types and subtypes of influenza viruses. Since the patent law does not bind researchers in calculating the efficacy, companies like Glenmark Pharmaceuticals, BDR pharma have received approval to trial favipiravir for Covid-19 in India. 

LS Davar takes immense pride to share that, out of the five patents extending protection to favipiravir in India, four were prosecuted and assisted in securing grant by the firm. The five patents of favipiravir in India are IN226506, IN219547, IN219369, IN261641, IN273554. 

Favipiravir is already in clinical trials for Covid-19 in the USA and Japan.  

During these testing times, it is not just pharma but other industry such as medical devices also share the brunt of patent protection. According to news, in the Brescia region of Lombardy devastated by the COVID-19 pandemic, there was a shortage of valves used in breathing devices. The company holding the patent for such valves were unable to meet the production requirement. A couple of engineers stepped in and used 3D printing technology to manufacture the valves. In response, the innovative company allegedly threatened a patent infringement lawsuit against them. Printing the physical valve is an act of committing direct infringement for “making” the patented device. However, later the company denies making any sort of threats. But it does pose a serious question amid the crisis that whether the company investing millions of dollar in R&D facilities to procure an IP is in its righteous frame of protecting it. Alternatively, or the violators flouting the IP rights and gaining monetary value in the aftermath of crisis are correct.           

In India, Sections 104 to 114 of the Indian Patents Act 1970 provide guidelines relating to patent infringement. Section 48 confers exclusive rights upon the patentee to exclude third parties from making, importing, using, offering for sale, or selling the patented process. Not to forget the compulsory license provisions also stands valid for both product and process patents. At present, the government of India has not made any official statements on the compulsory license. However, it may be premature to comment on the policy, only time shall tell whether the compulsory license comes down on one side of the fence or the other. As it is rightly pointed out by Sun Tsu, “In the midst of chaos, there is also opportunity”.