Wednesday, 26 May 2021

Compulsory licensing of patents related to Covid 19 vaccine

Of late, there has been a big clamour about transfer of vaccine technology including compulsory licensing of the Indian vaccines, to other companies in India. One can see intense debates on TV channels, social media and even in courts on this topic. Some commentators, analysts, political parties and intellectuals are spending a lot of time in demanding that provision of compulsory licensing under the Indian Patent Act should invoked for technology transfer. The Supreme Court also raised a similar viewpoint in terms of invoking Section 92 and Section 100 of the Patent Act while discussing availability of vaccines in India. 

As per Section 84 of the Act, a compulsory license can be awarded only in respect of a granted patent and that too, three years after the grant of the patent, on a specific request by a company desirous of taking up the manufacturing of the granted patent. The company requesting for compulsory license will have to establish its strength and capability to manufacture the vaccine. If there is no such request, the Patent Office cannot, suo-motu, take up awarding a license. However, Section 92 which is a kind of extension of Section 84, empowers the government to issue a notification for compulsory license in respect of a patent and interested parties may apply for a compulsory license; other conditions remain the same. There are other conditions as well which will have to be satisfied. The government can invoke Section 100 in respect of a filed application or a granted patent by which it may use the invention for its purpose without going through the compulsory license route. 

Let us do a reality check on granted patents related to Covid-19 in India and examine the applicability of compulsory licensing. There are four major foreign companies, whose inventions have been converted into products in the form of vaccines, are manufacturing in large numbers now. These companies are Moderna, Johnson and Johnson, BioNTech and Oxford Innovation Centre. The BioNTech vaccine is being majorly produced by Pfizer and the Oxford one by Astra Zeneca. Moderna does not have any patents granted in India, in fact it has not filed any patent application so far. 

BioNTech, whose invention has been used by Pfizer, has filed 49 patents applications in India since 2010 and has been awarded only two patents. One patent is “RNA Vaccine” which was granted in 2017. It is not clear if this patent covers the mRNA vaccine or not. This may be a candidate for compulsory license during this year and beyond. However, its capability to combat Corona virus will need to be established by competent people. Similarly, J&J also does not have any granted patent in India. 

Oxford Innovation Centre which owns the invention for the vaccine being produced by Astra Zeneca and the Serum Institute, does not have a patent granted in India. In fact, it filed a patent application in February 2021. The Serum Institute is bound by its agreement with Astra Zeneca and perhaps, Oxford Innovation as well and may not be free to sub-license the technology. Covaxin is based on ICMR’s inventive work for which no patent application has been filed. As the basic technology (lab level) has come out of a government institution, it may not be necessary to invoke compulsory licensing or Section 100. 

For transferring this technology, it would be essential to assess transferee’s capability and manufacturing strength for producing the vaccine and its readiness to obtain regulatory approvals such as GMP. In addition, the transferee will have to have BSL 3 facility and pool of qualified and trained human resources. There is no application for compulsory licensing reported to be pending in this regard with the Indian Patent Office. We must also reckon at the same time, that a granted patent such as the one granted to BioNTech may not be sufficient to manufacture the vaccine as manufacturing will depend on many other essential inputs like patents, know-how, trade secret etc. Therefore, the whole debate about compulsory licensing is without substance and should be kept at bay. 

© R Saha


  1. What a pragmatic approach and teasing the threads of complexities
    entailed in CL..Look before you leap....Indeed wonderful reading piece Sir!