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

Sunday, 23 May 2021

IPR Waiver and Covid 19 vaccine

It all started with India and South Africa submitting a proposal to WTO in October 2020 on IPR waiver in respect of Covid 19 vaccines. Interestingly, the proposal included waiver on patents, copyrights, designs and trade secrets associated with Covid vaccines. Initially, the proposal was not supported by the developed countries including EU, Japan, USA and UK which disagreed to even discuss the proposal. Some European parliamentarians did recommend to EU to support this proposal after a few months. 

Many other countries are now standing in support of this proposal. Most recently, USA decided to discuss this proposal in WTO. The US posture may be to gain a humanitarian image as it is not clear whether it will support the proposal or discuss it. It may be noted that many US companies are up-in arm against the current US stand and hence, the final US stand in WTO is debatable at this stage. The other countries EU, Japan and UK do not support the proposal even now. 

There is a weakness in the proposal that it is not practical to implement. Each country making use of the proposed waiver, especially developing countries, will find it difficult to manufacture vaccines without the active support of companies owning patents, trade secrets and know how. Patents in respect of all the vaccines in market are not yet granted anywhere and so was the case in October 2020. 

What waiver are we talking about? Perhaps, the thought may have been that the patents, whenever granted, should be waived so that any WTO member could use such patents for manufacturing the concerned vaccines without any risk of infringement. By the time WTO takes up this proposal for discussion, it is going to be few months from now. People familiar with WTO processes realize that any decision on a proposal may take some time, may be few months if all the members agree, as the decision making is through consensus and not through majority voting. We are already in May 2021, 7 months have elapsed since October 2020 and meaningful discussions on the proposal have not really taken place. The original proposal is likely to be modified before serious discussions start. Some indications are already visible. Each government has to further ratify the decision of the WTO to be inline with the local laws. This means more time for starting manufacturing vaccines. 

Technology experts know that a single or even few patents cannot lead to successful manufacturing unless other associated elements are in place. These elements are know-how, trade secrets, raw materials, manufacturing infrastructure, human resources, robust supply chain for raw materials and components like vials etc. Here is a big catch which WTO may not be able to address because most of these essentialities are not within the purview of WTO. 

The codified IPR like patents are in public domain and can be accessed by anyone for information. Such IPRs may be easier to handle through an amendment in TRIPS but it will be difficult, may be impossible, to regulate know-how and trade secrets because these are not in public domain and not accessible to public. Unless the companies holding know how, trade secrets and patents agree to license know how and trade secrets, there is no way for anyone to manufacture vaccines in a short time of few months or years just by obtaining the right to use such patents. Further, there are only a few vaccine manufacturing units in the world, especially in developing countries, hence rightly qualified human resources would be in short supply which are essential for ensuring quality of vaccine. 

In addition to approvals by the drug regulator, certificates for Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) would be required. Therefore, process of obtaining such approvals would be time consuming. The most practical approach on the global front would be to encourage licensing of IPR and total technology from the owners of IPR on terms and conditions which may be applied uniformly across countries. This may be easier said than done because details of licensing agreements would depend on local laws concerning licensing and negotiations between parties. 

Private companies will need to be compensated by somebody. The licensing agreements should include transfer of know-how, licensing of patents copyrights and trade secrets, convenient place for jurisdiction, supply chain etc. One can think in terms of uniform royalty rates and down payments which may be kept as low as possible low. Consideration, cooperation and collaboration (3C) would be essential for a way forward.
© R Saha