[This post has been authored by Debaditya Duttagupta, a student at the National Law University, Odisha.]

Introduction

There are more than 100 COVID-19 treatments in various stages of trials, approval and rollout across the world with antibody treatments are becoming one of the most popular drugs. Accordingly, one of the top-selling drugs of 2019 was that of monoclonal antibodies. The world is slowly shifting towards more biotechnology-based drugs and it is more evident now that monoclonal antibodies are going to shape the future of vaccines. It is rather interesting to see how Indian Patent Law would adapt to these new kinds of patents which prima-facie appears to be a Non-Patentable subject matter in India.

Biotechnology patenting strategies always have been different from the traditional pharmaceutical Industry. Notably, litigation over monoclonal antibodies is considered one of the most expensive and high-profile lawsuits in the US Court considering the high degree of expertise required.

1.     Introduction and history of monoclonal antibodies

Monoclonal Antibodies are widely accepted as antibodies that are Y- shaped proteins that are produced by the immune system and specifically bind with the particular foreign substance and neutralizes it. A specialized type of white blood cell called a B-lymphocyte or B cell is naturally activated when a foreign substance enters the body and grows into plasma cells that secrete antibody molecules similar to the foreign substance or antigen. Different types of B cells respond to different types of foreign substances as per their properties, and plasma cell antibodies that are coming from the of B cell have the same antigen specificity as the original B cell. Each molecule of an antibody has a particular affinity to a certain antigen or the foreign substance, and such specific binding affinity has made antibodies very useful for the diagnosis, treatment or research of diseases.[i]

However, until the 1970s the use of antibodies was very restricted. In 1975, George Kohler and Cesar Milstein developed the first Hybridoma cell line which retained the properties of both the parental cells. Hybridoma cells that were derived from the same B cells indefinitely produced monoclonal antibodies which specifically bound to that foreign substance or antigen. This technique is now standardized at least across the Indian Patent Law jurisprudence as the Hybridoma Technology.[ii]

2.     Narrow Scope of Antibody claims in India

The main dispute throughout US Patent Jurisprudence has been USPTO’s doctrine of antibody exception which provided for a very wide scope of patent claims over Monoclonal Antibodies. Under this doctrine, the USPTO considered that an “antibody that binds to an Antigen (E.g. F)” as sufficiently described. This was the driving force for the first generation of monoclonal antibody claims which benefitted initial research. However, obtaining for such wide antibody claims in the present era is becoming increasingly more difficult.[iii]

Sadly, there are very few Indian cases which have reached the courts and most of the matters are usually decided by the IPO itself. The lack of judicial Precedents in approval of these Monoclonal Antibodies means that these are highly dependent on different examiners across different branches of the IPO. This might prima facie may seem to be a good thing as it would allow for wider claims. This, however, is not the case in the Indian Context. There are several hurdles which prevent these from happening mainly being common grounds which include lack of novelty, lack of inventive step, naturally occurring. Sec. 3(j) of the Patents Act prevents monoclonal antibodies from having wide claims as it doesn’t involve an inventive step. Inventive Step, in this case, refers to Hybridoma Technology of creating it which the IPO considers as standard for antibodies. The only way around this would be to define the antibody specifically by their target antigen rather than its function. This narrows the scope of patent claims further as a functional definition would have resulted in covering the entire genus of antibodies that are capable of binding with it.

3.     Obvious and Natural occurrence?

In re Patent Application No. 5057/CHENP/2007,[iv] pre-grant opposition filed for a monoclonal antibody in the treatment of cancer had several objections to it. These included arguments of the antibody being obvious as it just needed general technical knowledge and skill of the hybridoma technology for developing the claimed antibodies. The patent claim was also opposed under Sec. 3(c) which bars patenting of substances which are naturally occurring. This was mainly because a monoclonal antibody, by its very nature, is merely an isolated antibody which was generated as an immune response by the host. The Controller dismissed both the objections. The former opposition was dismissed as the controller agreed with the applicant’s view that none of the general technical knowledge that was shown as prior art was sufficient enough for a POSA to develop the claimed antibodies. The latter was dismissed on the grounds that the monoclonal antibody was supported by an amended sequence listing.

This case was one of the few cases which provided much-needed clarity on the patentability of monoclonal antibodies in India. Clearly, the main point established here was that although monoclonal antibodies were artificially extracted, they were regarded as naturally occurring unless a distinction was made during the claims.

For a novel monoclonal antibody to overcome the patentability issues of obviousness and natural occurrence, it needs to establish having inventive and superior properties over previously known antibodies. The most minor of these superior properties would be enough to overcome these patentability issues.

Conclusion

In these unprecedented times, there is a clear need for a strong patent system in place. In the absence of any form of judicial precedents and uncertain IPO practices, it is high time for regulators to think on their feet and clarify the ambiguities in the patentability of monoclonal antibodies. The need of the hour is a specific set of guidelines to facilitate for faster and wider patent claims which would result in a significant increase in the research of such antibodies in India as well.

[i] Grubb PW and Thomsen PR, Patents for Chemicals, Pharmaceuticals, and Biotechnology: Fundamentals of Global Law, Practice, and Strategy (Oxford University Press 2010).

[ii] In re Patent Application No. 5057/CHENP/2007.

[iii] “The Evolution of Antibody Patents” (IPWatchdog.com | Patents & Patent LawNovember 27, 2018) <https://www.ipwatchdog.com/2018/10/08/evolution-antibody-patents/id=101971/> accessed December 7, 2020.

[iv] “Indian Patent Office Granted Patent to Nivolumab after Dismissing Four Oppositions” (Lexology, July 6, 2020) <https://www.lexology.com/library/detail.aspx?g=84c44264-cd5c-43c8-bebd-dbda56ce794e> accessed December 8, 2020.