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Written by Nasreen Serji, student at Government Law College, Thrissur 

BTS Research International Pty Ltd Vs. The Controller General of Patents & Designs, Mumbai & Ors [IPDPTA 56 of 2023]

When does a biological invention created through human intervention become eligible for a patent? The following case is crucial in its findings for allowing patent to a biotechnology invention. The court considered the question of when a process that involves biological steps becomes patentable.

The Calcutta High Court set aside the order by the Controller General of Patents and Designs in the case of BTS Research International Pty Ltd Vs. The Controller General of Patents & Designs, Mumbai & Ors [IPDPTA 56 of 2023]. The judgement is important for understanding the scope of biological processes under the Patents Act. 

Chapter II of the Patents Act 1970 sets out exceptions for inventions that cannot be patented. Under section 3 (j), inventions that are parts or whole of plants and animals including essentially biological processes cannot be patented. Section 3 (c) excludes discovery of any living or non-living substance occurring in nature. 

The Appellants, BTS Research International, sought a patent for the method of generating tri-hybrid cell and its uses. A tri-hybrid cell is a fusion of three bodily cells, of which at least two cells are different types either from a human or mouse. The Appellant had been granted patent for the same invention from other jurisdictions.  The Respondents through an order, rejected the claim for patent of the tri-hybrid cell on the ground that the invention was not patentable under sections 3 (j) and (c) of the Act. The Appellants have challenged the said order in this case. 

CONTENTIONS

The Appellant claimed that the tri-hybrid cell is produced through an artificial process using genetic engineering techniques. It is not an organism or part of a plant or animal. Furthermore, it does not involve any essentially biological process for the production or propagation of plants and animals. The cell can only be created through human intervention. It was contended that no Second Examination Report (SER) was issued, even though it is mandated under Section 13(3) after filing a response to the First Examination Report. Additionally, the prior art was already cited in the European proceedings and was part of the European Search Report. 

The Respondents, through the challenged order, claimed that the process of making the hybrid cells is biological and comes within the scope of “essentially biological process” under section 3 (j) of the Act. Furthermore, it is produced from a line of cell that is naturally occurring. Hence, such a hybrid cell cannot be artificially produced. They also placed the subject under section 3 (c) which excludes the “discovery of any living thing or non-living substance occurring in nature” from being patentable. 

FINDINGS

The Court held that the respondents were negligent in issuing the SER and the court cited Oyster Point Pharma Inc vs. The Controller of Patents and Designs Anr [MANU/WB/1544/2023] to emphasize the importance of issuing SER regardless of the patent’s outcome. The statutory mandate of section 13(3) must be followed regardless of the consequences and the ultimate result thereof. Hence, the Assistant Controller erred in not issuing the SER in compliance with section 13(3) of the Act.

The Court held that despite the five prior art documents being cited in the European proceedings, the respondent authorities failed to consider the outcome of these proceedings or refer to the European Patent Office’s decision, which had granted the subject patent. Instead, the respondents proceeded mechanically and rejected the subject invention without giving any weight to the European proceedings. While it is true that the findings of the European Patent Office are not binding on the respondent authorities, given that all similar prior arts had been cited and considered, and all records were before the authority, they should have at least been considered before passing the impugned order. 

Following The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Section 3 (j) was amended into the Patents (Amendment) Act, 2002. The agreement allows member countries to exclude plants, animals and essentially biological processes for the production of plants or animals from the scope of patent. However, non-biological and microbiological process are not excluded from patent protection as per the agreement.  The court pointed out that “essentially biological process” under section 3 (j) is specifically “for production or propagation of plants and animals”. A biological process occurs naturally. The subject at hand, tri-hybrid cell, is produced only through advanced engineering techniques by fusing three bodily cells. This does not form in part or whole an animal or plant body. The expression “for production or propagation of plants and animals” is emphasized i.e. if the biological process does not lead to this, it is not excluded from patent protection. The court highlighted the importance of human intervention and its impact on the invention to determine if it falls outside the scope of “essentially biological”. When technical steps or human intervention result in a genetically modified invention, it is not an essentially biological process.

OUTCOME

The court set aside the respondents order rejecting the patent claim. It also pointed out that the impugned order did not consider the technical steps taken to invent the tri-hybrid cell. Inserting a feature through technical steps is not the outcome of a biological process and would be exempted from the scope of section 3 (j). The court disregarded the application of section 3 (c) as it is without basis. While determining whether a genetically modified process or product is patentable, it depends on the degree of human intervention involved. Therefore, an invention should be evaluated as a whole, not just based on the steps involved. In the present case, the invention is synthetic as it is obtained only through artificial engineering of cells to produce a tri-hybrid cell.

It is important to note that the patent eligibility of ‘non-biological and microbiological process’ has been clarified in this case as it is not explicitly stated in the Act. This case has also opened doors for bio technological inventions and their patentability under the Indian law.