In BTS Research International v. Controller of Patents, the Calcutta HC decided an appeal against the Controller’s order that refused to grant a patent to a trihybrid cell. The cell was held to be ‘part of an animal/human’ which is unpatentable u/s. 3(j). In my research, this is the first time CHC has decided a case on 3(j), particularly the scope of ‘essentially biological processes.’ The Court also discusses section 3(c) that prohibits patenting of “living substances and non-living substances occurring naturally.” In this post, apart from discussing the holding in the judgement, I will attempt to tease out a test to determine sufficient human intervention to overcome sec 3 (j) by relying on the Controller’s decision in the Sakata seed.
The Invention
Patent app. no. 41/KOLNP/2012 claims a tri-hybrid cell obtained using the somatic fusion of three cells. Going by the specification, prior attempts to create stable human hybrid cells without myeloma cells have been unsuccessful. The disadvantage of myeloma cells is that they may result in less than desired expression of the antibody protein. The present invention overcame this difficulty by creating a functionally stable trihybrid cell without myeloma cells. This trihybrid, in turn, can overexpress the desired proteins.
Controller’s Decision
The Controller rejected the Patent on the grounds of non-patentability u/s. 3(j). It held that the resulting hybrid cell was not artificially produced. Rather, it was produced from the hybridization of three naturally occurring cells obtained from animals. The resulting cell also possessed the structural and functional features of the naturally occurring cells. Therefore, in the officer’s view, the hybrid cell was a part of an animal. The Controller does not discuss the process used to obtain the trihybrid cell
To recall, 3(j) prohibits patent on “plants and animals in whole or any part thereof…and essentially biological processes(‘EBP’) for production or propagation of plants and animals.”
Collapsing 3(j) and 3(c) inquiry
The Court disagreed with the Controller’s reasoning. In Para 16, it was observed that no reasoning was provided for holding that the tri-hybrid cell was part of a human/animal u/s. 3(j). The Controller had said: “hybrid cell…possesses all the structural and functional features of the…cells from which it is derived which enable it to become structural and functional unit of an organism.”
The CHC answered that the trihybrid cells were synthetic and not naturally occurring, which meant they could not be classified as ‘plants’ or ‘animals.’ However, this collapses the inquiry u/s. 3(c) and 3(j).
3(c) declares as unpatentable ‘living substances and non-living substance occurring in nature.’ The question whether the invention is naturally occurring or not and whether the invention is a plant or animal or part thereof are separate questions. For instance, MHC in Genmab held that synthesized non-living substances are not hit by 3(c) since it is man-made and novel, which is not occurring naturally.
However, the test under 3(j) to decide whether something is part of plant, or an animal is different. Adarsh Ramanujan, in his book, argues that word ‘part’ u/s. 3(j) covers only those parts from which animals and plants can be regenerated. Why? Under TRIPS (art. 27.3), there is no exclusion of part of an animal or plant from patentability. Nevertheless, 3(j) bars their patentability. Prima facie, there seems to be a violation of 27.3. To avoid that, he offers an interpretation which harmonizes 3(j) and Article 27.3- “parts” will cover only those parts which are capable of regenerating, since plants and animals are already excluded.
I could not find other Indian case law on this. Thus, the Court could have either adopted the above test or devised its own to decide whether the trihybrid cell is a part of a plant or animal u/s. 3(j).
Human Intervention u/s. 3(j)
CHC said that the Controller failed to look at whether a technical step or human intervention took place in the hybridization process. What is human intervention, and what is its significance u/s. 3(j)?
To decide whether the claimed invention was EBP, the CHC considered the totality of human intervention and its impact on the result. The invention has to be assessed as a whole to decide if an invention is EBP. The degree of human intervention is required to decide the question of EBP. How much intervention is sufficient? The judgment does not answer this.
In the court’s view, the Controller failed to consider whether the artificial process involved, or the advanced genetic engineering used to produce the trihybrid cell, was sufficient human intervention to take it out of the shadow of EBP.
What is the sufficient level of human intervention: Shifting Sands
Kartikeya in his post discussed MHC’s decision in Sakata Seed. The MHC, in that case, remanded the application back to the Controller to be redecided on the issue: how the human intervention claimed by the appellant would not be sufficient to take it away from still being essentially a biological process?
Acknowledging that the invention required intervention, the Court was unclear on exactly how much intervention would suffice to take it out of the purview of Section 3(j).
The Controller, thereafter, gave an answer in the Sakata Seed application, which was redecided after the MHC’s order. (App. No.- 1221/CHENP/2015- decided on 30th December 2024)
It gives out a three-step test-
- Identify the essential features or steps of the claimed method
- Stages at which human intervention is required
- Assessing whether the human intervention is sufficient to establish that the method is not essentially biological.
In that application, using the above test, the Controller rejected the application. The reason provided was- “the core methodology (of the invention) relies solely on fundamental biological processes…which occur naturally without artificial manipulation of genetic material.”
Sakata Seed application claimed a patent for producing Eustoma plants. The plant was produced using successive backcrossing to combine traits. The human intervention was limited to selecting parent plants and screening progenies. Was this sufficient? The Controller said that the core of the method was successive backcrossing, which relies on natural principles and processes of biology. In other words, there was no human involvement at the core of the method.
How do you identify the essential feature or core of the method? The order does not give out a test. This adds another burden before going to the sufficiency of intervention.
Relying on the order, in my opinion, there are three steps-
- List out the steps involved in the method
- Identify which steps are essential to achieve the result. If the result cannot be obtained without that step, it is essential
- Core, among the essential, is the method which directly obtains the result.
The Controller, in the order, cites Tomatoes/STATE OF ISRAEL, which says that the “plants resulting from the crossing were determined by the underlying natural phenomenon of meiosis.” EPC guidelines says that “additional step of a technical nature which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant.”
Focusing on the underlined phrases, it becomes clearer that any essential method which directly obtains the result is the core of the method.
After identifying the core method, one has to figure out the human intervention, if any, involved in that part of the method. According to the Controller, such intervention must go beyond the natural process, i.e. achieve an outcome not possible through an unassisted biological process. The intervention, then, is sufficient if it results in something that could not be obtained by mere natural processes.
To sum up, identify the essential ‘core’ process which directly obtains the result. Then, identify the human intervention or technical step involved. Lastly, determine whether the intervention achieves the result which was not possible naturally.
Does the Tri-hybrid cell meet the threshold?
In the suit invention, the CHC writes that the application uses ‘advanced genetic technique’ to produce trihybrid cells. What is this technique?
The applicant, in its written submission to the Controller, wrote that the process of hybridization outlined at section 4.1.2 (page 63) of the description is not EBP.
The process, under 4.1.2, can be called ‘electrical cell hybridization.’ The three cells, with immortal B lymphoid cell in the middle, are positioned between two electrodes. AC current is conducted to align the cells using Dielectrophoresis. This process allows the cell to form a precise membrane contact for fusion. Then, electric pulses are delivered to fuse the cell membrane. High voltage pulses create transient pores in cell membrane. Then, the fused cell is transferred to recovery wells for incubation.
The result of the invention is fusion of the three cells i.e. trihybrid cell. In the method outlined, the process of Dielectrophoresis and electric pulses are directly resulting in the fusion of the cells and trihybrid. Using the Controller’s test, this forms the core of the method.
This is not a natural phenomenon. Dielectrophoresis and electrofusion require human intervention since it needs precise control of AC field, electric pulse, duration as well as spacing of electrode. Thus, the result is not derived using natural biological process.
To determine sufficiency, the remaining question is- could this hybridisation be achieved using natural processes? According to the specification, NO.
Also, the claimed product i.e. tri-hybrid cell, does not exist in nature or occur naturally. The issue of stability is always a concern when multiple animal cells are being fused as per the specification. The Controller also does not dispute that. However, using the method described, the cell obtained is not only functionally stable but also overexpresses desired protein. The resulting trihybrid cell obtained using the above process, therefore is something which goes beyond natural processes.
Thus, in my opinion, the invention is not hit by sec. 3(j).
(Hat tip to an anonymous reader for their insightful inputs on the post.)