Breaking down the Madras High Court’s decision in Sakata Seed Corporation v. The Controller of Patents and Designs, Kartikeya Srivastava, discusses interpretation of biological processes under Section 3(j). Kartikeya is a second-year law student of the LL.B. course at NLSIU Bangalore. Having freelanced as a patent research analyst, he developed an interest in patent prosecution and in exploring the Patents Act through various interpretative approaches. He is currently engaged in WIPO-Harvard Law School Course in Patent Law and Global Public Health. His previous post can be accessed here.
Human Intervention vs. Essentially Biological Processes: The Patentability Debate in Sakata Seed Corporation Case
By Kartikeya Srivastava
Patents related to biotechnological inventions always raise many questions which strike at the very core of Patent Law. They may include questions related to patentability criteria for naturally occurring substances considered as “new” if they are isolated or purified, or ethical questions related to patentability of life forms. Amongst these are questions that directly challenge the exclusions under Section 3 of the Patents Act, 1970 and require careful interpretation by patent examiners and the Courts.Section 3(j) of the Patents Act, 1970 excludes “essentially biological processes” from getting a patent. (See below for the screen shot of the provision)
In Sakata Seed Corporation v. The Controller of Patents and Designs, the High Court of Madras decided an appeal against the Controller’s order considering this Section. Sakata Seed Corporation is a multinational company, headquartered in Yokohama, Japan and develops genetically modified superior quality vegetables and ornamental flowers. They applied for a patent titled “Eustoma Having Cytoplasmic Male Sterility and Method for Producing Said Eustoma”. Eustoma plant is popular in horticulture, both as an ornamental, a potted indoor plant, and as a cut flower. Sakata claimed to use human intervention in six steps during the process. These involved screening of hybrid seeds and evaluating their characteristics under cultivation. It resulted in unexpected male sterile traits and consequently, distinguished it from an “essentially biological process”. The Controller acknowledged the steps involving human intervention but did not deem them enough to distinguish the process from being “essentially biological” (pdf). Hence, the patent was rejected under Section 3(j). In response, Sakata filed a Civil Miscellaneous Appeal under Section 117-A of the Patents Act, 1970 before the High Court of Madras.
The Court acknowledged that significant human intervention was involved in the process which led to unexpected male sterile traits. It noted that the only ground for rejection was the patent being “an essentially biological process” and that the Controller failed to provide sufficient reasoning for the rejection. It allowed the appeal, holding that the patent application needs further assessment and due consideration must be given to the claims along with reasoning. The Court directed reassessment of the patent application by a different Patent Controller within three months from the date of receipt of the judgement. In the reassessment, dated October 21, 2024, the Patent Office provided further observations on the claims of the patent application and set November 14, 22024 as the hearing date for the same. The Controller noted that the claims included successive backcrossing which entails natural-plant breeding processes. Although these steps include human intervention, that same intervention fails to introduce any technical step that transcends essentially biological processes. The Controller cites G 0001/08 (Tomatoes/STATE OF ISRAEL) to clarify that human intervention, such as using genetic markers in plant breeding, does not make the entire biological process patentable. A process does not evade this exclusion merely because it contains, as a further step or as part of any of the steps of crossing and selection, a step of a technical nature which serves to enable or assist the performance of the steps of sexually crossing the whole genomes of plants or of subsequently selecting plants. Therefore, the Controller found the claims not patentable under Section 3(j). This brings us to the broader question central to Sakata’s case: what qualifies as an “essentially biological process” under patent law, and how has this concept evolved?
What is an “essentially biological” process?
In 2002, India amended its Patent law and included almost all the exemptions mentioned in Article 27 of the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Article 27.3 (b) of TRIPS gives the member states a choice to exclude “essentially biological process” from patentability. (See below for the screen shot of the provision).
As explained by Nuno Pires de Carvalho in their book “The TRIPS Regime of Patent Rights” at pg. 217, this was inspired by Article 53(b) of the European Patent Convention (EPC) which provides exceptions to patentability and excludes “essentially biological processes for the production of plants or animals” from patentability. Interestingly, the appellant cited Rule 26(5) of the EPC which provides a definition of “essentially biological processes”: “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection”. In 2020, Rule 28(2) was inserted in the Implementing Regulations of the European Patent Convention which interpreted that patents will not be granted in respect of animals or plants “exclusively obtained by means of an essentially biological process”. The animals or plants that are obtained this way are typically claimed as products as explained by Adarsh Ramanujan here. He also explains that this amendment will not have an impact on the understanding in India. Given the Controller’s reliance on an EPC judgment, analysing EPC jurisprudence on “essentially biological processes” provides valuable context.
G 0002/07 and G 0001/08 are considered landmark decisions by the Enlarged Board of Appeal of the European Patent Office (EPO) regarding this exclusion. According to these judgements, a process involving sexual crossing of plants and subsequent selection for achieving desired traits is “essentially biological”. This may involve assistance from technical steps. Both of these judgments analysed the question whether technical assistance in such processes changes their status of exclusion and if so, how much technical intervention is needed for such a change. The Board explained it by stating that if the technical steps exist to merely assist the performance of crossing and selection, then the process will remain “essentially biological”. Additionally, the process will remain so, if the final outcome (traits) result from natural biological phenomena. They looked into the legislative history, going back to the Strasbourg Patent Convention, which intended to exclude conventional breeding methods from patentability.
To explain this further, take the example of T 0915/10, which was granted a patent and was not deemed an “essentially biological process”. The patent claimed a method of genetically modifying soybean plants by introducing a gene sequence into the genome of the plant through a genetic engineering step introducing heterologous DNA in plant cells. Here, the desired trait was a direct expression of the inserted DNA and not through traditional plant breeding methods. This technical intervention was deemed sufficient to transcend the exclusionary criteria for an “essentially biological process”.
Analysing Sakata’s Patent claims
Sakata’s patent application included four claims which can be read here. These claims involve backcrossing which is a classical breeding method relying on natural genetic processes (eg. meiosis). This feature falls within the scope of “essentially biological process” as per the tests laid down by EPO. The claims mention backcrossing with plants having a specific nucleotide sequence. While it is not mentioned, if this process involves Cytoplasmic Male Sterility (CMS) identification and selection of plants based on specific nucleotide sequences, it may be deemed as a technical step. This step is mentioned in their PCT Patent Application which can be read here. However, this may still be seen as a supporting technical step rather than a transformative one. Callus propagation (a stage in the process of growing plants from cuttings where a mass of irregular tissue forms at the cut end of the stem) may also be seen as a technical step. However, it is not claimed separately.
Most of the claims mentioned in Sakata’s patent application fall within the scope of “essentially biological process” exclusion, as per the tests laid down in the EPO cases. Specific claims such as “CMS identification based on specific nucleotides” and “callus propagation” may be seen as technical interventions, but at best, they are merely enabling the process and thus will not really assist in overcoming the 3(j) exclusion.
Way forward
The conundrum surrounding Section 3(j) remains unresolved. The Courts and patent examiners in India have mostly relied on EPO judgments and the tests developed there. Dr. Deepa Kachroo Tiku analysed a recent case involving Section 3(j) in India which can be read here. The considerable back and forth surrounding the insertion of Rule 28(2) of the EPC begs the question, if India should mimic the test developed by the EPO. While Rule 28(2) will not have an impact on India, it is merely due to the differences in statutory language. The language used for exclusion of “essentially biological processes for the production of plants or animals” is the same for India and the EPO. Does this warrant for the same tests in both jurisdictions? As seen in a previous example where the High Court of Delhi differentiated the Indian test for “person skilled in the art” under Section 2(1)(ja) from similar tests laid down in US and EU jurisdictions, the tests related to revocation and grant of patents in India have been intentionally changed due to many socio-economic and political reasons in the country. This is especially true for interpretation and adoption of provisions which have been explicitly left at the discretion of the member states by TRIPS. While the EPO has defined “essentially biological processes” in Rule 26(5) of the EPC, the Sakata case highlights the need for its clear definition under Section 3(j) in the Indian context. It is high time that the Government of India gives more clarity on this topic by explaining it in the Patents Act or the Guidelines for Examination of Biotechnology Applications for Patents, which was issued to explain such discrepancies.
I have a question with regard to this entire issue. The claims claim a method to produce a “Eustoma plant having a useful character to produce a
Eustoma plant that has a useful character and expresses cytoplasmic male
sterility” It has also states the steps taken to acquire this plant with a useful character. My question is, wouldn’t this be registered as a plant variety as India and the applicant can’t file a patent as, following the TRIPS mandate, has set up a sui generis plant variety protection act?
Or is it accurate to read the section as barring product claims to plants or animals (in this case, an Eustoma plant with a useful character) but not process claims (a method to produce an Eustoma plant with useful character) which are not essentially biological in character?
Firstly, the post is really detailed and covers all aspects of Madras HC’s reasoning. Discussion on Section 3(j) of the Patents Act, 1970 is generally limited, and the author has done a good job in undertaking the analysis of a relatively cryptic decision.
I agree with the author that perhaps the grant of the patent application ought to have been rejected. I think breaking down claim 1 of the claim would have been very useful here. Let’s look at Claim 1:
“1. A method for producing a Eustoma plant, comprising successively backcrossing a Eustoma plant having the nucleotide sequence represented by SEQ ID NO: 1 or 2 in its cytoplasm with a Eustoma plant having a useful character to produce a Eustoma plant that has the useful character and expresses cytoplasmic male
sterility”
(Kindly correct me if I’m mistaken) Claim 1 describes a method for producing a Eustoma plant through successive backcrossing. It goes through a three step process:
1. Starting with a Eustoma plant containing SEQ ID NO: 1 or 2 in its cytoplasm.
2. Backcrossing this plant with another Eustoma plant possessing a useful trait.
3. Producing a plant with the useful trait and cytoplasmic male sterility (CMS).\
Res ipsa loquitor- looking at the first and the second step themselves, one can surmise that the said claim is actually claiming a process of backcrossing to produce a plant having certain useful traits. It is not at all clear where does the question of human intervention arise – so as to distinguish is fully from a essentially biological process. As far as I understand, backcrossing does not inherently require human intervention beyond the selection of parent plants and the facilitation of reproduction, which are common activities in traditional breeding practices. Thus, the essence of the claimed method is in producing a derived plant with desirable traits through successive natural reproductive cycles. A particular ‘Human intervention’ would have actually been used earlier when the Eustoma plant containing the specific genetic sequence was produced- by usually introgressing the specific traits using any of the DNA recombination techniques.
Thank you and yes, I completely agree with your analysis. The human intervention part is selection of plants based on specific nucleotide sequences and to some extent, callus propagation. If we look at EPO jurisprudence regarding this, the novelty of steps taken as human intervention is not essential here, hence even though selection of plants based on specific nucleotide suequences and callus propagation are processses that are known to person skilled in the art if seen individually, it would not have been significant in the test for essentially biological process. But in this case, these interventions are simply enabling the biological process (backcrossing) and are not significant enough to make the process cross the threshold for essentially biological process. Of course the boundaries of this threshold are blurry and is worth looking into, but previous EPO cases do give a clear idea that this much enabling intervention is clearly not distinguishable from an essentially biological process.