Breaking down the Madras Excessive Courtroom’s determination in Sakata Seed Company v. The Controller of Patents and Designs, Kartikeya Srivastava, discusses interpretation of organic processes beneath Part 3(j). Kartikeya is a second-year legislation pupil of the LL.B. course at NLSIU Bangalore. Having freelanced as a patent analysis analyst, he developed an curiosity in patent prosecution and in exploring the Patents Act by varied interpretative approaches. He’s at the moment engaged in WIPO-Harvard Legislation Faculty Course in Patent Legislation and International Public Well being. His earlier submit might be accessed right here.
Human Intervention vs. Primarily Organic Processes: The Patentability Debate in Sakata Seed Company Case
By Kartikeya Srivastava
Patents associated to biotechnological innovations at all times increase many questions which strike on the very core of Patent Legislation. They could embrace questions associated to patentability standards for naturally occurring substances thought-about as “new” if they’re remoted or purified, or moral questions associated to patentability of life types. Amongst these are questions that immediately problem the exclusions beneath Part 3 of the Patents Act, 1970 and require cautious interpretation by patent examiners and the Courts.Part 3(j) of the Patents Act, 1970 excludes “basically organic processes” from getting a patent. (See under for the display screen shot of the availability)
In Sakata Seed Company v. The Controller of Patents and Designs, the Excessive Courtroom of Madras determined an attraction towards the Controller’s order contemplating this Part. Sakata Seed Company is a multinational firm, headquartered in Yokohama, Japan and develops genetically modified superior high quality greens and decorative flowers. They utilized for a patent titled “Eustoma Having Cytoplasmic Male Sterility and Technique for Producing Stated Eustoma”. Eustoma plant is fashionable in horticulture, each as a decorative, a potted indoor plant, and as a lower flower. Sakata claimed to make use of human intervention in six steps throughout the course of. These concerned screening of hybrid seeds and evaluating their traits beneath cultivation. It resulted in surprising male sterile traits and consequently, distinguished it from an “basically organic course of”. The Controller acknowledged the steps involving human intervention however didn’t deem them sufficient to tell apart the method from being “basically organic” (pdf). Therefore, the patent was rejected beneath Part 3(j). In response, Sakata filed a Civil Miscellaneous Enchantment beneath Part 117-A of the Patents Act, 1970 earlier than the Excessive Courtroom of Madras.
The Courtroom acknowledged that vital human intervention was concerned within the course of which led to surprising male sterile traits. It famous that the one floor for rejection was the patent being “an basically organic course of” and that the Controller failed to offer enough reasoning for the rejection. It allowed the attraction, holding that the patent software wants additional evaluation and due consideration have to be given to the claims together with reasoning. The Courtroom directed reassessment of the patent software by a unique Patent Controller inside three months from the date of receipt of the judgement. Within the reassessment, dated October 21, 2024, the Patent Workplace offered additional observations on the claims of the patent software and set November 14, 22024 because the listening to date for a similar. The Controller famous that the claims included successive backcrossing which entails natural-plant breeding processes. Though these steps embrace human intervention, that very same intervention fails to introduce any technical step that transcends basically organic processes. The Controller cites G 0001/08 (Tomatoes/STATE OF ISRAEL) to make clear that human intervention, similar to utilizing genetic markers in plant breeding, doesn’t make the complete organic course of patentable. A course of doesn’t evade this exclusion merely as a result of it incorporates, as an extra step or as a part of any of the steps of crossing and choice, a step of a technical nature which serves to allow or help the efficiency of the steps of sexually crossing the entire genomes of crops or of subsequently choosing crops. Due to this fact, the Controller discovered the claims not patentable beneath Part 3(j). This brings us to the broader query central to Sakata’s case: what qualifies as an “basically organic course of” beneath patent legislation, and the way has this idea developed?
What’s an “basically organic” course of?
In 2002, India amended its Patent legislation and included virtually all of the exemptions talked about in Article 27 of the Commerce-Associated Points of Mental Property Rights (TRIPS). Article 27.3 (b) of TRIPS provides the member states a option to exclude “basically organic course of” from patentability. (See under for the display screen shot of the availability).
As defined by Nuno Pires de Carvalho of their e-book “The TRIPS Regime of Patent Rights” at pg. 217, this was impressed by Article 53(b) of the European Patent Convention (EPC) which gives exceptions to patentability and excludes “basically organic processes for the manufacturing of crops or animals” from patentability. Curiously, the appellant cited Rule 26(5) of the EPC which gives a definition of “basically organic processes”: “A course of for the manufacturing of crops or animals is actually organic if it consists completely of pure phenomena similar to crossing or choice”. In 2020, Rule 28(2) was inserted within the Implementing Laws of the European Patent Conference which interpreted that patents is not going to be granted in respect of animals or crops “completely obtained by the use of an basically organic course of”. The animals or crops which can be obtained this fashion are sometimes claimed as merchandise as defined by Adarsh Ramanujan right here. He additionally explains that this modification is not going to have an effect on the understanding in India. Given the Controller’s reliance on an EPC judgment, analysing EPC jurisprudence on “basically organic processes” gives helpful context.
G 0002/07 and G 0001/08 are thought-about landmark choices by the Enlarged Board of Enchantment of the European Patent Workplace (EPO) concerning this exclusion. In keeping with these judgements, a course of involving sexual crossing of crops and subsequent choice for reaching desired traits is “basically organic”. This may increasingly contain help from technical steps. Each of those judgments analysed the query whether or not technical help in such processes modifications their standing of exclusion and in that case, how a lot technical intervention is required for such a change. The Board defined it by stating that if the technical steps exist to merely help the efficiency of crossing and choice, then the method will stay “basically organic”. Moreover, the method will stay so, if the ultimate end result (traits) end result from pure organic phenomena. They seemed into the legislative historical past, going again to the Strasbourg Patent Conference, which supposed to exclude standard breeding strategies from patentability.
To elucidate this additional, take the instance of T 0915/10, which was granted a patent and was not deemed an “basically organic course of”. The patent claimed a way of genetically modifying soybean crops by introducing a gene sequence into the genome of the plant by a genetic engineering step introducing heterologous DNA in plant cells. Right here, the specified trait was a direct expression of the inserted DNA and never by conventional plant breeding strategies. This technical intervention was deemed enough to transcend the exclusionary standards for an “basically organic course of”.
Analysing Sakata’s Patent claims
Sakata’s patent software included 4 claims which might be learn right here. These claims contain backcrossing which is a classical breeding technique counting on pure genetic processes (eg. meiosis). This characteristic falls throughout the scope of “basically organic course of” as per the assessments laid down by EPO. The claims point out backcrossing with crops having a selected nucleotide sequence. Whereas it isn’t talked about, if this course of includes Cytoplasmic Male Sterility (CMS) identification and collection of crops based mostly on particular nucleotide sequences, it could be deemed as a technical step. This step is talked about of their PCT Patent Utility which might be learn right here. Nonetheless, this will nonetheless be seen as a supporting technical step moderately than a transformative one. Callus propagation (a stage within the strategy of rising crops from cuttings the place a mass of irregular tissue types on the lower finish of the stem) can also be seen as a technical step. Nonetheless, it isn’t claimed individually.
A lot of the claims talked about in Sakata’s patent software fall throughout the scope of “basically organic course of” exclusion, as per the assessments laid down within the EPO instances. Particular claims similar to “CMS identification based mostly on particular nucleotides” and “callus propagation” could also be seen as technical interventions, however at finest, they’re merely enabling the method and thus is not going to actually help in overcoming the three(j) exclusion.
Manner ahead
The conundrum surrounding Part 3(j) stays unresolved. The Courts and patent examiners in India have principally relied on EPO judgments and the assessments developed there. Dr. Deepa Kachroo Tiku analysed a latest case involving Part 3(j) in India which might be learn right here. The appreciable backwards and forwards surrounding the insertion of Rule 28(2) of the EPC begs the query, if India ought to mimic the check developed by the EPO. Whereas Rule 28(2) is not going to have an effect on India, it’s merely as a result of variations in statutory language. The language used for exclusion of “basically organic processes for the manufacturing of crops or animals” is identical for India and the EPO. Does this warrant for a similar assessments in each jurisdictions? As seen in a earlier instance the place the Excessive Courtroom of Delhi differentiated the Indian check for “particular person expert within the artwork” beneath Part 2(1)(ja) from related assessments laid down in US and EU jurisdictions, the assessments associated to revocation and grant of patents in India have been deliberately modified on account of many socio-economic and political causes within the nation. That is very true for interpretation and adoption of provisions which have been explicitly left on the discretion of the member states by TRIPS. Whereas the EPO has outlined “basically organic processes” in Rule 26(5) of the EPC, the Sakata case highlights the necessity for its clear definition beneath Part 3(j) within the Indian context. It’s excessive time that the Authorities of India provides extra readability on this subject by explaining it within the Patents Act or the Tips for Examination of Biotechnology Functions for Patents, which was issued to elucidate such discrepancies.