Introduction

In a recent judgment in Sakata Seed Corporation v. Deputy Controller of Patents and Designs [1], the Madras High Court set aside a patent refusal order issued by the Controller of Patents for patent application No. 1221/CHENP/2015. The refusal was based on non-compliance with Section 3(j) of the Indian Patents Act, 1970 (“the Act”). This case clarifies that if a claimed process involves human intervention, it may not be considered a mere biological process and thus might not fall under the restrictions of Section 3(j) of the Act.

This blog provides an in-depth analysis of the case, its broader implications on biotechnology patents, especially in India’s agricultural sector, and practical takeaways for patent applicants. Whether you’re a patent attorney, an innovator in biotechnology, or simply interested in intellectual property law, this blog will offer valuable insights into how human intervention can change the patentability of inventions.

Facts

Sakata Seed Corporation filed a patent application titled “Eustoma having Cytoplasmic Male Sterility and method for producing said Eustoma” with the Indian Patent Office. Claim 1 disclosed “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 plant with the useful character and cytoplasmic male sterility.”

The claimed invention involved the use of cytoplasmic replacement technology to create a new combination of nuclear and cytoplasmic genomes. Specifically, the invention described a method of backcrossing a cultivated Eustoma species, like Eustoma grandiflorum, with a cytoplasmic genome derived from a wild Eustoma species. The result of this method was the creation of a cytoplasmic male sterile (CMS) plant, which does not naturally occur in Eustoma plants. By applying human intervention, particularly through selective backcrossing and screening, the invention aimed to produce plants with specific, desirable traits (e.g., male sterility), which are beneficial in hybrid seed production.

The Controller of Patents rejected the application, citing Section 3(j) of the Act, which restricts patents on plants, animals, and biological processes for the production and propagation of plants and animals. The Controller argued that the backcrossing method described was an essentially biological process excluded under Section 3(j).

Relevant Law

Section 3(j) of the Indian Patents Act states, “plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties, and species and essentially biological processes for production or propagation of plants and animals [are not patentable].”

Contentions of the Appellant

The appellant argued that the Controller had failed to recognize that the claimed process involved human intervention at relevant points, resulting in surprising outcomes. They stressed that this human intervention distinguished the process from being a natural biological phenomenon.

The appellant relied on the European Patent Office’s Rule 26(5) to assert that backcrossing is not a natural phenomenon and requires human intervention. They contended that the claims go beyond Rule 26(5) because the human interventions, such as screening hybrid seeds, led to unexpected results, such as male sterility.

The appellant also cited a 2013 Intellectual Property Appellate Board (IPAB) decision in O.A/02/2012/PT/DEL [2], which held that human intervention in a plant cell process could not be considered merely biological.

Issues Before the Court

Was the claimed invention a natural phenomenon or a biological process, or did it involve human intervention?
Does a method for producing a plant that involves human intervention fall under the purview of Section 3(j) of the Act?

Decision of the Court

The Court observed that only ground on which the Appellant’s invention has been rejected is that it is only essentially a biological process. The Controller’s reasoning was that the process described in the application, particularly the backcrossing of Eustoma plants, was similar to natural biological processes for plant breeding and propagation.

However, the Court found the Controller’s reasoning insufficient. The Court noted that the claimed invention involved human intervention, particularly in screening and selecting plants with cytoplasmic male sterility—a trait that does not occur naturally in Eustoma plants. The Court held that despite taking up the argument that there was insufficient human intervention, the Controller did not provide sufficient reasoning on how the human intervention claimed by the Applicant was insufficient to exclude the invention from the scope of Section 3(j).

The Court agreed with the Appellant’s submission that the European Patent Conventions, especially Rule 26(5) defines what is essentially biological process, i.e., where the process is for production of plants and animals and it consists of entirely a natural phenomenon.

The Court further held that from the specifications as well as the patent applications, it is clear that the patent sought for by the appellant is not a mere biological process. The screening and checking of the hybrid seeds and its characteristics clearly move it away from the realm of natural phenomenon. Therefore, it is the human intervention at particular points of time which are claimed to throw up unexpected male sterile characteristics.

The matter was therefore remanded back to the Patent office for fresh consideration and early disposal.

Our Analysis

This ruling clarifies the interpretation of Section 3(j) of the Act by distinguishing between mere biological processes and those involving human intervention that lead to unexpected results. The judgment clarifies that a method for preparing a plant will not be considered as a mere biological process if its characteristics significantly deviate from natural phenomena, especially when it involves human intervention that gives surprising results. This judgment further emphasizes the need for adequate reasoning from the Controller while rejecting the application.

Focus on Human Intervention in Indian Patent Law

The Sakata Seed Corporation case significantly broadens the interpretation of **human intervention in Indian patent law. By recognizing that processes involving artificial, human-driven steps** are distinct from purely biological processes, the Court has opened up possibilities for inventions in fields like biotechnology, synthetic biology, and even pharmaceuticals.

Patent applicants in these fields should take note of this ruling when drafting patent applications. Emphasizing the novelty of human intervention at key stages in the invention’s process will strengthen their case, particularly when facing Section 3(j) rejections.

Practical Implications for Patent Applicants

This ruling provides crucial guidance for patent applicants, particularly those in biotech and agriculture:

Highlight human intervention: Ensure that the novelty and inventiveness of human intervention is detailed and clearly distinguished from natural biological processes.
Prepare for detailed scrutiny: Applicants should document each step of human intervention in the process to avoid Section 3(j) rejections.
Preempt objections: By providing clear explanations of how the human-driven steps in the invention diverge from natural phenomena, applicants can overcome objections during examination.

This judgment also highlights the importance of detailed reasoning in patent decisions. Applicants should demand clear justifications from the Patent Office for any rejection and be prepared to challenge vague or insufficient reasoning, as demonstrated in this case.

Impact on Future Biotechnology Patents

This ruling is significant for biotechnology patents, especially in the fields of agriculture and genetic engineering. The decision clarifies that processes involving human intervention at critical points may not be excluded under Section 3(j), allowing for broader patent protection for biotechnology innovations.

For biotech companies, this ruling opens up the possibility of securing patents for genetic modification, backcrossing, and other processes involving human-driven innovation. Future patents involving methods for creating new plant varieties or genetically modified organisms (GMOs) will now have a clearer path for approval, provided that the human intervention aspect is well-documented. The ruling ensures that human involvement in developing new plant traits, especially in fields like GMOs and hybrid seeds, will be given due consideration under Indian patent law.

Focus on the Agricultural Sector in India

India’s agricultural sector is poised to benefit significantly from this ruling. The ability to patent methods involving hybrid seed development, genetic modification, and backcrossing will foster innovation in crop improvement. With Indian agriculture increasingly reliant on advanced technologies to improve crop yields, pest resistance, and climate resilience, this ruling gives agro-tech companies the confidence to invest in research and development.

This case will also encourage Indian agro-companies to pursue patent protection for novel plant varieties and genetically engineered crops. Given the global push towards sustainable agriculture, Indian innovators in this field will now have stronger legal grounds to protect their inventions, contributing to India’s agricultural economy and improving food security.

Comparison with Other Jurisdictions

By referencing EPC’s Rule 26(5), the Madras High Court has adopted a similar stance in recognizing human intervention as a differentiating factor.

In the United States, the Supreme Court’s decision in Mayo [3] established a framework for patenting processes that involve natural laws. The U.S. courts have upheld that human involvement must be “significantly more” than a natural phenomenon for a process to be patentable.

The present judgment brings India in line with these jurisdictions, allowing for a more consistent and predictable approach to biotechnology patents globally.

Conclusion

The Madras High Court’s ruling in Sakata Seed Corporation v. Deputy Controller of Patents and Designs significantly expands the scope for patenting biotechnological innovations involving human intervention. By distinguishing such processes from natural biological phenomena, the Court has paved the way for broader patent protection in fields like agriculture, biotechnology, and genetic engineering. This judgment will shape how patent law evolves in India, influencing future patent applications and encouraging innovation in sectors critical to India’s economy.