Essentially Biological Processes for Production of Plants

Summary: Indian law excludes from patentability ‘essentially biological processes’ under Section 3(j) of the Patents Act, but does not explain what degree of human intervention can shift an invention away from being deemed ‘essentially biological’. A recent decision of the Madras High Court attempts an interpretation of this provision, highlighting also the importance of well reasoned orders from the patent office.

Introduction

Under Indian patent law, ‘essentially biological processes’ are excluded from patentability, but no further explanation as to what constitutes such processes is provided in the statute. Specifically, what is the degree of human intervention required to tilt the scale away from a process being “essentially biological” to one where it is not? The scope of this expression has occasionally been discussed by courts, most recently by the Madras High Court, which also discusses the importance of well-reasoned orders.

The legal position

Section 3(j) of the Indian Patents Act, 1970 (the Act) excludes from patentability “essentially biological processes for production or propagation of plants and animals”. The expression “essentially biological process” is not defined in the Act. However, the Guidelines for Examination of Biotechnology Applications for Patents issued by the Indian Patent Office (IPO) provide an example of what might be considered an essentially biological process covered under Section 3(j) of the Act, thus: a method of producing at least one of substantially pure hybrid seeds, plants and crops, comprising the steps of –

(i) producing a male parent which is male fertile,

(ii) breeding the male parent with a female parent which is substantially male sterile, and

(iii) harvesting seeds from the female parent which contain pure hybrid seeds.

Looking beyond India, Rule 25.6 of the European Patent Convention (EPC) clarifies that, “A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.”

The EPC Guidelines further clarify that:

“A process for the production of plants or animals which is based on the sexual crossing of whole genomes and on the subsequent selection of plants or animals is excluded from patentability as being essentially biological. This applies even if the process comprises human intervention, including the provision of technical means, serving to enable or assist the performance of the process steps or if other technical steps relating to the preparation of the plant or animal or its further treatment are present in the claim before or after the crossing and selection steps.”

The EPC Guidelines also note that genetic engineering techniques differ profoundly from conventional breeding techniques as they work primarily through the purposeful insertion and/or modification of one or more genes in a plant are patentable.

The case

The Madras High Court in Sakata Seed Corporation vs The Controller of Patents and Designs (CMA (PT) No.30 of 2023) dealt with the scope of the expression, “essentially biological process”. The concerned application (1221/CHENP/2015) related to an invention titled “Eustoma having Cytoplasmic Male Sterility and method for producing said Eustoma”, which had been rejected by the Controller for relating to essentially a biological process.

As per the file wrapper available on the IPO website, the claim under consideration was directed to:

“A method for producing a Eustoma plant, comprising successively back-crossing a Eustoma plant having the nucleotide sequence represented by SEQ ID NO: 1 or 2 in its cytoplasm with a Eustoma plant having a character derived from E. grandiflorum to produce a Eustoma plant that has the character derived from E. grandiflorum and expresses cytoplasmic male sterility.”

Before the court, the appellant (Sakata) submitted that the method claimed was not essentially a biological process, but included human interventions at relevant points of time, which gave surprising results.

In support of its case, the appellant also referred to Rule 25.6 of the EPC, as well as an order of the (now obsolete) Intellectual Property Appellate Board (IPAB), O.A/02/2012/PT/DEL. In its order, the IPAB noted that the claimed method included an act of human intervention on a plant cell and producing in that plant cell some change. The claim under consideration was directed to a method of producing a transgenic plant comprising the step of inserting into the genome of plant cell a recombinant DNA molecule.

The decision

In its decision, the Madras High Court, with reference to Rule 26(5) of the EPC, noted that the test in the instant case was whether the claimed invention was merely a natural phenomenon or otherwise a biological process, as defined by the EPC, or whether any intervention had been shown by the appellant.

Referring to the patent specification, the Court stated that it was clear that the claimed process was not a mere biological process. The screening and checking of the hybrid seeds and its characteristics clearly moved it away from the realm of natural phenomenon. Therefore, it was human intervention at particular points of time, as claimed, which caused unexpected male sterile characteristics to emerge. The Court further noted that the Controller, despite taking up the argument that there was human intervention, had not concluded on this issue by sufficient reasoning as to how human intervention (as claimed) would not be sufficient to take it away from still being essentially a biological process. For this limited purpose, the matter was remanded to the Controller for reconsideration.

Conclusion

“Human intervention” is foundationally relevant to patentability, and particularly so, for inventions that  might otherwise run the risk of being deemed essentially natural or biological phenomena or processes. Understanding what is the degree of human intervention in a particular case, and how germane it is to an invention involves a deep and clear understanding of the science involved. Any patent application in this field should be considered carefully and with great scrutiny, with proper reasons provided in the order for rejection or grant, particularly explaining how the invention is deemed essentially biological or otherwise. This Madras High Court decision lays down these basic principles required to be followed in handling such applications, and in some ways, expands the understanding of the term “human intervention”. It will be immensely useful as a guiding principle for future patent applicants, who must tread this space with care and clarity.