5 judgments of the Delhi High Court, the Calcutta High Court and 1 other court applying Patents Act s.3(j), from 2024–2025, each with a headnote by BRB Legal.
Two appeals dismissed on section 3(i). The Court held that the fact a method is performed in vitro does not by itself make it patentable so long as the purpose of the process is to diagnose a medical condition: here the method of methylation of samples drawn from a pregnant woman produced a result sufficient to eliminate her from further testing, which brought it within the exclusion. Grants of the same invention in foreign jurisdictions could not displace the statutory prohibition in India. As the second application differed from the first only in the polynucleotide sequences, the analysis in the first bound the appellants in both.
Refusal of an application for a method of generating hybrid cells set aside. The Court held that tri-hybrid cells, being synthetic and not naturally occurring, do not fit the description of plants or animals under section 3(j), and that the impugned order failed to engage with the contention that the cell is by its nature not an essentially biological process for propagation or production of a plant or animal. The conclusion under section 3(c) was equally baseless because it ignored the technical intervention and human step involved, that provision operating independently to declare naturally occurring living and non-living things inherently unpatentable. Monsanto was distinguished as concerning a man-made DNA construct inserted into plants so as to pass into future generations, a different extent of human intervention.
Refusal under sections 3(i) and 3(j) set aside. The claim had been amended from a transgenic non-human mammal to a nucleic acid molecule, which took the section 3(j) objection away, yet the Controller never discussed the amended claims and merely extracted the claims as filed and at the First Examination Report stage. The section 3(j) objection had not been raised at the earliest point in any event. On section 3(i) the order concluded the invention was only a vaccination method with no discussion or reasoning at all, and on inventive step neither discussion nor reasons were given. Since nucleic acid was clearly disclosed in the specification, the amendment was not beyond the scope of the original claim and section 59 could not be held against the applicant.
On section 3(j) the Court adopted the test in Rule 26(5) of the European Patent Convention: a process for the production of plants or animals is essentially biological only if it consists entirely of natural phenomena such as crossing or selection. Screening hybrid seeds and checking their characteristics at defined points takes a process out of that, and the Controller, having noted the argument on human intervention, never reasoned his way past it.
Refusal under sections 3(i) and 3(j) set aside. Section 3(j) was never raised in the hearing notice yet became a ground of rejection, which denied the applicant any opportunity to contest it and breached natural justice. On section 3(i) the Court drew a distinction that decided the appeal: between a method of treatment and a method for producing a substance or composition which may have a specific use in a method of surgery, therapy or diagnosis. The claims here were to a method of producing a protein-enriched blood serum using gold particles, which is a method of producing a novel composition; the possible use of that serum in transfusion is an application of the product and was not part of the claims at all. Failing to recognise the distinction led to an erroneous application of the provision. The Court noted that the European Patent Office had granted the patent notwithstanding Article 53(c) of the European Patent Convention, which is to similar effect.
