Natera Inc. & Anr. v. The Assistant Controller of Patents and Designs

Relevant Acts and provisions

Patents Act, 1970

Section 10(4)Section 117ASection 2(1)(j)Section 2(1)(ja)Section 3(i)Section 59

Provisions considered: Sections 2(1)(j), 2(1)(ja), 3(i), 10(4), 59 and 117A of the Patents Act, 1970.

Brief facts

Natera Inc. and a co-applicant appealed against an order refusing a patent application for methods of lung cancer detection. Claims directed to tracking single-nucleotide variants associated with tumour mutations in individuals suspected of a specific carcinoma were refused as a diagnostic method under Section 3(i), and further claims restored after the hearing from the original international application were refused under Section 59 as an impermissible amendment.

Issues before the Court

1. What is the scope of the exclusion of diagnostic methods from patentability under Section 3(i), and does it distinguish in vivo from in vitro processes?
2. Does the claimed method of tracking tumour-associated variants in individuals already suspected of a specific cancer amount to an excluded diagnostic method?

Court's findings

The Court, assisted by an amicus curiae, held that Section 3(i) does not distinguish in vivo from in vitro diagnostic methods, since the provision, unlike its European counterpart, does not require the process to be practised on the human or animal body.

The Court observed that a method is a diagnostic method where it results in a definitive finding usable for diagnosis for curative purposes, drawing on European Patent Office jurisprudence and the Madras High Court's decision in the Chinese University of Hong Kong case.

Examining the complete specification and the final claims, the Court noted that the described embodiments were directed at determining whether a patient had a particular cancer and its stage, leaving no doubt that the claimed process was one of diagnosis, and held that the claims were correctly refused under Section 3(i), making it unnecessary to examine the amendment objection.

Decision

Appeal dismissed; refusal of the patent application upheld on the ground that the claimed method is an excluded diagnostic method under Section 3(i).

Keywords

Biotechnology Claim Construction Patent Prosecution Section 3(i) Sufficiency Of Disclosure