COMMON JUDGMENT

Background By order dated 26.03.2021, the first respondent rejected the application of the Chinese University of Hong Kong for grant of patent [Indian Patent Application No.4863/CHENP/2012 dated 04.06.2012 (IN 4863)]. The said order was originally challenged by filing W.P.No.7666 of 2023. Upon the constitution of this Division, CMA (PT) No.1 of 2023 was filed assailing the same order. For the sake of convenience, throughout this order, the Chinese University of Hong Kong is referred to as the appellant.

2. The appellant originally filed Application No.

PCT/EP2010/066935 under the Patent Co-operation Treaty (PCT). IN 4863 is the national phase application derived from the said PCT application.

3. In relation to IN 4863, the appellant received the First Examination Report (FER) on 17.11.2017 raising multiple objections, including objections under Section 3(i) and (k) of the Patents Act, 1970 (the Patents Act). The appellant responded thereto on 14.05.2018 and submitted revised claims. The claims were further revised, pursuant to receipt of the notice of hearing on 07.05.2019, by introducing disclaimers stating that the invention involved a non- diagnostic method and was carried out in vitro on a biological sample.

4. The amended claim 1, as of 07.05.2019, of the appellant is as under:

“1. A non-diagnostic in vitro method for measuring a sequence imbalance in a biological sample from a pregnant female subject, wherein the biological sample includes nucleic acid molecules that are part of nucleic acid sequences, the nucleic acid molecules from the fetus and the pregnant female subject, the method comprising:

for each of a plurality of the nucleic acid molecules in the biological sample:

measuring a size of the nucleic acid molecule;

identifying which nucleic acid sequence the nucleic acid molecule is derived;

a computer system determining a size distribution of the nucleic acid molecules corresponding to a first sequence of the identified nucleic acid sequences; and based on the determined size distribution, determining a classification of whether a sequence imbalance exists for the first sequence.”

5. At the hearing before the authority, the appellant contended that the detection of a sequence imbalance does not ipso facto lead to the conclusion that there is foetal chromosomal aneuploidy and, therefore, it cannot be concluded on the basis of paragraph [0006] or the other paragraphs of the complete specification that the claimed invention is a diagnostic method for detection of foetal chromosomal aneuploidy. By the impugned order, except amended claims 23, 34 and 46, the amendments relating to the other claims were held to be permissible under Section 59 of the Patents Act. It was concluded, however, that amended claims 1 to 46 lack an inventive step in view of prior art documents, D1 and D2.

6. The Assistant Controller of Patents examined the issue of applicability of Section 3 of the Patents Act to the claimed invention and reached the conclusion that claims 1 to 22, 24 to 33 and 35 to 45 are not patent-eligible under Section 3(i) of the Patents Act because the said claims qualify as a diagnostic method. In support of such conclusion, the Assistant Controller relied upon paragraphs [0006] to [0009] of the complete specification before holding that the claimed invention is a process of diagnosing foetal chromosomal aberrations by measuring the size distribution of foetal chromosomal nucleic acid molecules. In relevant part, the final conclusion (at page 144 of convenience compilation – Part II)

is as under:

“.... Thus the claimed diagnostic method

1-43 involves a number of steps leading towards identification of a size-based analysis to perform a prenatal diagnosis of a sequence imbalance (e.g. a fetal chromosomal aneuploidy) in a biological sample obtained from a pregnant female subject, a size distribution of fragments of nucleic acid molecules for an at-risk chromosome can be used to determine a fetal chromosomal aneuploid