Section 3(i) of the Patents Act excludes diagnostic methods from patent eligibility, necessitating clarity in defining diagnostic versus non-diagnostic processes.

JUDGMENT

(Prayer: IN CMA(PT)/1/2023 This Civil Miscellaneous Appeal filed under Section 117 A of the PATENTS ACT , 1970, to set aside the order dated 26th March 2021 passed by the Respondent in Patent Application 4863/CHENP/2012 as the same is contrary to law, manifestly erroneous and wholly unjust and consequently direct the respondent to restore the Appellant's patent for further prosecution.

Writ Petition is filed under Article 226 of the Constitution of India to issue a Writ of Certiorarified Mandamus calling for the records of the order dated 26th March 2021 passed by the Respondent in Patent Application 4863/CHENP/2012 and quashing the same and consequently direct the respondent to restore the petitioner's patent for further prosecution.)

Common Judgment

Background

1. 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