The court interpreted Section 3(i) of the Patents Act to exclude diagnostic methods from patentability, affirming that non-invasive prenatal testing qualifies as such despite claims of non-diagnostic nature.

1. This hearing has been done through hybrid mode.

2. The present appeals involve an interpretation of the exclusions from patentability in respect of diagnostic processes/methods under Section 3 (i) of the Patents Act, 1970 (hereinafter “the Act”).

3. These are two appeals filed under Section 117A of the Act, challenging the impugned order dated 12th December, 2019, (hereinafter “first impugned order”) in C.A.(COMM.IPD-PAT) 448/2022 and impugned order dated 20th January, 2020, (hereinafter “second impugned order”) in C.A.(COMM.IPD-PAT) 13/2022, passed by the Assistant Controller of Patents.

4. The Appellants had preferred the following two Patent Applications:

* No. 2476/DELNP/2011 (hereinafter “first patent application”)

* No. 3139/DELNP/2012 (hereinafter “second patent application”)

Both the first and second patent applications were in respect of inventions titled “Process and Compositions for Methylation-Based Enrichment of Fetal Nucleic Acid from a Maternal Sample Useful for Non Invasive Prenatal Diagnoses” (hereinafter “the subject inventions”). The Claims in the said two applications were identical, except in respect of the polynucleotide sequences of ‘sequence identifier no.’ (hereinafter “SEQ ID No.”) mentioned in Claim 1, of the subject patent applications, i.e., SEQ ID 1 to 89 and SEQ ID 90 to 261, respectively.

5. Vide the first impugned order the Respondent has refused the grant of the corresponding patent application on the grounds that the subject invention lacks inventive step under Section 2 (1)(ja) of the Act, and is not patentable under Sections 3 (b), 3(d), 3(i) and 3(j) of the Act. Further, vide the second impugned order the Respondent has refused the grant of the patent application on the ground that the Claims thereto are not patentable under Section 3 (i) of the Act.

6. In both the Appeals, Appellant No. 1 – Sequenom Inc., and Appellant No.2 - Sequenom Center for Molecular Medicine, are entities having their registered office in the United States of America.

I. Factual Background in C.A.(COMM.IPD-PAT) 448/2022

7. In this appeal, the Appellants claim priority from a U.S. Patent Application No. 61/192,264 dated 16th September, 2008. The first patent application was originally filed with 28 Claims. However, during the prosecution of the said application, the Claims have been restricted to 10 claims.

8. The Appellants had filed the request for examination of the first patent application on 16th August, 2012. The First Examination Report (hereinafter “FER”) was issued by the Respondent on 22nd June, 2017, raising various objections including lack of inventive step under Section 2 (1)(ja) of the Act and non-patentability under Section 3 (b), (d), (i), and (j) of the Act. The Appellants had filed their response to the FER on 13th March, 2018, and after considering the same, the hearing notice dated 8th June, 2018 was issued by the Respondent fixing the date for hearing the Appellants on 3rd July, 2018. In the hearing notice, the Respondent maintained the objections, inter alia, under Section 2 (1)(ja) of the Act, and Sections 3 (b), (d), (i), and (j) of the Act.

9. The Appellants sought adjournment of the personal hearing on two occasions and thus, the Appellants were finally heard on 31st August, 2018. Pursuant to the oral submissions made in favour of patentability of the subject invention, the Appellants also submitted written submissions on 14th September, 2018. However, vide the first impugned order, the Respondent has refused the first patent application on the grounds that the subject invention lacks inventive step under Section 2 (1)(ja) of the Act, and is not patentable under Sections 3 (b), 3(d), 3(i) and 3(j) of the Act.

10. The Appellants being aggrieved by the first impugned order, have preferred the present appeal.

II. Factual Background in C.A.(COMM.IPD-PAT) 13/2022

11. In respect of the second patent application, the Appellants claim priority from a U.S. Patent Application No. 12/561,2