JUDGMENT

Background By order dated 31.03.2021, the respondent rejected the application of the appellants for grant of patent [Indian Patent Application No.4812/CHENP/2012 dated

01.06.2012 (IN 4812)] and the said order is impugned herein.

2. The appellants claim priority from multiple U.S.

Provisional Applications for IN 4812, which is the national phase filing derived from a Patent Cooperation Treaty (PCT) application in respect of a claimed invention entitled “Fetal Genomic Analysis From a Maternal Biological Sample”.

3. IN 4812 was originally filed with 44 claims. The appellants received the First Examination Report (FER) on 29.11.2012 raising multiple objections, including objections under Sections 2(1)(j), 2(1)(ja), 3(i) and 10(5) of the Patents Act, 1970 (the Patents Act). The appellants responded thereto on 28.05.2018 by deleting original claims 1-33 and submitted amended claims 1-12.

4. At the hearing before the authority, the appellants contended that the determination of the foetal fraction does not diagnose a disease and that, therefore, the claimed invention is not a diagnostic method.

5. 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 amended claims 1 to 12 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 paragraph [0007] of the complete specification before holding that the claimed invention is a process of diagnosing that the foetus is suffering from genetic or other diseases. In relevant part, the conclusion (at page 448 of the appeal paper book) is as under:

“In addition to this as discussed and accepted by the Applicant in the reply, the whole description mentions method of diagnosis. And the claimed method discloses a maternal sample for elucidating the fetal haplotype, sequencing and analysing the sample and a size fractionation step can also be performed on the nucleic acid molecule then analysing the size then parental genomes are used as scaffolds which can be compared against genetic information of the fetus obtained from the maternal sample containing fetal DNA and constructing fetal genome from maternal genome and determination of the parental alleles inherited by the fetus. To determine the fractional fetal DNA concentration be useful for determining a cutoff to determine a classification of which haplotype and/or genotype are inherited. Thus it is very clear that the claimed method of determining a fractional concentration of fetal DNA in a biological sample is not patentable u/s 3(i) of the Patents Act, 1970 as the said claims are diagnostic method.”

Counsel and contentions

6. Oral arguments were advanced by Ms.Vindhya S.

Mani, learned counsel for the appellants; and by Mr.Diwakar, learned SPC, assisted by the Assistant Controller of Patents and Designs, on behalf of the respondent. Mr. Adarsh Ramanujan, learned counsel and author of “Patent Law Cases and Materials, A Synthesis for India”, Thomson Reuters (2021), was heard as amicus curiae. For effectively assisting and shining the light on the nuances and intricacies of the issues that arise for consideration, I record my deep appreciation.

7. Ms. Vindhya Mani submitted that the object and purpose of the amendment to Section 3(i) is to prevent the grant of patents to methods of diagnosis performed by a medical doctor on patients so as to ensure that medical doctors are in a position to adopt the best methods of diagnosis and treatment, without the apprehension that a patent infringement action would be initiated against them. In fact, learned counsel referred to the communication from the Indian Permanent Mission to the Negotiating Group on Trade-Related Aspects of Intellectual Property Rights and pointed out that the said communication indicated clearly that only diagnostic methods practised on the human body