The Madras High Court has ordered grant of patent to Chinese University of Hong Kong and American company Sequenom Inc with respect to an invention related to determining ‘foetal fraction’ through analysis of fragments of nucleic acid molecules taken from a biological sample containing both foetal and maternal DNA.
Justice Senthilkumar Ramamoorthy allowed a joint appeal filed by them and set aside an order passed by the Assistant Controller of Patents and Designs in Chennai on March 31, 2021. The Assistant Controller had rejected the patent application on the ground that the invention was a diagnostic method and hence ineligible for patent.
However, differing with the view, Justice Ramamoorthy held that the invention was per se incapable of identifying the existence or otherwise of a disease, disorder or medical condition and since further testing would be required for such purpose, it would not become ineligible for patent under Section 3(i) of Patents Act, 1970.
The judge pointed out that ‘foetal fraction’ was the proportion of cell free foetal DNA in a biological sample. According to medical literature, the foetal fraction should not be less than 4% to enable further testing to identify chromosomal aberrations such as chromosomal aneuploidies. Until further testing gets done, treatment would not be possible.
“Therefore, in my view, determination of foetal fraction is related to diagnosis but it is not diagnostic. In effect, the claimed invention only provides an indicator i.e., foetal fraction which is relevant for further testing to arrive at a diagnosis. Therefore, the impugned order (order under challenge in the appeal) calls for interference,” the judge concluded.
Though the counsel for the Assistant Controller claimed that the invention could also be used for sex determination, the judge said, such submission was irrelevant from a patent application evaluation perspective because there was a separate law in place prohibiting sex selection and prescribing penalties in respect thereof.
Another appeal
Justice Ramamoorthy, however, dismissed another appeal filed solely by the Chinese University of Hong Kong with respect to an invention related to measuring sequence imbalance in a biological sample from a pregnant female. He held that it was a diagnostic method and hence ineligible for patent under Section 3(i) of the 1970 Act.
Though the appellant contended that the detection of a sequence imbalance need not ipso facto lead to a conclusion that there would be foetal chromosomal aneuploidy (presence or absence of chromosome), the judge said, a skilled medical professional would certainly be able to arrive at a diagnosis with respect to chromosomal aberration.
He also rejected the other argument that the ineligibility for patents prescribed under Section 3(i) of the Act would be applicable only to in vivo (performed or taking place in a living organism) processes and not in vitro (a process that takes place in a test tube and not inside a living body) processes such as the appellant’s invention.
“I conclude that the word ‘diagnostic’ should receive a construction which is in consonance with text and context. Such construction does not call for curtailment by limiting the scope of ‘diagnostic’ to in vivo or definitive diagnosis,” the judge wrote while dismissing the patent appeal along with a writ petition seeking same relief.
However, before parting with the case, the judge said though his conclusions in the case was solely on the basis of interpretation of Section 3(i) of the Act by examining the text thereof in context, he had noticed that the Patent Office had granted patents to some in vitro pocess and there was inconsistency in such grant.
Further, recognising several technological advancements made in diagnosis especially by using genomic tools, the judge said, the law makers could consider restricting the scope of the expression ‘diagnostic’ to in vivo processes and counter balance it by providing for compulsory licensing.
Such a measure would encourage inventors in the cutting edge areas, of course, without compromising on public policy exclusion from patent eligibility of methods of diagnosis and treatment adopted by medical professionals. “Since this is squarely within the province of law makers, I stop with urging such reconsideration,” the judge concluded.
