In Bigtech Pvt. Ltd. vs The Assistant Controller of Patents and Designs [(T)CMA(PT) No.107 of 2023], the Madras High Court set aside the order refusing patent application number 625/CHE/2011, entitled “Nucleotide Sequences, Reaction Mixture, Method and Kit Thereof”, and remanded the matter to the Patent Office for reconsideration.

The subject invention was aimed at enabling efficient determination of the presence of the Hepatitis B Virus (HBV) in a biological sample. Claim 1 covered specific nucleotide sequences (SEQ ID Nos. 1, 2 and 3), which constituted the probe and primers. The Controller had refused the application on two grounds: lack of inventive step and non-patentability under Section 3(c) of the Patents Act, 1970.

Inventive Step

The impugned order had relied on prior art document D7 to conclude that the claimed sequences were obvious, reasoning that no surprising effect had been demonstrated over the sequences disclosed in D7.

The Appellant argued that the Controller disregarded the experimental evidence that demonstrated unexpected effects over prior art sequences. Amplification plots were furnished comparing the probes and primers of cited prior art document D7 with SEQ ID Nos.1, 2 and 3 of the claimed invention, which showed that the claimed sequences achieved greater amplification than the corresponding SEQ IDs of D7. The Appellant distinguished the claimed invention from D7 by pointing out that D7 used fixed, immobile probes, whereas the invention deployed a probe with a different design, and D7 disclosed the use of at least two probes, while the claimed invention required one probe and two primers.

The Court noted that although the amplification plots were acknowledged in the impugned order, it had not been considered in the operative portion of the order. The Controller had simply concluded that the sequences were obvious to a person skilled in the art in view of D7 without recording any findings on the claimed unexpected effects. The Court held that the Controller’s failure to discuss and record findings regarding the claimed unexpected effects warranted reconsideration.

Section 3(c) of the Patents Act

The Controller had held that SEQ ID Nos. 2 and 3 of the claimed invention listed HBV as the species of origin and, thus, constituted mere discoveries from nature.

The Appellant argued that the nucleotide sequences of the claimed invention were chemically synthesised, not merely discovered from a living thing or non-living substance occurring in nature, and that SEQ ID No.1 incorporated a fluorophore for detection of HBV. Since the primers of SEQ ID Nos. 2 and 3 were designed to work in conjunction with the said probe of SEQ ID No.1, the claimed invention did not fall within the scope of Section 3(c).

The Court clarified that Section 3(c) applies only in respect of a mere discovery of something by the isolation thereof from nature.

Further, the Court noted that although the Controller had acknowledged the Appellant’s submissions, no reasons were recorded forrejecting the same.  Specifically, the impugned order did not deal with the assertions that the nucleotide sequences were synthesised and the oligonucleotide probe of SEQ ID No.1 contained synthesized compounds from the fluorescein group such as fluorophore and quencher for detecting HBV.

In conclusion, the Court found that the Controller summarily applied Section 3(c) without dealing with the Appellant’s submissions and failed to properly examine the evidence of unexpected technical effects. Accordingly, the impugned order was set aside and the matter was remanded to the Patent Office for reconsideration.