BIGTEC PRIVATE LIMITED VS. THE ASSISTANT CONTROLLER OF PATENTS & DESIGNS

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BIGTEC PRIVATE LIMITED VS. THE ASSISTANT CONTROLLER OF PATENTS & DESIGNS

(T)CMA(PT) No.107 of 2023

(OA/10/2018/PT/CHN)

An appeal was filed dated April 1, 2024 in the Madras High Court pertaining to the order passed on August 16, 2017 for rejecting the Indian Patent Application bearing no 625/CHE/2011. The invention, titled as "Nucleotide Sequences, Reaction Mixture, Method and Kit Thereof", relates to detecting Hepatitis B Virus (HBV) using specific nucleotide sequences.

Core Claims:

Involve nucleotide sequences SEQ ID No.1 (a probe), and SEQ ID Nos.2 and 3 (primers), with SEQ ID No.1 conjugated with a fluorophore and quencher for HBV detection.

Facts of the case:

The appellant's patent application was rejected on grounds of lack of inventive step u/s 2(1) (ja) in view of citations D1 to D7 and particularly regarding citation D7 along with exclusion under Section 3(c) of the Patents Act. The appellant argued that their sequences provided unexpected amplification results compared to prior art.

Controller’s Reasoning:

The Assistant Controller maintained that the claimed sequences were obvious and routine for a person skilled in the art and hence, not inventive u/s 2 (1) (ja). They referenced D7, stating that SEQ ID No. 1 and 2 were 100% identical to SEQ ID No. 290 of D7, and that the sequences were naturally occurring or derived from HBV, thus falling under the exclusionary clause of Section 3(c) (which bars patents on mere discoveries of naturally occurring substances).

Appellant's Contentions:

The appellant argued that their claimed invention was aimed at efficiently detecting and quantifying Hepatitis B Virus (HBV) using specific nucleotide sequences—SEQ ID Nos. 1, 2, and 3. They emphasized the novelty and non-obviousness of their patent application as SEQ ID No. 1 is a probe conjugated with a fluorophore and quencher, while SEQ ID Nos. 2 and 3 are primers specifically designed to function with the probe. The appellant contended that the sequences provided surprising and superior amplification effects compared to prior art, particularly document D7, and that this effect was substantiated with empirical data including amplification plots and comparative analysis.

Courts Finding:

The Court, presided by Justice Senthilkumar Ramamoorthy, identified several procedural and substantive lapses in the original decision. Notably, the impugned order failed to adequately consider the amplification data or evidence of surprising effects submitted by the appellant, which was crucial in determining whether the invention exhibited unexpected and non-obvious effects over the prior art. The court emphasized that the determination of inventive step requires a thorough examination of the claimed invention's effects compared to prior art, particularly when unexpected results are claimed. Furthermore, the rejection under Section 3(c) was based largely on the origin of the sequences (HBV), without engaging meaningfully with the appellant’s argument that the sequences were synthesized and functionally distinct from naturally occurring ones, particularly in their use of fluorescent conjugates and primers..

Conclusion

The court found procedural and substantive lapses in how the patent rejection was handled, especially regarding the inventive step and Section 3(c) exclusion. The judgment set aside the rejection and remanded the matter for reconsideration. Further, the court directed that a different officer has to review the application to avoid bias. Moreover, the court added that review must focus on the issues raised in the last hearing notice and a fresh order must be issued within four months. It emphasized that where technical evidence of inventiveness is offered, it must be directly addressed.