Observing that the plaintiffs failed to fulfil the mandatory requirements of Section 104A of the Patents Act, 1970, the Delhi High Court has held that no direction can be issued to the defendant to disclose its manufacturing process filed in a sealed cover.
Relying on various precedents, the Court noted that the intent behind Section 104A is to shift the onus of proof from the plaintiff to the defendant in cases involving infringement of process patents, subject to certain pre-conditions – one being that the plaintiff must show that the defendant’s product is identical to the product directly obtained from the plaintiff’s process patent. It was observed that only when the plaintiff proves that its product and the defendant's product are identical, the Court may direct the defendant to disclose its process to show that the same is different from the patented process.
The High Court in F-Hoffmann-LA Roche AG and Another v. Zydus Lifesciences Limited also rejected the plaintiff’s contention that Section 104A cannot be invoked by the defendant at the interim stage of the suit and the same comes into play only at the stage of final adjudication of the suit. The Court noted that from a plain reading of Section 104A, there is nothing to suggest that it cannot be invoked at an earlier stage, particularly when the plaintiff was seeking disclosure of the defendant's process by way of an interlocutory application. According to the Court, if the Court can refuse disclosure at the final stage, it can surely refuse to direct the defendant to disclose its process at an earlier stage.
It may be noted that the High Court in this case also held that Section 104A would prevail over the discovery provisions under the Civil Procedure Code (CPC) as amended by the Commercial Courts Act, 2015. It was observed that the Patents Act is a specialized legislation whereas the Commercial Courts Act, 2015 is a general legislation dealing with all commercial disputes, and that it is a settled position of law that provisions of a special statute would always prevail over the provisions of general law.
Further, contention of the plaintiff that Section 104A will have no application in respect of biological drugs, as two different biological drugs, by their very nature, cannot be identical to each other, was also rejected by the Court. The Court in this regard observed that the threshold of proving identity in substance and composition under the said section cannot be diluted in biologic cases merely because absolute replication is scientifically difficult.
The Court also rejected the contention that the defendant's product was identical to the plaintiffs' product as the defendant itself has used the plaintiffs' product, as a reference biologic in its application before the CDSCO for approval of a similar biologic. It was held that the filing of the aforesaid application by the defendant with the CDSCO by itself would not fulfil the requirement of Section 104A. Also, relying upon the Guidelines on Similar Biologics, 2016, the Court was of the view that even if a drug is stated to be the similar biologic of a reference biologic, it does not naturally follow that the process of manufacturing the same is identical to that of the ‘reference’ biologic.