Introduction

In India Patent Application No. 202417006578, the Assistant Controller of Patents & Designs, issued an order in the context of a Pre-grant Opposition (‘PGO’) against Pharmazz Inc.’s said patent application. This decision is particularly notable as it represents the first application of a new rule requiring the establishment of a prima facie case before issuing a notice in a PGO. The order emphasizes the necessity of establishing a prima facie case before issuing a notice in a PGO. It involves a detailed prima facie analysis before accepting a PGO application and addresses the sustainability of amendments that dilute the requirements stipulated in the Patents Act, 1970 (as amended). The patent amendments introduced in March 2024 have introduced significant changes to the PGO process, including stricter timelines and evidential requirements, which aim to streamline the opposition process and reduce frivolous claims. This decision warrants further analysis due to its implications on the procedural and substantive aspects of pre-grant oppositions and the broader impact of recent patent law amendments.

Background

Pharmazz Inc., a pharmaceutical company, had filed a patent application for a novel invention. However, before the patent could be granted, a pre-grant opposition was filed. Pre-grant opposition is a procedural safeguard that allows third parties to challenge the validity of a patent application after its publication but before it is granted.

This mechanism ensures that only inventions meeting all legal requirements are granted patents.

Grounds for Opposition under Section 25 of the Indian Patents Act, 1970

The opposition against Pharmazz Inc.’s application was based on the following grounds:

1. Lack of Novelty (under Section 25(1)(b)
2. Inventive Step (under Section 25(1)(e)
3. Insufficient Disclosure (under Section 25(1)(g)
4. Non-Patentable Subject Matter under Section 3(d) and 3(e) (under Section 25(1)(f))
5. Non-disclosure of foreign filing details under Section 8 (under Section 25(1)(h)

The Decision

The Assistant Controller meticulously evaluated the opposition and the response from Pharmazz Inc. The order addressed the merits of the opposition, considering the evidence and arguments presented by both parties. The decision entailed a detailed analysis of the novelty, inventive step, sufficiency of disclosure, and foreign filing information of the claimed invention.

Outcome

The specific outcome of the opposition is pending before the Indian Patent Office Be that as it may, in the interim, it was established that a prima facie case ought to be made out before the issuance of a notice in a PGO. The order emphasizes the necessity of establishing a prima facie case before issuing a notice in a PGO.

Conclusion

The recent order in Patent Application No. 202417006578 underscores the importance of pre-grant opposition in safeguarding the quality and integrity of the patent system. By allowing third parties to challenge patent applications, the system ensures that only deserving inventions are granted patents, thereby fostering innovation and protecting public interest.