Pharmacyclics LLC v. Deputy Controller of Patents: the evolving landscape of divisional applications in India

The Calcutta High Court’s recent judgment in Pharmacyclics LLC v. Deputy Controller of Patents marks a pivotal moment in Indian Patent Law, offering a clear and definitive interpretation of Section 16 of the Indian Patents Act. For years, a persistent ambiguity surrounding divisional applications has created hurdles for inventors. This ruling, by affirming a progressive and liberal approach, not only resolves that ambiguity but also reinforces India’s commitment to a more applicant-friendly patent regime.

Earlier restrictive approach

For many years, the interpretation of Section 16 of the Indian Patents Act has been a point of contention for practitioners and the Indian Patent Office (IPO). This provision governs the filing of divisional applications, which are filed to protect distinct inventions disclosed in a single parent application. The debate centered on a seemingly simple yet critical question: What is the legal basis for filing a divisional application? Must the “plurality of inventions” be present in the claims of the parent application, or is it sufficient for them to be merely disclosed in the complete specification? The IPO and some judicial interpretations held a restrictive view, insisting that a divisional application must be supported by a plurality of inventions already present in the claims of the parent application. This meant that if an applicant, for example, had claims for a single compound, they couldn’t later file a divisional application for a combination therapy, even if that combination was extensively described in the parent patent’s detailed specification. This approach was often seen as overly rigid, failing to account for the dynamic nature of scientific discovery and the strategic needs of innovators.

The present matter before Hon’ble Calcutta High Court

In this case, Pharmacyclics LLC, the Appellant, filed a patent application (No. 3985/KOLNP/2012) in India, which was subsequently amended to a product claim for the compound Ibrutinib for treating non-Hodgkin’s lymphoma. The company later filed a divisional application under Section 16 of the Indian Patents Act, for a different invention: a combination of Ibrutinib with an anti-CD20 antibody. This combination was disclosed in the parent application’s complete specification, but was not part of the parent’s claims.

The Deputy Controller of Patents rejected the divisional application. The rejection was based on the premise that a divisional application must be supported by the claims of the parent application, and not merely by the disclosure in its complete specification.

Significance of disclosures in specification to allow claim amendments

However, the Calcutta High Court unequivocally rejected this line of reasoning. Regarding the interpretation of Section 16, the Court explicitly adopted the rationale of the Delhi High Court’s landmark ruling in Syngenta Limited v. Controller of Patents & Designs. This precedent established that the plurality of inventions required for a divisional application to be valid must be disclosed in the provisional or complete specification, and not necessarily in the claims of the parent application. The Court thus overruled the earlier, more restrictive interpretation.

Further, on the maintainability of the divisional application, the Court found no issue with the maintainability of Pharmacyclics’ divisional application. It noted that there was no overlapping of claims between the parent application (for a compound) and the divisional application (for a combination of two active ingredients). The Court also found it significant that the First Examination Report (FER) had not initially raised any objections regarding the maintainability of the divisional status.

Lastly, regarding the legal sustainability of the order, the Court concluded that the Deputy Controller’s order was legally untenable because it was based on an interpretation of the law that higher courts had already overturned. The Court also observed that the Deputy Controller’s actions were inconsistent, having initially acknowledged in the First Examination Report (FER) that the parent application supported the claims.

Decision

The Court finally set aside the Deputy Controller’s rejection order and remanded the matter back to the IPO for a fresh consideration of the application. The Court ordered that a different Patent Controller hear the case and that a fresh, reasoned order be issued within six months.

Conclusion

The Pharmacyclics judgment is more than just a legal victory; it is a reaffirmation of the Indian judiciary’s role as a guardian of innovation. This ruling will undoubtedly shape future patent prosecution in India, making the system more robust, predictable, and supportive of technological advancement.

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