Summary
The Calcutta High Court set aside the rejection of Pharmacyclics’ divisional patent application involving ibrutinib and anti-CD20 antibodies. The judgment clarifies key provisions of Indian patent law on divisional applications.
Introduction
Pharmacyclics’ divisional patent application for a cancer therapy involving ibrutinib and anti-CD20 antibodies has been upheld by the Calcutta High Court. The decision reverses a rejection by the Indian Patent Office and clarifies the legal framework surrounding divisional applications under Section 16 of the Patents Act, 1970.
Background
Pharmacyclics LLC (hereinafter “Pharmacyclics”) filed Indian Patent Application No. 201838043708, a divisional application under Section 16 of the Patents Act, 1970, arising out of parent application no. 3985/KOLNP/2012. The divisional claims were directed to a combination of ibrutinib with an anti-CD20 antibody such as rituximab or ofatumumab for treating hematological malignancies. Pharmacyclics argued that the combination demonstrated unexpected synergistic results, reducing infusion-related reactions associated with anti-CD20 therapy and showing improved efficacy.
The Deputy Controller of Patents and Designs (hereinafter “Controller”) rejected the divisional application and stated that the parent application was originally filed with method claims, later voluntarily amended to product claims, and that the divisional claims to combinations were not permissible. The application was rejected as not maintainable and as amounting to impermissible amendment under Sections 57–59 of the Patents Act. Aggrieved by this rejection, Pharmacyclics filed an appeal under Section 117A before the Calcutta High Court (hereinafter “Court”).
Issues
• Whether a divisional application under Section 16 was maintainable when the claims, though absent in the parent claims, were disclosed in the parent specification.
• Whether the Controller was correct in holding that the divisional claims went beyond the permissible scope of amendment under Sections 57–59 of the Patents Act, 1970.
• Whether the divisional application was required to be examined independently of the result of the parent application.
Court’s Analysis
Placing reliance on Syngenta Limited v. Controller of Patents & Designs reported in 2023: DHC: 7473-DB, Gensquare LLC v. The Assistant Controller of Patents and Design in CMA(PT) No. 35 of 2023, and Victaulic Company v. The Controller of Patents and Designs in CMA(PT) No. 14 of 2024, the Court opined that a divisional application was maintainable so long as a plurality of inventions was disclosed in the specification of the parent application, and was not necessary for the divisional claims to be derived from the claims of the parent.
The Court noted that in the First Examination Report of the divisional application, the Controller had observed that the divisional claims were supported by the parent specification, and no objection regarding maintainability had been raised at that stage. On the issue of amendment, the Court observed that no amendments had been made in the divisional application and that the claims were filed in their original form. Referring to Allergan Inc. v. The Controller of Patents reported in 2023/DHC/000515, the Court reiterated that amendments supported by the description were permissible.
The Court also considered the technical data submitted by Pharmacyclics which showed that the combination of ibrutinib with anti-CD20 antibodies reduced infusion-related reactions and provided enhanced efficacy. The Court held that under Section 16(3), a divisional application was to be treated as a substantive application to be examined independently, and that the Controller had erred in linking its outcome to the parent’s amended claims.
Conclusion
The Court found that the refusal order was not sustainable under law and accordingly set it aside. The matter was remanded to the Controller for fresh consideration by a different Controller, with a direction to conclude the process within six months. The appeal was allowed.
Citation: I.P.D.P.T.A. No. 4 of 2024
Link: https://indiankanoon.org/doc/50479366/
Article review and accessibility review by: Dr.Neetha Mohan
