The division of any patent application and its admissibility under Section 16 of the Patents Act, 1970, have seen many ups and downs in the patent practice and jurisprudence in India. For the Patent Office, voluntary division by the applicant has remained a matter of concern, and in many cases, patent applications have been denied in the past. For instance, when division of an application moved by the applicant of its own motion was denied by the patent office in Syngenta Limited vs Controller of Patents & Designs reported in 2023: DHC: 7473-DB, Hon’ble Division Bench of the Delhi High Court held that Section 16 does not suggest or conceive of a distinction between the contingency of a Divisional Application when moved by the applicant of its own motion or where it comes to be made to remedy an objection raised by the Controller. In either of those situations, the plurality of inventions would have to be tested based upon the disclosures made in either the provisional or complete specification.
In Gensquare LLC vs The Assistant Controller of Patents and Design (CMA(PT) No. 35 of 2023 dated March 13, 2024), where division of patent application was denied by the patent office, the Madras High Court held that Section 16 of the Patents Act only requires that the divisional application must flow from the specification in the parent application, and does not say that the claims made in the divisional application must flow from the claims made in the parent application.
In Victaulic Company vs The Controller of Patents and Designs (CMA(PT) No. 14 of 2024 dated July 26, 2024), where the divisional application was refused by the Controller, the Madras High Court held that the Patents Act only requires that the divisional application ought to flow from the specifications in the parent application. It does not say that the claims made in the divisional application flow from the claims made in the parent application. With this kind of precedence in place when appeal against the refusal order of divisional patent on Combination drug was filed in Calcutta High Court, in Pharmacyclics LLC vs Deputy Controller of Patents & Designs (I.P.D.P.T.A. No. 4 of 2024 order dated September 2, 2025), the Court relied on the above-mentioned precedence to set aside the refusal order of the Controller and directed reconsideration of this matter by another officer.
Factual Matrix of the Case
The Deputy Controller of Patents and Designs, by order dated March 5, 2024, refused the grant of a patent to divisional Patent Application 201838043708 filed by Pharmacyclics LLC based on the parent Application 3985/KOLNP/2012. The claims of the patent application were directed to “A compound (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d] pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one for use in treating relapsed or refractory non-Hodgkin’s lymphoma”. Thereafter, Pharmacyclics LLC filed an appeal against the said order of the Deputy Controller.
Case of the Appellant
The appellant submitted that they filed a divisional application to claim an invention directed to a combination of a compound of formula I, an anti-CD20 antibody selected from rituximab and of atumumab disclosed in the parent patent specification. They submitted that the subject matter of the divisional application under Section 16 is in relation to a combination of two active ingredients, namely: (a) Ibrutinib and (b) rituximab/ ofatumumab, which were disclosed in the parent complete specification. The appellant further contended that the unexpected technical advantage of the combination of the two active ingredients (synergic effect) was supported by the data filed along with the response to the first examination report. This, according to the appellant, demonstrates that the combination of Ibrutinib with anti-CD20 antibodies provided excellent efficacy. The appellant contended that said combination demonstrates unexpected results, which support the inventiveness of the claims.
Respondent’s Reason for Refusal
The respondent in the refusal order dated March 5, 2024, stated the divisional patent was refused on the following grounds:
- “the parent application was filed with 133 claims and it was directed at a method for treating a hematological malignancy in an individual. The said method was comprising of
- administering to the individual an amount of an irreversible Btk inhibitor sufficient to mobilize a plurality of cells from the malignancy; and
- analyzing the mobilized plurality of cells.
- The appellant Applicant amended the claims of the parent application into product claims (33) on 24th December 2012,
- At the time of filing the divisional application, the applicant changed the scope of the originally filed claims and amended the claims into combination claims.
- The reason provided for the amendment filed on 24th December 2012 was given to be a voluntary amendment and clearly stated to be restricted in nature.
- The appellant ought to have provided reasons for making the said amendment.”
Submissions of the Appellant
The appellant submitted that in the First Examination Report (FER), no objection with regard to either the maintainability of the divisional application or the amendment of the claims was raised. In fact, the respondent observed that the FER that the claims of the divisional application are adequately supported by claim 33 of the mother (parent) application, which effectively means that the claims were supported by the mother application. The appellant submitted that the request for amendment was filed in the parent application, which is not a divisional application that was pending adjudication before the respondent. In the divisional application, the appellant pursued claims directed to a combination of two active ingredients, namely: (a) Ibrutinib and (b) rituximab/ofatumumab, which now forms the subject matter of the divisional application.
Court’s Analysis and Decision
The Court observed that Section 16 of the Act provides that a further divisional application shall be accompanied by a complete specification, but such complete specification shall not include any matter not in substance disclosed in the complete specification filed in pursuance of the first-mentioned application. According to Section 16(3), the complete specification of the divisional application should not include a claim for any matter claimed in other application. The Court found that in the present case, the parent application is directed to a method for treatment which was later amended to compound (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one for use in treating relapsed or refractory non-Hodgkin’s lymphoma.
The Court concluded that the divisional application filed during the pendency of the parent application was disclosed in the complete/provisional specification and relates to a plurality of inventions. The parent application is for “Compound”, whereas the claims for the divisional application are for “a combination of two active ingredients”. The Court ruled that the requirement of Section 16(3) of the Patents Act, 1970, is met if the divisional application claims are based on the disclosure in the complete specification and there is no overlapping of the claims of the parent and divisional application.
The Court also observed that there is no requirement that the claims of the divisional application should be based on the original PCT claims filed with the parent application. The Court ruled that the subject matter of the divisional application is not limited to what was claimed in the parent application, as long as the divisional claims are supported by the entire specification as originally filed. Agreeing with the appellant, the Court held that the application was filed in relation to a combination, specifically, based on the Patent Amendment Rules, 2004 and in the present divisional application, no voluntary amendment was filed as alleged by the respondent.
Court’s Decision
Placing reliance on the rulings relating to the allowability of divisional application in Syngenta, Gensquare, Victaulic Company and Allergan Inc. (on allowability of amendments), the Court set aside the refusal order dated March 5, 2024. It directed that the matter shall be reconsidered afresh by another officer, by giving an opportunity of hearing to the applicant.
Takeaways
When the amendments in the parent application were not objected to by the patent office, the divisional application filed thereafter based on such amendments cannot be denied. In this case, when the respondent rejected the divisional application of the appellant by placing reliance on the claims of the parent application, the Court rightly observed that there is no requirement that the claims of the divisional application should be based on the original PCT claims filed with the parent application. The Court ruled that the subject matter of the divisional application is not limited to what was claimed in the parent application, as long as the divisional claims are supported by the entire specification as originally filed.
The Court also observed that once the respondent has recognised the maintainability of the divisional application in the First Examination Report, the respondent should have proceeded with this divisional application as a substantive application under Section 16(3), wherein the outcome of the parent will have no bearing on the examination of the divisional application. This clarification by the Court will go a long way to avoid such a refusal of a divisional application in future. The Court further ruled that the subject matter of the divisional application is not limited to what was claimed in the parent application, as long as the divisional claims are supported by the entire specification as originally filed.
Author: DPS Parmar
First Published by: Mondaq here