High Court:Therapeutic efficacy not a requirement for Divisional Applications(Novartis v.Controller)
In a recent judgment passed by the Delhi High Court in the case of NOVARTIS AG v. CONTROLLER OF PATENTS AND DESIGNS [C.A.(COMM.IPD-PAT) 12/2022], the Court considered the maintainability of an elective divisional application i.e. a divisional application filed based on an objection on “plurality of inventions” raised by the Indian Patent Office in the parent application. Even though the divisional application was filed only in view of an objection raised by the Patent Office, the divisional application was eventually refused by the Patent Office on the ground that the subject matter of the granted claims of the parent application and that of the divisional application formed a single inventive concept.
Aggrieved by the decision of the Indian Patent Office, the patent applicant preferred an appeal before the Delhi High Court submitting that the divisional application was filed in pursuance to the plurality objection raised by the Indian Office and with the refusal of the divisional application, the Appellant was being made to suffer on both counts.
Brief facts of the case:
On 19th October, 2007, Indian Application 8114/DELNP/2007 was filed in respect of various pharmaceutical preparations for compositions and methods for treatment of eye disorders. During examination, the Controller amongst other objections raised a ‘lack of unity’ objection confirming that the permutations and combination of the rings of the Markush formula were multiple in number and so broad that the actual scope of invention was difficult to ascertain. An amended set of claims was thereafter filed in reply restricting the claims to only three specific compounds which were finally granted by the Patent office on July 27, 2017.
In between, On September 19, 2014, the appellant filed a divisional application, the application at issue in this appeal, claiming a broad range of compounds including the Markush structure of the parent application. . The divisional application, however, was rejected by the Patent Office in September 2020, on the grounds that the subject matter of the divisional application and the parent application belong to the same broad class and the pharmaceutical compositions comprising LFA-1 antagonist of the Markush compounds claimed in the divisional application had already been granted in the parent application thereby forming a single inventive concept.
Court’s analysis:
The first question taken up by the Hon’ble Court was whether the claims in the divisional application fulfilled the requirements outlined in Section 16 of the Patent Act.
The Court relied upon the recent judgment in Boehringer Ingelheim International GMBH v. The Controller of Patents & Anr. [C.A. (COMM.IPD-PAT) 295/2022, judgment dated 12th July 2022] and pointed out that there are twin conditions under Section 16 of the Patent Act, 1970 for filing of divisional application:
● The divisional application has to be in respect of an invention disclosed and claimed in the provisional or complete specification already filed in respect of the first mentioned application.
● There cannot be duplication of claims in the two specifications, i.e., the parent and divisional specifications.
Accordingly, as per S. 16 the claims of the divisional application cannot be outside the scope of the claims of the parent specification and at the same time, there cannot be any duplication of claims.
The Court opined that it is not in dispute that the main core structure in the parent and in the divisional is the same. However, the main core structure did not form part of the final granted claims of the parent which is now granted only qua three compounds and their pharmaceutical compositions. The Court, therefore, affirmed that under such circumstances, it cannot be held that the compound or composition claimed in the divisional application is covered by the granted claims of the parent application, and therefore there is no reason to refuse the divisional application on the ground that it is not a valid divisional application.
The Court also analysed the objections in the hearing notice issued in respect of the divisional application where the Patent Office raised an objection related to Section 3 (d) of the Patent Act indicating that the claimed moiety of the divisional application did not bring about any increase in therapeutic efficacy as laid down by Section 3(d) of the Patent Act, 1970.
The Hon’ble Court held that the question of therapeutic efficacy under Section 3(d) of the Act would only arise only if the application in question was completely independent and did not originate from a parent application. Such an objection cannot be raised in the divisional application vis-à-vis the compounds disclosed/claimed in the parent application since the divisional application originates from the parent application and does not constitute prior art.
The Court finally accepted the validity of the divisional application and remanded the matter back to the Patent office to consider the divisional application on its merits.
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