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Divisional Patent Application And Test Of Enhanced Therapeutic Efficacy

  • What is significance of enhanced efficacy in relation to devisional Patent Application? Or
  • Put in another way, can Test of enhanced therapeutic efficacy be applied to evaluate patentability of Divisional Patent Application?

This issue has been addressed by Hon'ble High Court of Delhi in its Judgement dated 23.08.2022 passed in Appeal bearing No. CA (Comm.IPD-PAT) 12 of 2022 titled as Novartis AG Vs Controller of Patents and Designs.

Let us first of all understand as to what is the devisional application? When specification of Single Patent Application contains multiple inventions, then devisional Patent Application can be filed in relation to each single invention out of those multiple inventions disclosed in the Patent Patent Application. This is but natural that Divisional Patent Application can only be filed after filing of Parent Patent Application.

Section 16 of the Patent Act 1970 provides for filing of Divisional Patent Application.
The same is reproduced as under:
  1. A person who has made an application for a patent under this Act may, at any time before the grant of the patent, if he so desires, or with a view to remedy the objection raised by the Controller on the ground that the claims of the complete specification relate to more than one invention, file a further application in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first mentioned application.
     
  2. he further application under sub-section (1) 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.
     
From bare perusal of the afore mentioned provision, i.e. Section 16 of the Patent Act 1970 ,it is clear that for a Divisional Patent Application to succeed, following criterion has to be satisfied.

The First one is that it has to be in respect of an invention disclosed in the provisional or complete specification already filed in respect of the first mentioned application.

Another requirement for divisional Patent Application is that there should not be duplication of claims in the two specifications i.e., the parent specification and the divisional specification.

It means all the claims of the divisional application must be present in the original patent application.

Another requirement is that there should not be any repetition of claim in the provisional application, which were already present in the Parent Application.

Now coming on the facts of the case, this Appeal was filed against the order dated 28.09.2020 passed by Controller of Patent where by divisional application for Patent Application filed by the Appellant under No. 7863/DELNP/2014 was refused.

The finding of Controller for rejecting the divisional application was that subject matter of the said divisional application under No. 7863/DELNP/2014 was that it belongs to the same broad class and group as the subject matter of granted claims 1 to 3 of the parent application under No. 8114/DELNP/2007.

The objection of controller of Patent was that replacement of benzofuran of the parent compound by indazole moiety in claim 1 of the divisional application did not bring about any increase in therapeutic efficacy and showed same therapeutic behaviour.

The Hon'ble High Court of Delhi , however observed that the question of therapeutic efficacy under Section 3(d) of the Act would arise only if the application in question was a completely independent application and did not originate from a parent application.

The Hon'ble High Court of Delhi was pleased to set aside the finding of the controller of Patent and observed that since the divisional application traces its origin to the parent application, the test of therapeutic efficacy would not apply while judging as to whether the compound claimed in the divisional application is a valid claim in a divisional application or not.

Thus it is apparent that test of therapeutic efficacy can not be a criteria for evaluating a divisional Patent Application.

Case Law Discussed:
Novartis AG Vs Controller of Patents and Designs
Judgement Date:23.08.2022
Case No. CA (Comm.IPD-PAT) 12 of 2022
Hon'ble High Court of Delhi
Prathiba M Singh

Written By: Ajay Amitabh Suman, IPR Advocate, Hon'ble High Court of Delhi.
[email protected], 9990389539

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