An appeal challenging the order of the Controller of Patents vide which the divisional application of the Novartis AG, the Appellant, being 7863/DELNP/2014 was rejected has been allowed by the Delhi High Court (DHC) and the order of the Controller set aside.

The divisional application was refused by the Controller as being not maintainable on the ground that the subject matter of the granted claims of the parent application being 8114/DELNP/2007 and the subject matter of the divisional application belong to the same broad class and group of inventions linked to form a single inventive concept.

The parent application included claims directed to a Markush formula defining LFA-1 antagonist.  The Controller during examination of the parent considered that the Markush Formula defining the LFA-1 antagonist showed plurality of inventions and the number of substituents of the formula showed variations that do not fall in a single inventive concept.  The parent application was redirected towards three specific compounds and their composition. The applicant then proceeded with the composition of a fourth compound in the divisional.

The Hon’ble Delhi High Court held that there are twin conditions under Section 16 of the Act for filing of divisional application:

• The divisional application has to be in respect of an invention disclosed 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 specification and the divisional specification.

In the present case, the Court held that it is not in dispute that the compound being claimed in the divisional application is within the scope of the parent application. This is clear from a reading of the description and claim 54 in the parent application as originally filed.

Further, on review of the comparison of the granted claims of parent and the claims of the divisional, the Court noted that the Markush claim has clearly not been retained in the parent application which is now granted only qua three compounds in Claims 1 to 3 and their pharmaceutical compositions. Under such circumstances, the Court noted that it cannot be held that the compound or composition claimed in the divisional application is covered by the granted claims of the parent application. Therefore, there is no duplication of claim in the parent and the divisional.

The Court further noted that in the objections taken in the hearing notice issued in respect of the divisional application, the Patent Office raised an objection that the 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 Court held that question of therapeutic efficacy under Section 3(d) of the Act would arise only if the application in question a completely independent application is and did not originate from a parent application. 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.

Under these circumstances, the Court held that the divisional application in question is a valid divisional application and deserves to be examined in accordance with law. Accordingly, the impugned order was set aside. The matter has now been remanded back to the Patent Office for considering the divisional application on its own merits in respect of other objections.