An appeal arising out of the order dated 25^th March, 2022 by which the Controller of Patents had rejected the request of the Appellant/Applicant for pursuing a divisional application bearing no.20178031279 has been rejected by the Hon’ble Delhi High Court.

The Applicant had filed a National Phase PCT Application on 14th November, 2008, for ‘Use of DPP IV Inhibitors’. The patent specification had a total of 1 to 18 Claims, with two claims numbered as 15 (one is referred to as 15 and the other 15A).  The First Examination Report was issued on 24th March, 2014, in response to which the Applicant amended its Claims on 24th October, 2014 (Amendment No.1). In the said Amendment No.1, the Applicant sought to delete all Claims except Claims 14, 15 & 15A.  Thereafter, the application remained pending. On 20^th  March, 2015 and 18^th February, 2016, two Forms-13 were filed by the Applicant seeking two further amendments (“Amendment No.2” and “Amendment No.3”). These two amendments were, thereafter, sought to be converted into a divisional application filed on 4^th September, 2017.

The Parent application amendemdnts were refused as the controller considered that the scope of protection of original filed claims, i.e. use of DPP IV inhibitor of formula I or formula II alone or in combination with other active substances, cannot be extended to the protection of a medicament combination of a DIPP IV inhibitor with metformin/telmisartan as such such change in contents of amended claims does not wholly fall within the scope of original filed claims. Further said amendments were not considered to be done by way of disclaimer, correction, clarification or explanation as there is clear change in category of claims wherein “use claims” were amended to “product claims”. Thus, the Controller applied Section 59 of the Patents Act, 1970 and held that the said amended claims are beyond the scope of originally filed Claims and rejected the parent application.

The Controller, while rejecting the divisional application had stated that the divisional application had similar claims, as had already been preffered in the refused amendment applications in the parent and the divisional application does not fall within the scope of the parent application.

The Delhi High Court noted the following about the divisional and the parent case:-

• The present appeal is a case where the patent Applicant is seeking to file a divisional application to claim a monopoly in respect of DPP IV Inhibitors, which were originally not claimed in the parent application at all. A perusal of the Claims in the parent application shows that all Claims including Claim 1 which is the main claim, relate to ‘Uses of DPP IV inhibitors of formula 1 or formula 2.
• Amendment No.1 filed in response to the FER dated 24^th March, 2014, reduced the Claims to the following: “Isolation or storage medium for islets of Langerhans or beta cells, characterised in that the medium contains 1nmol/1 to 1 μmol/1 of a DPP iv inhibitor for enhancing the vitality and secretion capacity of the cells.“
• Two more Amendments were carried out after this. Claim No.1 of Amendment No.2 reads as under: “A medicament combination of a DPP IV inhibitor which is 1- [( 4-Methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-l-yl)-8-(3- (R)aminopiperidin-l-yl)-xanthine, or one of the therapeutically active salts thereof, in a dosage of 2.5 mg to 10 mg for oral administration, with metformin..
• Claim No.12 of Amendment No.3 reads as under: “A medicament combination of a DPP IV inhibitor which is 1 -[(4-Methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-I-yl)-8-(3- (R)amninopiperidin-1-yl)-xanthine, or one of the therapeutically active salts 1hereof, with telmisartan.”
• Thus, Amendment Nos. 2 and 3 were for different combinations of DPP-IV inhibitors with Metformin and Telmisartan respectively in medicament i.e., product form.
• The divisional application consisted of 25 claims. Claims 1-11, 14-18, 20-25 are all product claims for medicaments which are DPP IV Inhibitors in various combinations, modes of administration, dosage forms, etc. Claims 12, 13 and 19 were method claims for some combinations and dosage forms.

The Court while dismissing the appeal held the follwoing:-

1. From Section 16 and 10, it is clear that a divisional application under Section 16 of the Act, has to be an application which arises from a parent application disclosing a “plurality of inventions”.
2. In Section 16(1), the phrase “the claims of the complete specification relate to more than one invention” makes this position clear. Section 16(3) also makes it clear that there cannot be duplication of the claims in the two specifications i.e., parent specification and the divisional application.
3. In order to determine “plurality of inventions”, guidance can be drawn from Section 10 of the Act which elaborates on the meaning of complete specification and scope of claims.
4. A perusal of Section 10 shows that the title indicates the subject matter of the invention. The content of the specification describes the invention. The complete specification also describes the procedures, processes, methods, including the best methods. But what is crucial to note, is the fact that the invention itself is defined in the claims. While such claims do have to be based on the disclosure in the specification, however even if a person does not read the complete specification and wishes to identify the invention, the place to look for it is in the ‘Claims’. The Invention thus resides in the Claims. Accordingly, “unity of the invention”/ “plurality of inventions” and whether they form a “single inventive concept” has to be gleaned from a reading of the claims. This position has been examined and held so by the IPAB

In view of the above, the Court held that a divisional application in the present case cannot be filed since there was no “plurality of inventions” in the parent application. In the present case, the original ‘DPP IV inhibitor’ arising out of a Markush formula, in various permutations and combinations describing its use and method for treatment, which is only mentioned in the examples in the specification, cannot be permitted to be claimed as separate product Claims in a divisional application, as there were no product Claims in the parent application.

The Claims in the parent application only related to method or use claims whereas, the Claims in the divisional application concern “products” i.e., medicaments or their combinations. Once the product Claims were not sought in the original application and the said products were clearly disclosed in the content of the complete specification, the products ought to be treated as having been disclaimed. Thus, the parent application cannot be interpreted to have included a “plurality of inventions”, i.e., completely new product Claims, cannot be patentable by way of a divisional application.

The Court not only rejected the appeal but rejected the same with a cost on the applicant of Rs.50,000/-  for such long drawn process and number of amendments.