A recent judgement in the matter of Boehringer Ingelheim International Gmbh V. The Controller Of Patents & Anr. dated 12th July 2022 (corrected & released on 20th July, 2022) by the single judge bench of Justice Prathiba M. Singh, in Delhi High Court, adjudicates the challenge raised by the Appellant by way of civil appeal against rejection of a divisional patent application by Controller of Patents under Section 15 of the Patents Act, 1970 (hereinafter “Act’). The verdict of the High Court is based on the maintainability of divisional applications as per Section 16 of the Act, particularly those ones where either similar claims as that in parent application are filed or divisional claims are not divided from parent claims.
The Appellant/Applicant, Boehringer Ingelheim International Gmbh, filed a divisional patent application bearing no. 201718031279 (hereinafter “divisional”) dated 4th September 2017 and sought patent protection for “A medicament of a DPP inhibitor”. The parent application bearing no. 9501/DELNP/2008 (hereinafter “parent”) is a National Phase PCT Application filed on 14th November, 2008, for ‘Use of DPP IV Inhibitors’. The parent had a total of 18 Claims, with two claims numbered as 15 (considered as claims 15 and 15A). The Respondent (Controller of Patents) issued a First Examination Report (FER) in the parent on 24th March, 2014 in response to which Claims were amended (hereinafter “Amendment No.1”). In the said Amendment No.1, the Appellant sought to delete all Claims except Claims 14, 15 & 15A. Thereafter, the parent claims were further amended through two Form 13s filed by the Applicant on 20th March, 2015 and 18th February, 2016 (hereinafter “Amendment No.2” and “Amendment No.3” respectively). In Amendment No.2, the Applicant expanded from three Claims to Claims 1 – 11 and in Amendment No.3, the Applicant amended the Claims to 1 to 15, i.e., added four new Claims. These two amendments were, thereafter, sought to be converted into the instant divisional application. The Respondent refused the parent application u/s 15 rejecting the Amendment No. 1 of the parent application on the merits and rejecting Amendment Nos. 2 and 3 u/s 57 & 59 of the Act for going beyond the scope of the originally filed claims asserting that these amendments does not wholly fall within the scope of original filed claims as the original claims were directed to use of DPP IV inhibitor whereas the amended claims were extending the protection to a medicament combination of a DIPP IV inhibitor i.e., “use claims” were amended to “product claims”.
With regard to the divisional, the Respondent issued an FER on 16th July, 2019 objecting to the validity of the divisional u/s 16(1) of the Act providing reason that claims of the divisional were already examined and refused in the parent, and therefore same claims cannot be allowed in another application. A reply to the FER was filed by Appellant explaining why the divisional application is valid and maintainable. Further, a pre-grant opposition dated 27th January, 2021, was also filed qua this divisional application. Following this, an opportunity of hearing was offered to the Appellant and a hearing notice was issued, wherein the Respondent maintained his stand regarding the validity of the divisional application u/s 16(1) of the Act. After hearing the pre-grant opponent and the Applicant, the Respondent refused the divisional application providing the reason that since the divisional Claims had been already examined and refused in the parent application, the same Claims cannot be allowed in another application.
Ground of Appeal
Pursuant to objections raised by the Respondent, the Appellant submitted that the claims in Amendment Nos. 2 & 3 were for various medicaments of DPP IV Inhibitors, which were disclosed in the original National Phase PCT application. Thus, they were within the scope of the parent and amended claims fell well within the ambit of Section 59(1) of the Act. The Appellant further submitted that Claims 1 to 25 of the divisional are clearly based out of the original specification and thus, since the scope of the parent specification includes the claimed products and formulations, the same can be the subject matter of the divisional application in terms of the Section 16 of the Act and thus cannot be held to be in contravention of Section 16(1) of the Act.
Objection of the Respondent
The raison d’etre for dismissing the divisional application was that the parent application was for use of DPP IV inhibitors and not for the inhibitor/medicament itself. The manner in which the Amendments were sought to be made for seeking exclusivity qua the inhibitor was contrary to Section 10(4) of the Act and, therefore, were not permissible as per the scheme of Section 57 and Section 59 of the Act. Once the Amendments were refused as being beyond the scope of claims, Section 16 of the Act cannot be invoked by the Appellant for filing a divisional application for the same claims.
In fact, the Appellant replicated amended claims of the parent application in the divisional application. The scope of protection of original filed parent 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 change in contents of amended claims does not wholly fall within the scope of original filed claims. Further, said amendments cannot be 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” entirely changing the scope.
Non–allowance of the already examined and refused claims under section 15 in parent application would not be a case for divisional application. Perhaps, the amended claims could have been allowed in the parent application itself if meeting all criteria. Therefore, failure to get patent on the parent application is not an eligible criteria for divisional application.
Analysis And Findings
Divisional application is maintainable only when the claims of the parent application disclose a “plurality of inventions”-
The High Court observed that a divisional application in the present case cannot be filed since there was no “plurality of inventions” in the parent application. 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 Court further observed that as the product Claims were not pursued in the original application even though 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, patentable by way of a divisional application.
The Court held that from Section 16 and Section 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”. 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.
The Court further held that an invention primarily is defined by the claims. While the 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’. If applicants are permitted to file divisional applications on the basis of disclosure in the complete specification, without such inventions being claimed in parent applications, it would defeat the fundamental rule of patent law i.e., ‘what is not claimed is disclaimed’. Therefore, “unity of invention” or “plurality of inventions” and whether they form a “single inventive concept” has to clearly exist and ought to be gleaned from a reading of the claims of the parent application.
The Court cited and relied on various authorities to arrive at the above conclusion. The rationes decidendi referred to this effect, inter alia, are Milliken & Company v. Union of India, ESCO Corporation v. Controller of Patents & Designs, Nippon A&L Inc. v. The Controller of Patents, and LG Electronics, Inc. v. Controller of Patents & Designs.
Under Section 16 of the Act, the question of whether there is “unity of invention” or whether the claims of the complete specification relate to “plurality of inventions” and whether there is a “single inventive concept” should be derived only from the claims of the parent application. Divisional applications shall be filed on the basis of inventions being claimed in parent applications and not just on the basis of disclosure in the complete specification. However, there cannot be duplication of the claims in the two specifications i.e., parent specification and the divisional application. Thus, the Court, in a way, reiterated the fundamental rule of patent law i.e., ‘what is not claimed is disclaimed’ and ruled that a divisional application would be maintainable only when the claims of the parent application disclose “plurality of inventions”.
In this article, Manisha Singh and Virender Singh, discuss the recent judgement passed by the Delhi High Court in the matter of Boehringer Ingelheim International Gmbh versus The Controller of Patents & another on the maintainability of divisional patent applications in India. The verdict of the High Court is based on the maintainability of divisional patent applications as per Section 16 of the Patents Act, 1970, particularly those where either similar claim as that in parent application are filed or divisional application claims are not divided from parent application claims.