Boehringer Ingelheim International GMBH vs The Controller Of Patents & Anr. on 12 July, 2022
Delhi High Court
Facts / Background
The Applicant, Boehringer Ingelheim International GMBH, had filed a National Phase PCT Application on 14th November, 2008, for ‘Use of IV Inhibitors’. The patent specification had Claims numbered 1 – 18, with two claims numbered as 15, which were referred to as 15 and 15A.
The First Examination Report (“FER”) was issued on 24th March, 2014, in response to which the Applicant amended its Claims on 24th October, 2014 (“Amendment No.1”), and sought to delete all Claims except Claims 14, 15 & 15A.
In Amendment No.2 dated 20th March, 2015, the Applicant sought to expand from three Claims to 11 and in Amendment No.3 dated 18th February, 2016, the Applicant amended the Claims to 15, i.e., added four new Claims. On 5th July, 2017, a hearing notice was issued by the Patent Office, which raised the objections that amendments carried out in claims went beyond the scope of claims as on record before the amendments, and that Claims 1-3 lacked novelty and inventive step under section 2(1)(j) of Patents Act,1970.
Thereafter, the application remained pending.
On 5th July, 2017, a hearing notice was issued by the Patent Office and the following objections were raised:
“2. The examination report is based on the claims filed on 24/10/2014 as form-13 filed on 23/02/2015 and 19/02/2016 not allowed as amendments carried out in claims, via said forms, goes beyond the scope of claims as on record before the amendments. Claims 1-3 lack novelty and inventive step under section 2(1)(j) of Patents Act,1970. …”
The FER, referring to four prior art references (D1-D4), stated that “Each of the documents D1-D4 represents per se the closest prior art, since the use of specific DPP-IV inhibitors for the treatment of diabetes mellitus in various facets is disclosed and it appears that there is no technical advancement achieved with the compounds of the present application with respect to its closest prior art documents.
Claims 1-3 don’t contain any technical feature except DPP inhibitors which is already known from the above-cited documents D1-D4.
So inventive step cannot be acknowledged for the present set of claims 1-3.”
Pursuant to this hearing notice, the objections raised were contested by the Applicant. The hearing on the objections was held in August, 2017. The decision on the said parent application and the Amendments was rendered finally in January, 2018.
These two amendments were, thereafter, sought to be converted into a divisional application filed on 4th September, 2017. After issuance of FER and filing of response by the Applicant, and filing of response to the pre-grant opposition, this application was rejected by the impugned order dated 25th March, 2022. The Controller of Patents rejected the request of the Applicant for pursuing a divisional application bearing no. 20178031279, stating that the divisional application had similar claims, as had already been proffered in the refused amendment applications and the divisional application did not fall within the scope of the parent application.
Whether divisional applications can be filed for claims, when such claims are not part of the claims in the parent application.
Section 59(1)– No amendment of an application for a patent or a complete specification or any document relating thereto shall be made except by way of disclaimer, correction or explanation, and no amendment thereof shall be allowed, except for the purpose of incorporation of actual fact, and no amendment of a complete specification shall be allowed, the effect of which would be that the specification as amended would claim or describe matter not in substance disclosed or shown in the specification before the amendment, or that any claim of the specification as amended would not fall wholly within the scope of a claim of the specification before the amendment.
The Applicant submitted that its claims in the Amendments, which were sought in 2015 and 2016, i.e., Amendment Nos. 2&3, were disclosed in the original National Phase PCT application, and thus were within the scope of the parent application. The Applicant further submitted that Claims 1 to 25 were clearly based out of the original specification and thus, since the scope of the parent specification included the claimed products and formulations, and the same could be the subject matter of the divisional application.
The Applicant relied upon the judgement of the IPAB in Milliken & Company v. Union of India [OA/61/2012/PT/MUM, decided on 5th January, 2016] to argue that in the said case, the rejection of the second divisional application was set aside by applying Section 16 of the Act and holding that the applicant has a right to divide the inventions into separate divisional applications. It was submitted that the fact situation in the present case was similar, inasmuch as in Milliken (supra), in the first divisional application, Form 13 was filed seeking amendments and after the amendment was refused, a second divisional application was filed and was permitted.
On behalf of the Controller, it was submitted that the impugned order must not be interfered with, as 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. Once the Amendments were refused as being beyond the scope of claims, Section 16 of the Act could not be invoked by the Applicant for filing a divisional application for the same claims. The Respondent distinguished Milliken (supra) by submitting that in the said case, the Controller himself had raised an objection that there was a plurality of inventions and multiple independently worded claims in the parent application, which was not allowable, as they fall beyond the scope of the main claims. Hence, the division was allowed in a completely different fact situation.
The Court found that the patent Applicant was 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 (Para 17).
The Court held that that a divisional application in the present case could not be filed since there was no “plurality of inventions” in the parent application. It found that the Claims in the parent application only related to method or use claims, whereas the Claims in the divisional application concerned “products” i.e., medicaments or their combinations. The Court opined that, 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 could not be interpreted to have included a “plurality of inventions”, i.e., completely new product Claims, patentable by way of a divisional application (para 35).
Accordingly, the Court dismissed the appeal as devoid of merits, and ordered the Applicant to pay costs of Rs.50,000/- within four weeks. The costs were imposed considering the long-drawn proceedings emanating from one parent application and time consumed between 2008 to 2017, and the timing of the divisional application.
- From the above provisions, 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. This leads us to the question as to how to determine “plurality of inventions”. For this, guidance can be drawn from Section 10 of the Act which elaborates on the meaning of complete specification and scope of claims.
Importantly, Section 10 of the Act clearly requires the applicant to define the scope of the invention. It provides that every complete specification has to:
- Begin with a title indicating the subject matter of the invention;
- Fully and particularly describe the invention;
- Fully and particularly describe the operation or use of the invention;
- Fully and particularly describe the manner which the invention has to be to performed;
- Disclose the best method of performing the invention, which is known to the applicant and for which the applicant is entitled to claim protection;
- End with a claim or claims – the claims define the scope of the invention for which the protection is sought; and
- Have an abstract of the invention.
- A perusal of these conditions as stipulated under 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 as well in ESCO Corporation v. Controller of Patents & Designs [OA/66/2020/PT/DEL, decided on 27th October, 2020], where the IPAB observed:
“10. Therefore, looking at the provisions of law and the settled practices, we reach the following conclusions that a patent application can only be divided, if it claims more than ‘one invention’. Now the question therefore is how “one invention” is defined. We look at the provisions of “unity of invention” as provided in section 10(5) of the Patents Act, 1970. It says ‘The claim or claims of a complete specification shall relate to a single invention, or to a group of inventions linked so as to form a single inventive concept”. Means if any specification claims either a single invention or a group of invention linked so as to form a single inventive concept, the requirement of “unity of invention” is satisfied. Hence, if there is no objection on the ground of ‘plurality of distinct inventions’ means the claims of the complete specification, contains either a single invention or a group of inventions linked so as to form a single inventive concept and in such a scenario, no divisional application is allowable.”
- Using this understanding of how an invention is ascertained in a patent application, it is clear that under Section 16 of the Act, the “plurality of inventions” should clearly exist in the claims of the original parent application and within the scope of the specification of the parent application. Therefore, under Section 16, the question of whether the claims of the complete specification relate to more than invention i.e., a “plurality of inventions” has to be seen from the claims of the parent application. Obviously, the claims in turn, have to be based on the disclosure in the specification. However, if the invention is not contained in the claims of the parent application, the divisional application cannot be permitted to be filed solely on the basis of disclosure made in the specification, in respect of alleged inventions. If applicants are permitted to file such 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 claim is disclaimed’.1 Similarly, Section 59 also makes it clear that amendments beyond the scope of the specification and claims would not be permissible. This is the settled legal position, as also held by this Court in Nippon A&L Inc. v. The Controller of Patents [C.A. (COMM.IMPD-PAT) 11/2022, decided on 5th July, 2022]. Thus, the divisional application would be maintainable only when the claims of the parent application disclose “plurality of inventions”.
Citation: Boehringer Ingelheim International GMBH vs The Controller Of Patents & Anr., Decided by High Court of Delhi on 12 July, 2022 https://indiankanoon.org/doc/164938320/ (last visited on 23rd August, 2022)
This post is contributed by Ms. Ashwini Arun, Managing Associate.
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