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Date of Decision: 2nd December, 2024 C.A.(COMM.IPD-PAT) 225/2022
BOEHRINGER INGELHEIM VETMEDICA GMBH .....Appellant
Through: Mr. Ankush Verma, Mr. Debashish Banerjee, Ms. Vaishali Joshi, Mr. Pankaj Soni, Mr. Vineet Rohilla, Mr. Rohit Rangi and Mr. Tanveer Malhotra, Advs.
Through: Mr. Siddhartha Shankar Ray, CGSC
JUDGMENT
1. The present appeal has been filed under Section 117A of the Patents Act, 1970 (hereinafter the ‘Patents Act’) and is directed against impugned order dated 29th March, 2022 passed by the Assistant Controller of Patents & Designs (hereinafter the ‘Controller’), whereby the Indian Patent Application No. 3157/DELNP/2012 titled “Containers for Compositions Comprising Meloxicam” (hereinafter the ‘subject patent application’) has been refused under Section 15 of the Patents Act.
BRIEF FACTS
2. Brief facts necessary for deciding the present appeal are set out below:
2.1. The appellant, Boehringer Ingelheim Vetmedica GMBH, had filed the subject patent application relating to containers for storage, dispensing and preservation of compositions containing meloxicam on 12th April, 2012 at the Patent Office, New Delhi.
2.2. A request for examination was filed on 12th August, 2013 by the appellant under Section 11B of the Patents Act.
2.3. Subsequently, the subject patent application was examined by the Controller and a First Examination Report (hereinafter, ‘FER’) was issued on 14th January, 2019. The FER essentially contained objections, inter alia, that the claims of the subject patent application were not patentable in terms of Section 2(1)(j) and Section 2(1)(ja) of the Patents Act.
2.4. A detailed response was filed on behalf of the appellant to the aforesaid FER on 17th May, 2019 along with a set of amended claims addressing the objections raised in the FER.
2.5. On 28th October, 2021, a hearing notice was issued by the Controller fixing the date of hearing for 24th November, 2021, wherein once again, objections were taken with regard to lack of novelty and lack of inventive steps in view of the cited prior art documents.
2.6. At the oral hearing, the appellant made submissions denying the Controller’s objections with regard to novelty and inventive steps, especially in light of the cited prior art documents.
2.7. In terms of Rule 28 (7) of the Patent Rules, 2003, the appellant had filed written submission along with further set of amended claims, in respect of the objections raised in the hearing notice on 9th December, 2021.
2.8. In compliance with the requirements under Section 8(1) of the Patents Act, the appellant filed the latest Form 3 update before the Patent Office on 23rd March, 2022.
3. On 29th March, 2022, the impugned order was passed by the Controller rejecting the subject patent application filed by the appellant on the grounds of lack of novelty under Section 2(1)(j) as well as lack of inventive steps under Section 2(1)(ja) of the Patents Act, in view of the cited prior art references, WO2008152122A[2] (D[1]) and WO2009049304A[1] (D[2]). The relevant extracts from the impugned order are set out below:
preservative salts in plastics. Further applicant requests that the volume of containers mentioned in D[2] are smaller, however changing the volume size again does not constitutes to inventive step. The applicant fails to demonstrate as to what are the specific components in the claimed invention that corresponds to the inventiveness of the idea over the cited prior art. Hence the applicant’s arguments are not persuasive as all the features are disclosed in document D1-D[2] as explained above or are the common general knowledge in field and a skilled person in the art can arrive to the subject matter. Thus the subject matter of claims is not inventive as anticipated by document D1-D[2].”
SUBMISSIONS BY THE PARTIES
4. Counsel appearing on behalf of the appellant submits that the aforesaid extracts from the impugned order are in substance, a reproduction of the objections raised in the hearing notice issued to the appellant. It is further submitted that detailed written submissions were made on behalf of the appellant in response to the FER as well as the hearing notice, wherein the subject invention has been distinguished from the prior arts cited by the Controller. However, the Controller has passed the impugned order without dealing with the submissions made on behalf of the appellant. Reliance in this regard is placed on the judgments passed by this Court, Agriboard International LLC v. Deputy Controller of Patents and Designs, 2022 SCC OnLine Del 940 and F.Hoffmann-La Roche Ltd. & Anr v. Cipla Ltd., 2015 SCC OnLine Del 13619.
5. Per contra, counsel appearing on behalf of the respondent submits that the appellant has failed to provide any justification or grounds for distinguishing the subject invention from the prevailing prior arts.
ANALYSIS AND FINDINGS
6. I have heard the learned counsel for the parties and examined the records of the case.
7. At this stage, reference may be made to the judgment of a Coordinate Bench of this Court in Agriboard International (supra). The relevant observations are set out below:
The judgment in Agriboard International (supra) has been consistently followed in several other cases. [reference may be made to C.A.(COMM- IPD-PAT) 8/2022 titled Auckland Uniservices Limited v. Assistant Controller of Patents and Designs, N.V. Satheesh Madhav and Anr. v. Deputy Controller of Patents and Designs, 2022 SCC OnLine Del 4568]
8. In the present case, the appellant had filed detailed written submissions post hearing on 9th December, 2021, wherein the appellant had sought to distinguish the prior arts D[1] and D[2] from the subject inventions. The relevant extracts from the said written submissions distinguishing subject patent application from the D[1] and D[2] individually and in combination which are not addressed in the impugned order are reproduced below: Differentiation from D[1]: “Document D[1] discloses multi-layered plastic polymeric containers that are useful for the storage of sterile or non-sterile pharmaceutical compositions, such containers comprising at least three polymeric layers, a gas barrier layer and an adhesive layer. The complex containers of D[1] are therefore very different from the simple containers of the present invention consisting of polypropylene or PET homopolymers and/or copolymers.” Differentiation from D[2]: “D[2] does not teach or suggest the solution of the present invention, which is selection of a specific container wall material for increasing the shelf life. In contrast, the solution of D[2] for the stability problem is a special arrangement of container compartments. In this regard, D[2] suggests a container with a storing cavity and a dispensing end in defined size ratios (Fig. 1, claim 1, working examples) D[2] does not suggest that specific plastic container materials could affect absorption of certain substances. Even further, it is not disclosed that PP or PET could be advantageous in this regard, let alone for preventing absorption of sodium benzoate. In section [0047] of D[2], it is only noted in general that the container material should not “react” with the formulation. Overall, D[2] is not only silent about the solution of the present invention, but clearly teaches away from it. It is emphasised again that the relevant question is not whether the skilled person could have taken into account D[2], and thus a PP or PET container material disclosed therein. Instead, the relevant question is whether he would have done so, i.e. whether he had an incentive to do so. Obviously, D[2] does not provide an incentive to solve the problem of enhanced shelf-life by using a PP or PET container material instead of PE or glass as disclosed.” Differentiation from combined teaching of D[1] and D[2]: “Furthermore, there is also absolutely no disclosure of the advantageous effect according to the present invention: here, a plastic container is used in a predefined volume range, which allows a stable storage of the sodium benzoate containing meloxicam suspension in a predefined volume range by avoiding the mandatory presence of stabilising additives and by avoiding a significant loss of sodium benzoate during such storage.” [emphasis supplied]
9. Despite the above submissions seeking to distinguish the prior arts from the subject invention, the impugned order has been passed without going into the explanation/justification offered on behalf of the appellant with regard to the prior arts. The impugned order, in a blanket manner, concludes that the arguments made by the appellant in written submissions or on the date of oral hearing are “not fully persuasive” without giving any justification for the same.
10. As noted above, the impugned order has substantially reproduced the contents of the hearing notice. In the judgment passed in Huhtamaki OYJ and Anr. v. Controller of Patents, 2023 SCC OnLine Del 3272, this Court had expressed concerns about the tendency in the Office of Controller of Patents and Designs to reject patent applications by relying on the objections issued to the applicant without considering the submissions of the applicant filed in response thereto.
11. In light of the foregoing analysis, the impugned order dated 29th March, 2022 rejecting the subject patent application of the appellant is set aside and the matter is remanded back to the Patent Office for fresh consideration. The fresh consideration would take into account the material already on record and more particularly, the submissions filed on behalf of the appellant with regard to the cited prior arts.
12. The Patent Office shall endeavour to pass a reasoned order taking into account all the relevant considerations within two months. List before the Controller of Patents on 16th January, 2025.
13. The Registry is directed to supply a copy of the present order to the Office of the Controller General of Patents, Designs & Trademarks of India on the e-mail ID- llc-ipo@gov.in for compliance.
14. The appeal stands disposed of in terms of the above. AMIT BANSAL, J DECEMBER 2, 2024