Oxular Limited v. The Assistant Controller of Patents and Designs

1. The present appeal has been filed under Section 117-A (2) of the Patents Act, 1970 [‘the Act’] against the impugned order dated 09.01.2024 passed by the Assistant Controller of Patents and Designs, whereby the patent application bearing number 201817034819, and titled “OPTHALMIC DELIVERY DEVICE AND OPTHALMIC DRUG COMPOSITIONS” [‘subject application’] has been refused.

2. Brief facts leading to filing of the present appeal are that the appellant/applicant filed the subject application at the Patent Office, New Delhi on 14.09.2018 through its authorised Patent Agent.

3. The request for examination was filed at the Patent Office on 13.03.2020, which was within the 48 months’ period from the date of priority. The Patent Office issued First Examination Report [‘FER’] on 27.08.2020 The relevant objections raised in the said FER are as under: a) The claims 1-31 are not novel under Section 2(1)(j) of the Act in view of the following documents: i) D[1]: WO 2013/028936 A[1] ii) D[2]: US2011/238075 A[1] iii) D[3]: WO2016/042162 A[1] iv) D[4]: WO2016/042163 A[2] b) The subject matter of claims 1-31 does not constitute an invention under Section 2(1)(ja) of the Act for lack of inventive step in view of the afore-cited documents D[1] to D[4]: c) The subject matter of the invention claimed in claims 1-31 falls within scope of Section 3 (d) of the Act, and is, hence, not patentable. d) The subject matter of claims 1-31 does not fulfil requirement under Section 10 (5) of the Act.

4. The applicant/appellant through its authorized agent on 18.02.2021, duly filed its reply to said FER along with the amended claims 1-26.

5. A hearing notice was issued by the Patent Office on 02.08.2023. However, after several adjournments, the hearing happened on 31.10.2023 based on re-issued hearing notice dated 18.09.2023. The relevant objections outstanding in the hearing notice were as follows: i) The two independent apparatus claims (claims 1 and 2) lack conciseness; ii) Subject matter of the amended claims 1-26 does not constitute an invention under Section 2(1)(j) of the Act for lack of novelty in view of the following prior arts: a) Dl: WO 2013/028936 Al b) D[2]: US 2011/238075 Al c) D[3]: WO 2016/042162 Al d) D[4]: WO 2016/042163 Al e) D[5]: WO 2009/089409A[2] f) D[6]: WO 2012/051575 A[2] iii)Subject matter of amended claims 1-26 does not constitute an inventive step under Section 2(1)(ja) of the Act for being obvious in view of the afore-cited prior arts D[1] to D[6].

6. After hearing, the appellant filed its written submissions on 15.12.2023 along with amended claims 1-26.

7. Thereafter, impugned order was passed by the Assistant Controller refusing the subject application under Section 15 citing lack of inventive step as prescribed under Section 2(1)(ja) of the Act. The relevant extracts from the impugned order are set out below: - “Thus, a person having knowledge of D[1] is aware of use of flexible cannula deployed from a needle that penetrates the sclera to deploy the cannula to the suprachoroidal space or supraciliary space of human eye without any concern. Similarly, D1-D[4] and D[6] also teaches about the delivery of active agent containing composition into the suprachoroidal space or supraciliary space of human eye. Thus, a person skilled in the art has sufficient motivation of using supraciliary space of human eye over the flexible or non-flexible cannula as disclosed in D[1] in combination of teaching of D1-D[4] and D[6]. Further, it may be noted that selection of liquid, or semisolid composition, round shape of cannula etc is routine selection for a person skilled in art and does not involve any inventive skill. Hence, argument submitted by the applicant regarding the use of supraciliary space of human eye is not found to involve any inventive skill. Hence, claims 1-26, do not meet the requirement of section 2(1)(ja) of the Patents Act, 1970. [Emphasis Supplied]

8. Ms. Vindhya S. Mani, learned counsel appearing on behalf of the appellant, submits that the Respondent had failed to appreciate the written submissions dated 15.12.2023 filed by the appellant in response to the hearing notice by the Respondent.

8.1. She states that the Respondent has not considered the distinguishing feature of the subject application, i.e., the self-actuated deployment mechanism of the device in comparison with prior arts D[1] to D[6]. She further states that the Controller has failed to demonstrate that how it is obvious for a person skilled in the art to reach subject invention, i.e., self-actuating deployment mechanism regardless of the thickness of the overlying sclera or the orientation and speed of the needle insertion; whether examined independently or in combination. She also argued that the Respondent has also not applied five steps test to examine inventive step laid down in the case of F. Hoffmann- La Roche Ltd & Anr. vs. Cipla Ltd. ((2016) 65 PTC 1 (DB)) or as prescribed under Agriboard International LLC v. Deputy Controller of Patents & Designs (2022 SCC OnLine Del 4786).

9. She states that the contents of the impugned order [at pages 126-127 of the paper-book] is a reproduction of Claim 1 of the EP claims dated 01.02.2021 and Figure 2 referred to in the impugned order is also from the corresponding EP application. She states that however the Controller failed to take into consideration that Petitioner has already been granted Patent by the European Patent office. She states that the impugned order appears to have been collated to a process of copying and pasting significant portions from various sources and bereft of any substantive reasoning.

10. In response, learned counsel for the Respondent states that the impugned order records reasons which led the Respondent to hold that the subject matter of the patent application lacks inventive step as per Section 2(1) (ja) of the Act. Further, he relied upon the written submissions filed in the present appeal.

11. This Court has heard the counsel for the parties.

12. A perusal of the impugned order would show that the subject application has been refused on the ground of lack of inventive step as per Section 2(1)(ja) of the Act.

13. It is clear from the impugned order that the Respondent has gone on to discuss prior arts and decided on the obviousness of the subject invention based on them. However, in the impugned order Respondent has failed to consider the detailed arguments dated 05.12.2023 submitted by the appellant in response to the hearing notice issued by the Respondent. Moreover, the Respondent has failed to satisfy the Court that they have applied tests approved in F. Hoffmann- La Roche Ltd & Anr. vs. Cipla Ltd. (Supra) or in Agriboard International LLC v. Deputy Controller of Patents & Designs (supra). For clarity, the said tests are reproduced hereinbelow: 13.[1] The test prescribed in F. Hoffmann- La Roche Ltd & Anr. vs. Cipla Ltd. (Supra) is: