IN THE HIGH COURT OF DELHI AT NEW DELHI
Tejas Karia, J
Steigerwald Arzneimittelwerk Gmbh – Appellant
Versus
Assistant Controller Of Patents And Designs – Respondent
C.A.(COMM.IPD-PAT) 423/2022
| Table of Content |
|---|
| 1. factual background of the patent application and the history of the patent controller's rejection. (Para 1 , 2 , 3 , 4 , 5 , 6 , 7) |
| 2. parties' contentions regarding the novelty and inventive step of the process method. (Para 8 , 9) |
| 3. court's analysis of the technical methodology vs. existing prior art. (Para 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31) |
| 4. requirement for reasoned analysis of obviousness and the 'could-would' test for inventive step. (Para 32 , 33 , 34 , 35 , 36 , 37) |
| 5. remand of the application for fresh consideration due to lack of adequate reasoning. (Para 38 , 39 , 40 , 41) |
JUDGMENT
TEJAS KARIA, J
INRTODUCTION
1. The present Appeal is filed under Section 117A of the Patents Act, 1907 (“Act”) read with Section 151 of the Code of Civil Procedure, 1908 against the order dated 25.07.2017 (“Impugned Order”) whereby the Assistant Controller of Patents and Designs (“Respondent / Controller”) refused to grant the patent on the ground of lack of novelty and inventive step as required under Section 2(1)(j) of the Act.
FACTUAL MATRIX
2. The Indian Patent Application No. 1285/DEL/2009 titled as “METHOD FOR THE PRODUCTION OF A PLANT-BASED MEDICAMENT” was filed on 23.06.2009 (“Subject Application”).
3. The Subject Application relates to a method for the production of a plant-based medicament which contains Iberis amara, Menthae piperitae folium, Matricariae flos, Carvi fructus, Melissae folium, Angelicae radix, Liquiritiae radix, Cardui mariae fructus and Chelidonii herba in the form of alcoholic extracts and a medicament produced according to this method, and its use (“Suit Patent”).
4. The Respondent issued a First Examination Report dated 27.07.2015 (“FER”) in the Subject Application. The main objection raised in the FER was that the claims do not have an inventive step in view of cited prior art including Kroll et al. Phytomedicine, 2006, 13, 12-19 (“D1”), WO1993002688A1 US7985433B2 (“D2”), Khardmaanaj (“D3”), Nuskha-e sharbat (“D4”), Rasabandhana (“D5”) and Madhuyasti Guna (“D6”).
5. The Appellant submitted a detailed response to the FER on 11.07.2016 (“Reply”) wherein how the present invention was completely different from that disclosed by the cited prior arts. Despite a detailed Reply, the Respondent maintained their objections of lack of inventive step under Section 2(1)(j) of the Act and invention being contrary to the provisions under Sections 3(d), 3(e) and 3(p) of the Act.
6. The Respondent issued a hearing notice dated 02.03.2017 (“Hearing Notice”) scheduling a hearing on 07.04.2017 (“Hearing”) under Section 15 of the Act to resolve the objections raised in the Hearing Notice. During the Hearing, the Appellant advanced their submissions in response to all the objections raised by the Respondent and submitted the post-hearing written submissions on 24.04.2017. During the Hearing, the Appellant was directed to take the approval of the National Biodiversity Authority for filing the Subject Application for the present invention. Accordingly, the Appellant filed the application for approval of the National Biodiversity Authority for filing the Subject Application for the present invention on 21.04.2017.
7. Thereafter, the Respondent vide the Impugned Order refused the grant of the Suit Patent under the Subject Application on the grounds of lack of novelty and inventive step, as required under Section 2(1)(j) of the Act.
SUBMISSIONS ON BEHALF OF THE APPELLANT
8. The learned Counsel for the Appellant submitted that:
8.1. Iberogast is a plant-based medicament (herbal combination preparation, phytopharmaceutical product), which is used for the treatment of functional dyspepsia and in gastrointestinal multi-target therapy. It has proved to be problematic to obtain a constant effective substance content in the finished medicament Iberogast and to obtain a consistent, reproducible quality. Corresponding investigations with regard to the ph


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