IN THE HIGH COURT OF JUDICATURE AT MADRAS
Judge, J
Petitioners – Appellant
Versus
Respondent – Respondent
O.P. (PT) No.5 of 2024 | O.P. (PT) No.6 of 2024
| Table of Content |
|---|
| 1. execution of letters rogatory (Para 1 , 2 , 3 , 5 , 6 , 7) |
| 2. respondent's objections and defenses (Para 9 , 10 , 11 , 12 , 13 , 14 , 18 , 19 , 20 , 21) |
| 3. court's analysis of international comity and evidence (Para 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 , 56 , 57) |
| 4. court's directive for execution of letters rogatory (Para 58 , 59 , 60 , 61 , 62 , 63) |
| 5. final orders and directions (Para 64) |
COMMON ORDER
These petitions have been filed before the Intellectual Property Division (IPD) of this Court under Order XXVI Rules 19 - 22 read with Sections 78 and 151 of C.P.C. , seeking to execute the Letters Rogatory dated 13.05.2024 issued by the United States District Court under the Hague Convention , 1870, seeking judicial assistance from this Court against the respondent. Letters Rogatory are formal requests from one Court to another to obtain judicial assistance.
2. The petitioners in O.P. (PT) No.5 of 2024 claim that in the case pending before the United States District Court at Delaware, they had alleged, among other things, that the submission of Abbreviated New Drug Application (ANDA) No.218409 by CIPLA, which seeks approval from the FDA to market a generic version of VYNDAMAX® ("CIPLA's ANDA Product") before the expiration of the petitioners' "441 Patent", constitutes an act of infringement with respect to the "441 Patent".
3. The petitioners in O.P. (PT) No.6 of 2024 claim that in the case pending before the United States District Court at Delaware, they had alleged, among other things, that the submission of Abbreviated New Drug Application (ANDA) No.218205 by Zenara (now Hikma), which seeks approval from the FDA to market a generic version of VYNDAMAX® ("Zenara's ANDA Product") before the expiration of the petitioners' "441 Patent", constitutes an act of infringement with respect to the "441 Patent".
4. Since the directions sought for in both the petitions are similar in nature, they are disposed of by a Common Order.
5. A patent dispute is pending adjudication before the United States District Court between the petitioners and Zenara Pharma Pvt. Ltd. (hereinafter referred to as 'Zenara'), CIPLA and other Indian pharmaceutical Companies viz., Aurobindo Pharma Limited and Dexcel Pharma Technologies and Limited.
6. The present petitions pertain to Zenara's ANDA Product, which according to the petitioners, infringes their "441 Patent" issued by the U.S. Patent Office for their TAFAMIDIS 61 mg capsules sold under the brand name VYNDAMAX®, which are used for treatment of TRANSTHYRETIN AMYLOID CARDIOMYOPATHY. According to the petitioners, they believe that the respondent and its employees who are associated with Zenara possesses information and documents relating to Zenara ANDA product that are relevant for proving infringement of 441 Patent belonging to the petitioners.
7. In the Civil proceedings, pending before the United States District Court at Delaware between the petitioners and Zenara, CIPLA and other Indian pharmaceutical companies, the petitioners filed a request for international judicial assistance (Letters Rogatory) as per Hague Convention of 18.03.1970 for taking evidence abroad in Civil or Commercial matters to which both India and the Unites States are signatories and to obtain evidence for the purpose of being used in the Civil proceedings before the United States District Court for the District of Delaware.
8. The United States District Court for the District of Delaware has issued Letters Rogatory dated 13.05.2024 requesting this Court for obtaining the deposition of documents from the respondent herein. Subsequent to the issuance of Letters Rogatory, Zenara, one of the defendants in the U.S. proceedings, raised confidentiality concerns regarding certain portions of the Letters Rogatory and requested the petitioners' counsel not to divulge the Letters Rogatory unless a c
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