1.Present application has been preferred on behalf of the Plaintiffs seeking leave to file additional documents under Order 11 Rule 1 (4) CPC.
2.Plaintiffs, if they wish to file additional documents at a later stage,shall do so strictly as per the provisions of theCommercial Courts Act,2015.
3.Application is allowed and disposed of.
4.Subject to the Plaintiffs filing originals, clearer copies, exact margins,and/or typed copies of documents which are handwritten or English translations, which they may seek to place reliance on, within four weeks from today, exemption is granted.
5.Application is allowed and disposed of.
(Exemption from filing court fees)
6.For the reasons stated in the application, Plaintiffs are permitted to filerequisite Court Fees within two weeks from today.
7.Application is allowed and disposed of.
8.Present application has been preferred by the Plaintiffs under Order 11 Rule 2 read with Section 151 of the Code of Civil Procedure 1908 seeking leave to serve the Defendants with the enclosed interrogatories.
9.Issue notice to the Defendants through all prescribed modes,returnable on 29.08.2022.
10.Let plaint be registered as a suit.
11.Upon filing of process fee, issue summons to the Defendants, through all permissible modes, returnable on 11.07.2022. Summons shall state that the written statement shall be filed by the Defendants within 30 days from the receipt of summons. Along with the written statement, Defendants shall also file an affidavit of admission/denial of the documents of the Plaintiffs.
12.Replication be filed by the Plaintiffs within 15 days of the receipt of the written statement. Along with the replication, an affidavit of admission/denial of documents filed by the Defendants, shall be filed by the Plaintiffs. If any of the parties wish to seek inspection of any documents, the same shall be sought and given within the timelines.
13.List before the Joint Registrar on 11.07.2022.
14.List before the Court on 29.08.2022.
(under Order 39 Rule 1 and 2 of CPC)
15.Present application has been preferred by the Plaintiffs under Order 39 Rules 1 and 2 read with Section 151 of the Code of Civil Procedure 1908 for grant of ex-parte ad-interim injunction.
16.Issue notice to the Defendants through all prescribed modes,returnable on 29.08.2022.
17.It is averred that Plaintiff No.1 is a company incorporated in 1991 under the laws of Switzerland. Plaintiff No.1 is also known by alternatenames, Vifor (International) AG, Vifor (International) SA and Vifor (International) Inc. in various jurisdictions.
18.It is averred that Plaintiff No.2, Emcure Pharmaceuticals Ltd. is a company incorporated under the Companies Act, 1956. Plaintiff No.2's strength lies in developing and manufacturing differentiated pharmaceutical products in-house, which it commercialises through its marketing infrastructure across geographies and through its relationships with multi-national pharmaceutical companies.
19.It is further averred that Plaintiff No.1's invention FERRIC CARBOXYMALTOSE is used for the intravenous treatment of iron deficiency and iron deficiency anaemia, when oral iron preparations are ineffective or cannot be used. The properties of the aforesaid complex such as advanced stability, easy sterilization, reduced toxicity makes the invention the first non-dextran iron complex for high intravenous which can be administered in less than 15 minutes. The INN name has been assigned by
the WHO and the same has been adopted by USAN Council.
20.The details of date of filing the application including the date of publication, date of priority and date of grant of the patent etc. have been furnished in the plaint. It is stated that the patent expires on 20.10.2023.
21.It is averred that patents corresponding to the suit patent have been granted in favour of the Plaintiff No.1 in 57 jurisdictions across the world, including major patent jurisdictions such as US and EU. The family of patents corresponding to the suit patent claims priority from the German Patent application no. DE 10249551.1 dated 23.10.2002 and its member
patents are all based on essentially the same subject matter i.e. a water soluble iron (III) carbohydrate complex and/or the process for obtaining the same.
22. It is stated in the plaint that the increasingly successful commercialisation of the suit patent is reflected in the global sales figures which are mentioned in paragraph 38 of the plaint.
23.It is contended by learned counsel for Plaintiffs that Plaintiff No.1 has been pro-active and extremely vigilant in protecting its right in the suit patent. Numerous suits for infringement have been filed wherein injunctions/decrees have been granted against third parties. A list of various suits filed and pending in this Court or disposed of has been furnished in the
plaint in a tabular form.
24.It is contended that Defendant No.1/Hetero intends to immediately launch a generic, infringing version of the Plaintiffs' drug comprising FERRIC CARBOXYMALTOSE, under the brand name HETROFER,possibly within the next 7-10 days. It is further contended that Defendant No.1/Hetero has already commenced marketing the product which is evident from the promotional/marketing material which the Plaintiff No.1's distributor in India came across during routine marketing surveillance. The marketing material comprises of an image of the packaging of the infringing product, mentioning the name of Defendant No.1 at the right bottom corner and clearly indicates that the product HETROFER is a FERRIC CARBOXYMALTOSE injection. Moreover, the use of graphics showing red blood cells on the packaging and the logo is designed to indicate that the drug is meant for treatment of iron deficiency anaemia. The product with its packaging as brought forth in the plaint is scanned and placed below:
25.It is further contended that Defendant No.1/Hetero is a habitual offender and has been sued for infringement before this Hon'ble Court by several other innovator companies in the past few years and even restrained by orders of interim injunction in suits filed by pharma innovators such as Eli Lilly, Chugai and H. Lundbeck.
26.Contention of the learned counsel is that by virtue of the grant of the suit patent, Plaintiff No.1 has acquired the exclusive right, under Section 48 of The Patents Act, 1970, to prevent others from using, making, selling, offering for sale and/or importing any product protected by the said patent as also a product obtained directly from the process protected by the said
patent. The action of HETERO clearly amounts to infringement of the Plaintiffs' suit patent.
27.Having heard the learned counsel for the Plaintiffs, this Court is of the view that Plaintiffs have made out a prima facie
case for grant of ex parte ad-interim injunction. Balance of convenience lies in favour of the Plaintiffs and it is likely to suffer irreparable harm in case the injunction, as prayed for, is not granted.
28. Accordingly, Defendants, their directors, employees, officers,servants, agents, affiliates and all others acting for and on their behalf,including third parties dealing with the impugned products manufactured by the Defendants and sold to dealers, stockists, online retailers, either on exclusive or on principal to principal basis, are hereby restrained from using,making, selling, distributing, advertising, exporting, offering for sale,importing or in any other manner, directly or indirectly, dealing in any product comprising FERRIC CARBOXYMALTOSE under the brand H
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ETROFER, or any other brand or trademark, or any other product or process, that infringes the subject matter of the Plaintiff No. 1's registered suit patent No. 221536. 29.Defendants are further directed to disclose on affidavit sworn by their authorized signatory, the following details: i. Assets of each of the Defendants; ii. Quantity of products comprising FERRIC CARBOXYMALTOSE,including in API form or any other products that infringe the claims of IN 221536, manufactured, imported, exported, sold or otherwise distributed by the Defendants, since their inception; iii. Revenue earned by the Defendants through the sale of products comprising FERRIC CARBOXYMALTOSE, or any other products that infringe the claims in IN 221536. 30.Plaintiffs shall comply with the provisions of Order 39 Rule 3 CPC within ten days from today.