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I.A. 33509/2024 (Order XXXIX rules 1 & 2, CPC)

1. In a suit for permanent injunction of patents infringement, the plaintiffs have filed the present application under Order XXXIX rules 1 & 2 of the Civil Procedure Code, 1908 1 seeking the following reliefs:-

"a. Directing the Defendant, all its employees, agents, distributors, licensees, and all others acting for, through, or under them, to recall all of the stocks of the product "Sigrima" and/ or any similar biologic/ biosimilar of Pertuzumab, infringing the claims of IN 268632 and IN 4646464, from the market;
b. Restrain the Defendant, and all its employees and/ or agents, and all others acting for, through, or under them, from releasing any stocks of the product "Sigrima" and/ or any similar biologic/ biosimilar of Pertuzumab, infringing the claims of IN 268632 and IN 4646464, in the market;
c. Direct the Defendant to disclose on an affidavit, the extent of its sales of the product "Sigrima" and/ or any similar biologic/ biosimilar of Pertuzumab, infringing the claims of IN 268632 and IN 4646464, including the Batch No. wise quantities manufactured, sold, dates of such manufacturing and sale(s), held in stock, sale price, and details of parties it was sold to;"
3. The formulation as claimed in claim l, wherein pertuzumab comprises a light chain amino acid sequence shown as SEQ ID NO.15 and a heavy chain amino acid sequence shown as SEQ ID NO. 16.
4. The formulation as claimed in claim l, wherein the pH of the formulation is from about 5.8 to about 6.2."

2.14. The defendant i.e., Zydus Lifesciences Limited is a company incorporated under the Companies Act, 1956. As per its website https://zyduslife.com, it was formerly known as Cadila Healthcare Limited. The defendant is an Indian pharmaceutical company inter alia seemingly engaged in the manufacture and sale of drugs, oral and injectable, active pharmaceutical ingredients, tablets, capsules, etc. 2.15. As per the plaint, in January 2023, the defendant had procured 480 vials of the original innovator biologic reference product Pertuzumab (Perjeta) from the plaintiffs' affiliate, Roche Products (India) Pvt. Ltd. As a responsible corporate, the Roche Group, has always supported innovation, research, and development of new drugs in India. Therefore, plaintiff no.1's Indian affiliate Roche Products (India) Pvt. Ltd. supplied its products for clinical studies of several companies for development of similar biologic/ biosimilar products in India, including supply of 478 vials of Perjeta for clinical trials of the defendant.

"24. Biosimilars are designed to be highly similar to the reference product, but not identical. As discussed above, the Guidelines lay out the pathway for approval of biosimilar, however, these focus on the approval process and do not directly address patent issues. The determination of infringement must begin with understanding the scope of the patent(s) held by the reference biologic. We know that Patents can cover a wide range of protectable subject matter, including the biologic's molecular structure, the process by which it is manufactured, formulations, methods of use, and more. If the biosimilar or similar biologic utilizes or embodies any aspect that is patented by the reference biologic, only then there could be a case for patent infringement.