In the matter at hand, the plaintiffs, namely Vifor (International) Ltd. and Emcure Pharmaceuticals Ltd., have filed an application under Order XXXIX Rules 1 and 2 of the Code of Civil Procedure (CPC) seeking interim relief against the defendants.
Plaintiff no. 1, Vifor (International) Ltd., a Swiss company, is the patentee of Indian Patent No. IN 221536 (referred to as the 'Suit Patent'), which is set to expire in 2023. Plaintiff no. 2, Emcure Pharmaceuticals Ltd., is an Indian company and the exclusive sub-licensee of plaintiff no. 1 for the Suit Patent. The Suit Patent pertains to a product known as FERRIC CARBOXYMALTOSE, and it was granted marketing approval in 2011. The World Health Organization (WHO) has assigned the International Non-proprietary Name (INN) FERRIC CARBOXYMALTOSE to the invention claimed in Claim 1 of the Suit Patent.
The defendants are Indian group companies, with Biological E Limited being the parent company of defendant no. 2. On 07.06.2023, the defendants sent a notice to plaintiff no. 1, asserting that they are not infringing the Suit Patent as their process differs from the one disclosed and claimed in the Suit Patent.
The plaintiffs argue that the Suit Patent has been assigned an INN name by the WHO, which is typically reserved for unique products, not processes. Additionally, they contend that marketing approvals are granted to products, not processes, in accordance with Rules 122B and 122DA of the Drugs and Cosmetics Rules, 1945.
The defendants argue that the plaintiffs' product is a 'product-by-process' and not a 'product' and 'process' patent as claimed by the plaintiffs. They cite a previous case, Vifor (International) Ltd & Anr vs. Dharmendra Vora & Anr, where the plaintiffs themselves described the Suit Patent as related to a "product-by-process" invention. The defendants maintain that although they manufacture and market FCM, there is no infringement of the Suit Patent because their process for obtaining FCM is different from that of the plaintiffs. They point to previous orders by Co-ordinate Benches of the Court where interim injunctions were not granted in favour of the plaintiffs when defendants launched similar products.
Further, regarding the non-compliance with Section 105 of the Indian Patents Act of 1970, the defendants sent a notice under Section 105 to the plaintiffs on 07.06.2023, requesting an acknowledgement. The plaintiffs responded on 09.06.2023, stating that the information provided by the defendants was incomplete. However, without affording the defendants an opportunity to provide the missing information, the plaintiffs filed the present suit on 12.06.2023.
In the judgement, the Court has considered the irreparable injury suffered by the defendants and the fact that the defendants had already launched their products in the market before the suit was filed. To prevent irreparable loss to the defendants, the Court refused to grant a temporary injunction in favour of the plaintiffs. The court also referred cases from the coordinate benches and the Supreme Court, specifically Wander Ltd. v. Antox, highlighting the distinct factors to be considered when a defendant is already conducting business in the market as opposed to a situation where they have not yet initiated their operations.
Additionally, to protect the interests of the plaintiffs, the court observed and opted for an alternate approach where the Hon’ble Court directed the defendants to maintain the accounts of manufacture and sales of FCM until the expiry of the suit patent and further file these accounts via an affidavit within four weeks after the patent's expiration. Additionally, the defendants were instructed not to use a manufacturing process claimed by Plaintiff no. 1 in the Suit Patent.