The Delhi High Court on September 19 refused to grant an interim injunction to Vifor considering the launch of the Biological E’s FCM in the market. However, the court hesitated in passing a final word on whether FCM is a product-by-process patent or not, in light of the ongoing appeal before the Division Bench in Vifor v. MSN (see here). We are pleased to bring to you a post by SpicyIP intern Tejaswini Kaushal on this controversy. Tejaswini is a 3rd-year B.A. LL.B. (Hons.) student at Dr. Ram Manohar Lohiya National Law University, Lucknow. She is keenly interested in Intellectual Property Law, Technology Law, and Corporate Law.
Another Drop in the Bucket: Delhi High Court’s Interim Injunction Denial for Vifor in FCM Patent Infringement
Vifor (International) Ltd’s protracted legal struggle for the patent rights of “water soluble iron carbohydrate complex and a process for producing water soluble iron carboydrate complex,” commonly referred to as “ferric carboxymaltose” (“FCM”), has been going on for over a decade now, contributing significantly to the jurisprudence of interim injunction grants (see here) ‘product-by process’ patents (see here). In yet another interim order amidst a multitude of ongoing patent suits linked to FCM, the Delhi High Court has contemplated the grant of an ad interim injunction against an FCM manufacturer, Biological E Limited. This order is part of the piling mount of similar orders passed by the Delhi High Court. This analysis centers on how this particular order contributes to clarifying the existing dilemma surrounding the FCM patent.
Arguments Rendered by the Parties
The major arguments in the present case were two-fold. Firstly, Vifor (International) Ltd (“plaintiffs”) denied the patent’s ‘product by process’ nature on grounds that only two types of patents are recognized under section 2(1)(j) of the Patents Act, 1970, i.e., a “product” or a “process” patent to the exclusion of any third variety. It did so in a bid to establish patent infringement albeit Biological E Limited (“defendants”) using a different process to prepare the product. In defense, the defendants raised the court’s observations in the 2014 Vifor (International) Ltd v. Dharmendra Vora case, the 2015 Vifor (International) Ltd. v. Mr. Pankaj Ramanbhai Patel case, the 2018 Vifor (International) Ltd v. Maxycon Health Care Private Limited case, and the 2018 Vifor (International) Ltd. v. Venkat Jasti case, where the respective courts discussed the categorization of the plaintiff’s patent but failed to reach a conclusive decision regarding it being a ‘product-by-process’ patent or not (for a more detailed discussion on the ‘product-by-process’ patent jurisprudence, see here).
Secondly, the plaintiffs claimed that the defendants had neither entered the market nor offered their products for sale to the general public yet. They claimed a reasonable apprehension of the defendants’ intent to do so, which would “irreversibly alter the market” and cause “irreparable harm” to the plaintiffs. However, the defendants claimed the release of the product prior to the suit’s filing and successfully established so.
Additionally, the defendants argued that the patent did not favor the plaintiffs in light of F. Hoffmann-LA Roche Ltd. and Ors. v. Cipla Ltd., citing the plaintiffs’ lack of pre-grant or post-grant opposition. They further claimed that the denial of their right to respond to the plaintiff’s reply infringed section 105 of the Patent Act.
Analysis of the Court’s Reasoning
The court has directed the defendants not to use the plaintiff’s process for FCM manufacture and to maintain accounts of FCM manufacture and sales till the expiry of the tenure of the suit. The court’s decision to refrain from granting an interim injunction to the plaintiffs but explicitly enjoin the defendants from using the plaintiff’s process is noteworthy. However, this order leaves various persisting ambiguities still unaddressed, mirroring the trend seen in previous judgments. It offers a dual-pronged analysis that reevaluates the jurisprudence evolved through the numerous FCM patent infringement cases.
Firstly, the court refrained from categorizing the patent definitively, opting to maintain the status quo within the jurisprudential landscape. While some clarity was introduced in the matter by Vifor v. MSN Labs in their ‘product by process’ claims order (see here), but post the Division Bench’s stay (see here) on those directions and halting of the launch of generic FMC once again for MSN, the product-by-process patent remains a vague concept. The decision at hand acknowledges the MSN orders and the enduring dilemma on patent categorization, but does not contribute to its further resolution. It permits the core challenges to persist unabated without providing a decisive clarity of the patent’s scope. Currently, the Court has not recognized the patent as a ‘product-by-process’ patent because the defendant has been explicitly instructed not to employ the manufacturing process claimed by the plaintiff in the patent lawsuit.
Secondly, the denial of an ad interim injunction in this case is consistent with a broader trend in which the court considers the balance of convenience, particularly when defendants have already introduced their products to the market. The court draws on principles outlined in the Wander Ltd. v. Antox, emphasizing the differing considerations when a defendant is already operating in the market compared to a scenario where they are yet to commence their enterprise: “The court also, in restraining a defendant from exercising what he considers his legal right but what the plaintiff would like to be prevented, puts into the scales, as a relevant consideration whether the defendant has yet to commence his enterprise or whether he has already been doing so in which latter case considerations somewhat different from those that apply to a case where the defendant is yet to commence his enterprise, are attracted.” In the present case too, the defendants pointed out that the Delhi High Court has consistently applied this principle in recent orders revolving around the FCM patent, including the order dated April 18, 2023, in the case of Vifor (International) Ltd. v. Macleods Pharmaceuticals Ltd, the order dated April 11, 2023, in the case of Vifor (International) Ltd. v. Biokindle Lifesciences Private Limited, its orders on April 25, 2023 and May 1, 2023 in the case of Vifor (International) Ltd & Anr. v. J.B. Chemicals. In the current case, the court primarily leaned on these past orders to deny the injunction grant without evaluating the three-fold criteria for granting an injunction from the ground up.
One of the most notable takeaways from this order is the reevaluation of the ‘product-by-patent’ issue, a concept that has remained relatively unfamiliar in the Indian patent regime. While the court does not explicitly lay the groundwork for the future, as it did in the MSN case, it does contribute to the ongoing discussion surrounding ‘product-by-process’ claims in the Indian context. It also bolsters the argument against granting injunctions when products have been introduced into the market beforehand. However, in its entirety, this order is another drop in the bucket of the growing number of orders on FCM patents. Hopefully, future rulings will provide more definitive guidance and clarity regarding the ongoing dispute.