Introduction:
The Delhi High Court recently denied to grant interim injunction to Vifor (International) Limited regarding the launch of Ferric Carboxymaltose (FCM) drug for patients affected by iron deficiency/anaemia by Biological E in the market. However, the court has hesitated to label FCM as a product-by-process patent. Amidst the ongoing appeal in Vifor v. MSN, this hesitation hints at the complex legal landscape surrounding FCM patent infringement. In spite of the denial to grant injunction, Delhi High 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.
Arguments rendered by the parties:
The major arguments rendered by the parties were covered in two-fold, as follows:
1. Product-by-process nature of the patent
Firstly, the plaintiff, Vifor International Ltd. denied the patent's product-by-process relying on section 2(1)(j) of the Patents Act, 1970. The Act recognizes only two types of patents- a product and a process, excluding any third variety. This argument was made by the plaintiff in a bid to establish patent infringement, although Biological E had used a different process to prepare the end product, FCM. As a reponse to the said claim, the defendants raised the court's observations in certain cases like Vifor International Ltd. v. Dharmendra Vora1, Vifor (International) Ltd v. Maxycon Health Care Private Limited2 etc. In all these cases, the respective courts debated whether or not the plaintiff's patent should be classified as a "product-by-process" patent but were unable to come to a definitive conclusion.
2. Sale of the product in the market
Secondly, the plaintiffs also contended that the defendants have not entered the market and the product is also not available for sale to the general public yet. They asserted a plausible suspicion of the defendants' intention to do so, which would "irreversibly alter the market" and result in "irreparable harm" for the plaintiffs. However, as a defense to this claim of the plaintiff, the defendants asserted and successfully proved that the product had been released before the lawsuit was filed.
Observations and Reasoning given by the court:
The defendants have been ordered by the court to keep records of FCM production and sales up and to refrain from using the plaintiff's method of manufacturing FCM until the conclusion of the lawsuit. It's important to note that the court explicitly forbade the defendants from using the plaintiffs' process rather than granting the plaintiffs an interim injunction. However, this decision continues a trend from earlier rulings by leaving a number of persistent ambiguities unresolved. It provides a two-pronged analysis that reevaluates the legal precedent created by the numerous FCM patent infringement cases.
The important takeaways from the case are that firstly, the court refrained from giving a definite category to the patent and hence maintaining the long lasting status quo within the jurisprudential landscape. The division bench putting a stay on the launch of generic FCM has once again kept the concept of product-by-process patents a vague one. The court has definitely recognized the dilemma over the product-by-process categorization of patents but has not contributed further towards its resolution. 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 to grant interim injunction denotes the trend of maintaining balance of convenience particularly when defendants have already introduced their products to the market. The court emphasized that there are different considerations when the defendant has already launched the product in the market as compared to when the defendant is yet to commence in the market. For this, reliance was laid upon Wander Ltd. v. Antox3 wherein it was stated:
"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."
Conclusion:
In this case, the concept of product-by-process was reevaluated which has remained relatively unfamiliar in the Indian Patent jurisdiction. While the court restricted from providing anything conclusive with regard to assigning a definite category to product-by-process patents, it did contribute to the ongoing discussion regarding the same. Moreover, the court also followed a liberal approach against granting injunctions when products have already been introduced into the market. As a whole this order adds to the various decisions regarding FCM Patents. We can currently only hope of getting a substantial and definite ruling regarding product by process patents in India.
Footnotes
1. CS(OS) 4083/2014
2. CS(COMM) 712/2018
3. CA NO. 9844 OF 2018
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