Our Associate, Sandeep Gupta discusses “Eli Lilly v. Natco Pharma”
Recently the Delhi High Court, in Eli Lilly and Company & Anr. v. Natco Pharma Limited & Anr., granted an ad-interim injunction in favour of the plaintiffs restraining the defendants from making commercial use of the plaintiff’s patented drug Abemaciclib.
The plaintiffs alleged that defendants projected and listed itself as a seller/ supplier from India “offering a wide range of Abemaciclib” on the third-party business listing website TradeIndia. As per the plaintiffs such use infringes the claim specification of its patented drug Abemaciclib, which was granted on May 19, 2018. The plaintiffs further contended that they were granted approval by the US FDA in 2017, and by India’s Central Drug Standard Control Organization in 2019 for import and marketing of the Abemaciclib drug.
The counsel for the defendants, appearing on advance notice, argued that neither the defendants nor its employees had put up the e-commerce listing. Counsel further stated that on receipt of the notice for the present lawsuit, the defendants had requested the e-commerce website to takedown the advertisement. The defendants further argued that they are only at the stage of research and development which is protected under Indian patent law. Lastly, the defendants stated that they are willing to provide the plaintiffs with an undertaking stating that as and when the defendants intend to launch the Abemaciclib drug, they will give prior notice to the plaintiffs so that they can approach the court for appropriate relief. In light of this, counsel contended that no injunction should be granted in favour of the plaintiffs at this stage.
The plaintiffs countered the arguments of the defendants by informing the court that the defendants were a habitual offender and had provided similar undertakings in other matters also. However, the plaintiffs contended that, the defendants have a habit of dumping large quantities of the infringing medicines in the market and subsequently claiming that the product is now out of their hands. Such conduct, on the part of the defendants, has caused irreparable loss to patent holders.
The Delhi High Court observed that, despite the defendants offering an undertaking, the plaintiffs have made out a prima facie case in their favour. As per the court, since the plaintiffs have made out a prima facie case, an ad-interim injunction cannot be denied solely on the ground that the defendants are offering to provide undertakings. The court further held that not only is a prima facie case made out, the balance of convenience lies in favour of the plaintiffs, who would suffer irreparable loss if an ad-interim injunction is not granted.
Based on the above, the court granted an ad-interim injunction in favour of plaintiffs restraining the defendants from manufacturing and selling the Abemaciclib drug. However, the court also stated that the defendants’ use of the patented Abemaciclib drug for purposes of research and development would not constitute infringement of the plaintiff’s patent since such use is allowed under Indian patent law.