By Renu Bala and Bani Mittal
Vacation of Interim Injunction
An Interim Injunction is one of the remedies available to a patentee that enables them to maintain the status quo of the granted patent. This remedy may be granted in cases where the balance of convenience favors its issuance. This is a temporary court order that prevents a party from taking certain actions until disposal of the case. However, these orders may be vacated by the court on a request made by the party against whom the injunction was granted. The request for vacation of the Interim Injunction may be made on the grounds including change in circumstances, reassessment of balance of convenience or irreparable harm. In the case of Novartis AG & anr Vs. Natco Pharma Limited[1], the Hon’ble High Court of Delhi vide its order dated April 9, 2024 dismissed the request for vacation of Interim Injunction filed by Natco Pharma Limited, and held that voluntary non-perusal of Divisional Application by Novartis cannot be regarded as refusal of the divisional matter on merits. The Court’s ruling further addressed the grounds to be considered while vacating an Interim Injunction.
Brief Facts
Novartis AG (hereinafter referred to as Plaintiff) was granted a patent, IN276026 (formerly application number 3951/DELNP/2009), titled as “Compounds and Compositions as Protein Kinase Inhibitors”. The patent (hereinafter referred to as suit patent) was filed via Patent Convention Treaty (PCT) route with PCT number PCT/US2007/085304 and claims priority from US Application no. US 60/869,299 dated December 08, 2006 in USA. The suit patent claimed Markush structures of Formulas (1-3) and encompassed a compound of the Formula 5-chloro-N2-(5-methyl-4-piperidin-4-yl-2-[(propan-2-yl)oxy]phenyl)- –N4 -(2-(propan-2-sulfonyl) phenyl) pyrimidine-2,4-diamine (having generic name Ceritinib) in claims 1, 4 and 5. The compounds of the suit patent are useful as Anaplastic Lymphoma Kinase (ALK) inhibitors. Ceritinib is an antineoplastic kinase inhibitor used to treat anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) in patients with inadequate clinical response or intolerance to crizotinib[2].
Natco Pharma Limited (hereafter referred to as the Defendant) filed post grant opposition against the suit patent under section 25(2) of the Indian Patents Act, 1970 on September 26, 2017 and the patent was revoked vide the Controller’s decision dated August 16, 2019. However, this order was set aside by the IPAB on September 29, 2020.
In the meantime, the Defendant exploited the suit patent without license during the pendency of the post grant opposition before the IPAB. Accordingly, they were restrained to exploit the said compound through an injunction vide order dated January 9, 2023 of the Hon’ble High Court of Delhi. Aggrieved by this order, the Defendant sought vacation of the aforesaid injunction under order XXXIX Rule 4 of Code of Civil Procedure 1908.
Contentions of the Defendant
The Defendant Natco contended that the suit patent was vulnerable to invalidity as it was anticipated both by prior claiming as well as by prior disclosure and was obvious from the prior art. Further, the counsel of the Defendant also stated that Novartis filed a divisional application (IN5338/DELNP/2014) of the suit patent. This Divisional Application was later refused by the patent office. The Defendant submitted that the refusal would not be tantamount to abandonment of Divisional Application but to be treated as a “decision on merits”. Also, abandoning of Divisional Application render Ceritinib in public domain. Furthermore, relevant documents pertaining to Divisional Application stood omitted in Plaint. This lacuna compromised the decision of Hon’ble Court announced on January 9, 2023 and hence, this lacuna sufficiently justifies that the Interim Injunction should be vacated.
Contentions of the Plaintiff
The counsel of the Plaintiff countered the above contentions of the Defendant and stated that fate of a divisional application can have no impact on suit patent and further submitted that voluntary abandonment could not be treated as rejection on merits wherein the Controller was duly informed about decision of the Plaintiff to not pursue the application. Further, only the suit patent can invalidate a Divisional Application, implying that invalidated divisional application cannot invalidate its parent application. Furthermore, the first examination report of Divisional Application cited the same prior arts (namely WO’454, WO’894 and WO’940) as mentioned in first examination report of suit patent and both the aforesaid applications in later stage of patent prosecution included Ceritinib. In these circumstances, the Plaintiff decided to abandon the Divisional Application and Controller was informed accordingly. Thus, the said refusal cannot impact order dated January 9, 2023. The Plaintiff also asserted that Defendant cannot seek to plead undue hardship after the decision since undue hardship should arise after the order of Interim Injunction have been passed.
Court Order and Analysis
Upon considering the arguments from the Defendant and the Plaintiff, the Hon’ble Court determined that Divisional Application was voluntarily abandoned and not rejected on merits. Further, the abandonment of Divisional Application cannot impact the merit of the case even if verdict would have been otherwise. Furthermore, Ceritinib being available in public domain after refusal of Divisional Application does not imply that any third party can exploit the said compound since suit patent still stands valid. Accordingly, the application of vacation of injunction by Defendant was dismissed. As per the Hon’ble court, “It is only, therefore, suppression of a fact which, if disclosed, would alter the outcome of the case, which can be regarded as a material fact, as would justify a revisitation of the order of Interim Injunction”.
Conclusion
The Interim Injunction order may only be revisited if there is significant new evidence or a crucial fact that was previously suppressed at the time of passing the order, such fact having the potential to alter the outcome of the case.
[1] CS(COMM) 229/2019