Delhi HC given Green Signal to Natco Pharma for generic of Novartis cancer drug Ceritinib
New Delhi: In a major relief to Natco, the Delhi High Court has lifted a ban on Natco Pharma from manufacturing fresh stock of on-small cell lung cancer (NSCLC) drug API Ceritinib. The court has suspended the previous ruling which barred Natco Pharma from manufacturing drugs consisting of active pharmaceutical ingredient (API) ‘Ceritinib’.
Justice Prathiba M. Singh in an order dated August 20, 2019, set aside the restrictions imposed on Natco Pharma from manufacturing and selling Ceritinib which had come in wake of a petition filed by Swiss pharma major Novartis AG.
Novartis, in its injunction application, had claimed to have been granted a patent for Ceritinib which it said was a “novel and inventive compound” for treatment of non-small cell lung cancer (NSCLC). The firm submitted that the suit patent was filed as a Patent Convention Treaty application claiming priority since 2007, and was granted on 28th September 2015.
On March 29, the company had come across ‘Ceritinib capsules’ launched by Natco Pharma under the mark Noxalk at a pharmaceutical conference at Kolkata. Following this, Novartis moved the court.
"Natco Pharma, having been well aware of the fact that the patent stood granted and the fact that the post-grant opposition was pending adjudication, ought not to have launched the product while the decision was pending in the Patent Office. Accordingly, the Defendant is restrained from carrying out any fresh manufacturing of pharmaceutical preparations comprising of the active pharmaceutical ingredient (API) ‘Ceritinib’ till the next date,”
On July 11 2019, the matter was again brought up before the court. The court directed that the Controller General shall go ahead and proceed to pass orders in the post-grant opposition within a period of one month from today.
Earlier this month, the controller ruled that Novartis’ patent “lacked novelty”, and removed protection for Ceritinib.
in the latest hearing, Natco Pharma informed the court that the order in the post-grant opposition proceeding has since been passed on 16th August 2019 and the patent has been revoked. The court then observed
A perusal of the said order passed by the Controller shows that, after examining the matter, it has been held that the suit patent lacks Novelty and the patent has thereafter been revoked. Once a patent is revoked, a suit for infringement of the patent itself would not be maintainable.
However, Mr Hemant Singh, Novartis counsel, submitted that the order passed in the post-grant opposition proceedings has been appealed against by Novartis and the same was listed before the Intellectual Property Appellate Board (IPAB) on 19th August 2019.
The court said Novartis was “at liberty” to seek a further order should IPAB rule in its favour.
The Plaintiffs are, however, granted liberty to seek appropriate orders if any orders are passed in favour of the Plaintiffs by the IPAB, in the appeal preferred by them. Accordingly, I.A under Order XXXIX Rule 4 CPC is disposed of. I. A under Order VII Rule 11 CPC be listed on the next date.
The Delhi High Court has now put that order into effect, lifting the ban on Natco manufacturing generics of the drug Ceritinib.