Delhi HC Restrains Hyd-Based Natco Pharma From Making Cancer Drug Ceritinib Claimed To Be Patented By Novartis [Read Order]

The Delhi High Court has restrained Hyderabad-based Natco Pharma from manufacturing fresh stock of drugs comprising of compound named 'Ceritinib' meant for treatment of non small cell lung cancer but allowed it to sell the existing stock keeping in the interest of the patient community.

Justice Pratibha M Singh passed the order while directing Natco to file response to the injunction application moved by Swiss Pharma major Novartis which claimed to have been granted patent for Ceritinib which it said was a "novel and inventive compound" for treatment of non small cell lung cancer (NSCLC).

Novartis claimed that the suit patent was filed as a Patent Convention Treaty application claiming priority since 2007, and was granted on 28th September, 2015.

Novartis said it was forced to move court for injunction after it came across 'Ceritinib capsules' lanched by Natco under the mark NOXALK at a pharmaceutical conference at Kolkata on March 29.

It informed the court that Natco Pharma Ltd. filed a post grant opposition under the Patents Act and with the Opposition Board having reserved its order on April 10, 2019, Natco should have waited for the decision in the said proceedings rather than launch the product while the post grant opposition is yet to be decided.

Natco, on the other hand submitted that the molecule Ceritinib is neither novel nor inventive and is covered under the broad Markush formula which is disclosed in the AstraZeneca and Rigel patents, and two earlier Novartis patents.

Referring to Section 48 of the Patents Act, the court said, the provision grants rights in favour of a patentee, which are not affected during the pendency of a post-grant opposition."

"During the pendency of the post-grant opposition, the rights of a patentee subsist – though they may be crystallized once the opposition is actually decided. The Defendant ought to have awaited the decision in the post grant opposition before launching its product. However, since it chose to launch earlier, the Plaintiff has filed the present suit," noted Justice Singh.

"The Defendant's product NOXALK is described as 'Ceritinib capsules'. Considering that this is a drug for treating non small cell lung cancer (NSCLC), stopping the sale of the Defendant‟s products which are already manufactured would not benefit the patient community in any manner. Thus, the drugs already manufactured by the Defendant under the mark NOXALK (Ceritinib) are allowed to be sold during the pendency of the hearing in the application under Order 39 Rule 1 and 2 CPC and till further orders of this Court.

"However, 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," the court ordered.

While posting the matter for July 11, the court requested the Controller General of Patents, Designs and Trade Marks that the order on the post grant opposition may be passed by the Patent Office before the next date of hearing before this Court so that this Court" may have the benefit of the decision of the Patent Office".

[Read Order]