Setback: Delhi HC restricts Natco Pharma from manufacturing cancer drug Ceritinib
New Delhi: In a major setback to the Hyderabad-based Natco Pharma, the Delhi High Court has passed an interim order barring the company from manufacturing fresh stock of drugs consisting of active pharmaceutical ingredient (API) ‘Ceritinib’. Ceritinib is indicated for the treatment of non-small cell lung cancer(NSCLC).
However, the court has permitted Natco Pharma to sell the drug already manufactured by it under the brand name Noxalk (Ceritinib).
The move comes in wake of a petition filed by Swiss pharma major Novartis AG seeking an order to restrict Natco Pharma from manufacturing and selling Ceritinib.
Novartis, in its injunction application, has 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 came across 'Ceritinib capsules' launched by Natco Pharma under the mark Noxalk at a pharmaceutical conference at Kolkata. Following this, Novartis moved the court wherein the matter was looked into by Justice Pratibha M Singh.
The court was further informed that Natco pharma filed a post-grant opposition under the Patents Act. However, the Opposition Board reserved its order on April 10, 2019.
It was further stated that Natco should have waited for the judgment in the said proceedings rather than launching the said formulation while the post-grant opposition is yet to be decided.
On the other hand, Natco pharma contended 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.
The court directed 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".
The matter has been posted for July 11.
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