Intellectual Property Apellate Board stays cancellation of Novartis patent for Anti-Cancer Drug Ceritinib

The order is likely to create a direct impact on the patent battle with Natco Pharma, as it was manufacturing generic Ceritinib and with the latest order, it would have to cease production of the drug.

Ceritinib is a prescription drug used for the treatment of non-small lung cancer, developed and patented by Novartis (IN 276026, US 8377921). Novartis obtained an Indian patent in 2016, claiming priority from the year 2007. It has been selling the drug under the brand name of 'Spexib' in India, and 'Zykadia' in international markets.

In March 2019, Natco started producing generic Ceritinib capsules branded as 'Noxalk'. Novartis sued Natco for infringement in the Delhi High Court. However, in August 2019, the Controller of Patents passed an order cancelling Novartis' patent. Resultantly, the Delhi High court lifted its injunction against Natco, allowing it to manufacture generic versions of Ceritinib.

Medical Dialogues team had earlier reported that the Delhi High Court had 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.

Also Read: Delhi HC Given Green Signal To Natco Pharma For Generic Of Novartis Cancer Drug Ceritinib

The court had directed that the Controller General to go ahead and proceed to pass orders in the post-grant opposition. Lat year, the controller ruled that Novartis' patent "lacked novelty", and removed protection for Ceritinib.

The court had noted,

"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that, after examining the matter, it has been held that the suit patent lacks Novelty and the patent has thereafter been revoked.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."

Aggrieved by the revocation of the patent, Novartis moved IPAB with an appeal.

The board observed that the revocation has not been decided properly and also noted oversight in examining issues relating to genus-and-species patents, as well as several procedural lapses.

The board stated that the Controller's order was based on additional evidence filed by Natco on April 4 after the fixing of the hearing. This is in clear violation of Rule 60 of the Patent Rules 2003 which prohibits any party from filing further evidence, once the hearing has been fixed.

No copy of the additional evidence filed on April 4, 2019, was served on Novartis by Natco. The same was noticed by Novartis' attorney from the website of the Indian Patent Office on April 5, 2019. A letter was submitted objecting to taking on record such additional evidence by the patentee's attorney on April 8, 2019.

The opposition proceedings were taken up for hearing on April 9 and 10, 2019. No notice was issued by the Controller on Rule 138 application with additional evidence filed by Natco. No orders were passed either accepting or rejecting the said evidence. No orders were passed either granting opportunity to the patentee to file any rebuttal evidence, it stated.

Justice Manmohan Singh, Chairman, IPAB, subsequently set aside the revocation and held;

"Even on merit, the Controller has gone completely wrong in arriving at a finding that the patent lacks novelty. The Controller has further completely disregarded the recommendation and the findings of the Opposition Board constituted under Section 25(2) of the Indian Patents Act which had recommended vide order dated May 18, 2018, that the patent is novel, normal and inventive and upheld its validity. The said recommendation of the Opposition Board has been disregarded by the Controller without assigning any reasons whatsoever."

To access the official judgement, click on the link below-

Also Read: Delhi HC Given Green Signal To Natco Pharma For Generic Of Novartis Cancer Drug Ceritinib