Novartis Ceritinib India Case: Court Rebuke Amid Wait For Patent Decision
Executive Summary
An Indian court has frowned upon Novartis and opponent Natco for seemingly delaying proceedings before the Controller General of Patents in a case concerning the Swiss firm’s anticancer ceritinib. The patent office wasn’t spared either, with the court asking the Controller to ensure that once orders are reserved, a time period is prescribed for delivering the decision.
The ongoing legal case pertaining to alleged infringement of the local patent for Novartis AG’s ceritinib in India is delicately poised, with a court making some sharp observations against the Swiss multinational, opponent Natco Pharma Ltd. and the Indian Patent Office as well.
Novartis had earlier moved the Delhi High Court seeking to restrain Natco from manufacturing and selling its version of ceritinib, after the Indian firm chose to launch the product without waiting for the decision in its post-grant patent opposition case before the Patent Office.
Round one played out somewhat evenly, with the court restraining Natco from carrying out any fresh manufacturing of ceritinib until the next date of hearing, although ceritinib already manufactured by the company was allowed to be sold (the product is marketed as Noxalk by Natco). The court observed at the time that Natco, having been “well aware” of the fact that the ceritinib patent was granted and given that the post-grant opposition was pending adjudication, “ought not to have launched the product” while the decision was pending in the Patent Office.
India’s Controller General of Patents, Designs and Trade Marks then requested that the order on the post-grant opposition be passed by the Patent Office before the next date of the court hearing in July.
But at the hearing earlier this month, the Delhi High Court rebuked Novartis and Natco, saying that both companies were “holding up” the proceedings before the Controller General. The court noted that both parties had, after order was reserved before the Controller General on 10 April 2019, filed "written submissions and further set of documents."
Novartis did not comment on specific issues raised by Scrip around the case but said that it has “full faith” in the judiciary. “As the matter is sub judice we will not be able to comment on the same,” the company said.
Patent Office Asked To Follow Strict Timeline
The court had some tough words for the Indian Patent Office too. It observed that the Controller General was expected to follow “strict timelines” once judgment is reserved (in the case before the office) and that “neither party ought to have been permitted to file anything further.” Natco had filed an affidavit on 30 April and Novartis had filed a counter affidavit.
“In future, the patent office shall ensure that when the hearing is concluded, it is clarified whether any time is being given for filing written submissions or not and specific communication shall be addressed to all the parties giving the time within which written submissions have to be filed,” Justice Prathiba M Singh said.
The judge added that once arguments are heard and the order is reserved, “not more than 15 days are needed to be given to parties” to file any submissions which they may want to file. “Further, the Controller General shall also ensure that once orders are reserved, a time period is prescribed for passing of the order,” Singh said in an order dated 11 July.
In the ceritinib post-grant opposition case, arguments were heard on 10 April, 2019 by the Controller General and an order had not been passed until 11 July, the Delhi High Court noted.
“This is detrimental to the timely adjudication of opposition matters which is not permissible,” Justice Singh said. The Controller General has been asked to pass an order in the post-grant opposition case within a month and no further filing is to be done by the companies, the judge said. A decision by the Controller General is anticipated anytime now.
Counter Claim
Meanwhile, in the main suit, Natco had filed a counter claim seeking declaration of non-infringement and invalidity. However, plaintiff Novartis had not filed a replication/rejoinder and has now been given time to do so by 25 July. Natco has been allowed to file “its replication in the counter claim” by 8 August, with the case scheduled to list on 22 August.
It’s not immediately clear how Natco’s Noxalk has fared commercially so far on the Indian market versus the original Novartis drug (marketed as Spexib in India and Zykadia elsewhere).
During the course of the case, Natco had undertaken to file an affidavit with a complete statement of stock, including the batch numbers of the products which have been manufactured.