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29 August 2019GenericsRory O'Neill

Delhi court approves Natco generic of Novartis cancer drug

The Delhi High Court has cleared the way for a generic version of Novartis’ small-cell lung cancer drug Ceritinib, after the Swiss pharmaceutical company’s patent was revoked.

In the order, issued August 20, the court suspended Novartis’ infringement suit against Natco Pharma on the back of a decision to invalidate the patent protecting the drug.

Natco had previously been barred from manufacturing a generic version of the drug. Following the court’s ruling, however, that ban has now been lifted.

Novartis gained patent protection for the drug in India in 2015 (number 276026). Natco, an Indian drugmaker, then sought to have the patent invalidated.

The Indian pharmaceutical company proceeded to launch its own generic, Noxalk, in March this year.

A previous ruling in the Delhi High Court, issued in May, restrained Natco from manufacturing any more of the products pending the conclusion of the opposition proceedings.

“[Natco] ought not to have launched the product while the decision was pending in the Patent Office,” the court had ruled.

The ruling permitted Natco to continue selling products that had already been manufactured.

In July 2019, noting that the patents controller-general had yet to issue any decision relating to the opposition proceeding, the court compelled the office to rule on the case within one month.

As such, earlier this month, the controller ruled that Novartis’ patent “lacked novelty”, and revoked protection for Ceritinib.

The Delhi High Court has now put that order into effect, lifting the ban on Natco manufacturing generics of the drug.

According to the latest judgment, Novartis has appealed the decision to the IP Appellate Board (IPAB).

The court said Novartis was “at liberty” to seek a further order should IPAB rule in its favour.

Last month, WIPR  reported on the backlog facing IPAB, which had left the technical member of patents post vacant since May 2016.

The Delhi High Court authorised the technical member for plant varieties to deal with outstanding cases relating to other types of IP.

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Americas
29 October 2019   Swiss pharmaceutical company Novartis has filed a patent infringement lawsuit against three Indian rivals in a US federal court over proposed generics of its heart failure drug Entresto.
Asia
21 October 2021   Pfizer is seeking to block a generic version of its cancer drug Ibrance from entering the market until the patent covering the drug expires in May 2036.
Biotechnology
16 December 2021   Public biopharmaceutical company NextCure has been accused of misappropriating trade secrets in order to create a direct competitor to a biotech’s cancer immunotherapy technology.