IPAB quashes revocation of Novartis patent for anti-cancer drug Ceritinib

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

In a reprieve to Swiss pharma major Novartis, the Intellectual Property Apellate Board (IPAB) has set aside the revocation of the former’s patent for Ceritinib, a prescription-only drug used for the treatment of non-small cell lung cancer.

As part of the running patent battle, Natco Pharma had filed a post-grant opposition against Novartis’ Ceritinib patent and acting on it, the deputy controller of patents in Delhi, on August 16, 2019 revoked the patent, on the grounds of lack of novelty and inventive steps while pointing out that invention was not patentable under Section 3(d) of the Patent Act.

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

In its September 29, 2020 order , IPAB while setting aside the revocation of Ceritinib patent, came down heavily on deputy controller saying that she ought to have considered the view of the members of the opposition board who were of the opinion that the present opposition may be dismissed and the current patent may be allowed to stand.

The patent tribunal said that it was evident that the other grounds such as lack of inventive step, objection under Section 3(d) and that related to insufficiency of disclosures were also decided without proper reasoning. Novartis obtained the Indian patent on September 28, 2016 for Ceritinib and the Swiss drugmaker has been selling the drug under the brand name Spexib in India and Zykadia’ globally.

Natco filed a post-grant opposition against the patent on September 26, 2017, on grounds of obviousness and lack of inventive step. The Hyderabad-based drugmaker in March 2019 started producing generic Ceritinib capsules under the brand name Noxalk even while its opposition was pending before the patent office.

Novartis sued Natco for infringement of its patent in the Delhi high court and the court, on May 2, 2019, restrained Natco from manufacturing generic Ceritinib capsules. The court directed Natco that it should have waited for the decision in the post-grant opposition, before venturing into launching the product. Later, on August 16, 2019 the deputy controller of patents passed an order revoking Novartis’ patent. Subsequently, the high court on August 29, 2019 suspended the earlier interim relief granted to Novartis and allowed Natco to manufacture generic versions of Ceritinib.

The court held there can be no claim for infringement with respect to a patent which has been revoked in a post-grant proceeding and that patent infringement actions are maintainable only in respect of granted and live patents.

Novartis then appealed to the IPAB, which had stayed the revocation order, on July 20, 2020, without going to the merits of the case. IPAB had stayed the revocation of the patent as it was convinced that the revocation has not been decided properly.

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