Natco Prohibited from Manufacturing Generic Ceritinib

The Delhi High Court through order dated 2nd May 2019 prohibited Natco Pharma Ltd. from manufacturing generic Ceritinib capsules in a suit for infringement of Indian patent number 276026 (IN276026) of Novartis AG.

IN276026 relates to the compound Ceritinib, a drug for the treatment of non-small cell lung cancer (NSCLC). The Plaintiff contested that this drug, which forms part of a broader group of 2,4-diamino pyrimidines, is novel and inventive. Earlier patents granted to AstraZeneca and Rigel Pharmaceuticals in relation to said broad group of compounds did not disclose formula 2 of the suit patent or the compound Ceritinib within the scope of said formula 2. However, the Plaintiff sought a license from AstraZeneca in the U.S.A to obtain freedom to operate. The Plaintiff also disclosed that they had two additional patents, namely, IN240560 and IN232653 which related to the broad class of 2,4-diaminopyrimidines. The Plaintiff also submitted that a post-grant opposition against IN276026 filed by the Defendant was pending before the Indian Patent Office. The opposition board’s recommendations were in favour of the Plaintiff and the hearing in the opposition had been concluded.

The Defendant chose to launch Ceritinib capsules under the brand name Noxalk® even while their opposition was pending at the Indian Patent Office.

The Defendant challenged the novelty and inventive step of the molecule Ceritinib and asserted that the broad Markush formula disclosed in AstraZeneca’s and Rigel’s patents as well as in Novartis’s earlier patents covered Ceritinib. The Defendant also asserted that the Plaintiff while obtaining patent term extension in the U.S.A claimed that Ceritinib was also covered by the U.S equivalent of IN240560 and that this was an evergreening attempt as while IN240560 expires in India in 2024 the suit patent is valid till 2027.

The Defendant, based on the decision of the Supreme Court in Aloys Wobben and Anr. vs. Yogesh Mehra and Ors. AIR 2014 SC 2210, also contended that once a post-grant opposition is filed, the rights in the patent are yet to be crystallised till the post-grant opposition is decided.

After hearing both the parties the Court concluded the following:

  1. The drug license to the Defendant’s product was granted in January 2019, that is, after the post-grant opposition was filed and after the opposition board had given its recommendations. The Defendant launched their generic Ceritinib on 20th March 2019 while the decision in the post-grant opposition was pending. Thus the Defendant chose to launch the product during the pendency of the post-grant opposition. While the Supreme Court in Aloys Wobben held that patent rights would crystallise once the post-grant opposition is decided, the scenario of the Opponent opposing the patent launching a product in infringement of the very same patent did not arise in that case. The Court further held that the rights granted to the Patentee under section 48 of the Patents Act are not affected during the pendency of the post-grant opposition even though they may crystallise once the opposition is decided. The Court was of the opinion that the Defendant should have waited till the decision in the post-grant opposition was issued before launching their product.
  2. The Court further observed that considering that the drug was for the treatment of non-small cell lung cancer, stopping the sale of the Defendant’s product which was already manufactured would not benefit the community in any manner. Based on the same the Court permitted the Defendant to continue marketing their products which had already been manufactured but estopped them from undertaking any fresh manufacture of pharmaceutical preparations of Ceritinib until the next date of hearing.
  3. The Court further directed the hearing officer in charge of the post-grant opposition at the Patent Office to issue a decision in the post-grant opposition prior to the next date of hearing in the Court.

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