This post explores the decision of the Delhi High Court in the case of Novartis v. Natco, involving a patent dispute concerning Ceritinib, a cancer treatment drug protected by Novartis’s Indian Patent IN 276026 (“Novartis’s patent”). The court reaffirmed the validity of Novartis’s Patent and held that Natco had failed to establish any grounds for vacating the court’s earlier injunction.
Background
Novartis AG, filed a patent application for an invention titled “Compounds and compositions as protein kinase inhibitors” in the year 2009 and the same was granted by the Indian patent office in 2016. The patent pertained to a compound used for ALK-inhibitor therapy in Non-Small Cell Lung Cancer (NSCLC) treatment. Novartis had filed a suit against Natco Pharma for patent infringement of its patent in 2019 (CS (COMM) 229/2019) which was decided by the Delhi High Court on January 9, 2023. In this suit, Novartis had accused Natco of manufacturing and selling its patented drug -Ceritinib without a license.
In its decision of January 9, 2023, the Delhi High Court granted an interim injunction in favor of Novartis, restraining Natco from manufacturing or selling Ceritinib pending final adjudication of the suit. Natco subsequently filed an application seeking vacation of the injunction, arguing that Novartis had suppressed material facts related to a divisional application that was refused by the Controller of Patents.
Natco’s arguments against validity of patent on Certinib
Natco primarily argued that the divisional application filed by Novartis, which included claims related to Ceritinib, was refused by the Controller of Patents under Section 15 of the Patents Act. Natco contended that this refusal implied that the claims for Ceritinib were invalid and placed the compound in the public domain.
Natco further alleged that Novartis had suppressed this fact from the court during the proceedings leading to the grant of the interim injunction. Natco argued that the outcome of the divisional application constituted a change in circumstances, justifying the vacation of the injunction.
Additionally, Natco sought to rely on prior art patents to demonstrate that Ceritinib was obvious to a person skilled in the art (PSA) and lacked inventive step.
Novartis’s Arguments
Novartis contended that the claims in the suit patent were valid and satisfied the requirements of novelty and inventive step under Sections 2(1)(j) and 2(1)(ja) of the Patents Act, 1970. Novartis submitted that the inventive step in synthesizing Ceritinib was reflected in the tri-substituted N2-phenyl ring linked to the pyrimidine core, which was not disclosed in prior art. Novartis also highlighted that Ceritinib offered significant therapeutic benefits over existing treatments, including fewer side effects, further establishing its inventiveness.
Novartis maintained that the divisional application cited by Natco was irrelevant to the present suit. It explained that the divisional application had not been pursued, and its refusal by the Patent Office did not constitute an adjudication on merits. Moreover, the divisional application’s outcome had no bearing on the validity of the suit patent, which continued to be enforceable.
Court’s Observations and Analysis
The court conducted a detailed analysis of the issues raised by Natco, particularly regarding the divisional application and the prior art.
1. Refusal of the Divisional Application
The court found that the divisional application was not refused on merits but because Novartis chose not to pursue it. The Patent Office’s decision explicitly noted that the application was refused under Section 15 due to the applicant’s decision to not attend the hearing or comply with the objections. The court held that the refusal of the divisional application did not affect the validity of the suit patent.
2. Materiality of the Divisional Application
The court emphasized that the outcome of the divisional application was irrelevant to the prima facie findings in its earlier order granting the interim injunction. It noted that the prior art cited by Natco in its challenge to the suit patent had already been considered in the January 2023 judgment.
3. Suppression of Material Facts
Addressing the allegation of suppression, the court held that only suppression of facts material to the merits of the case would justify revisiting the injunction. Since the divisional application’s outcome would not have altered the earlier findings, its non-disclosure was immaterial.
4. Validity of the Suit Patent
The court reaffirmed its prima facie finding that the suit patent satisfied the requirements of novelty and inventive step under the Patents Act. It observed that the inventive step in Ceritinib was reflected in its unique molecular structure, which was not disclosed in the prior art. The court also highlighted the therapeutic advantages of Ceritinib, including reduced side effects, as evidence of its inventive step.
5. No Change in Circumstances or Undue Hardship
The court held that the facts related to the divisional application did not constitute a change in circumstances as required under Order XXXIX Rule 4 of the CPC. It also rejected Natco’s claim of undue hardship, noting that the injunction was granted after considering all relevant factors, including potential harm to both parties.
Conclusion
The Delhi High Court concluded that Natco’s arguments failed to establish any grounds for vacating the interim injunction. It held that the refusal of Novartis’s divisional application had no bearing on the validity of the suit patent, which continued to be enforceable. The court therefore dismissed Natco’s application and reaffirmed the injunction against the manufacture and sale of Ceritinib by Natco, pending final resolution of the suit.
Citation: Novartis AG v. Natco Pharma Ltd., CS(COMM) 229/2019 (H.C. Delhi Apr. 9, 2024). Available on https://indiankanoon.org/doc/116308782/
Authored by Gaurav Mishra, BananaIP Counsels
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