In the realm of pharmaceuticals, innovation is paramount. Companies invest significant resources into research and development to bring new drugs to market. However, this innovation must be protected through intellectual property rights, such as patents. However, disputes often arise when one party allegedly infringes upon the patents held by another. A recent case before the High Court of Delhi exemplifies such a dispute between Novartis AG and Natco Pharma Limited highlights the importance of patent protection and the consequences of infringement and opposition.
Background
In the High Court of Delhi at New Delhi, a landmark case was pronounced on 9th January 2023, revolving around patent infringement allegations between Novartis AG & Anr (referred to as Novartis) and Natco Pharma Limited. Novartis AG, the plaintiff, holds Indian Patent IN 276026, titled “Novel Pyrimidine Compounds and Compositions as Protein Kinase Inhibitors.” This patent, originally granted to M/s IRM LLC, has been assigned to Novartis. Natco Pharma Limited, the defendant, is accused of infringing upon this patent by manufacturing and selling Ceritinib tablets (NOXALK) without obtaining a license from Novartis.
Allegations
Novartis alleges that Natco’s actions constitute patent infringement, as Ceritinib is exemplified in Example 7 of the suit patent. Claim 1 of the patent includes a Markush structure, from which Ceritinib can be obtained through select substitutions. Ceritinib itself is specifically claimed in Claim 4. Natco filed a post-grant opposition against the suit patent, arguing lack of novelty and inventive step, citing prior art in US 7153964 of AstraZeneca AB patent. The plaintiff further contends that Ceritinib contains heterocyclic piperidinyl ring and its connection to the N2 phenyl group via a carbon-to-carbon bond. Novartis has pinpointed that carbon-carbon bond as the primary inventive feature of Ceritinib, as it effectively inhibits undesirable metabolic oxidation, thereby reducing its toxicity. Novartis acknowledges the existence of other patents involving a core piperidine ring with N2 and N4 phenyl ring substituents linked via amine groups, and even instances where the N2-phenyl ring is further tri-substituted, including with a heterocyclic ring which provides toxicity. In contrast, Novartis developed Ceritinib with a specific focus on reducing toxicity by employing the heterocyclic piperidinyl ring and its carbon-to-carbon bond linkage to the N2 phenyl group.
The Court’s Decision
After considering the arguments presented by both parties, the Hon’ble Mr. Justice C. Hari Shankar delivers the judgment on January 9, 2023. The court affirms Novartis as the rightful holder of the suit patent, which includes claims related to Ceritinib. It concludes that Natco has indeed infringed upon the patent by manufacturing and dealing in Ceritinib without obtaining a license from Novartis. As a result, the court grants an injunction in favor of Novartis, restraining Natco from dealing in the infringing product, NOXALK, or any formulation containing Ceritinib that would infringe upon the suit patent IN 276026 of Novartis.
Conclusion
The case of Novartis AG vs. Natco Pharma Limited underscores the significance of patent protection in the pharmaceutical industry and highlighted the significance of inventive steps in patent claims. It demonstrates the importance of respecting intellectual property rights and obtaining licenses when necessary to avoid legal repercussions. This case serves as a reminder to all stakeholders of the need for diligence in intellectual property matters, ultimately fostering innovation and advancement in the pharmaceutical sector.
Prepared By: Elisha Patel