Delhi High Court favours Novartis in Patent Infringement suit against Natco Pharma

Delhi High Court favours Novartis in Patent Infringement suit against Natco Pharma

The Delhi High Court in the case of Novartis Ag and Another vs Natco Pharma Limited, issued an order restraining the respondent- Natco Pharma Ltd, its management and distributors from infringing the patent rights of Novartis on its cancer drug Ceritinib, branded as Zykadia internationally.

The single judge, Justice C. Harishankar while hearing the petition filed by Novartis observed that Natco's submissions had failed to establish that the suit patents were vulnerable to revocation on the ground of obviousness, as being anticipated from prior art. The Court concurred with Novartis's argument that the suit patent in the case were not anticipated neither obvious from the cited prior art.

In the aforementioned case, a petition was moved by Novartis alleging that Natco Pharma was infringing the patent rights of Ceritinib by manufacturing and selling the drug in the market without obtaining a license from the company. Novartis contented that it holds the rights on the patent titled 'Novel Pyrimidine Compounds and Compositions as Protein Kinase Inhibitors,' as assigned by M/s. IRM LLC to whom the suit patent had been originally granted.

The dispute relates to a Markush structure (representations of chemical structures with variable substituents that are used in patent documents to specify groups of related chemical compounds, according to World Intellectual Property Organisation) and to Ceritinib.

The suit patent was granted by the Patent Office of India in favor of M/s. IRM LLC on 30 September, 2016 and still remains valid till 20 November, 2027. Novartis has been selling Ceritinib in India since May, 2016 under the brand name Spexib and internationally since 2014 under the brand name Zykadia.

The patent dispute between Novartis and Natco started with the latter filing a post grant opposition with the Patent Office in September, 2017. It has been also alleged that Natco launched its brand of Ceritinib in India on March 29, 2019, under the brand Noxalk even though the post grant opposition was awaiting decision by the Controller of patents.

In its petition, Novartis sought a permanent injunction prohibiting Nacto and all others acting on its behalf from directly or indirectly dealing in any formulation containing Ceritinib either alone or in combination with any other active pharmaceutical ingredient or other compound, as would infringe the suit patent.

The Court, in its order dated 2 May, 2019, stopped Natco from manufacturing any fresh stock of the drug while permitting it to trade the stock already manufactured and remaining with itself. In the meantime, the Controller of Patent annulled the patent in August, 2019 on the ground that it lacked novelty. Even as Novartis approached the Intellectual Property Appellate Board (in short IPAB), the appellate authority during that time.

The Delhi High Court suspended the continuance of its interim injunction granting liberty to Novartis to seek appropriate orders from the Court in the event of any order favorable to it being passed by the IPAB.

The IPAB stayed the revocation order in July, 2020, following which the Delhi High Court restored its interim restriction, which continued to operate till the latest order dated 9 January, 2023. IPAB however in September, 2020, set aside the Controller's order, consequently restoring the suit patent. Natco filed a Writ Petition against the said order, on which no interlocutory orders were passed till the single judge issued an order on January 9, 2023.

The Court, in an Order dated January 9, 2023, concluded that Novartis is the holder of the suit patent, and prima facie found that Claim 1 and Claims 4 and 5 (Ceritinib) are novel and inventive, and satisfy clauses (j) and (ja) of Section 2 of the Patents Act.

According to the Court the suppression of an adverse chemotherapeutic side effect, in cancer therapy is, therefore, a marked advancement over the state of existing knowledge. Even by itself, therefore, this would constitute an ―inventive step within the meaning of Section 2(1)(ja) of the Patents Act.

The Court held, that "the suit patent continues to subsist till date and Natco has, without obtaining any license from Novartis, commenced manufacture and dealing in Ceritinib under its own brand. The defense of Natco, solely predicated on questioning the suit patent as vulnerable to challenge, cannot be treated as 'credible' in view of the above discussion and Novartis is, therefore, entitled to an injunction."

In view of the discussion, the Court ruled that the respondent- Natco, its directors, associates, licensees, franchisees, agents, distributors, and others acting on its behalf were restrained from dealing in the infringing product NOXALK and/or any Active Pharmaceutical Ingredient, pharmaceutical product or formulation containing Ceritinib alone or Ceritinib in combination with any other compound or API, as the same would infringe the suit patent IN 276026 of Novartis.