Novartis v. Natco_The abandonment of a divisional patent application does not render the parent patent unenforceable.

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Patent in suit: IN276026 (Novartis: Expiry:    20/05/2024)

Molecule: Ceritinib

Annual sale in India: 105,947,883 INR (As per Form 27, 2019) & 87,671 261,970,291 INR (2022-23: As per Form 27)

Judgment Pronounced on : 9 April 2024.

Conclusive Remark: The Delhi High Court has rejected the O39R4 application filed by the Defendant, NATCO, which sought to lift the injunction order in favor of the Plaintiff, Novartis.

Interesting fact & remark of DHC :

1.     The Division application filed by Novartis was not rejected on its merits but because Novartis chose not to pursue the application. This decision does not prevent Novartis from contesting the validity of the patent challenged by the opponent.

2.     Even if the rejection of the division application were considered on its merits, the Controller's decision is not binding on the court. Upon independent analysis, the court has found that the suit patent is not vulnerable to invalidity under Section 64 of the Patent Act.

3.     Unless there is a change in circumstances or the Injunction order causes hardship to the Defendant, as per the second proviso to O39R4, the court cannot revisit the injunction order, which was not the case here.

4.     The Interim Injunction order can only be revisited on the grounds of suppression of facts if the disclosure could change the outcome of the case.

5.     The refusal of the division application does not invalidate the suit patent.

Background:

1. The Novartis are the holders of Indian Patent IN276026 titled ―Novel Pyrimidine Compounds and Compositions as Protein Kinase Inhibitors, having been assigned rights, in respect of the said patent, by M/s IRM LLC, to whom the suit patent had been originally granted. The dispute relates to a Markush structure and to Ceritinib, claimed as Claims 1 , 4 and 5 in the suit patent.

2. The Novartis, allege that the defendant Natco Pharma Limited (Natco), by manufacturing and selling Ceritinib tablets in the Neutral Citation Number : 2023/DHC/000113 market, without obtaining a license from the plaintiff, is infringing the suit patent IN276026. Ceritinib is admittedly exemplified in Example 7 in the suit patent. A Markush formula, with suggested substitutions, by effecting select substitutions from which Ceritinib could be obtained is claimed as Claim 1.

Series of event:

·        3rd July 2015: The Drugs Controller General of India (DCGI) granted approval for Ceritinib as a first line treatment for ALK-positive NSCLC.

·        25th September 2017: Post grant opposition, to the suit patent, was filed by Natco  . The opposition board, constituted under Section 25(3)3 of the Patents Act, read with Rule 56(4) of the Patents Rule recommended, on 18th May 2018, upholding of the validity of the suit patent.

·        29th March 2019: While the post grant opposition filed by Natco was still awaiting decision by the Controller of patents, Natco launched its brand of Ceritinib in India.

·        Novartis, in these circumstances, instituted the present suit before this Court, alleging that Natco, thereby, infringed the suit patent. The suit, accordingly, seeks a decree of permanent injunction, restraining Natco 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 (API) or other compound, as would infringe the suit patent IN’026.

·        2nd May 2019: Court, restrained Natco from manufacturing any fresh stock of pharmaceutical preparations containing the API Ceritinib, even while allowing Natco to sell the stock already manufactured and lying with it.

·        16th August 2019: IN '026 was revoked by the controller on the ground that the suit patent lacked novelty. Novartis challenged the said order before the learned Intellectual Property Appellate Board.

·        28th August 2019: Court, by order, suspended further continuance of the earlier ad interim order dated 2nd May 2019, granting liberty to Novartis to seek appropriate orders from this Court in the event of any order favourable to Novartis being passed by the learned IPAB in the appeal preferred by Novartis before it.

·        20th July 2020: The learned IPAB stayed the operation of the order dated 16th August 2019 passed by the learned Controller revoking the suit patent IN026.

·        21st August 2020: Court, vide order passed in I.A. 6729/2020 restored the ad interim injunction granted by this Court on 2nd May 2019. The order continues to operate till date. The present order, therefore, disposes of I.A. 6729/2020.

·        29th September 2020: During the pendency of these proceedings, the learned IPAB, vide a detailed judgment, set aside the order dated 16th August 2019 of the learned Controller, revoking the suit patent IN '026 and, therefore, restoring the suit patent. WP (C) 9487/2020 has been preferred by Natco, challenging the said decision. 

·        09^th Jan 2023: Beach of C. Hari Shankar passed the order that defendant Natco, its directors, associates, licensees, franchisees, agents, distributors and others acting on its behalf are 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 would infringe the suit patent IN 276026 of Novartis.