Delhi High Court Refuses To Vacate Interim Injunction Granted In Favour Of Novartis For Compound Ceritinib



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In a recent judgement passed on 09 April 2024 by the Delhi High Court, an essential position of law was discussed regarding the vacation of interim relief granted by the Court.
India Intellectual Property
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In a recent judgement passed on 09 April 2024 by the Delhi High Court, an essential position of law was discussed regarding the vacation of interim relief granted by the Court. Natco Pharma has filed IA 4636/2023 to vacate the interim relief granted to Novartis by judgment dated 09 January 2023.

Through IA 6384/2019, Novartis approached the Court to obtain an order to restrain Natco Pharma from exploiting their patented invention covered under Indian Patent No. IN 276026 (IN'026). The patent IN'026 relates to "Novel Pyrimidine Compounds and Composition as Protein Kinase Inhibitors", and specifically, it relates to the active compound "Ceritinib”. The primary reasons why the Court has granted interim relief to Novartis are as follows:

(i) the Court observed that a markush claim in a genus patent could said to disclose only those compounds which could be synthesized by a person skilled in the art. The disclosure is required to be enabling in nature. Thus, obviousness from prior art was the determinative criterion based on which the Court would ascertain whether the claim in the species patent was obvious from the teachings in the genus patent.

(ii) Further, the Court also stated that the fact that the genus patent has remained in existence for a number of years and the species patent was not synthesized by anyone prima facie indicated that the specie patent was not obvious from the teachings in the genus patent.

(iii) the Court also observed that for obviousness, Natco has cherry-picked selected radicals from the several substituents to arrive at the molecular structure of Ceritinib. However, no specific averment has been made to support choosing the selected substituent from the several substituents suggested in the prior art. The submission made by Natco that there is no distinction between coverage and disclosure was rejected by the Court.

(iv) The Court held that if the claim in the suit patent is obvious to a person skilled in the art from the teachings of the complete specification, only then can the patent be regarded as vulnerable to invalidity on the grounds of anticipation and obviousness.

(v) Novartis contended that over other drugs that act as ALK-inhibition therapy, Ceritoinib possessed the advantage of fewer side effects, which constituted an inventive step, as the suppression of adverse side effects is a matter of vital importance in chemotherapy.

(vi) Natco's submission that Novartis is bound to submit X-ray diffraction pattern was found by the Court as without substance given Division bench judgement in the matter of Merck Sharp & Dohme Corporation v. Glenmark, which has held that at the stage of adjudication under Order XXXIX Rules 1 and 2 of the CPC, the Court cannot examine X-ray diffraction patterns.

(vii) Natco also relied on the fact that while applying for Patent Term Extension (PTE) for the US'592 patent, Novartis stated that the patent claimed Ceritinib. The Court observed that it was noted that the Markush claim in US'592 covered Ceritinib.

(viii) Natco also sought reliance on the fact that while obtaining NDA for ZYKADIA, the brand name under which Ceritinib is sold, Novartis has mentioned all the prior art documents referred by Natco. The Court observed that it was done to comply with the U.S.C. § 355(b)(1).

Keeping in view all the above factors, the Court was of the opinion that the patent seems valid prima facie. Thus, interim relief was granted in favour of the patentee, Novartis, and Natco Pharma was restrained, pending the disposal of the suit, from exploiting the patent IN'026 or manufacturing or selling Ceritinib without obtaining a license from Novartis.

Natco, in the present matter, approached the Court to vacate the interim order. The interim injunction was not contested on merit; the only ground Natco raised was that Novartis had filed a divisional application no. 5338/DELNP/2014, with respect to some of the claims of IN'026. As per Natco's argument, Ceritinib was claimed as a compound 66 in the claims of divisional application. Natco's submission was that since the divisional application was finally refused, it was incumbent on Novartis to disclose it. It was also the fact that it was finally denied, as it would have seriously impacted the outcome of the interim injunction.

Natco contended that since the compound was claimed in the divisional application and has been refused, it is now available to the public. Also, it was argued that since the refusal of the application was under section 15, it has to be treated as a decision on merits.

Novartis argued that they chose not to prosecute the divisional application further. Thus, it was abandoned, and this should not be treated as rejection on merits. Also, it was submitted by Novartis that, as per law, the parent patent could invalidate the divisional application and not vice-versa. Further, Novartis also submitted that suppression and concealment could not be used as grounds for seeking a vacation of the interim order.

After considering all the facts and circumstances, the Court concluded that the order passed in the divisional application clearly states that the applicant has informed that they do not wish to pursue the application further. Thus, the divisional application cannot be considered as refused on merits. The Court held that the decision not to pursue the divisional application cannot estop the patentee from contesting the grounds on which the validity of the patent was sought to be assailed by the defendant.

The Court also held that even if the order under section 15 is considered to be an order on merits, the Controller's decision is not binding on this Court. The Controller's opinion can hardly be cited as grounds for the High Court to revisit its decision.

Regarding order XXXIX Rule 4, the Court held that though there is an averment in the present application that it has been necessitated owing to a change in circumstances, the averment is not supported by any material whatsoever. The abandonment of divisional application cannot constitute a 'change in circumstances" within the meaning of order XXXIX Rule 4 of the CPC.

The Court categorically held that there can be no question or revisiting the decision merely based on the submission made by Natco regarding the divisional application and its outcome. The Court also concluded that the suppression of a fact that, if disclosed, would alter the result of the case, which can be regarded as a material fact, would justify a revisitation of the order of interim injunction. While refusing the present application filed by Natco, the Court held that refusal of the divisional application does not, either in fact or in law, extinguish the suit patent. The compound Ceritinib is covered under the suit patent; thus, until and unless the suit patent is invalidated, it remains valid, and any exploitation of Ceritinib would amount to infringement of the suit patent.

This judgment by the Delhi High Court has once again established robust jurisprudence in favour of the innovators. This judgement would send a good signal globally that India gives due respect to the innovator's rights, and just on the basis of public interest, the rights of the patentees would be jeopardized. This would definitely encourage the innovators to secure their intellectual property in India. We expect more such judgments from the courts, which would send a strong message to the public at large that infringement of intellectual property rights may not be tolerated by Indian courts.

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