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GRANT OF INTERIM INJUNCTION TO LUNDBECK AND INTERPRETATION OF THE TERM “EXPORT”
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A patent titled “Pharmaceutical Composition Comprising Phenyl Piperazine Derivatives as Serotonin Reuptake Inhibitors” (Patent number -IN227963) was granted to H LUNDBECK A/S & ANR on 27 December 2009. The IIN name of the molecule for which Lundbeck A/S obtained patent is Vortioxetine (anti-depressant drug).
The Plaintiff alleged that the defendants manufactured and exported substantial quantities of generic version of VORTIOXETINE to Latin America and Canada. Further, based on information received from an independent investigation agency appointed by the plaintiff, the defendants had imported the API Vortioxetine thrice in 2016 and were engaged in export of substantial quantities of Vortioxetine Hydrobromide to other countries. It further alleged that Defendant No. 2 (nowhere the name of the second defendant is mentioned) sought environmental clearance at Telangana to expand the manufacturing capacity of Defendant’s unit which includes manufacturing various products, one among the list of products being Vortioxetine Hydrobromide.
The defendants argued that the drug was not used in India, and the export of the drug was solely for research and development purpose. However, the defendants failed to provide any evidence which clarifies that the use of the drug was solely for research and development purpose.
The Delhi High court rejected the arguments presented by the defendants as they failed to provide any evidence in support of their arguments. Further, the court interpreted the term “Export from India” as “Use in India” and granted an interim injunction to the plaintiff.
Learned counsel for the defendants states that the defendants are not using the product in India but exporting it for the purposes of research and development purposes. However, at the moment, there is no material to come to this conclusion that this substantial amount of exports is only for research and development purposes. Further, under Section 107 of the Patents Act, export of the products from India would amount to use of the product in India.
Considering the averments in the plaint as also the documents filed therewith, this Court finds that the plaintiffs have made out a prima facie case in their favour and in case no ex-parte ad-interim injunction is granted, the plaintiffs would suffer an irreparable loss. The balance of convenience also lies in favour of the plaintiffs and against the defendants. Consequently, an ad-interim injunction is granted in favour of the plaintiffs and against the defendants in terms of prayer (i) and (ii) of para 23 of IA 12589/220 till the next date of hearing before this Court.
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Impact of Post Grant Opposition on Rights of a Patentee
An interim order of the High Court of Delhi in Novartis AG Vs. Natco Pharma Limited dealt with rights of a patent owner when the patent is subjected to post grant opposition. The judgment can be downloaded here
Natco had filed a post grant opposition on a patent granted to Novartise. The Opposition Board has reserved its order on April 10, 2019. In the meantime, Natco launched a product under the mark NOXALK even before the decision on the post grant opposition could be issued. In response, Novartise brought a suit seeking permanent injunction alleging infringement of its patent by Natco.
From a patent law perspective, the issue to be decided was whether a patent owner can initiate infringement proceedings when a post grant opposition is pending.
Natco relied on the decision of the Supreme Court in Aloys Wobben and Anr. vs. Yogesh Mehra and Ors. AIR 2014 SC 2210 to argue that once a post grant opposition is filed, the rights therein are yet to be crystallized, since the post grant opposition is pending. The Supreme Court in Aloys Wobben (supra) had held that right of a patent holder crystallizes only after challenges (post grant opposition) raised to the grant of a patent are disposed of favorably, to the advantage of the patent holder. Natco contended that, in the absence of such crystallization, the rights available to the patent holder under Section 48 of the Patents Act does not exist. In other words, Natco contended that since the decision in the post grant opposition is pending, Novartis lacks the right to initiate a patent infringement suit.
The judgment can be downloaded here
The High Court of Delhi, while acknowledging the decision of the Supreme Court, made a distinction that that although the rights are not crystalized, the rights still subsists even during the pendency of post grant opposition. The High Court further added that “Section 48 of the Patents Act grants rights in favour of a patentee, which are not affected during the pendency of a post-grant opposition.” Furthermore, the High Court observed that the facts of the present case in which an allegedly infringing product is launched prior to the decision in the opposition by the entity opposing the Patent, did not arise in the facts of Aloys Wobben (supra). In view of the foregoing, the High Court of Delhi passed an order restraining Natco, for the time being, from carrying out any fresh manufacturing of pharmaceutical preparations comprising of the active pharmaceutical ingredient (API), “Ceritinib”.
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