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.
Delhi High court decision:
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.
Excerpts from the order:
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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Originally published 19 February2021.
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