Biogen secured an interim injunction on 29 July 2022 preventing Neuraxpharm and Laboratorios Lesvi (Neuraxpham) from launching a generic version of Biogen's multiple sclerosis drug Tecfidera. At a subsequent hearing on 2 August 2022, in which Neuraxpharm did not appear, the High Court granted Biogen an interlocutory injunction. Neuraxpharm subsequently applied to have the injunction lifted.
Twomey J delivered his judgment on 26 October 2022. He discharged the interlocutory injunction, and refused Biogen a new injunction in lieu.
Judgment of Twomey J
The Parent Patent
Of significant influence behind Twomey J's judgment was the fact that the parent of the patent in question had been revoked by the Technical Board of Appeal in January 2022. The divisional patent, upon which Biogen sought the injunction, was granted on 20 July 2022 (nine days before the grant of the interim injunction). In light of the parent patent having been held invalid, Twomey J was of the view that Biogen had enjoyed "an unlawful monopoly" in Tecfidera since the grant of the parent patent; that this monopoly came at a large cost to the taxpayer, and that such injustice could weigh in the balance when deciding the matter.
Justice Twomey found that the public interest arose for consideration as the injunction was sought by the owner of the patented drug to prevent the sale of a cheaper generic drug in Ireland which would cost the HSE and taxpayer circa €8 million between the time of the application before him, and the ultimate trial date in 18 months. Twomey J observed that the risk of taxpayer injustice was further compounded by the fact that if the divisional patent was ultimately revoked at the substantive trial, the taxpayer would have overpaid for a drug based on an unlawful monopoly.
The judge commented that the "unlawful monopoly" issue was the decisive factor in the balance of justice. Biogen, having previously benefitted from an invalid parent patent, was now seeking to benefit from a monopoly derived from that invalid parent patent.
Adequacy of Damages
Twomey J acknowledged that while it would be difficult to precisely calculate the exact amount of financial harm suffered by each party, it would not be impossible. He concluded that damages would be an adequate remedy for both parties, if it turns out the injunction was wrongly refused or wrongly granted.
"Clearing the Way"
Twomey J was not swayed by Biogen's claim that the defendant did not "clear the way" for the generic drug by commencing invalidity proceedings against the divisional patent in Ireland because Neuraxpharm had already secured determinations of invalidity against the parent patent.
While Neuraxpharm was successful in its application, the discharge of the interlocutory injunction was stayed pending an appeal by Biogen. Therefore, at the time of writing, the injunction remains in force.
Biogen's appeal was heard by the Court of Appeal (COA¬) on 20 December and focused on several aspects of Twomey J's decision including:
- The conclusion that Biogen had benefited from an unlawful monopoly for seven years through its now invalidated parent patent. Biogen argued that Tecfidera was separately protected by regulatory data exclusivity for much of that period and the validity of the parent patent was not a relevant factor in that respect; and
- The emphasis on the public interest in weighing the balance when enforcing the rights of a patentee. Biogen questioned the approach of the High Court on this issue and the decision of the COA is awaited with particular interest; and
- The view that damages would be an adequate remedy. Biogen have questioned the finding that damages would be an adequate remedy in this case.
The COA judgment is expected in early 2023. We will update you further when the judgment issues.
Contributed by Aisling Casey, Kate Sullivan.
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