Home Knowledge Preliminary Injunction Refusal in Generic Drug Patent Infringement Case Overturned

Preliminary Injunction Refusal in Generic Drug Patent Infringement Case Overturned

The Court of Appeal has ruled in favour of Biogen, overturning the High Court’s decision to refuse preliminary injunctive relief to restrain Neuraxpharm from infringing Biogen’s patent.

The Court of Appeal held the High Court erred in principle in having regard to the fact that Biogen had an unlawful monopoly based on a parent patent (which was ultimately declared invalid) and, more particularly, that it was a decisive factor against the granting of an injunction.

High Court Decision

In its decision of 26 October 2022 (discussed here), the High Court discharged the interlocutory injunction secured by Biogen on 2 August 2022, which prevented the launch of a generic form of Biogen’s multiple sclerosis drug, Tecfidera, until the trial of the main action between the parties.

This decision was stayed pending the appeal, which effectively meant that the injunction secured by Biogen on 2 August 2022 remained in situ.

The High Court pointed to several factors in its decision to overturn the injunction, most notably that:

  • The patent in suit was a divisional of a parent patent which the Technical Board of Appeal had revoked in January 2022. It was the view of the High Court that Biogen had enjoyed an “unlawful monopoly” since the grant of the parent patent; that this monopoly came at a high cost to the taxpayer; and that this injustice was a “decisive factor” to be weighed in the balance when deciding the matter.
  • Flowing from that injustice, a public interest consideration arose in maintaining the injunction and preventing the sale of the generic that would deny the public health authority and, therefore the taxpayer, the opportunity to save circa €8 million in the period between the injunction hearing and the hearing of the main action.
  • Damages would be an adequate remedy for both parties.
  • Biogen’s argument that the defendants did not clear the way was unconvincing given the successful revocation actions against the parent patent.

Court of Appeal Decision

In allowing Biogen’s appeal, the Court of Appeal concluded that:

  • The High Court erred in its determination that the monopoly afforded to Biogen by the parent patent was made “unlawful” by its subsequent revocation. Similarly, the profits derived from that monopoly were not “tainted with impropriety”.
  • The public interest in cheaper drugs does not override a patent holder’s rights as a decisive factor against granting a preliminary injunction.
  • In any event, the divisional patent in question is a standalone patent, presumptively valid upon grant. A generic manufacturer must make a strong case for invalidity to overcome this presumption. The trial judge erred in not giving appropriate weight to the decision of the Examining Division of the EPO to grant the divisional patent in determining the presumptive validity of the divisional patent. Additionally, the outcome of interlocutory applications in other Member States did not afford a basis to refuse relief, nor could these decisions be said to be “successive determinations” in the respondents’ favour.
  • The failure to clear the path is a factor to which weight should be given.

The Court of Appeal decision provides further clarity on the principles set out by the Supreme Court in Merck Sharpe & Dohme v Clonmel Healthcare (discussed here). It also confirms that the presumption of validity of a patent is a determinative factor in deciding whether to grant preliminary interlocutory relief.

For further information, please contact any member of our contentious intellectual property team.

Contributed by
Aisling Casey, Kate Sullivan, Charleen O’Keeffe