Biogen MA Inc & Anor v Laboratories Lesvi SL & Anor (Approved) [2023] IECA 71 (29 March 2023)

Biogen MA Inc & Anor v Laboratories Lesvi SL & Anor (Approved) [2023] IECA 71 (29 March 2023)

The Court of Appeal found that the trial judge erred in failing to properly apply the presumption of validity to the 873 patent and in giving disproportionate weight to the prior monopoly under the revoked parent patent and public interest factors. The divisional patent is independent and must be assessed on its own merits. The balance of justice, as established in Merck Sharpe & Dohme, favours the grant of an interlocutory injunction unless a strong case for invalidity is made, which was not sufficiently established by the respondents. Damages are not a fully adequate remedy for either party, and the status quo should be preserved pending trial.

Citation
[2023] IECA 71
Parties
Plaintiff/appellant: Biogen MA Inc.; Plaintiff/appellant: Biogen International GmbH; Defendant/respondent: Laboratorios Lesvi S.L.; Defendant/respondent: Neuraxpharm Ireland Limited
Jurisdiction
Ireland
Judgment Date
29 March 2023
Procedural Posture
Civil Appeal / Court of Appeal Judgment
Legal Topics
Patent Validity, Interlocutory Injunctions, Public Interest, Balance of Justice, Generic Pharmaceuticals
Intellectual Property Pharmaceutical Law Patent Validity Interlocutory Injunctions Public Interest Balance of Justice Generic Pharmaceuticals

Case Brief

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Parties

Biogen MA Inc.

Plaintiff/appellant

Biogen International GmbH

Plaintiff/appellant

Laboratorios Lesvi S.L.

Defendant/respondent

Neuraxpharm Ireland Limited

Defendant/respondent

Procedural Posture

Civil Appeal / Court of Appeal Judgment

Legal Issues

  1. 1 Whether appellants are entitled to an interlocutory injunction restraining respondents from infringing European Patent No. 2 653 873 by launching a generic medicinal product
  2. 2 Whether the divisional patent (873) is presumptively valid despite revocation of the parent patent
  3. 3 Adequacy of damages as a remedy for both parties

Ratio Decidendi

The Court of Appeal found that the trial judge erred in failing to properly apply the presumption of validity to the 873 patent and in giving disproportionate weight to the prior monopoly under the revoked parent patent and public interest factors. The divisional patent is independent and must be assessed on its own merits. The balance of justice, as established in Merck Sharpe & Dohme, favours the grant of an interlocutory injunction unless a strong case for invalidity is made, which was not sufficiently established by the respondents. Damages are not a fully adequate remedy for either party, and the status quo should be preserved pending trial.