Biogen MA Inc. v Laboratorios Lesvi SL

• Jurisdiction: Ireland
• Judge: Ms. Justice Costello
• Judgment Date: 29 March 2023
• Neutral Citation: [2023] IECA 71
• Court: Court of Appeal (Ireland)
• Docket Number: Record Number: 2022 No. 249

Between/

Biogen MA Inc. and Biogen International GmbH

Plaintiffs/Appellants

and

Laboratorios Lesvi S.L. and Neuraxpharm Ireland Limited

Defendants/Respondents

[2023] IECA 71

Costello J.

Noonan J.

Allen J.

Record Number: 2022 No. 249

THE COURT OF APPEAL

CIVIL

Injunction – Patent – Infringement – Appellants seeking an injunction restraining the respondents from infringing the appellants’ patent – Whether damages were an adequate remedy

Facts: The appellants, Biogen MA Inc. and Biogen International GmbH, sought an injunction restraining the respondents, Laboratories Lesvi S.L. and Neuraxpharm Ireland Ltd, from infringing the appellants’ European Patent No. 2 653 873 (the 873 patent) by the launch of their generic medicinal product (the generic). On 26 October 2022, the High Court (Twomey J), discharged the order of Owens J granting an interlocutory injunction restraining the launch of the generic and refused to grant the interlocutory injunctions sought by the appellants. The appellants appealed to the Court of Appeal.

Held by Costello J that the trial judge erred in having regard to the benefits which accrued to the appellants from the parent patent at the expense of the taxpayer prior to its revocation when determining that they were not entitled to an injunction to restrain an imminent breach of the divisional patent, the 873 patent. She held that the monopoly enjoyed prior to the revocation of the parent patent was not unlawful and the profits generated were not tainted with impropriety. She held that the profits derived from the exploitation of a registered patent which is subsequently revoked is not a matter to which a court may have regard when considering an application to restrain infringement of a different patent; in so doing the High Court failed to give effect to the separate rights enjoyed under each patent and the presumption of validity which applies in favour of each patent until revoked. She held that the trial judge erred in concluding that the public interest in cheaper drugs can override the rights of the patent holder in advance of a determination that the claim is invalid and that this was a decisive factor against the granting of an injunction. She held that the trial judge erred in tentatively concluding that the respondents’ case for the invalidity of the 873 patent was strong and accordingly was a factor which justified the court in refusing to restrain the respondents from launching the generic; he did so in the absence of independent expert evidence which could support his conclusion and it was not sufficient to rely upon the opinion of the respondents’ expert lawyer. She held that, in reaching his conclusion, he failed to give appropriate weight to the decision of the Examining Division of the European Patent Office to grant the 873 patent. She held that the decisions of the courts of other Member States did not afford a basis to refuse the appellants relief. She held that there were no judgments on the substance of the claim of invalidity; furthermore, the decisions variously granted and refused interlocutory relief and could not be said to be “successive determinations” in the respondents’ favour. She held that there were no material differences between the facts in this case and those in Merck Sharpe & Dohme v Clonmel Healthcare [2019] IESC 65 which would justify the High Court in reaching the opposite conclusion to the Supreme Court on the question of whether the parties could be adequately compensated by damages if they lost on the application for an injunction but succeeded at trial; the High Court erred in so doing. She held that the trial judge was correct to hold that the presumption of the validity of the 873 patent was determinative in favour of the grant of an injunction on the facts in this case, but he fell into error in concluding that this was outweighed by the “unusual factors” to which he erroneously had regard. She held that the trial judge was correct to discharge the injunction granted on 2 August 2022 in the absence of the respondents and to rehear the application for an interlocutory injunction, as any other course would have inflicted a grave injustice on the respondents with no corresponding detriment to the appellants.

Costello J allowed the appeal in relation to refusal of an injunction restraining the infringement of the 873 patent and refused the appeal in respect of the discharge of the injunction of the 2 August 2022.

Appeal allowed in part.

[Approved]

[No Redaction Needed]

JUDGMENT of Ms. Justice Costello delivered on the 29 ^th day of March, 2023

1 . The issue for consideration in this appeal is whether the appellants are entitled to an injunction to restrain the respondents from infringing the appellants' European Patent No. 2 653 873 (“the 873 patent”) by the launch of their generic medicinal product (“the generic”).

Background

2 . The appellants are each part of the international Biogen group of companies, which is a global biotechnology business involved in the research of neurological and neurodegenerative diseases. The medicinal products at issue in these proceedings are used in the treatment of multiple sclerosis.

3 . On 7 February 2008 a member of the Biogen group filed an application for a patent for the treatment of multiple sclerosis with the active ingredient dimethyl fumarate (“DMF”) with the European Patent Office (the “EPO”). On 29 May 2013, EP 2 137 537 (“the parent patent”) was granted by the Examination Division of the EPO. On 30 January 2014 Tecfidera ^® was authorised as a medicinal product in Europe for the treatment of multiple sclerosis. Tecfidera® was protected by the parent patent. 1

4 . Opposition papers were filed against the parent patent and on 13 June 2016 the parent patent was revoked by the Opposition Division of the EPO on the grounds of added matter and lack of inventive step. Biogen appealed this decision and the Technical Board of Appeal of the EPO affirmed the revocation of the parent patent on 20 January 2022. The reasons for the decision were published on 3 June 2022.

5 . The 873 patent is a divisional application of the parent patent. An application to recognise the patent was filed but the examination of the application was adjourned pending the determination of the appeal of the parent patent. Third parties wrote to the Examining Division of the EPO objecting to the grant of the 873 patent on the grounds that the parent patent had been revoked and the divisional patent, it was said, suffered from the same infirmities and thus no patent should be granted. On 28 April 2022 at an oral hearing in respect of the 873 patent, the Examining Division of the EPO indicated that it intended to grant the patent. The minutes of the hearing were published on 12 May 2022. On 23 June 2022 a committee of three members of the Examining Division of the EPO, one of whom had been part of the panel which affirmed the revocation of the parent patent, issued its decision to grant the 873 patent. The grant of the 873 patent was published in the European Patent Bulletin on 20 July 2022. Accordingly, the 873 patent has been in force in Ireland since 20 July 2022. If not revoked, it will expire on 7 February 2028.

6 . Biogen MA, the first appellant, is the proprietor of the 873 patent. Biogen International, the second appellant, is the exclusive licensee of the 873 patent in Ireland.

7 . The 873 patent protects the medical product, Tecfidera ^®, the active ingredient of which is dimethyl fumarate (“DMF”). Tecfidera ^® is the only DMF product currently available on the market in Ireland used to treat multiple sclerosis. Multiple sclerosis is an inflammatory auto immune disorder affecting the central nervous system. It causes a loss of function to the nervous system and a loss of communication between the brain and the body. There is no cure for MS and the primary purpose of MS treatment is to reduce the frequency of relapses in symptoms and to slow the progress of the disease.

8 . The Health Service Executive operates a High Tech Ordering and Management Scheme (“the High Tech Scheme”) for the provision of certain medicinal products. It publishes a list of agreed prescribable medicinal products which are reimbursed by the HSE. When clinicians prescribe a treatment, they must choose a specific product on the list. The order must be approved by the HSE before the order for the medicine can be placed by a pharmacy with a wholesaler. The medicine will be dispensed to the patient by the pharmacist once it is supplied by the wholesaler. The wholesaler is reimbursed by the HSE to the value of the agreed reimbursement price of each particular medicine. Thus, the HSE – and not the individual patient – incurs the cost of the medicinal product prescribed, which it agrees with the individual supplier.

9 . The respondents are engaged in the manufacture and sale of pharmaceuticals inter alia for disorders affecting the nervous system. The respondents decided to launch in the State a medicinal product known as dimethyl fumarate neuraxpharm, a generic version of Tecfidera ^® (the “generic”). The generic contains dimethyl fumarate and is used in the treatment of multiple sclerosis, and prima facie it infringes the 873 patent. On 13 May 2022 the Health Products Regulatory Authority granted the first named respondent a licence (bearing Licence Number EU/1/22/1637/001-002) to supply dimethyl fumarate neuraxpharm, the generic. On 27 July 2022 the first respondent's generic was included on the HSE's list of agreed prescribable medicinal products to be dispensed under the HSE's High Tech Scheme with effect from 1 August 2022. Subsequent to the institution of these proceedings, the respondents confirmed that they intended to launch the generic in the week commencing 1 August 2022 in advance of other generic manufacturers in order to secure “first mover advantage”. In this regard...