Biogen MA Inc. v Laboratorios Lesvi SL

• Jurisdiction: Ireland
• Judge: Mr. Justice Twomey
• Judgment Date: 26 October 2022
• Neutral Citation: [2022] IEHC 592
• Court: High Court
• Docket Number: Record No. 2022/3782P

Between

Biogen MA Inc.

and

Biogen International GmbH

Plaintiffs

and

Laboratorios Lesvi S.L

and

Neuraxpharm Ireland Limited

Defendants

[2022] IEHC 592

Record No. 2022/3782P

THE HIGH COURT

COMMERCIAL

Patent – Interlocutory injunction – Balance of justice – Plaintiffs seeking an interlocutory injunction – Whether the interlocutory injunction should be granted on the balance of justice

Facts: An interlocutory injunction was sought in a patent dispute about a drug which was used to treat multiple sclerosis (MS) and in particular to prevent the sale of a generic drug. The public interest arose because the owner and marketing company of the patented drug at issue – the plaintiffs, Biogen MA Inc and Biogen International GmbH (Biogen) – sought an injunction, pending the trial (at which the validity of the patent at issue would be decided). The injunction was sought against the owner and marketing company of a competing generic drug – the defendants, Laboratorios Lesvi SL and Neuraxpharm Ireland Ltd (Neuraxpharm). This dispute between two large international pharmaceutical companies related to the launch of a generic drug in Ireland to compete with a drug called Tecfidera. Like most patent disputes, it was a dispute about the money which is capable of being generated by the holder of a State-backed monopoly to supply a product/service based on the patent. In this case, the amount of money at issue was very significant, since Tecfidera had worldwide sales of $1.95 billion in 2021. Biogen sought to prevent the launch of the generic drug (Dimethyl Fumarate Neuraxpharm) by Neuraxpharm on the grounds that it infringed the underlying patent for Tecfidera, i.e. patent EP (IE) 2 653 873 (the 873 Patent). The launch of the generic was originally planned for 1st August, 2022, but it was halted by the grant of an interim injunction on the 29th July, 2022. However, Neuraxpharm claimed that this 873 Patent underlying Tecfidera was invalid on the grounds that the parent patent of the 873 Patent, i.e. patent EP 2 137 537 (the 537 Patent) had itself been revoked on the basis, inter alia, that it did not involve an inventive step. Furthermore, since Tecfidera was reimbursed in the amount of €1,030.80 per 240 mg dose by the HSE, while a similar amount of the generic had been agreed to be reimbursed by the HSE at €418.64 per 240 mg dose, Neuraxpharm claimed that preventing the launch of its generic drug would cost the taxpayer €5.5 million per annum. On that basis, it estimated that if an injunction was granted preventing the sale of the generic until the trial was heard in 12-18 months’ time, the taxpayer would miss the opportunity to save circa €8 million.

Held by Twomey J that the following were the circumstances which the Court believed tipped the fine balance, to which O’Donnell J referred in Merck Sharpe and Dohme v Clonmel Healthcare [2019] IESC 65, in favour of refusing the injunction: (i) Biogen had had an unlawful monopoly in Tecfidera for seven years; (ii) the Divisional Patent was a derivative of the invalid Parent Patent; (iii) the case for the invalidity of the Divisional Patent was strong; (iv) judgments in other jurisdictions which had rebutted the presumption in this case; (v) Biogen was not seeking to rely on the Divisional Patent in the UK; (vi) the considerable sums recouped to date from Tecfidera by Biogen; and (vii) the public interest/taxpayers’ interests.

Twomey J held that on the balance of justice, the interlocutory injunction should be refused and so the interim injunction should be lifted.

Relief refused.

JUDGMENT OF Mr. Justice Twomey delivered on the 26 ^th day of October, 2022

INTRODUCTION

1 . Should the public interest (in this instance, saving the taxpayer money) weigh in the balance of justice when a court is determining a dispute between two private parties, and, in particular, whether to grant an interlocutory injunction to one of those parties?

2 . In this case, an interlocutory injunction is being sought in a patent dispute about a drug which is used to treat multiple sclerosis (“MS”) and in particular to prevent the sale of a generic drug. The public interest arises because the owner and marketing company of the patented drug at issue (the plaintiffs, together referred to as (“Biogen”)) seek an injunction, pending the trial (at which the validity of the patent at issue will be decided). The injunction is being sought against the owner and marketing company of a competing generic drug (the defendants, together referred to as (“Neuraxpharm”)).

3 . If this injunction is granted, it will prevent the sale of the cheaper generic drug in Ireland and cost the HSE/taxpayer circa €8 million in the period of up to 18 months between now and the trial date.

4 . This dispute between two large international pharmaceutical companies relates to the launch of a generic drug in Ireland to compete with a drug called Tecfidera. Like most patent disputes, it is a dispute about the money which is capable of being generated by the holder of a State-backed monopoly to supply a product/service based on the patent. In this case, the amount of money at issue is very significant, since Tecfidera had worldwide sales of $1.95 billion in 2021.

5 . Biogen seeks to prevent the launch of the generic drug (Dimethyl Fumarate Neuraxpharm) by Neuraxpharm on the grounds that it infringes the underlying patent for Tecfidera, i.e. patent EP (IE) 2 653 873 (the “873 Patent”). The launch of the generic was originally planned for 1 ^st August, 2022, but it was halted by the grant of an interim injunction on the 29 ^th July, 2022.

6 . However, Neuraxpharm claims that this 873 Patent underlying Tecfidera is invalid on the grounds that the parent patent of the 873 Patent, i.e. patent EP 2 137 537 (the “537 Patent”) has itself been revoked on the basis, inter alia, that it did not involve an inventive step.

7 . Furthermore, since Tecfidera is reimbursed in the amount of €1,030. 80 per 240 mg dose by the HSE, while a similar amount of the generic has been agreed to be reimbursed by the HSE at €418. 64 per 240 mg dose, Neuraxpharm claims that preventing the launch of its generic drug will cost the taxpayer €5.5 million per annum. On this basis, it estimates that if an injunction is granted preventing the sale of the generic until the trial is heard in 12–18 months' time, the taxpayer will miss the opportunity to save circa €8 million.

8 . The primary issue therefore which this Court has to resolve is whether an interlocutory injunction should be granted to Biogen preventing the sale of the generic drug in Ireland pending the trial of the action, which trial will determine whether in fact Biogen's patent is invalid, as alleged by Neuraxpharm.

PRELIMINARY ISSUE

9 . However, this primary issue would not need to be addressed if this Court were to refuse to discharge the interlocutory injunction, which was granted to Biogen in August of this year and so is already in place. Accordingly, this Court must first deal with a preliminary issue, which is whether the interlocutory injunction, preventing the sale of the generic, which was granted during the court vacation (on 2 ^nd August, 2022), should be discharged, on the grounds that it was granted in the absence of Neuraxpharm and so without hearing its side of the case (even though notice of the hearing had been served on Neuraxpharm in accordance with the relevant court order).

10 . If the interlocutory injunction is discharged, then this Court will deal de novo with the question of whether Biogen is entitled to prevent the sale of the generic pending the trial, but now with the benefit of hearing from both sides.

Should existing interlocutory injunction be discharged?

11 . The background to this preliminary issue is that an ex parte interim injunction was granted by O'Moore J. to Biogen on the morning of Friday 29 ^th July, 2022, the last day of the legal term before the long vacation. The application for interlocutory relief was made returnable to the next business day, which was during the vacation, i.e. Tuesday, 2 ^nd August, 2022, the day after the Monday bank holiday.

12 . The first and second defendants are part of the Neuraxpharm group of companies and O'Moore J. provided for notice of his order to be served on them by email (the first defendant is based in Barcelona and second defendant is based in Ireland), to clientes@neurapharm.com, dpo@neuraxpharm.com and CRO@fod.ie. The first two email addresses were obtained by Biogen from the Neuraxpharm group websites. The CRO@fod.ie email address was the address provided on the CRO B1C Annual Return form of the second defendant. According to the terms of O'Moore J.'s order, the email notices were to be served, within hours of the hearing, i.e. by 2pm of Friday, 29 ^th July, 2022.

13 . The very tight time return date for the interlocutory injunction, i.e. the next business day in Ireland, and the consequent very tight deadline for the delivery of the emails, is illustrated by the fact that even Biogen itself, the party with notice of the injunction, failed to serve the notices inside the timeframe set by the court. This is because the emails were served on the defendants some 53 minutes after the 2pm deadline.

14 . On Tuesday 2 ^nd August, the morning of the return date, there was no appearance on behalf of the defendants and Owens J. granted the interlocutory application. No criticism is made by the defendants of Owens J.'s decision in this regard, since he was not aware of why the defendants were not present. However, this Court has been provided with sworn evidence, which has not been disputed by Biogen that due to the bank holiday weekend and the use of customer facing email addresses, which were not consistently monitored, the lawyers in Neuraxpharm did not become aware of the Tuesday morning interlocutory hearing until Tuesday afternoon, which was obviously too...