Actavis Group PTC EHF v ICOS Corporation, Court of Appeal - Patents Court, November 10, 2017, [2017] EWHC 2880 (Pat)

Resolution Date:November 10, 2017
Issuing Organization:Patents Court
Actores:Actavis Group PTC EHF v ICOS Corporation
 
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Neutral Citation Number: [2017] EWHC 2880 (Pat)

Case No: HP-2014-000040

HP-2015-000012, HP-2015-000048 and

HP-2015-000062

IN THE HIGH COURT OF JUSTICE

BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES

INTELLECTUAL PROPERTY (ChD)

PATENTS COURT

Appeal Refs: 2016/4110, 4094, 4104

Royal Courts of Justice

The Rolls Building

7 Rolls Buildings

London, EC4A 1NL

Date: 10/11/2017

Before:

MR. JUSTICE HENRY CARR

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Between:

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MR. ADRIAN SPECK QC and MR. THOMAS JONES (instructed by Bird &

Bird LLP) appeared for Actavis Group PTC EHF, and (instructed by Taylor Wessing LLP) appeared for Generics (UK) Limited (trading as Mylan) and (instructed by Pinsent Masons LLP) appeared for Teva Pharmaceutical Industries.

DR. JUSTIN TURNER QC and MS. KATHERINE MOGGRIDGE (instructed by

Allen & Overy LLP) appeared on behalf of ICOS and Eli Lilly.

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Page 9

MR. JUSTICE HENRY CARR:

Introduction

  1. This is an urgent application by the Defendant and Third Party (``Lilly'') for an interim injunction to stop the launch by the claimants, three well-known generic organisations, of 2.5 mg and 5 mg generic tadalafil for daily use for the treatment of erectile dysfunction (``ED''). The launch is schedule for Monday 13th November. On the same date, the SPC which protects 10 and 20 mg tadalafil for on demand use for ED will expire and generic equivalents will be launched.

  2. The background is that by a judgment dated 1st November 2017, [2017] EWCA Civ 1671 the Court of Appeal overturned a finding by Birss J that the patent in suit, which protected the 5 mg or less daily dosage regimen, was inventive. The Court of Appeal gave permission to Lilly to apply to the Patents Court for interim injunctive relief, pending determination of its application for permission to appeal to the Supreme Court. Lilly is currently petitioning the Supreme Court for permission to appeal. That application is unlikely to be determined for some months.

  3. It may seem counterintuitive to consider injunctive relief in respect of a patent which has been held to be invalid. However, where an appeal is pending which has a real prospect of success, the inquiry is more complex than might appear at first sight. The court is attempting to preserve the position so that if an appeal is successful, the appellant will not be deprived of the fruits of the appeal; or even if the appeal is not rendered nugatory, will not suffer greater harm which cannot be compensated in damages than the unsuccessful respondent.

  4. In Novartis v Hospira [2013] EWCA Civ 583; [2014] 1 WLR 1264 Floyd LJ summarised the principles to be applied when considering interim injunctive relief pending appeal at [41], which I shall apply in the present case:

    ``i) The court must be satisfied that the appeal has a real prospect of success.

    ii) If the court is satisfied that there is a real prospect of success on appeal, it will not usually be useful to attempt to form a view as to how much stronger the prospects of appeal are, or to attempt to give weight to that view in assessing the balance of convenience.

    iii) It does not follow automatically from the fact that an interim injunction has or would have been granted pre-trial that an injunction pending appeal should be granted. The court must assess all the relevant circumstances following judgment, including the period of time before any appeal is likely to be heard and the balance of hardship to each party if an injunction is refused or granted.

    iv) The grant of an injunction is not limited to the case where its refusal would render an appeal nugatory. Such a case merely represents the extreme end of a spectrum of possible factual situations in which the injustice to one side is balanced against the injustice to the other.

    v) As in the case of the stay of a permanent injunction which would otherwise be granted to a successful claimant, the court should endeavour to arrange matters so that the Court of Appeal is best able to do justice between the parties once the appeal has been heard.''

    Real prospect of success

  5. In contrast to the position of the appellant in Novartis v Hospira, Lilly has not been granted permission to appeal. The Court of Appeal has refused permission on the basis that the case does not raise a point of law of general public importance. From Lilly's perspective, any appeal is a hope which has not yet been realised. In those circumstances, it is common ground I have...

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