Actavis Group Ptc Ehf (a company incorporated under the laws of Iceland) (Claimant in HP-201400004-/Appellant) Actavis UK Ltd (Fourth Party in HP-2014000040/Appellant) Teva UK Ltd and Another (Claimants in HP-2015000048/Appellants) Generics (UK) Ltd (t/a Mylan) (Claimant in HP-2015000062/Appellant) v Icos Corporation (a company incorporated under the laws of the State of Washington, USA) Eli Lilly and Company (a company incorporated under the laws of the State of Indiana, USA) (Third Party)
| Jurisdiction | England & Wales |
| Judge | Mr. Justice Henry Carr |
| Judgment Date | 10 November 2017 |
| Neutral Citation | [2017] EWHC 2880 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP-2014-000040 |
| Date | 10 November 2017 |
[2017] EWHC 2880 (Pat)
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
Mr. Justice Henry Carr
Case No: HP-2014-000040
HP-2015-000012, HP-2015-000048 and HP-2015-000062
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.
Judgment Approved
Introduction
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 13 th 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.
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.
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.
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
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 the unusual task, for a first instance judge, of deciding for the purposes of this application whether the application for permission to appeal, and any subsequent appeal to the Supreme Court has a real prospect of success.
Dr. Turner, who argued this case with considerable skill on behalf of Lilly, submitted that the Court of Appeal has fallen into error on an important point of law. He said that the court should have asked itself two questions. First, was it obvious that a dose of 5 mg or less of tadalafil taken once daily would be efficacious for the treatment of erectile dysfunction at the priority date from the prior art read in the light of common general knowledge. Secondly, was it obvious to try this dosing regimen for this therapeutic purpose at the priority date with a reasonable prospect of success. Both of those questions are to be judged at the priority date, and not in the light of information subsequently obtained. If the answer to both questions is no, as in the present case, then the patent is inventive. Dr. Turner submitted the Court of Appeal fell into an error, which the judge at first instance did not make, by postulating a series of clinical trials, the results of which would then lead to a further clinical trial; the ultimate result of which would be to test the claimed dosage regimen of tadalafil, but even then, without a realistic prospect that it would be sufficiently efficacious to treat ED.
At [133] of his judgment in the present case Kitchin LJ referred to the guidance given by the Court of Appeal as to the relevance of whether a route was obvious to try and the skilled team's expectation of success in Novartis AG v Generics UK Limited (trading as Mylan) [2012] EWCA Civ 1623. In particular, he referred to paragraph 55 of that judgment, where he said:
"I of course accept that a patentee is entitled to have the issue of obviousness assessed by reference to the invention he has described and claimed. This was made clear by Lord Hoffmann in Conor at [19]. In deciding whether the invention was obvious to the skilled but unimaginative addressee at the priority date the court will have regard to all the circumstances of the case including, where appropriate, whether it was obvious to try a particular route with a reasonable or fair expectation of success. What is a reasonable or fair expectation of success will again depend upon all the circumstances and will vary from case to case. Sometimes, as in Saint Gobain, it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. So, as this court explained in that case, simply including something in a research project in the hope that something might turn up is unlikely to be enough. But I reject the submission that the court can only make a finding of obviousness where it is manifest that a test ought to work. That would be to impose a straightjacket upon the assessment of obviousness which is not warranted by the statutory test and would, for example, preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable." (emphasis added).
That statement of law, which is very well established, includes the proposition that where the results of an entirely routine test are unpredictable, nonetheless there may be a finding of obviousness. It is not inventive to carry out a routine test, and if the test results in an unexpected bonus, it is still not an invention. If this appeal is to succeed, that proposition needs to be successfully challenged.
Kitchin, Floyd and Lewison LJ gave separate judgments setting out why they considered that the appeal should be allowed....
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