BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY (ChD)
Appeal Refs: 2016/4110, 4094, 4104
Royal Courts of Justice
The Rolls Building
7 Rolls Buildings
London, EC4A 1NL
B e f o r e :
| ACTAVIS GROUP PTC EHF
(a company incorporated under the laws of Iceland)
|Claimant in HP-2014-00004-/Appellant
|ACTAVIS UK LIMITED
||Fourth Party in HP-2014-000040/Appellant
|TEVA UK LIMITED
|TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(a company incorporated under the laws of Israel)
|Claimants in HP-2015-000048/Appellants
|GENERICS (UK) LIMITED (t/a MYLAN)
||Claimant in HP-2015-000062/Appellant
- and ľ
(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)
1st Floor, Quality House, 6-9 Quality Court, Chancery Lane, London WC2A 1HP.
Telephone No: 020 7067 2900. Fax No: 020 7831 6864 DX 410 LDE
DR. JUSTIN TURNER QC and MS. KATHERINE MOGGRIDGE (instructed by Allen & Overy LLP) appeared on behalf of ICOS and Eli Lilly.
Crown Copyright ©
MR. JUSTICE HENRY CARR:
"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
"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 . 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.
"168 Overall, the judge considered that the team would embark on the project with a reasonable expectation of success in establishing tadalafil as a safe, tolerable and effective treatment for tadalafil. However, the claimants had failed to prove that efficacy at 5mg tadalafil was predictable or worth considering by the skilled team based on the properties of tadalafil as compared to sildenafil. The team would know that in principle there would be a minimum effective dose for tadalafil but would also know that its definition depends on a value judgment made by the team. In relation to the dose ranging studies, the team would conduct them hoping for a dose response. Following discovery of a plateau starting at 25 mg or 10mg, there would "very likely" be a subsequent dose ranging study which included 5 mg. The team would include a 5 mg dose in this study hoping to see a dose response but that does not mean they would have a reasonable expectation that 5mg would produce a clinically relevant effect at all nor one with minimal side effects. Assuming a 5 mg /day dose of tadalafil was tested, it would not be tested with a reasonable expectation of success. The result for the 5 mg/day dose was a surprising one: the existence of a useful effect with reduced side effects. A number of value judgments would be required of a skilled team in a programme which reaches the claimed invention. One was to define the level of clinical effect to be regarded as relevant. Another was to embark on investigating daily dosing. An important value judgment was what to do when an unexpected plateau in the dose response has been identified at the same time as a marketable dose.
169 I think that it was in these final steps in his reasoning that the judge fell into error. The whole purpose of embarking on the routine Phase IIb dose ranging study was to identify a dose response. The discovery of a plateau indicated that the routine study would have to be repeated at a lower dose, because it was not complete. Completion of the study would inevitably lead the skilled team to test 5 mg/day, whether that dose was still on the plateau, or in a region of the curve where a dose effect is observed. Which it is does not matter, because the result is that the skilled person would at this stage have arrived at a dosing regimen within the claim.
170 Whilst the existence of value judgments on the road to the invention are of course highly material, the judgments identified by the judge in this passage of his reasoning were collateral ones which had no impact on the decision to complete the Phase IIb study, or were not true value judgments at all. Thus the judge relied on the need to define the level of clinical effect to be regarded as relevant, i.e. the minimum effective dose. The identification of a dose response and the identification of a minimum effective dose are, however, different things. The need to complete the Phase IIb study and identify a dose response does not involve exercising a judgment about minimum effective dose. Likewise, if by referring to the decision to embark on investigating daily dosing the judge was intending to refer to chronic daily dosing, that is also not an obstacle to completing the Phase IIb trial with the 5 mg maximum daily dose and arriving within the claim by that route. Finally, the judge relied on the decision as to what to do when faced with the plateau. There was ample evidence to suggest that, far from being a value judgment, investigating lower doses was something the skilled team would do without further thought.
171 I think the judge also allowed himself to be side-tracked by his undoubtedly correct conclusion that the skilled team would not have been able to predict that the 5 mg/day dose would be effective. If the only thing which was driving the skilled team to test the 5 mg dose was its level of expectation that a 5 mg dose might be effective, the judge's conclusion about expectation of success as to efficacy would be highly material. The skilled team does not generally undertake steps with a given objective in mind without a reasonable expectation of success in obtaining that objective. Phase IIb tests are, however, conducted with a separate objective, namely to identify a dose response. The judge rightly held that it is very likely that these routine tests would be conducted for precisely that reason. Indeed that is the only basis on which his conclusion that the skilled person was very likely to do such tests is understandable. The absence of an expectation of success as to efficacy is, in these particular circumstances, not relevant."
Unquantifiable loss to Lilly if the injunction is refused
Unquantifiable loss to the Claimants
Public interest considerations
i) Generic manufacturers already had to start proceedings about two and a half years before launch in order to clear the way of patent protection, allowing for an appeal to the Court of appeal. It would be impractical to extend this period to five years to allow for the rare case of an appeal to the Supreme Court. This would be contrary to the public interest as it would discourage generic manufacturers from entering the market, which benefited the public by making available lower cost medicines.
ii) There is a public interest in obtaining lower cost medicines. Even though a cross undertaking in damages could be extended to the health services, recovery would be costly and would never be 100%.