Warner-Lambert Company, LLC v Actavis Group PTC EHF and Others The Secretary of State for Health (Proposed Intervener)
Jurisdiction | England & Wales |
Judge | Lord Justice Floyd,Lord Justice Ryder,Lady Justice Arden DBE |
Judgment Date | 28 May 2015 |
Neutral Citation | [2015] EWCA Civ 556 |
Docket Number | Case No: A3 2015 0221 |
Court | Court of Appeal (Civil Division) |
Date | 28 May 2015 |
[2015] EWCA Civ 556
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
The Hon Mr Justice Arnold
Royal Courts of Justice
Strand, London, WC2A 2LL
Lady Justice Arden DBE
Lord Justice Ryder
and
Lord Justice Floyd
Case No: A3 2015 0221
A3 2015 0669
and
Justin Turner QC and Tim Austen (instructed by Allen & Overy LLP) for the Appellant
Adrian Speck QC (instructed by Powell Gilbert LLP) for the Respondents
Richard Davis (instructed by the Government Legal Department) for the Secretary of State for Health
Hearing dates: 28, 29 April 2015
This appeal raises an issue of construction of a patent claim in "Swiss" form, that is to say a claim for the use of a compound in the production of a medicine for use in a particular therapeutic indication. In particular, the appeal is concerned with what is meant by the requirement in such claims that the medicament be "for" a therapeutic indication. The issue is an important one, as it concerns the scope of protection to be afforded to what is recognised to be an important class of inventions in the pharmaceutical field, namely those which are concerned with the discovery of new uses for known medicines.
The appeal is from two judgments of Arnold J in the Patents Court. The first ( [2015] EWHC 72 (Pat)) is dated 21 January 2015, and I shall refer to it as "the first judgment". The second judgment under appeal ( [2015] EWHC 249 (Pat)) is dated 6 February 2015. For reasons which I will explain, I will call this "the third judgment". By the first judgment Arnold J dismissed an application by the claimant and appellant, Warner-Lambert Company LLC ("Warner-Lambert"), for mandatory interim injunctive relief against the defendants (together "Actavis") based on its European Patent (UK) No 0 934 061 ("the patent"). The judge did so on the twin grounds that Warner-Lambert had shown no serious question to be tried on direct or indirect infringement of the patent, and that the interim relief sought was not justified on the balance of justice. I initially refused permission to appeal from the first judgment on the ground that, whilst there was clearly room for argument as to the construction of the claim and the test for infringement in such cases, there was no realistic prospect of this court interfering with the judge's evaluation of the balance of justice. As Warner-Lambert needed to succeed on both issues, an appeal would have had no real prospect of overturning the judge's refusal of interim relief. I was subsequently persuaded at an oral hearing that the judge might have relied, in evaluating the balance of justice, on matters for which there was no evidence, and I accordingly granted permission in relation to both issues.
Subsequent to the first judgment, Actavis applied to strike out the infringement claims, no doubt encouraged by the judge's finding that Warner-Lambert had not established a serious issue to be tried. By the time of the hearing of that application on 3 February 2015 Warner-Lambert had applied to amend its particulars of infringement. In a reserved judgment ( [2015] EWHC 223 (Pat)) delivered in the morning of 6 February 2015 "the second judgment") the judge explained that he considered that Warner-Lambert had still failed to plead a case of direct infringement, but nevertheless allowed that case to proceed to trial in view of the fact that an appellate court might in due course take a different view in an area of the law which was still developing, and that it was sensible in such circumstances to decide the facts first. There is no appeal from the second judgment. Warner-Lambert does not agree with the judge's reasoning in the second judgment, but given that the matter will now proceed to trial there is no order (as opposed to finding) against which it could appeal. In the third judgment, delivered later on the same day, the judge decided to strike out the claim of indirect infringement, and thus refused to allow it to proceed to trial. We have before us an application for permission to appeal the judge's decision on indirect infringement in the third judgment, with the appeal to follow if permission is granted. We heard full argument on indirect infringement. I would grant permission to appeal.
The current position is therefore that, subject to this appeal, the action is proceeding to a trial, on direct infringement only, on a date which has now been fixed for the end of June this year, notwithstanding the findings by Arnold J that the claim of direct infringement as before him at the time of the first judgment did not raise a serious issue to be tried and that the amended claim as before him at the time of his second judgment still had no real prospect of success.
Before us the case for Warner-Lambert was argued by Mr Justin Turner QC with Mr Tim Austen, and that for Actavis by Mr Adrian Speck QC.
The factual background
The patent claims the use of the drug pregabalin for the preparation of a pharmaceutical composition for treating pain (claim 1) or for treating neuropathic pain (claim 3). The remaining details of the patent do not matter for the purposes of the appeal. Patent protection for the drug molecule itself expired in 2013. I will refer to treatment for pain as "the patented indication", without predetermining any question about the scope of the claim.
Warner-Lambert, the patentee, is an indirect subsidiary of Pfizer Inc and part of a group of companies which includes Pfizer Ltd ("Pfizer").
Pregabalin is marketed by Warner-Lambert under the trade mark Lyrica with the benefit of marketing authorisations (held by Pfizer) not only for neuropathic pain but also for generalised anxiety disorder ("GAD") and epilepsy. I will refer to these two latter indications as "the non-patented indications", because no patent protection applies to the use of pregabalin in the manufacture of a medicine to treat these conditions. Lyrica had global sales in 2013 of US$ 4.6 billion. UK sales in the same year were about US$ 310 million. It is therefore an enormously successful pharmaceutical. Data made available by IMS Health showed that in the first nine months of 2014 54% of sales were for treating pain, 12% for psychiatric conditions (of which 18% was GAD), 2% for epilepsy and 32% for unspecified other diseases. Warner-Lambert says that the figure for pain is substantially higher, as some of the 32% categorised as "other diseases" is in fact for pain. Whether or not that is so is immaterial for present purposes. The market for the non-patented indications is, on any view, a real and substantial one, even if smaller than the market for the patented one.
Actavis' product is marketed under the trade mark Lecaent. Actavis have now obtained a marketing authorisation for Lecaent on the basis that Lecaent and Lyrica are bio-equivalent. So there can be no doubt that Lecaent is in fact suitable for treating neuropathic pain. However, the summary of product characteristics ("SmPC") and patient information leaflet ("PIL") for Lecaent only identify the medicine as suitable for epilepsy and GAD, i.e. the non-patented indications. It is important to understand that neither the SmPC nor the PIL contains any warning or injunction against using the medicine for other indications or indeed for the patented indication. The same is true of the packaging of the product. A marketing authorisation which is restricted in this way is described in the industry as a "skinny label" to reflect the narrowness of the indications compared with another authorisation with a wider range of indications. Another expression which is used is that the patented indication has been "carved out".
Actavis' product is made in Bulgaria by its Bulgarian group company and imported into this country for distribution here by the second and third defendants.
When a doctor prescribes a drug for a patient, he or she may do so by brand name or by reference only to its international non-proprietary name or "INN". Prescribing by INN is referred to as prescribing "generically", because it does not identify any particular manufacturer's product, only the drug itself. Prescribers are strongly encouraged to prescribe generically by means of guidance from NHS England and others and financial pressure from Clinical Commissioning Groups and Health Boards. Prescription software also hard-wires generic prescribing into doctors' practices, by forcing doctors to go through a decision tree which results in the prescription of the most economical drug which will be therapeutically effective.
Where a drug is prescribed by brand in the UK the pharmacist is obliged to dispense the branded product. Conversely where the INN is used, i.e. the drug is prescribed generically, the pharmacist is free to dispense either the branded drug or the generic one. There is a considerable incentive for the pharmacist to dispense the generic drug: the pharmacist will still be reimbursed (at least in the current circumstances relating to pregabalin) at the price for NHS reimbursement of the branded drug under the Drug Tariff. On the assumption that the generic drug is cheaper, the pharmacist will make more profit if he dispenses it.
Prescriptions do not normally specify the condition for which the drug is being prescribed. Accordingly, when the prescription is presented...
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