Dr Reddy's Laboratories (UK) Ltd v Warner-Lambert Company LLC
| Jurisdiction | England & Wales |
| Judge | Lord Justice Arnold,Lord Justice Nugee,Lord Justice Males |
| Judgment Date | 01 February 2023 |
| Neutral Citation | [2023] EWCA Civ 73 |
| Docket Number | Case No: CA-2022-000735 |
| Court | Court of Appeal (Civil Division) |
[2023] EWCA Civ 73
Lord Justice Males
Lord Justice Arnold
and
Lord Justice Nugee
Case No: CA-2022-000735
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE, BUSINESS AND PROPERTY
COURTS OF ENGLAND AND WALES, INTELLECTUAL PROPERTY LIST (ChD),
PATENTS COURT
Mr Justice Zacaroli
Royal Courts of Justice
Strand, London, WC2A 2LL
Richard Boulton KC and Tim Austen (instructed by Kirkland & Ellis International LLP) for the Appellant
Brian Nicholson KC and Christopher Hall (instructed by Mishcon de Reya LLP) for the First Respondent
Douglas Campbell KC and Daniel Selmi (instructed by RPC) for the Seventh to Twenty-first Respondents
Hearing dates: 17–18 January 2023
Approved Judgment
This judgment was handed down by the Court remotely by circulation to the parties' representatives by email and release to The National Archives. The date and time for hand-down is deemed to be 10:30 on 2 February 2023.
Introduction
This is an appeal by the Inquiry Defendant (“Warner-Lambert”) against an order of Zacaroli J dated 24 March 2022 in so far as it refused Warner-Lambert permission to make two amendments to its Points of Defence to claims by the Inquiry Claimants for orders that Warner-Lambert compensate the Inquiry Claimants for losses that the Inquiry Claimants allege they have sustained by reason of interim orders made by the Patents Court pursuant to cross-undertakings given to the Court by Warner-Lambert when those orders were made.
The judge granted Warner-Lambert permission to appeal with respect to its application to make the second amendment, but refused Warner-Lambert permission to appeal in relation to the first amendment. I granted Warner-Lambert permission to appeal with respect to the first amendment, whereupon the First Inquiry Claimant (“Dr Reddy's”) served a respondent's notice seeking to uphold the decision on additional or alternative grounds. During the hearing of the appeal Warner-Lambert twice applied for permission to amend its grounds of appeal and Dr Reddy's applied for permission to amend its respondent's notice. I would grant these applications, which were largely unopposed, and accordingly I shall address all the grounds relied upon by the parties.
Background
The background to the present appeal is of considerable complexity. It arises out of four sets of proceedings concerning European Patent (UK) No. 0 934 061 (“the Patent”): the first two between Warner-Lambert and Pfizer Ltd (“Pfizer”) on the one hand and Generics (UK) Ltd trading as Mylan (“Mylan”) and Actavis Group PTC ehf and related companies (collectively “Actavis”) on the other hand; the third between Warner-Lambert and Sandoz GmbH and Sandoz Ltd (collectively “Sandoz”); and the fourth between Warner-Lambert and Dr Reddy's.
Second medical use patents with claims in Swiss form
It has increasingly been recognised over the past 30 years or so that it is important to find new uses for existing medicines. Existing medicines have the advantage that they are known compounds which have been shown to have acceptable safety profiles, and therefore need much less testing from that perspective. Experience shows that a compound which has therapeutic benefit in one application not infrequently turns out to have therapeutic benefit in another application (sometimes more than one other application) which may be quite different to the first application. Thus there is significant potential for, and value in, finding such second (and third, etc.) medical uses. Discovering such second medical uses requires difficult and expensive research, however. How is such research to be funded? The answer which has been provided by the European patent system is to grant patents for second (and subsequent) medical uses of known compounds. The monopoly thus conferred on the inventor who finds the second medical use provides the return on the investment required to fund the research.
There are two significant obstacles to the grant of patents for second medical uses under the European patent system: first, the compounds themselves are not new, which is a fundamental requirement for patentability of a product; and secondly, methods of treatment of the human (or animal) body by therapy are not patentable, in order to protect doctors from claims for patent infringement. The European patent system has attempted to overcome these obstacles in two ways.
The first way was through a piece of judicial law-making which fudged some of the difficult issues. This involved the use of claims in Swiss form i.e. “use of substance X for the preparation of a medicament (or pharmaceutical composition) for treating indication Y” (a purpose-limited process claim): see G 05/83 Eisai/Second medical indication [1985] OJ EPO 64.
The second way was through legislation, namely Article 54(5) of the European Patent Convention 2000, which enables the grant of claims in the form “product X for treating indication Y” (a purpose-limited product claim). These have now superseded claims in Swiss form. This is a more satisfactory solution to the problems, although difficulties remain.
The Patent
The Patent was a second medical use patent with claims in Swiss form. The claims were directed to the use of pregabalin for treating pain. The claimed priority date was 24 July 1996. The application was filed on 16 July 1997. The Patent was granted on 28 May 2003. The claims of the Patent were centrally limited on 21 January 2015. The Patent expired on 16 July 2017. The proprietor of the Patent was Warner-Lambert.
Claims 1, 2 and 3 of the Patent (as centrally limited on 21 January 2015) were as follows:
“1. Use of [pregabalin] or a pharmaceutically acceptable salt thereof for the preparation of a pharmaceutical composition for treating pain.
2. Use according to Claim 1 wherein the pain is inflammatory pain.
3. Use according to Claim 1 wherein the pain is neuropathic pain.”
Claims 4–14 were limited to various specific types of pain. Claims 5 (“post-operative pain”), 7 (“burn pain”), 8 (“gout pain”) and 9 (“osteoarthritic pain”) covered specific types of inflammatory pain. Claims 10 (“trigeminal neuralgia”), 11 (“acute herpetic and postherpetic pain”) and 12 (“causalgia pain”) covered specific types of neuropathic pain, and in particular specific types of peripheral neuropathic pain.
The statutory framework
Section 60 of the Patents Act 1977 provides, so far as relevant:
“ Meaning of infringement.
(1) Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say—
…
(b) where the invention is a process, he uses the process or he offers it for use in the United Kingdom when he knows, or it is obvious to a reasonable person in the circumstances, that its use there without the consent of the proprietor would be an infringement of the patent;
(c) where the invention is a process, he disposes of, offers to dispose of, uses or imports any product obtained directly by means of that process or keeps any such product whether for disposal or otherwise.
(2) Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom.
…
(5) An act which, apart from this subsection, would constitute an infringement of a patent for an invention shall not do so if—
…
(c) it consists of the extemporaneous preparation in a pharmacy of a medicine for an individual in accordance with a prescription given by a registered medical or dental practitioner or consists of dealing with a medicine so prepared;
…”
Between 1 January 2005 and 1 October 2017 section 70 of the 1977 Act provided, so far as relevant:
“ Remedy for groundless threats of infringement proceedings.
(1) Where a person (whether or not the proprietor of, or entitled to any right in, a patent) by circulars, advertisements or otherwise threatens another person with proceedings for any infringement of a patent, a person aggrieved by the threats (whether or not he is the person to whom the threats are made) may, subject to subsection (4) below, bring proceedings in the court against the person making the threats, claiming any relief mentioned in subsection (3) below.
(2) In any such proceedings the claimant or pursuer shall, subject to subsection (2A) below, be entitled to the relief claimed if he proves that the threats were so made and satisfies the court that he is a person aggrieved by them.
(2A) If the defendant or defender proves that the acts in respect of which proceedings were threatened constitute or, if done, would constitute an infringement of a patent—
(a) the claimant or pursuer shall be entitled...
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