Actavis Group Ptc EHF v Pharmacia LLC
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 11 July 2014 |
| Neutral Citation | [2014] EWHC 2265 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HP14 A01503 |
| Date | 11 July 2014 |
[2014] EWHC 2265 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: HP14 A01503
Michael Tappin QC (instructed by Bird & Bird LLP) for the Claimant
Thomas Mitcheson QC and Tim Austen (instructed by Allen & Overy LLP) for the Defendant
Hearing date: 7 July 2014
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
This is my judgment on an application by the Defendant ("Pharmacia") for a stay of these proceedings until the final determination of parallel proceedings concerning the validity of European Patent No 1 536 792 ("the Patent") before the European Patent Office. The Claimant ("Actavis") opposes the application.
Background
The Patent is owned by Pharmacia, which is a subsidiary of Pfizer Inc, and exclusively licensed to Boehringer Ingelheim International GmbH ("Boehringer"). The Patent relates to sustained release dosage forms of pramipexole suitable for once-daily administration for the treatment of Parkinson's disease and restless leg syndrome. Its object is to provide a once-daily dosage form of pramipexole with side effects no greater than with a three times daily regimen of pramipexole immediate release tablets. Patent protection for pramipexole itself has expired.
The Patent claims priority from two applications dated 25 July 2002 and one application dated 18 June 2003. It was filed on 25 July 2003 and granted on 18 September 2013.
On 3 April 2014 Actavis commenced the present proceedings, in which it seeks an order for revocation of (the UK designation of) the Patent. Actavis challenges the validity of the Patent on the grounds that it is not entitled to any of the priority dates claimed, lacks novelty over two intervening publications, alternatively is obvious over one intervening publication and one prior publication, alternatively is insufficient. On 21 May 2014 Actavis applied for directions for trial. On 6 June 2014 Pharmacia applied for a stay. Both applications came before me on 7 July 2014. I reserved my decision on the stay application and made provisional directions for trial of the claim in a window between 1 June and 31 July 2015.
The deadline for opposing the Patent in the EPO expired on 18 June 2014. On 14 October 2013 Actavis filed an opposition. On 16 June 2014 a firm of European patent attorneys called Maiwald filed an opposition, no doubt acting for an undisclosed client. The oppositions raise similar, but not identical, grounds of invalidity as are raised in the English proceedings.
Actavis applied for a marketing authorisation for a generic sustained release formulation of pramipexole on 9 September 2013. Actavis has stated in evidence that it expects to be granted a marketing authorisation prior to the trial window, that it intends to launch its product as soon as possible thereafter and that it will give Pharmacia sufficient notice of the launch to enable Pharmacia to apply for an interim injunction to prevent it if Pharmacia so wishes. Actavis has not provided any further details of its preparations or plans, but I do not consider that it was necessary for it to do so.
Actavis has not suggested that its product will not infringe the Patent if the Patent is valid. Thus there is a clear threat by Actavis to infringe the Patent. Despite this, Pharmacia has not yet counterclaimed for threatened infringement of the Patent. Pharmacia has offered to do so, however, if required in order to facilitate expedition of the EPO proceedings (as to which, see below).
The UK market for sustained release pramipexole is worth about £14 million per annum. (According to Pharmacia, 47% of the market is represented by parallel imports, but I do not consider that this affects the present issue.) This makes it the second largest market in Europe, although significantly smaller than the German market. It is common ground that Actavis cannot effectively bring proceedings to revoke the German designation of the Patent while the EPO proceedings are ongoing, because such proceedings would automatically be stayed.
Although Pharmacia has given some rather vague evidence that third parties are selling non-infringing generic sustained release pramipexole elsewhere in Europe, there is no evidence that any third party has applied for a marketing authorisation in respect of an infringing generic product.
The applicable principles
The principles applicable to an application of this nature were recently reviewed by the Court of Appeal in IPCom GmbH & Co KG v HTC Europe Co Ltd [2013] EWCA Civ 1496, [2014] RPC 12 and re-stated by Floyd LJ at [68] as follows:
"1. The discretion, which is very wide indeed, should be exercised to achieve the balance of justice between the parties having regard to all the relevant circumstances of the particular case.
2. The discretion is of the Patents Court, not of the Court of Appeal. The Court of Appeal would not be justified in interfering with a first instance decision that accords with legal principle and has been reached by taking into account all the relevant, and only the relevant, circumstances.
3. Although neither the EPC nor the 1977 Act contains express provisions relating to automatic or discretionary stay of proceedings in national courts, they provide the context and condition the exercise of the discretion.
4. It should thus be remembered that the possibility of concurrent proceedings contesting the validity of a patent granted by the EPO is inherent in the system established by the EPC. It should also be remembered that national courts exercise exclusive jurisdiction on infringement issues.
5. If there are no other factors, a stay of the national proceedings is the default option. There is no purpose in pursuing two sets of proceedings simply because the Convention allows for it.
6. It is for the party resisting the grant of the stay to show why it should not be granted. Ultimately it is a question of where the balance of justice lies.
7. One important factor affecting the exercise of the discretion is the extent to which refusal of a stay will irrevocably deprive a party of any part of the benefit which the concurrent jurisdiction of the EPO and the national court is intended to confer. Thus, if allowing the national court to proceed might allow the patentee to obtain monetary compensation which is not repayable if the patent is subsequently revoked, this would be a weighty factor in favour of the grant of a stay. It may, however, be possible to mitigate the effect of this factor by the offer of suitable undertakings to repay.
8. The Patents Court judge is entitled to refuse a stay of the national proceedings where the evidence is that some commercial certainty would be achieved at a considerably earlier date in the case of the UK proceedings than in the EPO. It is true that it will not be possible to attain certainty everywhere until the EPO proceedings are finally resolved, but some certainty, sooner rather than later, and somewhere, such as in the UK, rather than nowhere, is, in general, preferable to continuing uncertainty everywhere.
9. It is permissible to take account of the fact that resolution of the national proceedings, whilst not finally resolving everything, may, by deciding some important issues, promote settlement.
10. An important factor affecting the discretion will be the length of time that it will take for the respective proceedings in the national court and in the EPO to reach a conclusion. This is not an independent factor, but needs to be considered in conjunction with the prejudice which any party will suffer from the delay, and lack of certainty, and what the national proceedings can achieve in terms of certainty.
11. The public interest in dispelling the uncertainty surrounding the validity of monopoly rights conferred by the grant of a patent is also a factor to be considered.
12. In weighing the balance it is material to take into account the risk of wasted costs, but this factor will normally be outweighed by commercial factors concerned with early resolution.
13. The hearing of an application for a stay is not to become a mini-trial of the various factors affecting its grant or refusal. The parties' assertions need to be examined critically, but at a relatively high level of generality"
I shall refer to the relevant paragraphs in this guidance as " IPCom 5" etc.
Application to the present case
It is common ground that, as stated in IPCom 5 and 6, the default option is that these proceedings should be stayed and it is for Actavis to show why a stay should not be granted. Actavis contends that a stay should be refused because the English proceedings will be resolved significantly earlier than the EPO proceedings, and that will provide it with reasonable commercial certainty at least in the UK and may assist in promoting settlement. In support of its application for a stay, Pharmacia has offered undertakings (a) to seek expedition of the EPO proceedings, (b) not to seek an injunction against Actavis or its customers until the determination of the EPO proceedings and (c) only to seek damages of 1% of Actavis' net sales during the period from launch until the determination of the EPO proceedings if the Patent is...
To continue reading
Request your trial
-
Eli Lilly and Company v Janssen Sciences Ireland UC (formerly Janssen Alzheimer Immunotherapy)
...assertions need to be examined critically, but at a relatively high level of generality." 8 Arnold J applied these factors in Actavis Group PTC EHF v Pharmacia LLC [2014] EWHC 2265 (Pat) (' Actavis'). That was a claim for revocation of a patent and it was accepted that the Actavis product w......
-
Actavis Group Ptc Ehf (a company incorporated under the laws of Iceland) v Pharmacia LLC (a company incorporated under the laws of the State of New Jersey, USA)
...of the parallel proceedings before the European Patent Office. The background is set out in full in my judgment of 11 July 2014 ( [2014] EWHC 2265 (Pat), and I will not repeat it here. As was set out in the postscript to that judgment at paragraph 33, following the circulation of a draft o......
-
The Basics Of Patent Law - Procedure, Trial, Appeal And Settlement
...party resisting the stay may be decisive in the court's decision as to where the balance lies. For example, in Actavis v Pharmacia [2014] EWHC 2265 (Pat), [2014] EWHC 2661 (Pat), proceedings in which Actavis was seeking the revocation of Pharmacia's patent, undertakings eventually offered b......