Teva Pharma BV and Another v Amgen, Inc. and Another
| Jurisdiction | England & Wales |
| Judge | The Hon Mr Justice Arnold,Mr Justice Arnold |
| Judgment Date | 27 November 2013 |
| Neutral Citation | [2013] EWHC 3711 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 27 November 2013 |
| Docket Number | Case Nos: HP13B04226, HP13B04399, HP13F04807 |
[2013] EWHC 3711 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case Nos: HP13B04226, HP13B04399, HP13F04807
James Abrahams (instructed by Bird & Bird LLP) for the Claimants
Thomas Hinchliffe (instructed by Hogan Lovells International LLP) for the Defendants
Hearing date: 21 November 2013
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
The issue which I have to decide is whether it is "desirable" within the meaning of CPR rule 19.2(3) for Amgen, Inc. ("AI") to cease to be a party to three claims relating to European Patent (UK) No. 2 345 724 entitled "G-CSF analog compositions and methods" ("724 (UK)") brought by Teva UK Ltd (in the case of the first and third claims) and by Teva Pharma BV and Teva UK Ltd (in the case of the second claim). It is not necessary for present purposes to distinguish between Teva UK Ltd and Teva Pharma BV, and I shall refer to them individually and collectively as "Teva".
The three claims are as follows:
i) Claim HP13B04226 is for revocation of 724 (UK) on grounds of lack of novelty, obviousness, insufficiency and added matter ("the Revocation Claim").
ii) Claim HP13F04339 is for a declaration that any Supplementary Protection Certificate based on 724 (UK) would not be valid, either because 724 (UK) is invalid or because lipegfilgrastim does not fall within the scope of 724 (UK) or because the grant of an SPC would be contrary to Articles 3(a) or 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the SPC Regulation") ("the SPC Claim").
iii) Claim HP13F04807 is for a declaration that Teva would not infringe 724 (UK) by dealings in a product called Lonquex, the active ingredient in which is lipegfilgrastim ("the DNI Claim").
The Revocation Claim and the SPC Claim were brought against AI. The DNI Claim was brought against AI and Amgen Manufacturing Ltd ("AML"). I shall refer to AI and AML collectively as "Amgen". As explained in more detail below, at the dates on which the Claims were brought, AI was the registered proprietor of 724 (UK), although AI had assigned 724 to AML. AML is now the registered proprietor of 724 (UK).
Background
Teva
Teva is a pharmaceutical company. Although best known as a manufacturer and supplier of generic pharmaceutical products, it also develops its own products. Lonquex is one such product. Teva's objective in bringing the Claims is to ensure that it may lawfully market Lonquex, which it intends to launch in the near future.
Lipegfilgrastim
Lipegfilgrastim is a long-acting granulocyte colony-stimulating factor (G-CSF) for the treatment of neutropenia. G-CSF is a polypeptide which stimulates bone marrow to produce granulocytes (a type of white blood cell). Neutropenia is a deficiency of white blood cells, typically caused by chemotherapy for cancer. The condition makes patients, who may already be very sick, susceptible to bacterial infections, and is therefore extremely serious.
Lipegfilgrastim is a pegylated G-CSF i.e. it has polyethylene glycol attached to the polypeptide. It is made by an enzyme-induced pegylation technology which was originally developed by Neose Technologies Inc ("Neose"). On 21 April 2004 Neose and a company called BioGenerix announced that they were collaborating on developing a long-acting G-CSF product using Neose's pegylation technology. On 15 July 2004 Neose's US Patent Application 2004/0137557 disclosing Neose's pegylation technology was published. Subsequently Teva acquired Neose's pegylation technology and the associated proprietary rights.
On 7 November 2007 Teva announced successful results from a Phase I trial of lipegfilgrastim. On 6 June 2011 Teva announced successful results from a Phase III trial of lipegfilgrastim. On 25 July 2013 Teva was granted a European marketing authorisation for lipegfilgrastim on the basis of a full regulatory dossier including the results of the Phase III trial.
Amgen
Amgen is a pharmaceutical company. Amgen markets its own long-acting G-CSF product called Neulasta. The active ingredient of Neulasta is pegfilgrastim. Neulasta currently enjoys annual global sales of around $4 billion.
AI is a corporation incorporated in the State of Delaware, USA and its principal place of business is in California. AML is a company incorporated in Bermuda. AML is (directly or indirectly) a wholly-owned subsidiary of AI. AML manufactures Neulasta at a facility in Puerto Rico.
and related patents
724 is part of a complicated family of European patents and patent applications, all of which claim priority from a US Patent Application dated 28 January 1993. The parent patent is European Patent No. 0 612 846, the application for which was filed on 27 January 1994 and which was granted on 16 August 2000. Three divisional applications from the parent were filed: Nos. 0 890 640, 0 965 638 ("638") and 0 974 655. None of those three applications was pursued to grant. Subsequently a divisional application from 638 was filed, No. 1 233 065 ("065"). This was not pursued to grant either. On 11 August 2004 a second divisional application from 638 was filed, No. 1 482 046 ("046"). This eventually proceeded to grant on 11 April 2012. On 29 September 2010 724 was filed as a divisional application from 065. This proceeded to grant on 3 July 2013. The claims of 724 are similar, albeit not identical, to those of 046.
Prior to 13 August 2013, all of the patents and applications in this family, and their counterparts worldwide, were owned by AI. AI also owns a completely different family of patents, including European Patent No. 0 733 067 and an SPC based on that patent, which protect Neulasta.
Lapse of the UK designation of 046
The due date for payment of the renewal fee for the UK designation of 046 ("046 (UK)") was 31 January 2013. The renewal fee was not paid by AI. The six month time limit for late payment of the renewal fee expired on 31 July 2013 without AI having paid the fee, and accordingly 046 (UK) lapsed. AI has not adduced any evidence that this was unintentional.
Assignment of 724
On 13 August 2013 AI and AML entered into an agreement whereby AI assigned 724 to AML ("the Agreement"). None of the other European patents or applications in the family were included, nor were any of their counterparts in other territories. The assignment was expressed to be in consideration of (i) an immediate payment of an amount which has not been disclosed and (ii) "an ongoing royalty upon first commercial sale of all products developed or commercialized from the Assigned Patent" at a rate to be negotiated between the parties. The Agreement is governed by Californian law.
On the same date AI and AML also entered into a short-form assignment of 724 which omits details of the consideration and other terms of the Agreement ("the Assignment").
Teva's evidence, which has not been controverted by Amgen, is that AML does not own any other patents.
German proceedings
On 14 August 2013 (i.e. the day after the Agreement) AI applied for a preliminary injunction against Teva in Germany alleging that dealings in Lonquex would infringe the German designation of 046 ("046 (DE)"). This application was unsuccessful, but AI has appealed.
The genesis of the present issue
Teva commenced the Revocation Claim on 19 September 2013. AI was named as the defendant. It is common ground that at that date (a) AI was the registered proprietor of 724 (UK) and (b) Teva was unaware of the Assignment or the Agreement. The Revocation Claim was served at AI's address for service (AI's patent attorneys) on the same day. On 4 October 2013 Amgen's solicitors filed an acknowledgement of service.
Teva commenced the SPC Claim on 7 October 2013. AI was named as the defendant. It is common ground that at that date (a) AI was the registered proprietor of 724 (UK) and (b) Teva was unaware of the Assignment or the Agreement. On the same day Teva's solicitors invited Amgen's solicitors to accept service of the SPC Claim. On 9 October 2013 Master Bragge granted Teva permission to serve the SPC Claim on AI out of the jurisdiction.
On 16 October 2013 Amgen's solicitors wrote to Teva's solicitors informing them about the Assignment and suggesting that Teva amend both sets of proceedings to substitute AML for AI, and indicating that, if this was done, they would accept service of the SPC Claim.
On 18 October 2013 AI issued an application for permission to serve a combined Defence to both Claims on the date on which the Defence was due in the SPC Claim.
On 25 October 2013 Teva served the SPC Claim on AI in California.
On 4 November 2013 Amgen applied for orders that AML be substituted for AI in both the Revocation Claim and the SPC Claim.
Teva commenced the DNI Claim on 6 November 2013. AI and AML were both named as defendants. As I understand it, Amgen's solicitors accepted service without prejudice to Amgen's contention that AI should not be a party to this Claim. Although Amgen has not issued a separate application notice in relation to the DNI Claim, the parties have sensibly proceeded on the basis that the court's decision in relation to the other two Claims will also apply to the DNI Clam.
Amgen's applications first came before me on 7 November 2013. By that time Teva had indicated that it was agreeable...
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