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You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Arrow Generics Ltd & Anor v Merck & Co, Inc [2007] EWHC 1900 (Pat) (31 July 2007) URL: https://www.bailii.org/ew/cases/EWHC/Patents/2007/1900.html Cite as: [2007] FSR 39, [2007] EWHC 1900 (Pat), [2008] Bus LR 487 |
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CHANCERY DIVISION
PATENTS COURT
Strand, London, WC2A 2LL |
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B e f o r e :
____________________
ARROW GENERICS LIMITED ARROW PHARM (MALTA) LIMITED |
Claimants |
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- and - |
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MERCK & CO, INC |
Defendant |
____________________
Justin Turner (instructed by Lovells) for the Defendant
Hearing date: 12 July 2007
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Crown Copyright ©
MrJustice Kitchin :
Introduction
i) Whether it can be said that an EP(UK) patent ever existed in circumstances where the European Patent Bulletin published the mention of grant with a "GB" designation but where that designation was withdrawn before the date of publication.
ii) Where one person holds over another a threat of patent infringement proceedings on the basis of divisional applications, whether this court should necessarily refuse to allow the person so threatened to seek a determination of its rights.
Background
i) Application 911.3 which currently has a claim for: "A pharmaceutical composition comprising about 70mg of a bisphosphonate selected from alendronate, pharmaceutically acceptable salts thereof, and mixtures thereof, on an alendronic acid active weight basis".
ii) Application 912.1 which currently has a claim for: "A kit adapted for a continuous dosing schedule of a bisphosphonate adapted for once weekly dosing comprising a number of unit doses of a pharmaceutical composition wherein the unit doses comprise 70mg of alendronate, pharmaceutically acceptable salts thereof, or a mixture thereof, on an alendronic acid active weight basis".
iii) Application 910.5 which currently has a claim for: "Use of risedronate or a pharmaceutically acceptable salt thereof for the manufacture of an oral medicament for treating osteoporosis in a human in need thereof according to a continuous schedule having a once-weekly dosage interval".
"Stefan Oschmann, chief of Merck's drug business in Europe, said any generic once-weekly alendronate - the chemical name for Fosamax - being sold after yesterday's ruling could be subject to legal challenge seeking damages.
"We will file law suits," Mr Oschmann told the Financial Times. "We would enforce our rights where the patent is valid."
He also said Merck recognised that this could be a shock to the healthcare system for many national programmes, and that the company wanted to ensure "patients have access to the medicine".
"We have to work with the European authorities to try to find a constructive solution," Mr Oschmann said.
The new patent could assist Merck as it restructures and help restore profit growth."
Arrow's claim
1. A declaration that European Patent (UK) no. 1 175 904 ("the Patent") is and has at all material times been invalid;
2. An order that the Patent be revoked;
3. A declaration that any other European patent (UK) for an alleged invention relating to osteoporosis medicaments for administration of about 70mg alendronate once-weekly would be invalid;
4. A declaration that the Defendant is not entitled to rely on the Patent or any other European patent (UK) granted pursuant to applications nos. 01201911.3, 01201912.1 and 01201910.5 and any further divisional applications arising under them to prevent the Claimants from selling or supplying their 70 mg once-weekly alendronate products;"
The claim in respect of EP (UK) 904
Legal framework
"(1) The request for the grant of a European patent shall contain the designation of the Contracting State or States in which protection for the invention is desired.
….
(3) The designation of a Contracting State may be withdrawn at any time up to the grant of the European patent. Withdrawal of the designation of all the Contracting States shall be deemed to be a withdrawal of the European patent application. Designation fees shall not be refunded."
Importantly, a designation may be withdrawn at any time up to the grant of the European patent.
"(2) If the Examining Division is of the opinion that the application and the invention to which it relates meet the requirements of this Convention, it shall decide to grant the European patent for the designated Contracting States provided that ….
…
(4) The decision to grant a European patent shall not take effect until the date on which the European Patent Bulletin mentions the grant. This mention shall be published at least two months after the start of the time limit referred to in paragraph 2(b)…."
"(1) A European patent shall, subject to the provisions of paragraph 2, confer on its proprietor from the date of publication of the mention of its grant, in each Contracting State in respect of which it is granted, the same rights as would be conferred by a national patent granted in that State."
And Art.2 EPC:
"(1) Patents granted by virtue of this Convention shall be called European patents.
(2) The European patent shall, in each of the Contracting States for which it is granted, have the effect of and be subject to the same conditions as a national patent granted by that State, unless otherwise provided in this Convention."
"(1) Subject to the provisions of this Act, a European patent (UK) shall, as from the publication of the mention of its grant in the European Patent Bulletin, be treated for the purposes of Parts I and III of this Act as if it were a patent under this Act granted in pursuance of an application made under this Act and as if notice of the grant of the patent had, on the date of that publication, been published under section 24 above in the journal; and-
(a) the proprietor of a European patent (UK) shall accordingly as respects the United Kingdom have the same rights and remedies, subject to the same conditions, as the proprietor of a patent under this Act;
(b) references in Parts I and III of this Act to a patent shall be construed accordingly.
…
(2) Subsection (1) above shall not affect the operation in relation to a European patent (UK) of any provisions of the European Patent Convention relating to the amendment or revocation of such a patent in proceedings before the European Patent Office."
Did EP (UK) 904 exist at the date of the claim form?
The claim for a declaration in the light of the divisional applications
Arrow's interest
i) that it will not contend (or maintain any current contention) that Arrow's 70mg alendronate product infringes any valid claim arising under the 904 patent, or under any valid claims that may be granted in relation to the divisional applications 911.3, 912.1 and 910.5, and any further divisional applications arising under them;
ii) within a reasonable time period, to withdraw the "GB" designations of each of the divisional applications 911.3, 912.1 and 910.5, and any further divisional applications arising under them.
As at the date of the hearing of this application Merck has shown no inclination to accept that invitation. Arrow therefore faces an ongoing threat by Merck that it will seek to enforce any patent rights that it may obtain in the UK against Arrow's 70mg once-weekly alendronate product.
Declaratory relief - the extent of the jurisdiction
"41. ……..The approach is pragmatic. It is not a matter of jurisdiction. It is a matter of discretion. The deployment of negative declarations should be scrutinised and their use rejected where it would serve no useful purpose. However, where a negative declaration would help to ensure that the aims of justice are achieved the courts should not be reluctant to grant such declarations. They can and do assist in achieving justice.
…..
So in my judgment the development of the use of declaratory relief in relation to commercial disputes should not be constrained by artificial limits wrongly related to jurisdiction. It should be instead kept within proper bounds by the exercise of the courts' discretion.
42. While negative declarations can perform a positive role, they are an unusual remedy in so far as they reverse the more usual roles of the parties. The natural defendant becomes the claimant and vice versa. This can result in procedural complications and possibly injustice to an unwilling "defendant." This in itself justifies caution in extending the circumstances were negative declarations are granted, but, subject to the exercise of appropriate circumspection, there should be no reluctance to their being granted when it is useful to do so."
"The court's power to grant a declaration is to be found in CPR Part 40.20, which in these terms:
"The court may make binding declarations whether or not any other remedy is claimed."
Accordingly, so far as the CPR are concerned, the power to make declarations appears to be unfettered. As between the parties in the section [sic], it seems to me that the court can grant a declaration as to their rights, or as to the existence of facts, or as to a principle of law, where those rights, facts, or principles have been established to the court's satisfaction. The court should not, however, grant any declarations merely because the rights, facts or principles have been established and one party asks for a declaration. The court has to consider whether in all circumstances, it is appropriate to make such an order.
…..
It seems to me that, when considering whether to grant a declaration or not, the court should take into account justice to the claimant, justice to the defendant, whether the declaration would serve a useful purpose and whether there are any other special reasons why or why not the court should grant the declaration."
"My reason, put shortly, is as follows. A line of authority funning from Guaranty Trust Company of New York v. Hannay & Co [1915] 2 KB 536 through Messier-Dowty Ltd v. Sabena SA [2001] 1 All ER 275, culminating in the judgment of Neuberger J in Financial Services Authority v. Rourke (unreported) 19th October 2001, establishes three relevant principles:
i) The correct approach to the question of whether to grant negative declarations was one of discretion rather than jurisdiction.
ii) The use of negative declarations should be scrutinised and their use rejected where it would serve no useful purpose, but where such a declaration would help ensure that the aims of justice were achieved, the court should not be reluctant to grant a negative declaration.
iii) Before a court can properly make a negative declaration, the underlying issue must be sufficiently clearly defined to render it properly justiciable."
"I do not say that anyone could apply for declarations of the kind sought by Nokia. There would have to be real commercial reasons for the person seeking the declaration to have standing to do so. An interest in making 3G telephones which must therefore comply with the standard is clearly sufficient."
Section 74 of the Patents Act 1977
"(1) Subject to the following provisions of this section, the validity of a patent may be put in issue-
(a) by way of defence, in proceedings for infringement of the patent under section 61 above or proceedings under section 69 above for infringement of rights conferred by the publication of an application;
(b) in proceedings under section 70 above;
(c) in proceedings in which a declaration in relation to the patent is sought under section 71 above;
(d) in proceedings before the court or the comptroller under section 72 above for the revocation of the patent;
(e) in proceedings under section 58 above.
(2) The validity of a patent may not be put in issue in any other proceedings and, in particular, no proceedings may be instituted (whether under this Act or otherwise) seeking only a declaration as to the validity or invalidity of a patent."
Applying the principles
Conclusion