Arrow Generics Ltd v Merck & Company Inc.
| Jurisdiction | England & Wales |
| Judge | THE HONOURABLE MR JUSTICE KITCHIN |
| Judgment Date | 31 July 2007 |
| Neutral Citation | [2007] EWHC 1900 (Pat) |
| Docket Number | Case No: HC 07 C 00852 |
| Court | Chancery Division (Patents Court) |
| Date | 31 July 2007 |
[2007] EWHC 1900 (Pat)
The Honourable Mr Justice Kitchin
Case No: HC 07 C 00852
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Daniel Alexander QC and Mark Chacksfield (instructed by Forsyth Simpson) for the Claimants
Justin Turner (instructed by Lovells) for the Defendant
Hearing date: 12 July 2007
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.
MrJustice Kitchin:
Introduction
This application raises two points of some importance:
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the European Patent Bulletin published the mention of grant with a “GB” designation but where that designation was withdrawn before the date of publication.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
The patents and applications in issue relate to a drug called alendronate which is used for the treatment of bone wasting diseases, including osteoporosis. It was first marketed in 1995 and by July 1997 it was approved in a 10mg oral dosage form for daily administration.
In July 1998, Merck filed patent application number 98935752.0 claiming an earliest priority date of July 1997. It was granted in November 2001 as EP 0 998 292 (“292”). The key idea of the patent was to treat osteoporosis patients with 70mg of alendronate once a week rather than with 10mg once a day. The justification for the idea was that it produced fewer adverse gastrointestinal events and was more convenient for patients.
Shortly after the grant of the 292 patent, Arrow and two other generic drug companies commenced proceedings for the revocation of its “GB” designation – EP(UK) 292. In January 2003, Jacob J held EP(UK) 292 invalid for lack of novelty and inventive step and because it was, in substance, a method of treatment of the human body by therapy. In November 2003, the Court of Appeal upheld his decision. EP(UK) 292 was therefore revoked.
In the meantime, the 292 patent was also the subject of opposition by no fewer than seven opponents in the EPO. At oral proceedings in July 2004, the Opposition Division revoked the patent on the same grounds as Jacob J. In March 2006, the Technical Board of Appeal dismissed the appeal, finding the patent invalid for added matter. The Board therefore did not proceed to consider the additional arguments of obviousness and lack of novelty.
Since the revocation of the 292 patent, Arrow and other generic companies have marketed 70mg once weekly alendronate for the treatment of osteoporosis in many countries within Europe, with the result that these markets have now become largely generic and seen a considerable reduction in the cost of the drug. For example, the cost of a 4x70mg pack in the UK has fallen from about £15–18 to about £1–2. This has no doubt resulted in a significant loss of revenue to Merck (which sells alendronate under the brand name Fosamax) but it has provided an obvious benefit to the health services. Full details of sales by Arrow were provided to me in a confidential exhibit but it is no secret they have been very substantial indeed.
The decisions of the Court of Appeal and the TBA have not, however, brought the dispute between the parties to an end. In the course of prosecution of the 292 patent, Merck filed four divisional applications: 01201913.9 (“913.9”), 01201911.3 (“911.3”), 01201912.1 (“912.1”) and 01201910.5 (“910.5”). All of these divisional applications were stayed during the 292 patent opposition proceedings but revived upon their conclusion.
As for 913.9, the Examining Division of the EPO has found that, despite the decisions of the Opposition Division, the Technical Board of Appeal and the UK courts in relation to the 292 patent, the subject matter it claims is inventive. It has therefore allowed the application to proceed to grant as EP 1 175 904 (“904”). Claim 1 is in “Swiss” form and directed to the use of alendronate to make a medicament for the treatment of osteoporosis in a human, where the medicament is orally administered as a unit dosage comprising about 70mg of alendronate, according to a continuous schedule having a once-weekly dosing interval. The key idea therefore appears to be essentially the same as that the subject of the 292 patent, namely give osteoporosis patients 70mg of alendronate once a week.
The Examining Division has apparently justified this change in position on the basis of a declaration by a Dr. Goldberg of Merck which is said to provide details of a statistically significant effect arising from administration of a 70mg alendronate tablet once a week, rather than a 10mg tablet once a day.
Despite its success in the earlier proceedings, Arrow therefore now finds itself facing a threat to its alendronate business from the 904 patent including, so it says, an EP (UK) patent (“EP (UK) 904”) resulting from the inclusion in the original application of a “GB” designation, in circumstances I shall explain. But it also now faces the possibility of patents being granted upon the other divisional applications. In particular,
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”.
Clearly 911.3 and 912.1 are of particular relevance but the claims of any of these applications can be amended during the course of prosecution and so it is quite possible that the claims of any patent granted on application 910.5 could also be directed to alendronate. Importantly, all of these applications include a “GB” designation. Merck estimates that 911.3 will not be ready for grant until the last quarter of this year, 910.5 until the middle to end of 2008 and 912.1 until the first quarter of 2008. Of course, they could take longer and it is possible that yet further divisional applications will emerge.
It is hardly surprising that Arrow has greeted these developments with dismay. It sought to “clear the way” by revoking the 292 patent and succeeded in doing so both in the UK and centrally in the EPO for all designated countries. It has since established a substantial market position selling once-weekly 70mg alendronate tablets for the treatment of osteoporosis. But it is now faced with the 904 patent and the possibility of the EPO granting yet further patents based upon the remaining divisional applications.
Moreover, it seems clear that Merck does intend to take action to enforce such patent rights it may obtain following this change in position by the EPO. In March of this year, and upon announcement of the decision by the EPO to grant the 904 patent, the Financial Times reported that Merck's “new patent on Fosamax” applies in 23 European countries, including key markets such as Germany (but not the UK), and will be valid until 2018. It also reported that Merck had “vowed to enforce its intellectual property rights on the drug” and continued:
“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.”
Moreover, Merck has brought proceedings against Arrow group companies in Italy and Sweden and has issued infringement proceedings against other generic companies in Holland, Sweden, Italy and France. On any reckoning the situation is a most unusual one. Arrow thought it had established its right to make and sell its once-weekly 70mg alendronate tablets but now faces a real threat to its business.
Arrow's claim
On 30 March 2007, Arrow therefore commenced proceedings against Merck seeking the relief set out in the claim form. It is common ground that, at that date, the 904 patent had been granted and, in respect of the UK, EP(UK) 904 had been published in the EPO Bulletin and was entered on the register of UK patents. Further, the other divisional applications to which I have referred were pending before the EPO.
As originally formulated, the claim sought declarations of invalidity in respect of non UK patents. In...
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