Actavis Uk Ltd v Merck & Company Inc.
| Jurisdiction | England & Wales |
| Judge | MR JUSTICE WARREN,Mr Justice Warren |
| Judgment Date | 06 June 2007 |
| Neutral Citation | [2007] EWHC 1311 (Ch) |
| Docket Number | Case No: HC06C02676 |
| Court | Chancery Division |
| Date | 06 June 2007 |
[2007] EWHC 1311 (Ch)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Honourable Mr Justice Warren
Case No: HC06C02676
Mr Simon Thorley QC and Mr Piers Acland (instructed by Bird and Bird) for the Claimant
Mr Antony Watson QC and Mr Thomas Hinchliffe (instructed by Linklaters LLP) for the Defendant
Hearing dates: 27 – 28, 30 March 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.
Mr Justice Warren
Introduction
In this action, the Claimant (“ Actavis”) seeks revocation of the Defendant's (“ Merck”) European Patent (UK) 0724 444 (the “ Patent”). The Patent concerns the use of a drug called finasteride. At the priority date (the earliest claimed priority date is 15 October 1993), finasteride was marketed by Merck in tablet form, under the name PROSCAR, for the treatment of a condition known as benign prostatic hyperplasia (“ BPH”). The conventional dose for treatment of BPH is 5mg daily. The basic patent for finasteride was EP 004 949 with a priority date of 13 April 1978.
The Patent relates to the use of a low dose of finasteride for the treatment of androgenic alopecia in humans, a condition which includes both male pattern baldness (“ MPB”) and female pattern baldness. The Patent discloses the result that low doses of finasteride are effective in treating androgenic alopecia, a result which Mr Watson QC and Mr Hinchliffe, who appear for Merck, describe very early in their skeleton argument as “surprising”. The focus of the argument has been on Claim 1 of the Patent which I will come to.
No separate point is made in relation to Claims 2 and 3. All three Claims stand or fall together.
Merck were also the applicants for European Patent (UK) 285 382 which is relevant to the state of the art.
Androgens are a class of steroid hormones which are responsible for the development and maintenance of masculine characteristics eg male sexual organs, deepened voice, facial hair, baldness and so on. Testosterone is the major circulating androgen in men. In certain tissues, the principal mediator of androgenic activity is not testosterone but one of its metabolites, dihydrotestosterone (“ DHT”). Testosterone is converted to DHT by the action of a membrane bound enzyme called 5a-reductase. This enzyme is present in a number of adult tissues including prostate, liver and skin.
It is now accepted science that there are two forms (“isozymes”) of 5a-reductase, which I shall refer to simply as “ type 1” and “ type 2”. Isozymes are variants of the same enzyme. They differ in amino acid sequence but catalyse the same reaction – in this case the conversion of testosterone to DHT. Mr Watson says that, at the priority date, type 1 was thought to be the enzyme present in the scalp, whilst type 2 was thought to be the enzyme present in the prostate. The precise state of the common general knowledge with regard to the properties of the two types is in dispute.
Finasteride is one of a class of compounds known as a 4-azasteroids. It is a strong inhibitor of type 2 but not of type 1. It is now known that type 2 is the relevant isozyme in relation to BPH; finasteride is therefore a suitable treatment for BPH, inhibiting reduction of testosterone to DHT in the prostate. Finasteride was first administered to humans in 1986 and was shown to cause a marked reduction in plasma levels of DHT. Subsequent clinical trials demonstrated that the drug was effective in reducing the size of the prostate. In 1992 finasteride was first licensed for use in the treatment of BPH at an oral dose of 5mg per day.
However, according to Mr Watson, it could not, at the priority date have been generally seen as a treatment, particularly in low doses, for MPB given that it is not a strong inhibitor of type 1.
Nonetheless, Merck discovered that finasteride in small doses is an effective treatment for MPB and is sufficient to make a marked impact on the condition. Finasteride is marketed by Merck in tablet form, under the name PROPECIA, for the treatment of MPB. The conventional dose for treatment of MPB is 1mg daily.
The Patent
The Patent specification describes a “method of treating androgenic alopecia with 5a-reductase inhibitors”. The actual Claims are as follows:
1. The use of [finasteride] for the preparation of a medicament for oral administration of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg
2. The use as claimed in claim 1 wherein the dosage is 1.0mg.
3. The use as claimed in claim 1 or 2 wherein the treatment is of male pattern baldness.
Amendment
Merck says that, as a matter of construction, Claim 1 of the Patent is limited to the stated dosage of finasteride per day. If the entire Patent is read, there is material in the description which supports that conclusion. However, that construction is disputed by Actavis, relying on the definition of the invention which makes no reference to dosage. However, Actavis does not oppose the amendment so that the dispute about construction is largely academic. I do not propose to decide the question of construction but instead allow the amendment for the purpose of these proceedings.
“Swiss form” and second medical use
It will be seen that Claim 1 is in “Swiss form” (for a general description of which see Terrell on the Law of Patents (16 th ed) at 6–122ff). I do not embark on an explanation of the justification for upholding patents in this form. But I should mention the legislation and a bit of history.
Sections 4(2) and 4(3) of the Patents Act 1977, which are derived from Article 52(4) of the Convention on the Grant of European Patents (the European Patent Convention) (“EPC”), state:
“(2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.
(3) Subsection 2 above shall not prevent a product consisting of a substance or composition being treated as capable of industrial application merely because it is invented for use in any such method.”
Section 2(6) of the 1977 Act, which is derived from Article 54(5) of the EPC, states:
“(6) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.”
The result is that it is possible to obtain a patent for the first medical use of a known substance or composition, where this substance or composition was not previously known to have any medical application: see Sopharma SA's Application [1983] RPC 195.
Owing to the prohibition on method of treatment claims in Article 52(4) of the EPC (which corresponds to sections 4(2) and 4(3) of the 1977 Act), the Enlarged Board of the European Patent Office has held that a European patent may not be granted for the use of a substance or composition for the treatment of the human or animal body by therapy.
However, it has also accepted, on policy grounds, and following the practice of the Swiss Federal Intellectual Property Office, that a European patent may be granted with claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application. This gave rise to the now widely used form of the second medical use, or so-called “Swiss form” claim: see Eisai/Second Medical Indication (1985) OJEPO, 64 (“Eisai”).
Accordingly, a claim in the form: “Use of [X] for treatment of [Y]” would not be accepted, whereas a claim “Use of [X] for the manufacture of a medicament for treatment of [Y]” would be accepted.
Lack of novelty, industrial application, method of medical treatment
Claims in the Swiss form have been considered by the UK courts in a number of cases. I need only consider the decision of the Court of Appeal in Bristol-Myers Squibb v Baker Norton [2001] RPC 1.
In that case, the pharmaceutical in question (taxol) was used in the treatment of cancer. Claim 1 read as follows:
“use of taxol and sufficient medications to prevent severe anaphylactic reactions, for manufacturing a medicamentation for simultaneous, separate or sequential application for the administration of from 135mg/m 2 up to 175mg/m 2 taxol over a period of about 3 hours or less as a means for treating cancer and simultaneously reducing neutropenia”.
The use of taxol in combination with other medications was known as a treatment for cancer. It was common ground that the only difference between the claim of the patent in suit in Bristol-Myers and the previously disclosed treatment regimen for using it lay in the dosing protocol. Previously the treatment had been for 24 hours, which involved an overnight stay in hospital. The claimed treatment reduced this period to 3 hours so that the treatment could take place on an out patient basis and, yet, the accelerated treatment reduced neutropenia (suppression of the rapid division of white blood cells).
The judge had held the patent to be invalid on the grounds of lack of novelty and obviousness. The proprietor of the patent appealed submitting that the Claim 1 was a valid “Swiss-type” claim as allowed by Eisai based on the previously unknown suitability of taxol for...
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