Actavis Ltd v Merck & Company Inc. (Costs)

JurisdictionEngland & Wales
JudgeLord Justice Jacob
Judgment Date21 May 2008
Neutral Citation[2008] EWCA Civ 444
Docket NumberCase No: A3/2007/1625 and A3/2007/1650 HC 06 C02676
CourtCourt of Appeal (Civil Division)
Date21 May 2008

[2008] EWCA Civ 444





The Hon Mr Justice Warren

Royal Courts of Justice

Strand, London, WC2A 2LL

Before :

Lord Justice Ward

Lord Justice Jacob and

Lord Justice Rimer

Case No: A3/2007/1625 and A3/2007/1650 HC 06 C02676

Between :
Actavis Uk Limited
Merck & Co Inc

Peter Prescott QC and Ian Karet (instructed by Messrs Linklaters)

appeared for Merck & Co Inc

Antony Watson QC and Thomas Hinchliffe (instructed by Messrs Linklaters)

appeared for Merck & Co Inc

Simon Thorley QC and Piers Acland (instructed by Messrs Bird & Bird)

appeared for Actavis UK Limited

Hearing dates: 4/5/6 March 2008

Lord Justice Jacob (giving the judgment of the court):


This is an appeal from a decision of Warren J [2007] (EWHC 1311 (Ch)). He held that Merck's Patent (EP (UK) 0 724 444) was invalid.


The case turns entirely on the validity of claim 1:

The use of [finasteride] for the preparation of a medicament for oral administration useful for the treatment of androgenic alopecia in a person and wherein the dosage amount is about 0.05 to 1.0 mg.

The dosage amount referred to is per day (see the judgment at [10]). Androgenic alopecia (“aa”) is a type of baldness occurring in men (male pattern baldness, “MPB”) and women.


Merck had patented finasteride itself in 1978 so, as a substance, it was known at the priority date of the patent (15 th October 1993). By then it was on the market in tablet form for the treatment of benign prostatic hyperplasia “(BPH)”. The dose was 5mg daily, that is to say five or more times the dose of claim 1.


The Judge summarised the basic science uncontroversially at [4–6]:

[4] 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.

[5] 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. ….

[6] 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.


The Judge held that claim 1 was invalid on the grounds that it was not novel pursuant to the provisions of the European Patent Convention (“EPC”) Art 54 (enacted as s.2 of the Patents Act 1977) and was unpatentable pursuant to EPC Art.54(5) (enacted as s.2(6)). But he would have rejected the obviousness attack. Merck appeals his findings as regards novelty and unpatentability, Actavis cross-appeals his finding of non-obviousness. For Merck Mr Peter Prescott QC argued the novelty and unpatentability points and Mr Antony Watson QC the obviousness point. Mr Simon Thorley QC undertook the burden of all three points for Actavis.


I set out the relevant language of the EPC which, it is common ground, governs this case (i.e. that before the amendments introduced by the EPC 2000):

Art 52 Patentable Inventions

(1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.

(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

Art 54 Novelty

(1) An invention shall be considered to be new if it does not form part of the state of the art.

(5) The provisions of paragraphs 1 to 4 shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Art 52(4), provided that its use for any method referred to in that paragraph is not comprised in the state of the art.

Art 56 Inventive Step

An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art …

Art 57 Industrial application

An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture.

Swiss form claims in general


Swiss form claims have been long accepted in the UK, see Wyeth [1985] RPC 545 and the “BMS” case, Bristol-Myers Squibb v Baker Norton [1999] RPC 253 at [44] (Jacob J at first instance) and [2001] RPC 1 Court of Appeal (at [37] per Aldous LJ and [80–81] per Buxton LJ). For convenience we here adapt Jacob J's explanation in BMS of the rationale of these. Such a claim steers clear of two obstacles to patentability, namely the requirement of novelty and the ban on methods of treatment of the human body by therapy. It follows a statement of practice regarding “use claims” issued by the Swiss Federal Intellectual Property Office, [1984] OJ EPO 581. The generalised form of such a claim is “the use of compound X in the manufacture of a medicament for a specified (and new) therapeutic use”. Such claims are unnecessary when X is new, for then X can be patented in itself by virtue of the last sentence of Art.52(4). But when X is old, a Swiss form of claim confers novelty and yet is not a claim to a method of treatment.


The Enlarged Board of the European Patent Office (“EPO”) so held in Eisai, G5/83 [1985] OJ EPO 64. It said:

[23] It is legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application, even in a case where the process of manufacture as such does not differ from known processes using the same active ingredient.”


So the manufacture of an old substance for use in a new treatment was considered by the Enlarged Board to be novel. The justification for novelty was the new therapeutic use. And since the claim was to the manufacture of the compound, it was not a claim to a method of treatment.


In BMS Jacob J wondered how such a claim might work so far as infringement is concerned and thought it might create difficulty. And so it might in some cases (e.g. where the product is just sold as a standard product, like aspirin tablets). But in many cases the difficulty may be more theoretical than real. This is because manufacturers, particularly for prescription medicines and probably many others, have to provide detailed instructions and information about the use(s) and dosage(s) of their products. So in practice you can tell whether someone has used X for the manufacture of a medicament for the treatment of Y. He will have to say that his product is for the treatment of Y on his product information leaflet.


This case is about the limits of what can be done with Swiss form claims. In outline the argument for invalidity runs as follows:

(a) Finasteride as a substance is not novel;

(b) Nor is its use as a medicine (for treating BPH);

(c) So its use for the manufacture of a medicament for use as a medicine lacks novelty;

(d) Moreover finasteride had been proposed for treating aa, but with a daily dosage of 5mg or more (see below);

(e) So its use for the manufacture of a medicament for treating aa also lacks novelty.

(f) Novelty cannot be saved by specifying a particular dosage regime even if that dosage was not proposed in the prior art.

(g) Even if that is wrong, this court is bound under the English rules as to precedent by its prior decision in BMS to hold that the patent lacks novelty and/or is in substance one for a method of treatment of the human and thus, by virtue of Art. 52(4) is not to be regarded as susceptible of industrial application.


Merck's counterargument runs thus:

(i) Points (a) to (e) are accepted.

(ii) But (f) is wrong and contrary both to Eisai and EPO Board of Appeal authority subsequent to BMS and this court should follow that,

(iii) There is no ratio decidendi of BMS, or at least not one clear enough, which precludes this court from so doing.

(iv) Even if there is such a ratio, this court should recognise (and apply) a new exception to the general rules of precedent for this court, rules adopted long ago and summarised in Young v Bristol Aeroplane Company [1944] KB 718.


We begin by dealing with the arguments without reference to the impact of BMS. There are three stages: first a detailed consideration of a Swiss form claim; secondly, why such a claim is treated as novel and not for a method of treatment, a close examination of Eisai; and thirdly, subsequent EPO and other cases.

Swiss form claims in more detail


One possible view of novelty in patent law (we speak generally rather than by reference to any particular legislation) is this: that a thing is either old or it is not....

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