Merck Sharp & Dohme Corporation v Clonmel Healthcare Ltd

• Jurisdiction: Ireland
• Judge: Mr. Justice Denis McDonald
• Judgment Date: 29 November 2019
• Neutral Citation: [2019] IEHC 814
• Date: 29 November 2019
• Docket Number: [2018 No. 3485 P.]
• Court: High Court

BETWEEN

MERCK SHARP & DOHME CORP

PLAINTIFF

AND

CLONMEL HEALTHCARE LIMITED

DEFENDANT

[2019] IEHC 814

Denis McDonald

[2018 No. 3485 P.]

THE HIGH COURT

COMMERCIAL

Intellectual Property Law – Supplementary Protection Certificate – Article 3 of Regulation (EC) No. 469/2009 – Defendant seeking to have Supplementary Protection Certificate declared invalid as in violation of Regulations – Whether the Supplementary Protection Certificate acquired by the Plaintiff was valid

Facts: The Plaintiffs had initiated proceedings against the Defendant seeking relief for an alleged infringement of their rights under a Supplementary Protection Certificate (SPC) granted in 2005 in respect of a cholesterol reducing medicine comprising of a compound of two active ingredients – namely ezetimibe and simvastatin. The Defendant’s counterclaim challenged the validity of the SPC, specifically, that it was in breach of Articles 3(a), (c), and (d) of Regulation (EC) No. 469/2009. This judgment was in respect of the validity of the SPC.

Held by McDonald J that the SPC was invalid as it was in breach of Article 3(a) of the Regulations. It was necessary for the product that is the subject of the SPC to be protected by a basic Patent in Force. A product cannot be considered protected by a basic patent in force within the meaning of Article 3(a) unless the product which is the subject of the SPC is either expressly mentioned in the claims of that patent or those claims relate to that product necessarily and specifically. Mc Donald J found that a ‘skilled person’ reading the 599 Patent would not deduce from the reference to the combination involving a compound of Formula 1 with a statin that the combination could be said to be a distinct innovation. McDonald J also gave much consideration to the test set out in Teva v Gilead and was satisfied that the combination of ezetimibe and simvastatin was not an invention covered by the Patent. As such, the Defendant was entitled to a declaration that the SPC was invalid and must be revoked.

McDonald J went on to find that the Defendant’s claims under Article 3(d) and in the alternative under Article 3(c) should be dismissed.

Relief granted.

JUDGMENT of Mr. Justice Denis McDonald delivered on 29 November, 2019

Table of Contents

The issues to be decided	2
Background	2
The SPC Regulation	4
Atherosclerosis	5
The development of cholesterol treatments	6
Combination therapy	7
The development of the combination in issue	13
The case made by the defendant in relation to Article 3 (a)	14
Relevant terms of the 599 Patent	15
The argument of the plaintiff based on the claims of the patent	18
The Teva v Gilead test	22
The role of the “skilled person”	23
Who is the skilled person for the purposes of the 599 Patent?	24
The application of the first limb of the Teva v. Gilead test	25
My conclusion in respect of Article 3 (a)	30
The case made under Article 3 (c)	30
The case made under Article 3 (d)	32
My findings in relation to Article 3 (d)	35
The impact of the Article 3 (d) finding on the case made under Article 3 (c)	39
Conclusion	39

The issues to be decided

1 These proceedings were commenced by the plaintiff against the defendant seeking relief in relation to the alleged infringement of the plaintiff's rights under Supplementary Protection Certificate (“ SPC“) no. 2005/2001 granted in 2005 in respect of a cholesterol-reducing medicinal product comprising a combination of two active ingredients namely ezetimibe and simvastatin. Ezetimibe is a member of a class of compounds known as azetidinones. As described in more detail below, simvastatin is a statin. In response to the plaintiff's claim, the defendant raised a counterclaim in which it challenged the validity of the SPC on three grounds. This judgment addresses the invalidity claim. The issues raised by the defendant are as follows:-

(a) In the first place, the defendant contends that the SPC breaches Article 3 (a) of Regulation (EC) No. 469/2009 ( “the SPC Regulation”) on the ground that the combination of ezetimibe and simvastatin is not protected by the underlying patent “and/or was not the core inventive advance to which the … Patent pertained” (to quote from para. 6 (a) of the Particulars of Objection annexed to the counterclaim). The patent in question is described in more detail in para. 2 below and is referred to in this judgment as the “599 patent”;

(b) Secondly, it is claimed that, in breach of Article 3 (c) of the SPC Regulation, the only compound protected by the 599 Patent (which the defendant contends is solely ezetimibe) was already the subject matter of an earlier SPC granted in 2003. In addition, during the course of the hearing, this contention appears to have been expanded to also make the case that, if the 599 patent protects the combination of ezetimibe and simvastatin, that combination had previously been the subject of the earlier SPC granted in 2003 (described further below). In those circumstances, it is contended that the 2005 SPC is not valid; and

(c) Thirdly, the defendant claims that the marketing authorisation for the combination was not the first marketing authorisation for such combination and that, in the circumstances, the SPC was granted contrary to the provisions of Article 3 (d) of the SPC Regulation.

Background

2 The plaintiff is the holder of Irish Patent 0 720 599 (“ the 599 patent“) which was granted by the European Patent Office (“ EPO“) on 19th May, 1999 with a priority date of 21st September, 1993. The patent relates to a treatment for atherosclerosis. There is no dispute between the parties that the 599 patent covers a number of azetidinone compounds including ezetimibe. There is equally no dispute between the parties that ezetimibe inhibits the resorption of cholesterol (known to be a cause of atherosclerosis) at the brush border of the intestinal villus in the small intestine. The mode of action of ezetimibe is different to that of other cholesterol lowering agents such as HMG-CoA reductase inhibitors commonly known as statins (including simvastatin) which act by increasing the breakdown of cholesterol in the liver. As described further below, there are also a number of other agents (each with their own mode of action) which are used to treat elevated levels of cholesterol.

3 In 2003, a marketing authorisation was granted in respect of a medicinal product under the trade name Ezetrol pursuant to national measures implementing Directive 2001/83/EC ( “the Medicinal Products Directive”) which permitted the marketing of 10mg tablets of ezetimibe for the following therapeutic indications namely:-

(a) In the case of primary hypercholesterolemia, the tablets were to be administered with an “HMG-CoA reductase inhibitor (statin) or alone” as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia. It should be noted that heterozygous familial hypercholesterolemia occurs where the relevant gene is inherited from one parent alone.

(b) For homozygous familial hypercholesterolemia, the tablets were to be administered with a statin and were indicated for use in patients with this condition. By way of explanation, homozygous hypercholesterolemia occurs where a child inherits the relevant gene from both parents.

(c) For homozygous sitosterolemia, the tablet was indicated for use in patients with this condition. In other words, the tablet was to be administered alone for this condition. I should explain that homozygous sitosterolemia is an inherited disorder of sterol metabolism in which an excess of plant sterols is absorbed and not enough is excreted.

4 In circumstances where a marketing authorisation was granted for ezetimibe (on the terms set out above), the plaintiff was in a positon to apply for the grant of an SPC. In 2003, an SPC was issued in respect of ezetimibe. This is the SPC on which the defendant relies in support of its case under Article 3 (c) of the SPC Regulation.

5 Subsequently in 2005, a new marketing authorisation was issued to the plaintiff in respect of a medicinal product with the trade name Inegy. This was in respect of tablets containing a combination of ezetimibe and simvastatin. The authorisation extended to four specific compositions namely 10 mg ezetimibe and 10 mg simvastatin, 10 mg ezetimibe and 20 mg simvastatin, 10 mg ezetimibe and 40 mg simvastatin and 10 mg ezetimibe and 80 mg simvastatin. According to the clinical particulars set out in the marketing authorisation, the therapeutic indications for this combination were:-

(a) In the case of primary hypercholesterolemia, Inegy was indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolemia or mixed hyperlipidaemia where use of a combination product is appropriate.

(b) For homozygous familial hypercholesterolemia, Inegy was indicated as adjunctive therapy to diet for use in patients with this condition.

6 Thereafter, the SPC, the subject matter of these proceedings was issued in 2005. It was issued in respect of ezetimibe or a pharmaceutically acceptable salt of ezetimibe in combination with “a cholesterol biosynthesis inhibitor such as simvastatin”.

7 It should also be noted that simvastatin was previously the subject of Irish Patent No. 51478 which was filed on 2nd February, 1981. Simvastatin also had the benefit of an SPC. However, that SPC expired on 5th May, 2003.

The SPC Regulation

8 In order to understand the issues which the defendant raises in relation to the validity of the SPC, it is necessary to refer, at this point in broad terms, to the provisions of the SPC Regulation. Under Article 3 (a) of the SPC Regulation, an SPC may only be granted where the product, the subject matter of the SPC is protected by “ a basic patent in force”. As noted above, the defendant maintains that...