Merck Sharp and Dohme Corporation v Clonmel Healthcare Ltd

• Jurisdiction: Ireland
• Judge: Ms. Justice Costello
• Judgment Date: 24 February 2021
• Neutral Citation: [2021] IECA 54
• Docket Number: Court of Appeal Record Numbers 2020/94
• Year: 2021
• Court: Court of Appeal (Ireland)

Between

Merck Sharp & Dohme Corp.

Plaintiff/Appellant

and

Clonmel Healthcare Limited

Defendant/Respondent

[2021] IECA 54

Costello J.

Haughton J.

Murray J.

Court of Appeal Record Numbers 2020/94

2020/95

THE COURT OF APPEAL

Supplementary Protection Certificate – Validity – Regulation (EC) No. 469/2009 – Respondent challenging the validity of a Supplementary Protection Certificate – Whether the certificate had been granted contrary to the provisions of Article 3(d) of Regulation (EC) No. 469/2009

Facts: The parties appealed to the Court of Appeal against the decision of the High Court (McDonald J) ([2019] IEHC 814). The defendant/respondent, Clonmel Healthcare Limited (CHL), challenged the validity of a Supplementary Protection Certificate (SPC) held by the plaintiff/appellant, Merck Sharp & Dohme Corp. (MSD), in respect of a cholesterol reducing medicinal product comprising a combination of two active ingredients, ezetimibe and simvastatin. The product is referred to as Ezetrol. CHL said that the SPC was invalid on three grounds: (i) it breached 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; (ii) it breached Article 3(c) of the SPC Regulation as ezetimibe, which, according to CHL, was the only compound protected by the patent, was already the subject matter of an earlier SPC granted in 2003; and (iii) 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. The trial judge held that the SPC was invalid as it breached Article 3(a) and (c). He rejected CHL’s claim that the SPC had been granted contrary to the provisions of Article 3(d). MSD appealed the findings in relation to Article 3(a) and (c). CHL appealed his finding in relation to Article 3(d).

Held by Costello J that, in this case, ezetimibe falls under the invention covered by the patent as it is one of the novel compounds invented by the patent and was claimed in Claim 8. She noted that, at the priority date, simvastatin was a known ingredient and had been the subject of a different patent, and a different SPC, and so cannot be considered to fall under the invention covered by the basic patent. She noted that the combination of ezetimibe and simvastatin was expressly claimed in Claim 9 of MSD’s basic patent. The trial judge rejected MSD’s argument that it was sufficient for the purposes of Article 3(a) that the two ingredients were expressly mentioned in the claims of the patent and that no assessment of the invention of the patent was either required or permitted. He held that the product did not fall under the invention covered by the patent and therefore it was not protected by the basic patent, and he revoked the SPC. Costello J held that the trial judge was correct in his approach and his assessment, and she agreed with his conclusion. She refused the appeal on this point. MSD argued that when considering whether the product satisfied the provisions of Article 3(c), the trial judge applied the same incorrect definition of “the product” that he applied in respect of Article 3(a) and therefore the error, it alleged, carried through into his analysis of its case in relation to Article 3(c) also. The parties agreed that “the product” identified for the purposes of Article 3(c) had to be the same as that found to be protected by the basic patent further to Article 3(a). In Costello J’s judgment, the trial judge correctly held that the product protected by the patent was ezetimibe, the mono-product, and not the combination of ezetimibe and simvastatin. It was accepted that ezetimibe had been the subject of an earlier SPC in respect of Ezetrol. She held that MSD’s appeal in relation to Article 3(c) also must fail.

Costello J held that the marketing authorisation to place the product Inegy on the market was for a combination product comprising two active ingredients, ezetimibe and simvastatin. She noted that previously MSD had obtained an SPC in respect of Ezetrol; this product comprised one active ingredient, ezetimibe, but for one indication in the authorisation it was required to be co-administered with a statin. She noted that the SmPC referred to clinical trials co-administering ezetimibe with simvastatin in specific dosages which were subsequently reproduced in the SmPC for Inegy. She held that this did not amount to a marketing authorisation of a combination product comprising ezetimibe and simvastatin; this combination product, therefore, had not been the subject of a previous SPC. She held that it follows that the marketing authorisation of Inegy was the first authorisation to place the product on the market as a medicinal product in accordance with Article 3(d) of the SPC Regulation. She held that the trial judge was correct to hold that the SPC was not invalid on the basis of the alleged breach of Article 3(d). For these reasons, Costello J rejected the appeal of CHL.

Appeal and cross appeal refused.

JUDGMENT of Ms. Justice Costello delivered on the 24th day of February 2021

Introduction

1 This is an appeal against the decision of the High Court (McDonald J.) ( [2019] IEHC 814). The defendant/respondent (“CHL”) challenged the validity of a Supplementary Protection Certificate (“SPC”) held by the plaintiff/appellant (“MSD”) in respect of a cholesterol reducing medicinal product comprising a combination of two active ingredients, ezetimibe and simvastatin. The product is referred to as Ezetrol. CHL said that the SPC was invalid on three grounds:-

The trial judge held that the SPC was invalid as it breached Article 3(a) and (c). He rejected CHL's claim that the SPC had been granted contrary to the provisions of Article 3(d).

• (i) it breached 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;

• (ii) it breached Article 3(c) of the SPC Regulation as ezetimibe, which, according to CHL, was the only compound protected by the patent, was already the subject matter of an earlier SPC granted in 2003; and

• (iii) 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.

2 MSD appealed the findings in relation to Article 3(a) and (c). CHL appealed his finding in relation to Article 3(d).

Background

3 The trial judge sets out the facts in considerable detail and I do not propose to repeat his careful exposition. This judgment should be read together with that of the High Court. A summary of the facts found by the High Court is sufficient. MSD is the holder of Irish Patent 0 720 599 (“the patent”) which was granted by the European Patent Office (“EPO”) on 19 May 1999, with a priority date of 21 September 1993. The patent relates to a treatment for atherosclerosis. The patent covers a number of azetidinone compounds including ezetimibe. Ezetimibe inhibits the reabsorption of cholesterol which is a known cause of atherosclerosis. 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. They act by increasing the breakdown of cholesterol in the liver.

4 In 2003, a marketing authorisation was granted in respect of a medicinal product under the trade name of Ezetrol which permitted the marketing of 10mg tablets of ezetimibe for three therapeutic indications as explained by the trial judge:-

• “(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.”

5 MSD applied for, and was granted, an SPC based on the marketing authorisation granted for ezetimibe under the trade name Ezetrol.

6 In 2005, a new marketing authorisation was granted to MSD in respect of a medicinal product with the trade name Inegy. This was in respect of tablets containing a combination of ezetimibe and simvastatin. It was for four specific compositions, namely 10mg ezetimibe and 10mg simvastatin; 10mg ezetimibe and 20mg simvastatin; 10mg ezetimibe and 40mg simvastatin and; 10mg ezetimibe and 80mg simvastatin. The therapeutic indications for the 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 nonfamilial) hypercholesterolemia or mixed hyperlipidaemia where use of a combination product is appropriate.

• (b) For homozygous familial hypercholesterolemia, Inegy was indicated as adjunctive therapy to...