Merck Sharp & Dohme Ltd v Clonmel Healthcare Ltd

• Jurisdiction: Ireland
• Judge: Mr Justice Peter Charleton
• Judgment Date: 21 February 2022
• Neutral Citation: [2022] IESC 11
• Docket Number: Supreme Court appeal number: S:AP:IE:2021:000052 High Court record number 2018/3485 P
• Court: Supreme Court

Between

Merck Sharp & Dohme Limited

Plaintiff/Appellant

and

Clonmel Healthcare Limited

Defendants/Respondents

[2022] IESC 11

[2021] IECA 54

[2019] IEHC 814

O'Donnell CJ

MacMenamin J

Dunne J

Charleton J

Woulfe J

Supreme Court appeal number: S:AP:IE:2021:000052

Court of Appeal record number: 2020/94

High Court record number 2018/3485 P

An Chúirt Uachtarach

The Supreme Court

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 of Regulation (EC) No. 469/2009

Facts: The appellant, Merck Sharp & Dohme, sought a reference to the Court of Justice of the European Union (CJEU) on the core issue in the appeal to the Supreme Court, namely, the appropriate interpretation and application of Articles 3(a) and 3(c) of Regulation (EC) No. 469/2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1. That application was opposed by the respondent, Clonmel Healthcare Ltd, which contended that a reference was unnecessary because the law was already clear.

Held by Charleton J that a set of issues had arisen concerning the interpretation of Article 3 of the Regulation which could not be said to be acte clair. Hence, the Supreme Court was compelled to make a reference.

The Supreme Court requested a ruling of the CJEU on the following questions: (1)(a) For the purpose of the grant of a supplementary protection certificate (SPC), and for the validity of that SPC in law, under Article 3(a) of the Regulation, does it suffice that the product for which the SPC is granted is expressly identified in the patent claims, and covered by it; or is it necessary for the grant of an SPC that the patent holder, who has been granted a marketing authorisation, also demonstrate novelty or inventiveness or that the product falls within a narrower concept described as the invention covered by the patent? (1)(b) If the latter, the invention covered by the patent, what must be established by the patent holder and marketing authorisation holder to obtain a valid SPC? (2) Where, as in this case, the patent is for a particular drug, ezetimibe, and the claims in the patent teach that the application in human medicine may be for the use of that drug alone or in combination with another drug, here, simvastatin, a drug in the public domain, can an SPC be granted under Article 3(a) of the Regulation only for a product comprising ezetimibe, a monotherapy, or can an SPC also be granted for any or all of the combination products identified in the claims in the patent? (3) Where a monotherapy, drug A, in this case ezetimibe, is granted an SPC, or any combination therapy is first granted an SPC for drugs A and B as a combination therapy, which are part of the claims in the patent, though only drug A is itself novel and thus patented, with other drugs being already known or in the public domain; is the grant of an SPC limited to the first marketing of either that monotherapy of drug A or that first combination therapy granted an SPC, A+B, so that, following that first grant, there cannot be a second or third grant of an SPC for the monotherapy or any combination therapy apart from that first combination granted an SPC? (4) If the claims of a patent cover both a single novel molecule and a combination of that molecule with an existing and known drug, perhaps in the public domain, or several such claims for a combination, does Article 3(c) of the Regulation limit the grant of an SPC; (a) only to the single molecule if marketed as a product ; (b) the first marketing of a product covered by the patent whether this is the monotherapy of the drug covered by the basic patent in force or the first combination therapy, or (c) either (a) or (b) at the election of the patentee irrespective of the date of market authorisation? And if any of the above, why?

Reference to CJEU.

UNAPPROVED JUDGMENT and DRAFT REFERENCE

Judgment of Mr Justice Peter Charleton delivered on Monday 21 February 2022

1 Merck Sharp & Dohme have sought a reference to the Court of Justice of the European Union on the core issue in this appeal, namely, the appropriate interpretation and application of Articles 3(a) and 3(c) of Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products [2009] OJ L152/1. That application has been opposed by Clonmel Healthcare Limited, which contends that a reference is unnecessary because the law is already clear. In consequence of that disagreement, it is appropriate to indicate the nature of the controversy as between the parties and to explain why this Court is obligated to refer; the draft reference being appended hereto for circulation to the parties and amended, if necessary, the final form appearing on the approval of this judgment. First, the nature of what is a complex area of law should be set out.

The issue

2 The human medication ezetimibe, while at this date out of patent, was the subject of a European Patent lasting 20 years. It was effective as and from the date of filing, 14 September 1994. Ezetimibe was subsequently granted a Supplementary Protection Certificate, an SPC. This medicinal therapy was marketed as Ezetrol upon the grant of a marketing authorisation. It is required for the patentee to apply within six months of such a marketing authorisation for an SPC; Article 7(1) of the Regulation. That SPC, which can endure for up to 15 years from grant, can give up to 5 years' protection post patent expiry; Recital 9 and Article 13 of the Regulation. The issue addressed by ezetimibe is excess cholesterol in the bloodstream leading to atherosclerosis. Prior to the marketing of ezetimibe, that condition was often treated by a statin. Statins enhance the liver's function with regard to reducing low density lipoproteins, LDL, in the blood. High concentrations of LDL are associated with an enhanced risk of atherosclerotic disease. A number of therapies have been developed for the treatment of LDL cholesterol. At the time of the priority date of this patent, statins were commonly used. Azetidinones such as ezetimibe operate, however, by inhibiting the absorption of cholesterol into the bloodstream at the borders of the intestinal villus in the small intestine. In the patent, the use of ezetimibe in combination with a statin, specifically mentioning simvastatin, is claimed. At all relevant times, simvastatin has been in the public domain.

3 In this instance, there is an SPC for the monotherapy of ezetimibe (SPC one for Ezetrol) and there is a second SPC for ezetimibe in an incipient combined with simvastatin (SPC two for Inegy). A common modern therapy for cholesterol would include a statin to decrease the natural production of cholesterol into the bloodstream. What is novel about ezetimibe is that it decreases absorption from the digestive system of cholesterol into the bloodstream. These two medicines were predicted to be mutually helpful to the health issue of atherosclerosis, a hardening or fogging of the arteries. Often a drug is prescribed for human or animal health with another or others and there may be additive or synergistic, meaning better than the sum of the parts, results. If a patented drug, ezetimibe marketed as Ezetrol, for which SPC 1 has been granted, is added to an existing drug in the public domain, simvastatin marketed as the single preparation Inegy, can a second SPC be granted? Is SPC 2 contrary to European law?

4 No drug can be sold, however, without marketing authorisation. A medicinal product for humans or animals cannot be placed on the market unless marketing authorisation has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC. Obtaining such an authorisation takes time, because of clinical trials and other checks, and while seeking it the patent protection is running but without value being generated by the invention because it cannot be marketed. The undertaking does clinical trials and receives a marketing authorisation only in 2008. Thus the period of effective patent protection would be reduced to 12 years. Applying within 6 months of the marketing authorisation for an SPC, 15 years may be granted from 2008, meaning the patent protection may be extended to 2023; extending the protection for 3 years to make up for the 8 years lost in clinical trials and obtaining marketing authorisation. On the market, and in the public domain, there is another drug, drug B, which has either additive or synergistic effects on the human or animal patient's condition. The patent also claims the combination of drug A with drug B. The undertaking adds drug A in an appropriate incipient to drug B and does clinical trials lasting two years from 2008. A marketing authorisation is sought for the combination in 2012 and granted. An SPC is sought and granted for drug A plus B. This means that the patented drug A and the public domain drug B have, as a combination, protection up to 2025, since an SPC cannot be granted for more than 5 years beyond the patent term.

5 That exemplifies the situation here. Some may argue that this is in substance the grant of an SPC twice for the same drug; or at least in respect of the same invention. Others may reply that if an SPC is merely a measure to extend the life of a patented medicine that, in reality, this is no more than the extension of, what would be, ordinary patent protection. Hence, that argument would run: during the ordinary monopoly life of a patented drug A, where A is claimed to be therapeutic on its own and is also claimed in combination with drug B, during the 20 years of the patent, no one could manufacture or put on the market any product which was either the monotherapy A or any combination of A with B or C or any drug, whether in the...