High Court: Clonmel Healthcare granted declaration that Merck’s Supplementary Protection Certificate was invalid

Clonmel Healthcare have been granted a declaration that a Supplementary Protection Certificate held by Merck Sharp & Dohme Corp for a combination therapy for cholesterol was invalid.

Merck brought infringement proceedings against Clonmel for marketing a generic competitor; however, considering Clonmel’s counterclaim, Mr Justice Denis McDonald agreed that the combination therapy was not the innovation of the underlying patent.


Merck was the holder of a European Patent for simvastatin (a statin for the treatment of cholesterol). Merck obtained an SPC, extending the term of the patent monopoly, which expired in May 2003. Merck also held a patent for ezetimibe (also used for the treatment of cholesterol). This patent expired in September 2014. The SPC in respect of ezetimibe was granted in 2003 and expired in April 2018. 

Inegy, which is a combination of simvastatin and ezetimibe, was also marketed by Merck, and covered by EP 0 720 599. In 2005, Merck obtained a separate SPC for Inegy which expired in April 2019. 

Clonmel Healthcare argued that this separate Inegy SPC was invalid, and therefore launched a generic competitor to Inegy the day after the ezetimibe SPC expired in April 2018.

Consequently, Merck commenced infringement proceedings against Clonmel, seeking relief in relation to the alleged infringement of the Inegy SPC. Merck also sought an injunction to restrain Clonmel from infringing the Inegy SPC, however this was refused. In the Supreme Court in August 2019, Mr Justice Donal O’Donnell held that the interlocutory injunction should have been granted.

Counterclaim challenging validity of SPC

In response to Merck’s infringement proceedings, Clonmel raised a counterclaim in which it challenged the validity of the SPC on three grounds:

  1. 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 Inegy patent “and/or was not the core inventive advance to which the …Patent pertained”.
  2. That, in breach of Article 3(c) of the SPC Regulation, the only compound protected by the Inegy patent (which Clonmel contends is solely ezetimibe) was already the subject matter of an earlier SPC granted in 2003. In addition, it was contended that if the Inegy patent protects the combination of ezetimibe and simvastatin, that combination had previously been the subject of the earlier SPC granted in 2003. In those circumstances, it is contended that the Inegy SPC is not valid;
  3. 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.

The skilled person

Article 3(a) of the SPC Regulation states that a SPC shall be granted if “the product is protected by a basic patent in force”. Clonmel argued that the combination of ezetimibe and simvastatin was not the “core inventive advance” – their principal argument was that a “skilled person” reading the Inegy patent with the benefit of common general knowledge (particularly in relation to combination therapy  at the date of priority) would not deduce that this combination was an independent innovation.

In effect, the Inegy patent says, “here is a new drug to be used in the treatment and prevention of high cholesterol that will join the pool of other such drugs already being used for this purpose, including statins, with which it can be combined”.

Clonmel argued that the “skilled addressee” for the Inegy patent was the general practitioner, however Mr Justice McDonald said the evidence suggested that “combination therapy was more likely to be encountered among specialist clinicians involved in the treatment of atherosclerosis”. Stating that it would be “unreal…to believe that the skilled person would be represented solely by clinicians of that kind”, Mr Justice McDonald said that the skilled addressee would comprise a team including a clinician familiar with atherosclerosis and a medicinal chemist.

Combination therapy not an independent innovation  

Mr Justice McDonald said it was clear from relevant publications that by the priority date of the Inegy patent, combination therapy (particularly involving statins) was already well recognised and established for certain types of cholesterol treatments.

Clonmel argued that a skilled person reading the Inegy Patent with the benefit of this common general knowledge would not deduce from the references to combinations involving a compound such as ezetimibe with a statin such as simvastatin that this could be said to be an independent innovation.

Stating that there was “considerable force in this submission”, Mr Justice McDonald said this was “especially so when one comes to consider the terms of the patent itself”. He said that the patent was “devoid of detail in relation to any of the potential combinations” and that the absence of data in relation to the combination was “striking”. Mr Justice McDonald contrasted this with the “very significant detail” in relation to the compounds in Formula 1 of the patent (which included ezetimibe).

Considering the evidence of a professor of organic chemistry (formerly of UCD), Mr Justice McDonald said that of all the expert witnesses “he was by far the most impressive”. Mr Justice McDonald said that Clonmel’s case got “significant support” from his “clear, straight forward, authoritative and frank” evidence that the combination of ezetimibe and simvastatin could not be considered to be the innovation of the patent.

Concluding that the combination was not an invention covered by the patent, Mr Justice McDonald agreed with Clonmel that the invention related to the Formula 1 compounds (the test in C-121/17 Teva v Gilead considered). Accordingly, Mr Justice McDonald held that the combination was not protected by the Inegy patent within the meaning of Article 3(a) of the SPC regulation. As such he granted Clonmel a declaration that the SPC was invalid and must be revoked.

© Irish Legal News Ltd 2021

Other judgments by Mr Justice Denis McDonald