On 29 November 2019 Justice Denis McDonald delivered judgment in Merck Sharp & Dohme Corp v Clonmel Healthcare Ltd. This case follows the decision of the Irish Supreme Court on 31 July 2019 involving the same parties which saw a change in approach to granting injunctions in Irish patent actions, see our article here.
The current proceedings relate to the defendant’s counterclaim challenging the validity of the plaintiff’s supplementary protection certificate (“SPC”) for a cholesterol reducing medicinal product containing a combination of two active ingredients ezetimibe and simvastatin (a biosynthesis inhibitor/statin).
The plaintiff is the holder of Irish Patent 0 720 599 (“the 599 Patent”) which was granted by the European Patent Office on 19 May 1999 with a priority date of 21 September 1993.
In 2003 the plaintiff was also granted an SPC on foot of the marketing authorisation to market 10 mg of ezetimibe under the trade name Ezetrol. In 2005 the plaintiff obtained an SPC for a combination of ezetimibe and “a cholesterol biosynthesis inhibitor such as simvastatin” on the basis of the 599 Patent, marketed as Inegy. Of relevance, a separate SPC was granted for simvastatin and it expired in May 2003. It was not disputed by the parties that the 599 Patent covers several compounds including ezetimibe.
The defendant challenged the validity of the 2005 SPC on the following grounds:
(a) the SPC breaches Article 3 (a) of the Regulation EC No 469/2009 concerning the supplementary protection certificate for medicinal products (“the SPC Regulation”) on the basis that the combination of ezetimibe and simvastatin is not protected by the 599 Patent;
(b) in breach of Article 3 (c) of the SPC Regulation, the only compound protected by the 599 Patent was already the subject matter of an earlier SPC granted in 2003. In addition, 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; and
(c) the marketing authorisation for the combination was not the first marketing authorisation for such combination and the SPC was granted contrary to the provisions of Article 3 (d) of the SPC Regulation.
McDonald J. noted that the principal decision applicable to this current case is the CJEU judgment in Teva v. Gilead. For background, see our previous article regarding the Commercial Court proceedings in Ireland. The issue in that case was whether the combination of TD and emtricitabine (“FTC”) were protected by a patent. The plaintiff subsequently obtained an SPC for this combination used as a treatment and prophylactic for HIV. McDonald J. noted that the factual distinction between the Teva v. Gilead case and the current case, is that the claims in the 599 Patent specifically provide for the combination of a statin and indeed simvastatin is identified, whereas the claims in Gilead’s patent did not refer to FTC.
On the basis that an identified combination is claimed in the 599 Patent, the plaintiff submitted that the two-stage test adopted by the CJEU in Teva v. Gilead did not apply in the present case as it should not apply where a specific combination is claimed in a patent. McDonald J rejected this premise on a number of grounds. In line with Article 69 of the EPC, the CJEU had stated that regard needed to be had to the description and drawings of the patent not solely to the claims. In addition, he stressed that the CJEU pointed out that it would be contrary to the objective of the SPC Regulation to grant an SPC for a product that does not fall within the invention covered by the original patent.
Referring to his discussion of the CJEU two step test in Gilead Sciences Inc & Ors v Teva B.V. & Ors and Mylan S.A.S & Ors, McDonald J. confirmed that the approach of the CJEU was to focus on the invention described by the patent. Further he noted that it was clear from the CJEU’s test that common general knowledge must be assessed at the priority date and not thereafter. For the purposes of the test, McDonald J found that the skilled addressee was a team made up of a clinician and a chemist.
Applying the first limb of the test, McDonald J considered the basis of common general knowledge of the skilled addressee and in light of the description and drawings of the invention in the 599 Patent, whether the combination of ezetimibe and simvastatin fell under the invention covered by the 599 Patent. On the basis of the evidence provided, McDonald J concluded that the skilled person would not deduce that the combination of ezetimibe and simvastatin was an independent innovation. Therefore, he held the combination was not covered by the 599 Patent. In these circumstances the judge noted that there was no requirement to apply the second limb of the test.
In response to the defendant’s claim concerning Article 3 (d) of the SPC Regulation, McDonald J referred to Lewison J’s (as he then was) decision in Yeda v. Comptroller General of Patents Designs and Trademarks, in which Lewison J. rejected the defendant’s argument on the basis that the manner in which a medicinal product is used does not form part of the identification of the product itself. Therefore, the judge dismissed the defendant’s argument that the combination of ezetimibe and simvastatin was authorised by the Ezetrol marketing authorisation.
Following his conclusion in relation to Article 3 (a) of the SPC Regulation, McDonald J rejected the defendant’s claim under Article 3 (c), in light of his conclusion in respect of Article 3 (d) of the SPC Regulation that the Ezetrol marketing authorisation was confined to ezetimibe.
McDonald J also refused the plaintiff’s request that he make a reference to the CJEU for guidance in relation to the meaning of “product” in Article 3 (c) versus “product” in Article 3 (a). He found that the “product” referred to in each section meant the same thing, as defined in Article 1 (b), namely the active ingredient or combination of active ingredients of a medicinal product.
The Court held that the defendant was entitled to a declaration that the SPC was invalid and must be revoked, on the basis that combination is not protected by the 599 Patent within the meaning of Article 3 (a) of the SPC Regulation.
  IEHC 814
 Case C-121/17
 CJEU’s two-stage test in Teva v Gilead:
“from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent”.
 2019] IEHC 683
  EWHC 1733 (Pat)