Background

This case concerns the successful challenge by Clonmel Healthcare Limited (CHL) (who were represented by this firm) to the validity of the supplementary protection certificate (SPC) held by Merck Sharp & Dohme (MSD) in respect of its cholesterol-reducing medicinal product ‘Inegy‘, comprising a combination of two active ingredients, ezetimibe and simvastatin. 

An SPC provides an additional period of protection (akin to patent protection) of up to five years beyond the expiry of a patent. Obtaining regulatory approval for a medicinal product takes time. The purpose of an SPC is to compensate a patent owner for the delay between the date of filing a patent in respect of an invention and the patent owner’s ability to commercially exploit that invention as a medicinal product following the grant of a marketing authorisation for that medicinal product. 

MSD first obtained an SPC in Ireland for its medicinal product ‘Ezetrol‘, which comprised the single novel active ingredient ezetimibe, based on a particular patent (basic patent). MSD was subsequently granted a second SPC in Ireland, based on the same basic patent, for a second medicinal product, ‘Inegy‘.  Inegy comprised a combination of ezetimibe and a second known statin compound, simvastatin. 

In the High Court (HC), Mr Justice McDonald held that MSD’s Inegy SPC was invalid on the grounds that it breached article 3(a) of Regulation (EC) No. 469/2009 (SPC Regulation), which requires that the product is protected by a basic patent in force and Article 3(c) of the SPC Regulation, which requires that the product has not already been the subject of an SPC. McDonald J held that the Inegy SPC did not fall foul of article 3(d) of the SPC Regulation.

The key issue concerning articles 3(a) and 3(c) was whether the combination product of ezetimibe and simvastatin was “protected by the basic patent as such ” within the meaning of the SPC Regulation. This included consideration of whether it was enough that the combination is referred to in the claims of the basic patent.  The key issue concerning Article 3(d) was whether the fact that regulatory documentation connected to the Ezetrol marketing authorisation referred to its being approved for administration together with a statin for certain indications (albeit not in the same tablet), meant that the Inegy medicinal product (of ezetimibe and simvastatin in a single tablet) had already been the subject of a prior marketing authorisation.

On appeal to the Court of Appeal (CoA), MSD challenged the HC’s finding in respect of articles 3(a) and 3(c) and, in turn, CHL challenged the decision in respect of article 3(d). 

CoA Analysis on Articles 3(a) and 3(c)

The CoA considered, in extensive detail, Court of Justice of the European Union (CJEU) case law concerning the application of articles 3(a) and 3(c) of the SPC Regulation to combination medicines, the interpretation of the European Patent Convention (EPC), and the Protocol on the Interpretation of article 69 of the EPC in domestic law.

Medeva Decision 

In considering the judgment in Case C-322/10 Medeva BV v. Comptroller General of Patents, Designs and Trade  (Medeva), the CoA noted that although the CJEU had expressed negatively that the SPC Regulation precludes the grant of an SPC relating to active ingredients which are not specified in the claims of the basic patent, this does not infer that an SPC must be granted simply because the active ingredients are specified in the wording of the claims. 

Sanofi Decision 

The CoA referred to C-443/12 Actavis Group PTC EHF and Actavis UK Ltd v. Sanofi Pharma Bristol-Myers Squibb SNC (Sanofi). In Sanofi, the CJEU acknowledged the public interest in preventing a scenario whereby multiple SPCs could be granted for differing combinations of active ingredients with the compound that is protected by the basic patent.  The CJEU found that the basic objective of the SPC Regulation is to compensate for the delay to the marketing of the “core inventive advance” that is the subject of the basic patent. The CoA quoted from the CJEU, emphasising:

“..if it were accepted that all subsequent marketing of that active ingredient in conjunction with an unlimited number of other active ingredients, not protected as such by the basic patent but simply referred to in the wording of the claims of the patent in general terms, ……conferred entitlement to multiple SPCs, that would be contrary to the requirement to balance the interests of the pharmaceutical industry and those of public health as regards the encouragement of research within the European Union by the use of SPCs…” 

Boehringer Decision 

The CoA referred to the CJEU’s findings in C-577/13 Actavis Group PTC EHF and Actavis UK Ltd v. Boehringer Ingelheim Pharma GmbH & Co. KG (Boehringer).  In Boehringer, the CJEU held that it would be contrary to the requirement under the SPC Regulation, to balance the pharmaceutical industry interests and those of public health, if the marketing of an active ingredient, which was the subject matter of the invention covered by the basic patent, in conjunction with an unlimited number of active ingredients which were not, entitled the patent holder to multiple SPCs in respect of each such combination product. 

In Boehringer, each of the active ingredients and the specific combination were expressly mentioned in the claims, however, this did not satisfy the requirements of article 3(a), as the second active ingredient was not the subject matter of the invention covered by the patent.

Teva Decision 

The CoA gave detailed analysis to Case C-121/17 Teva UK Ltd. v. Gilead Sciences Inc. (Teva). 

MSD argued that Teva marked a departure by the CJEU from the tests laid down in Sanofi and Boehringer and that a combination product will be protected by the basic patent within the meaning of Article 3(a), simply if the combination of the two active ingredients comprising the product is expressly mentioned in the claims. Essentially MSD argued that express mention in the claims is not merely necessary but is sufficient to satisfy the requirement of article 3(a).  MSD argued that this position was confirmed in Case C-650/17 Royalty Pharma Collection Trust v. Deutsches Patent – und Markenamt (Royalty Pharma).

Conversely, CHL argued that express reference to the second active ingredient in the claims is a necessary but not a sufficient condition in order to satisfy the requirements of article 3(a) and contended  that the CJEU had not ruled out the requirement to interpret the patent by reference to article 69 and the description and drawings of the patent, i.e. one does not look solely at the claims of the patent in analysing whether or not a product is “protected as such” by that patent for the purposes of the SPC Regulation and that one must also determine whether it falls under the ‘invention’ of the patent. In this regard, CHL argued that, in Teva, the CJEU had quoted with approval from Boehringer and that it had not overruled it. 

CoA Decision on Article 3(a) and 3(c)

The CoA found in favour of CHL’s analysis and held that Teva did not overrule Boehringer. The CoA noted that in Teva the CJEU expressly endorsed paragraphs 36 and 37 of Boehringer and it was “simply inconceivable” that the CJEU would do so but not clearly indicate it was departing from the decision if that was what it intended. The CoA also stated that for the purposes of the application of article 3 (a) and determining whether the product is covered by the ‘invention’ of the patent, the court cannot stop at the claims. Rather “the court must have regard to the description and drawings of the patent in order to ascertain what are the limits of the invention in the basic patent”. 

The CoA did not accept that Royalty Pharma excluded an assessment of whether a product comes under the invention covered by the basic patent in this regard. Rather, Royalty Pharma had simply excluded use of the more particular concept of ‘core inventive advance’.

The CoA also rejected the UK Court of Appeal’s assessment that the CJEU decision in Teva means that any express mention of the active ingredient in the claim is sufficient to satisfy the requirement of article 3 (a) and that the phrase  “fall under the invention covered by the patent ” prohibits the national court from engaging in an assessment of the invention covered by the patent. The CoA held that the national court is required to assess the invention of the patent by reference to the description and the drawings of the basic patent. 

In an unwavering endorsement of the HC decision, the CoA held that the approach and assessment of the trial judge was correct. The CoA rejected MSD’s arguments 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 no assessment of the invention of the patent was either required or necessary. As the trial judge had stated 

“If that was all that was required, it would mean an SPC would automatically be available for any combination product containing a combination of a novel product disclosed in a patent and a pre-existing production available off the shelf”.

The CoA held that MSD’s combination product, Inegy, did not fall under the invention covered by the patent and was therefore not protected by the basic patent. Therefore, the appeal under article 3 (a) was refused.

With respect to Article 3 (c), the CoA held that the HC had correctly found that the product protected by the basic patent was the mono-product ezetimibe and not the combination product.  Ezetimibe had already been the subject of an earlier SPC and therefore MSD’s appeal in relation to article 3 (c) failed.

CoA Decision on Article 3(d)

The CoA also upheld the HC’s decision in respect of article 3(d), finding that the marketing authorisation granted in respect of Inegy was the first marketing authorisation to place that combination product on the market as a medicinal product in accordance with article 3(d).  The CoA upheld the HC’s finding that the co-administration of two separate medicinal products, Ezetrol and a statin, as allowed under the Ezetrol marketing authorisation documentation, could not be equated to a marketing authorisation for the stand-alone combination medicinal product, Inegy.

Conclusion

This decision confirms the test for the validity of SPCs relating to combination products in Ireland. Rights holders should note that it is not sufficient that the claims of a patent contain an express reference to a combination of the active ingredients in question. The national court must also engage in an assessment of whether the combination product falls under the invention of the basic patent by reference to the description and drawings of the patent.

For rights holders it is also noteworthy that significant emphasis was placed on the balancing of interests of the pharmaceutical industry and in encouraging innovation and investment, as against the interests in public health, when extending protection. It was highlighted by the CoA that this balancing of conflicting interests underpins the SPC Regulation and the enforceability of SPCs.