Background
In EU and EEA countries (as well as the
As part of the criteria for SPC eligibility, Article 3(a) of the SPC Regulation (469/2009) requires that the approved product be "protected" by a basic patent in force. However, the precise meaning of "protected" has been the subject of fiercely contested litigation in
- The "infringement" test: under this test, it is simply sufficient that the approved product fall within the claims of the basic patent, with no additional criteria.
- The "specifically identifiable" (or "identified" or "specified") test: under this test, the approved product must not only fall within the claims of the basic patent, but also be sufficiently identifiable (preferably as a specific compound) within the claims and/or description of the basic patent.
- The "inventive advance" (or "invention" or "sole subject-matter of the patent") test: under this test, the approved product must also reflect the inventive contribution made by the patent.
Neither of tests 2 or 3 have any specific legal basis in the wording of the SPC Regulation. However, like all EU legislation, the SPC Regulation is interpreted in line with its aims and objectives (a so-called "teleological" interpretation). Both tests 2 and 3 can be considered to have their basis in the doctrine that the SPC should reflect the research that led to the basic patent, and should exclude from SPC protection products which had not been invented at the filing date of the basic patents. For example, the case law discussed below appears to have the intention of excluding SPCs based on patents where a biological target of a particular disease had been identified but drugs acting on it had not yet been invented. In relation to the issue of combination patents specifically, the case law appears to try to exclude the grant of an SPC to a combination where a drug had been discovered to work as a mono-product but combination products containing it had yet to be invented.
Prior CJEU case law on SPCs
For most of the first 20 years of SPCs in
In Teva v Gilead (C-121/17), the CJEU was once again asked to consider the validity of SPCs for combination products. The court laid down a two-part test for whether a combination product met the requirements of Article 3(a), as follows:
(i) the combination of actives necessarily, in the light of the description and drawings of that patent, fall under the invention covered by the patent, and
(ii) each of those active ingredients must be "specifically identifiable", in the light of all the information disclosed by the patent, at the filing or priority date of the application.
Part (ii) of the Teva test corresponds to test 2 outlined above. However, the CJEU notably did not use the term "inventive advance" in deciding Teva. This raised the question whether test 3 was still relevant in deciding SPC eligibility under Article 3(a) - in particular, did "the invention" mean the same as test 3?
In
The Merck v Clonmel litigation - ezetimibe and simvastatin
The case before the CJEU resulted from long-running litigation on a family of SPCs based on EP720599. The basic patent claimed the approved compound ezetimibe both generally and specifically, and also contained claims directed to combination products with statins, specifically reciting simvastatin. However, the patent contained no data showing the combination of ezetimibe and simvastatin (or any other combination partner) was independently inventive over and above ezetimibe as a mono-product.
Ezetimibe was first approved in
Following expiry of the basic patent and the SPC 1 family, the generic pharmaceutical manufacturer Clonmel began to market a combination ezetimibe / simvastatin product. Merck sued them for infringement of the patent and SPC 2 family, and Clonmel counter-claimed for revocation of the SPC 2 family.
It was not in dispute that both ezetimibe and simvastatin were "specifically identified" in the basic patent and therefore test 2 was met. However, Clonmel argued that SPC 2 was invalid on two grounds. First, they argued that test 3 was not met and SPC 2 therefore did not comply with Article 3(a). Second, they argued that the grant of SPC 1 before SPC 2 was filed precluded the grant of SPC 2 under Article 3(c), which requires that the approved product not already be the subject of an SPC.
Merck counter-argued that the "inventive advance" approach had been specifically rejected by the CJEU in
Differing decisions were reached in parallel litigation in courts across
Questions referred to CJEU
In view of the uncertainty in the current case law and the widely differing views of European courts, the
"1.(a) For the purpose of the grant of an SPC, and for the validity of that SPC in law, under Article 3(a) of [the SPC 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?"
The answers to questions 1 and 2 will likely decide the Article 3(a) issue in this litigation, and hopefully provide some clarity about whether test 3 is still relevant for determining compliance with Article 3(a). Questions 3 and 4 will likely decide the Article 3(c) issue.
The CJEU registry has entered this case onto its records as C-149/22, and the court will likely decide the case some time in 2023. After over a decade of uncertainty, can the court finally end its opaqueness on these issues and provide a clear ruling on SPC eligibility that both the research-based and generic pharmaceutical industries have been crying out for?
Of course, following Brexit, the
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