Just over 3 months after we reported a referral from the Finnish Market Court concerning Article 3(c) for combination products (see our news item, here), the
In essence, and similar to their colleagues in
Briefly, in C-443/12 (Actavis I), the CJEU held that Article 3(c) of the SPC regulation (which states that "A[n SPC] shall be granted if ... the product has not already been the subject of a certificate") must necessarily preclude grant from the same patent of both (i) a first SPC arising from a marketing authorisation (MA) for monotherapy using that active ingredient, and (ii) a second SPC arising from a (later) MA for combination therapy using that active ingredient in combination with another active ingredient, if the second active agent is not protected "as such" by the basic patent. C-577/13 (Actavis II) subsequently provided some clarification, stating that in order for a basic patent to protect an active ingredient "as such" within the meaning of Articles 1(c) and 3(a) of the SPC regulation, that active ingredient "must constitute the subject-matter of the invention covered by that patent" (a test that has become known more commonly as the "core inventive advance" test).
In more recent decisions C-121/17 (Teva) and C-650/17 (
Thus, the reasoning of the CJEU in these later "3(a) decisions" seems to contradict the approach taken in the "3(c)/(a) decisions" of Actavis I and II particularly in the context of a combination product. It is hoped that the Finnish and Irish referrals will help to resolve this apparent contradiction.
The precise questions to be referred by the Finnish court are yet to be published, but the four questions referred by the Irish court are reproduced in full below and the full text of the referring decision is also available here. The Irish decision includes a helpful summary both of the status of the Inegy® SPCs around
Whatever the CJEU ultimately decides, it is likely to have a considerable impact on protection strategies for medicinal products. SPCs for combination products are attractive to applicants because combinations are generally developed (and authorised) later than the associated monotherapies, and hence have later expiry dates. The pharmaceutical industry will of course be watching developments with interest.
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Questions referred by the
1. (a) For the purpose of the grant of a supplementary protection certificate, and for the validity of that SPC in law, under Article 3(a) ..., does it suffice that the product ... 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 content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
Mr
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