Patent decision
- BL number
- O/0705/25
- Concerning rights in
- SPC/GB22/021
- Hearing Officer
- Dr R Dinham
- Decision date
- 31 July 2025
- Person(s) or Company(s) involved
- Laboratorias Leon Farma SA
- Provisions discussed
- Regulation (EC) 469/2009 (Medicinal Products), Article 3
- Keywords
- Supplementary Protection Certificates
- Related Decisions
- None
Summary
An application was filed for an SPC to protect the medicinal product Slynd®, which contains the active ingredient drospirenone. There are earlier marketing authorisations (MA) for drospirenone in combination with an estrogen, as Yasmin® and Angeliq®, and in light of these, the examiner considered that the MA for drospirenone alone (Slynd®) was not the first MA for a medicinal product comprising drospirenone, and therefore the requirements of Article 3(d) of the SPC Regulation. The examiner’s arguments were based on the approach of the CJEU in case C-322/10 Medeva, which allows an SPC to be granted where the MA relied upon in support of the application is for a medicinal product that contains one or more other active ingredients, in addition to the those of the product for which protection is sought.
The applicant put forward arguments that Medeva was limited to multivalent vaccines only; the decisions of the CJEU in cases C-673/18 Santen and C-119/22 & C-149/22 Teva II, and the decisions of the UK Court of Appeal in Newron ([2024] EWCA Civ 128) and Merck Serono ([2025] EWCA Civ 45) overturn Medeva; and that even if Medeva is considered relevant, a certificate should still be granted. They also submitted an auxiliary request to amend item (6) of form SP1 to “drospirenone (without any estrogen)”, from “drospirenone” alone.
Taking into account the opinion of the Advocate General and the CJEU in Medeva, the hearing officer concluded that the intention was not to limit the decision of Medeva to multivalent vaccines. The hearing officer also carefully considered the extent to which Santen overturns Medeva, taking into account the judgments of the Court of Appeal in both Newron and Merck. Whilst acknowledging that the Courts dismissed the teleological reasoning in Neurim, the hearing officer found that that this did not necessarily extend to the dismissal of the reasoning behind the CJEU decision in Medeva. Furthermore, as Teva II was decision of the CJEU after IP completion date, the hearing officer was unable to take into account the approach therein to the interpretation of Article 1(b), to the extent that it differed from that of Medeva. As such the hearing officer considered that she was still bound by Medeva.
In light of this, the hearing officer concluded that, based on the understanding of Medeva as it currently stands, the MAs for both Yasmin® and Angeliq® authorise the product “drospirenone” to be placed on the market as part of their respective medicinal products. Therefore, the MA for Slynd® was not the first MA for the product “drospirenone”.
In considering the auxiliary request, the hearing officer acknowledged that there was little guidance on the issue of products defined in negative terms when applying the SPC Regulation. In Draco [1996] RPC 417, and amendment of the product description from “budesonide” to “additive-free budesonide” was proposed, but neither the hearing officer nor the judge in that case explicitly commented on the negatively defined product. Nevertheless, after careful consideration, the hearing officer concluded that there was nothing in the case law or the SPC Regulation that suggested that Article 1(b) should allow for a product to be defined in terms of the presence of one active ingredient in combination with the absence of another.
Therefore, the hearing officer concluded that the MA for Slynd® was not the first MA for the purposes of Article 3(d). The application was refused under Article 10(2).
Full decision O/0705/25 
457Kb
