In brief
- The High Court has confirmed that the European Court of Justice's decision in Medeva relating to combination supplementary protection certificates (SPCs) remains good law in the UK and applies broadly: specifically, where a prior marketing authorisation (MA) places a combination product "A+B" on the market, that MA constitutes the first authorisation for each of the individual active ingredients "A" and "B" for the purposes of article 3(d) of the SPC Regulation, regardless of whether it also contains other active ingredients.
- In this case, drospirenone was protected by the basic patent and authorised by an MA for the oral contraceptive Slynd, but earlier MAs for Angeliq and Yasmin (both of which contained drospirenone combined with an estrogen), meant that article 3(d) was not satisfied, and the SPC application failed.
- The result may not be consistent across jurisdictions. Applicants managing multi-jurisdictional SPC portfolios for single active ingredients should conduct careful due diligence on prior combination MAs and monitor developments across relevant jurisdictions closely.
Background
This case concerns an appeal to the Patents Court from the UKIPO, which had refused an application for a supplementary protection certificate (SPC) from Laboratorios Leon Farma (Leon) based on its product Slynd, an oral contraceptive containing drospirenone as its sole active ingredient, with no estrogen. Prior marketing authorisations (MAs) existed for Angeliq and Yasmin, both of which contained drospirenone combined with an estrogen.
The UKIPO accepted that article 3(a) to 3(c) of the SPC Regulation (Regulation EC 469/2009, which is assimilated EU law) were satisfied but refused the application based on article 3(d), which requires that the MA relied upon in the SPC application must be the first authorisation to place the product on the market. The UKIPO took the position that the Slynd MA was not the first authorisation to place drospirenone on the market, given the MAs for Angeliq and Yasmin. The UKIPO held that the CJEU decision in Medeva (C-322/10, EU:C: 2011:773) remained good law in the UK, and that pursuant to Medeva the previous MAs for Angeliq and Yasmin were both prior authorisations to place drospirenone on the market as a medicinal product.
Therefore, the sole dispute under appeal concerned article 3(d): was the Slynd MA the first authorisation to place drospirenone on the market? Stated more broadly: where an earlier MA for "A+B" has been granted, can an SPC for "A" alone based on a later MA satisfy article 3(d)?
Medeva in brief
The Medeva case arose from facts concerning multivalent vaccines: Medeva's patent claimed a combination of two antigens as active ingredients in a vaccine for treating whooping cough, and the SPC application relied upon an MA for a vaccine which contained those two antigens along with others. The decision focused on articles 3(a) and 3(b) of the SPC Regulation, inter alia, because the MAs relied upon did not contain only the active components or ingredients specified in the SPC application and in the patent claims. In this context, the CJEU decided in Medeva that:
- In relation to article 3(a): pursuant to the wording of the SPC Regulation, any SPC confers the same rights as conferred by the basic patent and is subject to the same limitations and the same obligations. It follows that article 3(a) of the regulation precludes the grant of an SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent.
- In relation to article 3(b): an SPC for a combination of two active ingredients, corresponding to that specified in the wording of the claims of the basic patent relied on, can be granted where the medicinal product for which the MA is submitted in support of the SPC application contains not only that combination of the two active ingredients but also other active ingredients.
The High Court's decision
The court dismissed Leon's appeal, in a judgment delivered by Recorder Douglas Campbell KC sitting as a Judge of the Patents Court. His key findings were as follows:
- The first MA for a product containing the active ingredient, whether alone or in any combination, may constitute the first authorisation for that active ingredient for the purposes of article 3(d) in the UK. In this case, the Angeliq MA was the first authorisation for drospirenone. The Slynd authorisation was not the first authorisation to place drospirenone on the market, and it did not matter that the Angeliq MA contained other active ingredients as well.
- Medeva applies broadly. The court held that Medeva is not limited to the specific circumstances of that case, as Leon suggested. On the contrary, the principles set out in Medeva apply to "all spheres" where a medicinal product is marketed with the patented active ingredient(s) alongside others; multi-disease vaccines were just "the example" considered in Medeva itself.
- Medeva applies to article 3(d), as well as article 3(b). The court found no logical justification for adopting a different approach to articles 3(b) and 3(d), noting it would be particularly odd if the word "product" had to be given the same meaning in each limb of article 3 but the phrase "marketing authorisation" was given different meanings as between articles 3(b) and 3(d).
- Teva II distinguished. The court clarified that Teva II, which concerned two joined cases (C-119/22 and C-149/22), dealt with the opposite situation to Medeva and therefore did not change the conclusion reached: Medeva established that an earlier MA placing "A+B" on the market was an MA for placing "A" alone on the market, whereas Teva II established that, if the earlier product only had "A" or only "B", it was not the same as a later product consisting of "A+B".
- Leon's auxiliary request failed. Amending the product description to "drospirenone (not containing any estrogen)" would not create a different product.
- No room for teleological arguments. The court's task was to apply Medeva, not to undertake an ad hoc balancing exercise or to perform its own teleological analysis. The Comptroller did not dispute that Leon had conducted valuable and important research, but that was not the test. Indeed, as the Comptroller submitted, the court noted that even research considered worthy of a Nobel Prize would not for that reason alone satisfy the requirements of the SPC Regulation.
Key takeaways
The Patents Court has endorsed the CJEU’s line of case law; Medeva remains good law in the UK and of general applicability. The result is that, in cases where a medicinal product is first authorised as a combination therapy (“A+B”), but a later monotherapy product (“A”) is developed and authorised, the later marketing authorisation to the monotherapy “A” cannot be used as the basis for an SPC application.
Notably, however, this result may not be consistent across jurisdictions: the court observed that in Hungary, for example, Leon's equivalent SPC application was granted after the Hungarian Patent Office raised similar article 3(d) objections, though no reasoned decision was available. This divergence may present both risks and opportunities for applicants managing SPC portfolios across multiple jurisdictions.
Applicants should therefore conduct careful due diligence on prior combination MAs before pursuing SPC applications for single active ingredients. Whilst pharmaceutical companies may welcome the court's confirmation that the CJEU's Medeva case law applies in the UK, the judgment illustrates that even innovative monotherapy research may not be rewarded with an SPC where the active ingredient was previously placed on the market as part of a combination therapy.
In the meantime, it is possible that Leon will seek to appeal further, including potentially asking the Court of Appeal to depart from Medeva.