Supplementary protection certificates (“SPCs”)

This article is part of the latest edition of our Patents: Review of the Year publication.

It is widely recognised and accepted, perhaps even with a degree of resignation, that the SPC Regulation⁷² is an imperfect instrument of legislation. Most readers will be aware that there have been numerous references to the CJEU in this area for the last 15 years or so and, regrettably, the often Delphic pronouncements of the Court have led to further confusion and debate.

In late April 2023, the European Commission introduced a draft proposal which, if implemented, may resolve some (but certainly not all) of the major outstanding questions in the law. In particular, for many years now, it has been a matter of debate whether it is possible for a patentee to obtain an SPC based on its own patent but a third party’s marketing authorisation (MA). The proposal seeks to amend Art. 6 of the SPC Regulation to make it clear that a patentee cannot obtain an SPC based on a third party’s MA without the consent of that party. Further, for a long time it has been clear that it is possible to obtain two SPCs for the same product based on different patents held by different parties and a practice has emerged whereby two companies in the same group hold SPCs for the same product. The Commission’s proposal provides an additional provision in Art. 3 that forbids companies holding an SPC on the same product if they are “economically linked”. If implemented, there is no doubt that both provisions would spawn further debate in the SPC community and possibly further references to the CJEU.

Potentially more game-changing than the proposed clarification of certain aspects of the SPC Regulation is the Commission’s proposal to introduce a centralised application process for SPCs to be handled by experienced national examiners working within the EU IPO. It has been observed by the Commission that the harmonised approach contemplated for the examination of SPCs by national IPOs has not been achieved: some IPOs thoroughly examine applications for SPCs, others carry out the most cursory of checks; some carry out examination straight away, others wait until close to expiry of the basic patent. The proposed centralised system would in some respects resemble the process for obtaining European patents at the EPO, including the ability to file third party observations. However the system would have several notable differences, including a process for pre-grant opposition. Further, at the end of the process, the EU IPO would issue an opinion which, if positive, would be transmitted to the national IPOs of each country in which an SPC was sought. The Commission’s proposal also provides for a unitary SPC system based on European patents with unitary effect. This would be similar to the regime described above but, at the end of the process, the EU IPO would grant a uSPC. Combined national and uSPC applications are contemplated.

Feedback on the proposals from stakeholders was published in October 2023. By and large, there is support for the centralised system although concerns were raised about whether the EU IPO was the right body to be assigned responsibility for this task and whether the prosecution/opposition system set out could be potentially used by SPC applicants and opponents alike to cause delay and uncertainty.

The Commission’s proposals were trailed by its advocate at a CJEU hearing on 8 March 2023 concerning combined references from the Finnish and Irish courts in relation to validity challenges to SPCs obtained by Merck for the combination of sitagliptin and metformin. The references concerned Art. 3(a) and Art. 3(c) of the SPC Regulation and whether: (i) the combination was protected by Merck’s patent (which was principally directed to sitagliptin but mentioned the possibility of combining this drug with other known medications) and (ii) a prior SPC to sitagliptin meant that Merck could not have a second SPC based on the same patent to a combination including sitagliptin. Frustratingly, the Advocate General’s Opinion which was due to be issued in July 2023 was postponed first until December 2023 and then until April 2024.

Back in the UK, there were two SPC decisions of interest from the English Patents Court in 2023. The first concerned an application by Newron for an SPC for a combination of safinamide, levodopa and a peripheral decarboxylase inhibitor (PDI)⁷³. The basic patent relied upon for the SPC was held to protect this combination and so it was common ground that Art. 3(a) was satisfied. The problem, however, lay with compliance with Art. 3(b) and the requirement for there to be an MA to place the product on the market as a medicinal product. The medicinal product relied upon by Newron was Xadago®, which lists safinamide as the sole active ingredient but makes reference to the medicine being used to treat Parkinson’s disease as an add-on therapy to a stable dose of levodopa alone or with PDIs. Having reviewed the CJEU case law including most notably Yeda⁷⁴, Recorder Douglas Campbell KC held that it was clear that the therapeutic use of a product could not be imported into the definition of the product and therefore that the MA was not directed to the combination product.

In December 2023, Michael Tappin KC, sitting as a Deputy Judge, dismissed an appeal by Merck against a decision of the UK IPO to refuse an application for an SPC for cladribine based on a basic patent entitled “cladribine for treating multiple sclerosis”⁷⁵. The UK IPO had refused the application for lack of compliance with Art. 3(d) of the SPC Regulation which requires that the MA relied upon for the SPC is the first MA to place the product on the market as a medicinal product in the EU. This was because there were earlier MAs for cladribine as a treatment for hairy cell leukaemia. Following the decisions of the CJEU in Abraxis⁷⁶ and Santen⁷⁷, it has been clear that the ruling in Neurim⁷⁸ which first permitted SPCs for second medical uses is no longer good law in the EU and the hearing officer accordingly refused the application. On appeal to the High Court, Merck raised 3 points: (i) that Santen is wrong and that the UK should follow its own trajectory in the case-law; (ii) that the facts of the case were distinguishable from Santen and (iii) that Santen had ex nunc rather than ex tunc effect such that Merck had a legitimate expectation that it would be granted an SPC in accordance with the law as stated in Neurim. Ultimately, the Judge found against Merck on points (ii) and (iii) and it was agreed that the High Court did not have the power to depart from CJEU case law. At the time of writing, it is understood that Merck has been given permission to appeal. This could provide the Court of Appeal with the opportunity to choose between following the CJEU case law and not permitting second medical use SPCs or following a different path. Given that Neurim was a reference from the English Court of Appeal⁷⁹ (on appeal from a decision of Arnold J) in which Jacob LJ stated: “In short, if Neurim are wrong [and an SPC should not be granted], then the Regulation will not have achieved its key objects for large areas of pharmaceutical research: it will not be fit for purpose”, it will be interesting to see what happens.

Finally, 2023 bore witness to the first substantive decision on the so-called manufacturing waiver which allows third parties, amongst other things, to manufacture in the EU during the SPC term for export outside the EU and to prepare for day 1 post-expiry launch within the EU⁸⁰. It came from the Munich District Court in a dispute between Janssen and Formycon following Formycon’s wish to produce a biosimilar to Janssen’s Stelara® medicine. Formycon notified Janssen and the German PTO of its intention to manufacture for export although it did not include a marketing authorisation number or confirmation of the third country to which export was intended to be made. Janssen was granted a preliminary injunction as the Court held that it was a requirement of the Regulation to provide the authorisation number for at least one country and that this country should be identified. Although this appears to be slightly at odds with the language of the Regulation, it seems that the Court held that the purpose of the manufacturing waiver, and in particular the 3-month notice period, is to enable the SPC holder to check whether an MA has been granted in the third country to which export is intended and that the information that Formycon had provided did not enable Janssen to carry out that analysis. 

Separately, Medicines for Europe reported in June 2023 on the findings of a survey about the fitness for purpose of the manufacturing waiver. Overall, it was reported that most generics/biosimilar companies were making use of the waiver but many members were continuing to manufacture outside the EU owing to the present legal uncertainty as well as, among other things, the requirement to disclose confidential information to third parties.

Continue reading the other sections in publication:

1. Claim construction and infringement
2. Validity
3. FRAND
4. Supplementary protection certificates (“SPCs”)
5. Procedural issues
6. Unitary Patent/Unified Patent Court

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