Pharma companies get some clarity on SPCs for combination products

However, it will be necessary to show that a combination product falls under the invention of the patent and that any combined effect is more than merely additive following the ruling, experts have said.

Alasdhair McDonald and Charlotte Weekes of Pinsent Masons, who specialise in the resolution of intellectual property (IP) disputes in life sciences, were commenting after the Court of Justice of the EU (CJEU) provided clarity on how two criteria relevant to a medicinal product’s eligibility for an SPC are to be interpreted and applied in the context of combination products – medicinal products that are made up by two or more active ingredients.

SPCs are provided for in EU law, and separately too in UK law post-Brexit, to enable pharmaceutical patent holders to effectively extend the period for which they can exercise monopoly rights over the sale of medicinal products they have invested a lot of time and money into developing. Patent protection lasts 20 years but it takes pharmaceutical companies several years to develop new medicines, carry out mandatory clinical trials and gain marketing authorisation. This means that the period of patent protection available to pharmaceutical manufacturers during which they can commercialise their products is typically much shorter than that which applies in other, less regulated, sectors. The SPC framework was developed to account and compensate for that.

In the EU, pharmaceutical companies are only eligible for SPCs if they meet the criteria for protection under the SPC Regulation. 

SPCs can only be granted if, in the EU country in which the application is submitted, the product is “protected by a basic patent in force” – as stipulated by Article 3(a); a marketing authorisation has been issued to place that product on the market as a medicinal product – as stipulated by Article 3(b); the product has not already been the subject of an SPC – as stipulated by Article 3(c); and the marketing authorisation relied on is the first to place the product on the market as a medicinal product – as stipulated by Article 3(d).

National courts in Ireland and Finland asked the CJEU to clarify how Articles 3(a) and 3(c) of the SPC Regulation apply in the context of combination products. Merck Sharp & Dohme is in dispute with Clonmel Healthcare and, separately, Teva Finland over SPC rights for different combination products before those national courts.

First, having confirmed the strict view to be taken on the concept of ‘product’ in Article 1(b) and that it must have the same meaning and scope whether interpreted for Article 3(a) or 3(c). the CJEU ruled that there is nothing in Article 3(c) of the SPC Regulation that precludes SPCs being granted for combination products. That is so even if an SPC has already been granted for one of the active ingredients of that product in isolation, that active ingredient is the only one of the product’s components to have been disclosed by the basic patent, and the other active ingredients were known at the filing date or priority date of that patent.

McDonald said the CJEU’s ruling on this point confirms that it does not matter, for the purposes of satisfying the Article 3(c) requirements, whether a combination product is used to treat the same conditions as specified in the basic patent the SPC is based on.

However, even if a combination product satisfies the Article 3(c) criteria, it must still meet the other three criteria under Article 3 – including the Article 3(a) requirements. In this regard, McDonald highlighted that the CJEU has now suggested that factors that may not preclude eligibility under Article 3(c) could nevertheless prevent a combination product satisfying the Article 3(a) test.

McDonald said: “The CJEU said that, to fall under 3(a), the combination product must necessarily fall under the invention covered by the basic patent, from the point of view of a person skilled in the art, and in the light of the description and drawings of that patent, at the filing date or priority date (confirming the earlier Teva and Royalty Pharma cases). This suggests that the combination product itself must form part of the inventive concept of the patent.”

“In many cases, the invention of patent will only actually relate to one pharmaceutical compound (A), but dependent claims will nevertheless also cover A plus B. It would appear this sort of patent will no longer support an SPC for the combination product. In accordance with recent European Patent Office (EPO) practice, a basic patent may only support an SPC for a combination product if it discloses, for the first time, non-obvious combined effects of A and B, wherein those effects are more than additive,” he said.

Weekes said the CJEU ruling provides clear guidance, rooted in the intention of the legislature, on important issues pertaining to SPC eligibility, including that the purpose of an SPC is not to extend the protection conferred by the basic patent beyond the invention which that patent covers.

She said the CJEU’s view that a strict view is to be taken of the concept of ‘product’ – that it is defined by reference to the active ingredient or combination of active ingredients and not by reference to the therapeutic application of an active or combination of actives – could inform how the Court of Appeal in London resolves a dispute over a product’s SPC eligibility, notwithstanding that courts in the UK are not bound to follow EU case law post-Brexit.

The case before the Court of Appeal has arisen in the context of a dispute between Merck Serono and the UK Intellectual Property Office (IPO). A hearing officer at the IPO previously rejected Merck Serono's application for an SPC for a new use of a product called "cladribine", which had previously been used in the treatment of multiple sclerosis.

According to the hearing officer, the application did not meet the requirements of Article 3(d) of the SPC, determining that, in light of case law developed by the CJEU in the 2020 Santen case, a marketing authorisation to place the product on the market as a medicinal product had already been issued. The High Court backed the hearing officer’s assessment in a ruling late last year. An appeal was raised by Merck Serono and was heard by the Court of Appeal on 11 December 2024.

“Determining whether products are identical or different depends on comparison of the active ingredient or ingredients they contain irrespective of their therapeutic application,” Weekes said. “In cases before the CJEU, A plus B is a different product to A or B alone.”

“The application of Article 3(c) for combination products now seems much clearer. The conclusions on Article 3(a) give a clear message as to the test and the intention but may still lead to further questions on interpretation in particular circumstances,” she said.