The regime of supplementary protection certificates: latest developments

The past year has witnessed a number of developments in supplementary protection certificates related regime, regarding both validity and enforcement related-issues, with considerable impact for the pharmaceutical industry.

1. New guidance on the validity of combination product SPCs: CJUE Merck Sharp & Dohme case (C-119/22 and C-149/22)

In a decision dated 19 December 2024, the CJEU issued a long awaited decision in the referrals made by the Finnish Market Court (C-119/22) and the Irish Supreme Court (C-149/22).

The referred questions relate to the interpretation of Articles 3(a) and 3(c) of Regulation 469/2009.

Regarding Article 3(c), which requires that the product has not already been the subject of an SPC, the issue was whether an SPC granted for an active ingredient A would preclude the granting of an SPC for the combination A+B.

The CJEU rules that article 3(c) must be interpreted as not precluding the grant of a SPC for a product consisting of two active ingredients even if one of those two active ingredients has already been, alone, the subject of an earlier SPC and it is the only one to have been disclosed by the basic patent, whereas the other active ingredient was known at the filing date .

The Court, following the opinion of Advocate General of 6 June 2024, adopted a strict definition of “product“, as “the active ingredient or combination of active ingredients of a medicinal product” (as ruled previously in Santen).

It therefore ruled that a combination of active ingredients A + B constitutes a different product than A or B. If the prior SPC was granted to A alone, a SPC cannot be refused on this ground for A+B.

Regarding Article 3(a), which requires that the product be “protected” by the basic patent, the issue was whether this condition is met if the product is expressly mentioned in the claims of said patent.

The case law in force has been established in the Teva case (C‑121/17), where it was ruled that
a product composed of several active ingredients with a combined effect is protected by a basic patent where, even if the combination of active ingredients is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose :

• the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
• each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.

However, uncertainties remained among SPC law practitioners, notably over whether these requirements were cumulative.

This debate was settled by the Court, which held that the two-step Teva test applies whether or not the product is explicitly mentioned in the claims of the basic patent.

Specifically, for SPCs relating to a combination of active ingredients, this condition is met where A and B are expressly mentioned in the claims of that patent and the specification of that patent teaches that A may be used as a medicinal product for human use alone or in combination with B, which is in the public domain, provided that the combination of A+B necessarily falls under the invention covered by the same patent.

The specification of that patent must disclose how the combination of those two active ingredients is a feature required for the solution of the technical problem.

The Court added that the two active ingredients must have a combined effect “going beyond the mere addition of the effects of those or priority date of that patent, provided that the combination of those two active ingredients and which contributes to the solution of the technical problem“.

It therefore essentially followed the recommendations of the Advocate General, whose opinion sheds light on the interpretation to be given to this judgment.

The Advocate General indeed pointed out that while this solution is similar to the ‘problem-solution’ approach for determining whether there is an inventive step under Article 56 of the EPC, the point here is not to assess whether the combination of A+B is inventive, but only of assessing a posteriori what the patent discloses.

Although this provides clarity as regards the obtention of SPCs for combination products, now the implementation of these new guidelines will be determined by how they are received and applied by national courts.

2. SPC manufacturing waiver : the approach of EU national courts

SPC protection enables patent holders to extend the period for which they can invoke patent protection on drugs for which the required development time has reduced their effective exploitation period.

However, in order to preserve the competitiveness of EU manufacturers compared to non-EU manufacturers in countries having less IP protection, Regulation (EU) 2019/933 established SPC waiver mechanisms :

The waiver regulation allows the following :

• Throughout the  SPC lifetime, the manufacturing (or any strictly necessary related act) for the purpose of export outside the EU of the SPC-protected active principle ingredient ;
• During the final six months of the SPC lifetime, the manufacture and stockpile (or any strictly necessary related act) of SPC-protected APIs ahead of EU launch.

However, some safeguards apply : the waiver only applies if the manufacturer notifies the SPC holder 3 months in advance of the first act that would otherwise be infringing.

A number of recent decisions in the European courts have dealt with the details of these notifications.

One of the first interpretations was that of the Munich Landgericht on 20 October 2023, in a case opposing Janssen Biotech, the patent holder, and Formycon, the manufacturer of biosimilars. The issue was whether Formycon had to provide a marketing authorization (MA) reference number and a list of export countries as part of its waiver notification to Janssen.

The Munich court gave primacy to the interests of the IP right holder in knowing the country of export, over the manufacturer’s interest in keeping such country confidential. It therefore held that the MA reference number or disclosure of information about future country of export must be provided, as this is the only way to check whether the export would conflict with a patent right.

Following this decision, considered by many practitioners as overly restrictive, the case law of other jurisdictions has led to changes in the interpretation of the regulations.

The Hague Court indeed also ruled, on 23 January 2024, on this issue. Samsung Bioepis intended to manufacture and stock a biosimilar in EU for exporting to third countries, where Janssen had patents, and marketing in EU after SPC expiry.

The court takes the opposite view to that of the Munich court and considers that the waiver notification does not require a reference number of a granted MA, as this can be provided later, as soon as publicly available. Further, it ruled that the Regulations do not require the export countries to be patent-free, and that it was legitimate to omit the identity of the third countries where products were to be exported.

Finally, it ruled that that it is not forbidden to stock products within the EU before exporting, as the waiver covers not only manufacturing but also related acts that are strictly necessary for export, such as temporary stocking. It adds that although Regulations do not mention a maximum term for the stock, stocking is allowed for a normal period of time.

Finally, this lenient approach was also chosen by the Brussels enterprise court, in a ruling of December 23, 2024.

As a result, it would appear that the prevailing interpretation regarding the requirements of waiver notification is as follows:

• It is not necessary to hold an MA number, which can be given provided as soon as available;
• It is not necessary that the intended export countries have no patent protection;
• Temporary storage of products to be exported is authorized, provided that it is strictly necessary for the export.