SPC waivers explained by the District Court of The Hague

The case law year started well for those interested in supplementary protection certificates (“SPCs”) for patents and waivers thereof: on 23 January 2024, the District Court of The Hague rendered a judgment in a lawsuit between Janssen Biotech Inc (“Janssen”) and Samsung Bioepis NL B.V. (“Samsung Bioepis”) on the requirements for the SPC manufacturing waiver. The judgment clarifies how to interpret the relevant European legislation, namely the original SPC Regulation and the amended SPC Regulation.

Why Samsung Bioepis allegedly could not invoke the waiver

In this particular case, Janssen argued that Samsung Bioepis could not fulfil the requirements of a SPC manufacturing waiver, for three reasons:

1. Samsung Bioepis provided the required notice that they will start manufacturing in three months, but this notice did not include a reference number of a granted marketing license in the countries where Samsung Bioepis wanted to export its products;
2. Janssen has patents in the alleged countries of export, so Samsung Bioepis would immediately infringe these patents after exporting; and
3. Janssen believes that under the SPC manufacturing waiver, it is forbidden to stock products within the EU before exporting: these products should be exported immediately.

Because Samsung Bioepis did not fulfil these three criteria, Janssen stated that Samsung Bioepis threatens to infringe on Janssen’s SPCs in Denmark and Italy.

Ruling District Court: Janssen was incorrect on all three arguments

The District Court first states that when interpreting European Union (“EU”) law, one must take into account the literal wording of the specific rule, but also its context, the recitals of the act that the rule is part of, and the development history of the rule. For the SPC Regulations, the District Court stresses the important ambition to create a level playing field for manufacturers of generic and biosimilar medicines in the EU compared to manufacturers in non-EU countries. This will improve the competitiveness of the EU.

Regarding reason 1, the District Court states that the notice does not require a reference number of a granted marketing license per se. According to the wording of the relevant rule, a manufacturer is obliged to provide this reference number as soon as this number is publicly available. If this is not the case yet when providing the notice, then the manufacturer gets the opportunity to provide the reference number later (namely, as soon as it is publically available).

What is interesting in this respect is that this argumentation by the Dutch court is opposite to a decision by the District Court of Munich of 14 November 2023. The Munich Court argued that the reference number should immediately be added and thus applies a restrictive interpretation of the SPC Regulations. The Dutch Court however states that the Munich Court is wrong in this respect: a restrictive approach places manufacturers in the position that they have to share private information before this information is publicly available. The Dutch Court argues that this could not be the intention of the SPC Regulations and thus rules otherwise.

Regarding reason 2, the District Court argues that no rule requires an export country to be patent-free and/or that the manufacturer should prove that this is the case. The District Court states that if this were the case, it would defy the purpose of the SPC Regulations (to create a level playing field), as then non-EU-manufacturers would not be bound by this legislation.

Regarding reason 3, the District Court states that not only the manufacturing itself is permitted, but also related acts that are strictly necessary for export. (Temporary) stocking of products is explicitly mentioned in the SPC Regulations as such a related act. In addition, the SPC Regulations do not mention a maximum term for the stock (except for the fact that stocking must be strictly necessary for export). The District Court thus rules that stocking is allowed for a usual period of time in regular businesses. This places EU manufacturers on a level playing field with their non-EU competitors.

Takeaway

What can one take away from this case? It teaches EU manufacturers three lessons:

1. It is not necessary to have a granted marketing authorization (and thus, a reference number thereof) when providing notice of future manufacturing. This can be added to the notice once publicly available;
2. It is not required that there are no valid patents in the countries to be exported to (even though one could still risk infringement proceedings); and
3. (Temporary) stocking medicines to be exported is allowed, as long as it is strictly necessary.