Supplementary protection certificates for medicinal products: no more extended protection for the second authorisation of an active ingredient

Supplementary Protection Certificates (SPCs) effectively extend the protection afforded by patents for medicinal products by up to 5 years. This compensates for disadvantages caused by long approval processes: Generally, years pass between a patent application for a new active ingredient and the approval of a drug. Without an extension, the actual patent protection would therefore be reduced so that the time to recoup investments in research might be insufficient.

An SPC requires a “basic patent” and a marketing authorisation for the active ingredient concerned. Furthermore, the authorisation must be the first authorisation to place the active ingredient (the “product” in the language of the SPC-Regulation[1]) on the market.[2] This is intended to prevent multiple extensions of patent protection for a “product”, which would lead to unjustified long protection.

Therefore an active ingredient or “product” may be the subject of several patents: For example, when the active ingredient itself is invented and, secondly, as the subject of an inventive new use (for example, in a new medical field or in a different form of administration). Under the SPC-Regulation, however, the second patent may no longer be “rewarded” with a protection certificate.

An exception to this rule existed since 2012 due to the CJEU-decision Neurim.[3] This case concerned an SPC for a medicinal product for human use, the active ingredient of which was previously marketed as a veterinary medicinal product. According to the CJEU, a protection certificate could be granted to the medicinal product for human use – even though the active ingredient was the same – since it concerned a “different therapeutic application” of a known active ingredient.

This case law was applied for eight years and was the basis for numerous SPCs.

Now, however, the CJEU made a U-turn with the Santen[4] decision, which also calls into question the SPCs issued so far: The current case concerned an SPC application by the pharmaceutical company Santen for the use of the active ingredient cyclosporine for corneal inflammation. However, in the 1980s this active ingredient had already received a marketing authorisation for various other indications (including the treatment of inflammation of the uvea, a part of the eyeball).

The national court now asked the CJEU to clarify the conditions under which a second marketing authorisation for an active ingredient may be considered to be for a “different application” (as stated in the Neurim decision), which allows the grant of a second SPC for the same active ingredient. The CJEU answered: In principle never! According to the new case law, once an active ingredient was the subject of an authorisation, no further SPCs may be granted for this active ingredient.

The CJEU based this conclusion on a straightforward interpretation of the wording of the SPC-Regulation. The term “product” is clearly defined in the regulation as the active ingredient of a medicinal product, without any other elements being mentioned (Article 1 lit b SPC-Regulation). The interpretation that the same active ingredient becomes a different product through a new indication was therefore on shaky ground from the outset.

Nevertheless, this sudden turn and complete departure from previous case law come as a surprise. Companies which have acquired SPCs based on the Neurim decision could probably legitimately rely on their validity. Investments (in research, marketing, etc.) made on the basis of these SPCs are now at risk of becoming frustrated. This raises the question of a protection of a legitimate expectation in the validity of the SPCs that were based on Neurim.

The decision can also be questioned from an economic perspective. Research into new applications of known active ingredients often requires no less investment than research into new active ingredients. Excluding new uses from SPCs therefore carries the risk of reducing investment in medical innovation.

It should be noted, however, that a known active ingredient is only excluded from SPC protection if it was previously authorised to be place on the market. If an active ingredient or its uses are known but have never been approved in the EU, an SPC may still be granted for a patent relating to the first medical authorization of the active ingredient. Under these circumstances, second medical use patents may therefore continue to form the basis of an SPC.

[1] Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products

[2] Article 3 (d) of Regulation (EC) No 469/2009.

[3] CJEU 19.7.2012, C-130/11 – Neurim Pharmaceuticals.

[4] CJEU 9.7.2020, C-673/18 – Santen.