Supplementary Protection Certificates: Only for First Use of an Authorised Product

A Supplementary Protection Certificate (SPC) can provide up to five years additional protection for a patented active ingredient of a pharmaceutical product that has received a marketing authorisation. The objective is to compensate a patent holder for the delay in being able to use the patent by the need to obtain the marketing authorisation.

An SPC does not simply extend the term of a patent, and not all patented active ingredients are eligible for SPC protection. In simplified form, in order to obtain an SPC, there must be a patent protecting the active ingredient and a granted marketing authorisation to place the active ingredient on the market as a pharmaceutical product. The patent may protect the active ingredient itself, a process to obtain the active ingredient, or an application of the active ingredient. While this sounds simple, there is extensive case law surrounding whether or not a given active ingredient is "protected by the patent". Moreover, the marketing authorisation must be the first to place the active ingredient on the market.

Back in July 2012, in the case of Neurim Pharmaceuticals (C-130/11), the CJEU approved an SPC for a product for human use after it had previously been authorised for veterinary use. On the face of it, this would appear to be excluded by the need for the marketing authorisation for the active ingredient being the first. The Neurim Decision led to confusion and controversy, with different EU member states taking different approaches.

The present case (C-673/18) originated in France, where Santen's application for an SPC was rejected on the basis that the product already had a marketing authorisation (albeit for an oral solution rather than an eye drop emulsion). The Paris Court of Appeal then made a referral to the CJEU to clarify the situation.

In July 2020, the CJEU decision provided its clarification, rejecting the approach taken in Neurim. It stated that the SPC Regulation defines a "product" independently of its use or approved therapeutic application.In particular, it decided that the scope of the basic patent relied upon was irrelevant in deciding whether a marketing authorisation is the first for that product. Therefore a new therapeutic application does not render an active ingredient a different product.The CJEU concluded:

"Article 3(d) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a marketing authorisation cannot be considered to be the first marketing authorisation, for the purpose of that provision, where it covers a new therapeutic application of an active ingredient, or of a combination of active ingredients, and that active ingredient or combination has already been the subject of a marketing authorisation for a different therapeutic application."

Whilst this decision simplifies some of the issues of interpretation of the SPC Regulation and should provide consistency across EU member states, one is left to wonder whether the regulation still meets its objective.In Europe, patents are available for further medical uses of known ingredients in order to incentivise research into such uses. Will the unavailability of an SPC extension render such research less attractive? Having said this, it should be noted that regulatory approval may take less time with a known compound since safety trials should already have been carried out, so perhaps the need for the extension is less in such cases.

Any effects of this decision on R&D in the pharmaceutical industry remain to be seen.