SPCs: extending protection lifespan

Supplementary protection certificates (SPCs) are intended to ensure that medicinal products requiring marketing authorisation (MA) are adequately protected. They safeguard a sufficient return for, and thereby incentivise, pharmaceutical research involving significant pre-clinical and clinical work. Such work can include not only the development of new active ingredients per se, but also new inventions involving existing active ingredients.

A fundamental question is how to interpret the requirement in article 3(d) of the SPC Regulation, which states: “(d) the authorisation [being relied on, that covers the product], is the first authorisation to place the product on the market as a medicinal product”.

In the context of the SPC Regulation, the term “product” means only “the active ingredient or combination of active ingredients of a medicinal product” and not any non-active ingredients such as excipients or adjuvants.

Until the Court of Justice of the European Union (CJEU)’s judgment in Neurim Pharmaceuticals (C-130/11), which was handed down on 19 July 2012, article 3(d) had been interpreted strictly to mean that an SPC for an active ingredient (or combination of active ingredients) could be granted based only on the first MA for the active ingredient(s). Hence, although SPCs could reward the development of new active ingredients, there was no reward available for new uses of existing active ingredients.

After Neurim

In Neurim, however, the CJEU departed significantly from this practice and ruled that: “The mere existence of an earlier MA obtained for a veterinary medicinal product does not preclude the grant of an SPC for a different application of the same product for which an MA has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the SPC.”

"The CJEU’s narrow literal interpretation of article 3(d) is no doubt a blow to innovators and is difficult to square with the more liberal interpretation adopted in Neurim."

This meant that Neurim’s SPC for melatonin (under the brand Circadin) for use in treating insomnia in humans was allowable despite there being a previous MA covering melatonin (under the brand Regulin) for use in regulating fertility in sheep.

The question grappled with by patent professionals ever since has been how broadly the term “different application” in Neurim can be interpreted to obtain an SPC.

The CJEU considered the issue in Abraxis (C-443/13), on March 21, 2019, and will scrutinise it further in Santen (C-673/18).

Abraxis

In August 2016, the UK Intellectual Property Office (UKIPO) refused Abraxis’ SPC application for “paclitaxel formulated as albumin bound nanoparticles” covering the product nab‑paclitaxel (Abraxane), on the basis that paclitaxel itself had already been approved.

On appeal at the UK High Court, Justice Arnold agreed with the UKIPO that the active ingredient in Abraxane is paclitaxel, not nab-paclitaxel. Hence, as paclitaxel was the subject of an earlier MA, the Abraxane MA did not constitute the first MA for
the ‘product’.

However, Abraxis argued that Neurim permits an SPC to be granted for a “different application” of a previously-authorised product and that “different application” should even cover a new formulation of a known active ingredient, such as Abraxane.

In view of the uncertain scope of Neurim, Arnold referred the following question to the CJEU: “Is article 3(d) … to be interpreted as permitting the grant of an SPC where the MA is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?”

No SPCs for new formulations

In its March 2019 judgment, the CJEU decided that SPCs cannot be granted for new formulations of previously-authorised active ingredients, even if the MA for the new formulation is the first one that falls within the scope of the basic patent relied on for
the SPC.

In arriving at this conclusion, the CJEU recalled earlier case law to confirm that the term “product” should be strictly understood as referring only to active ingredients that have a therapeutic effect on their own. Since excipients or carriers do not qualify, the court opined that the particular form of paclitaxel in Abraxane would not constitute a new “product”.