1 January 2012Big PharmaMike Snodin and Michael Pears

A brave new world for supplementary protection certificates?

Supplementary protection certificates (SPCs) are a unique form of intellectual property that came into existence in Europe in 1993. They provide an extended period of monopoly to patent holders who experience substantially reduced effective patent terms due to the need to obtain regulatory approval prior to selling their patented medicinal or plant protection products.

SPCs sit at the interface between the patent and regulatory systems.

That is, entitlement to SPC protection depends upon obtaining both a patent and a marketing authorisation for a regulated product. However, in order to provide a balanced system, the legislators stated their intention that SPC protection should be available only for new regulated products, with minor changes to those products (such as the use of a different salt, ester or pharmaceutical form) being barred from giving rise to additional SPCs.

For many years, the SPC legislation has been interpreted strictly with regard to the availability of protection for a specific ‘product’ (active ingredient or combination of active ingredients). This has resulted in the term of combined patent and SPC protection being capped to a maximum of 15 years (or 15½ years in some cases) from the date of the first authorisation in the European Economic Area for a medicinal product comprising the active ingredient(s) in question.

This strict interpretation of the legislation has led to some harsh results, with important medical innovations involving previously authorised active ingredients often being denied SPC protection. This is despite the fact that, in many instances, those innovations have been delayed in reaching the market for many years because of the regulatory burden imposed upon them.

The companies sponsoring the clinical trials for these medical innovations have been particularly affected by the unfairness of this situation when they have not been the ones to have benefited from prior sales of medicinal products comprising the active ingredient(s) in question.

However, a non-binding opinion provided on May 3, 2012, by Advocate-General Verica Trstenjak in the case of Neurim Pharmaceuticals (case C-130/11) means that this situation could soon change, and that SPC protection could become much more widely available for medicinal products that contain previously authorised active ingredients.


Case C-130/11 stems from a reference from the UK Court of Appeal, which had sympathy with the arguments presented by Neurim in its appeal against the refusal of the UK Intellectual Property Office (and the High Court) to grant an SPC for the ‘product’ melatonin.

The arguments from Neurim essentially related to the regulatory burden it had experienced prior to marketing the product Circadin® (as a treatment for insomnia, a therapeutic indication for melatonin patented by Neurim).


Although there had been earlier authorisations for medicinal products containing melatonin, these had been for unrelated veterinary uses (that did not fall within the scope of Neurim’s patent).

More importantly, those earlier authorisations did not lead to any significant reduction in the regulatory hurdles that Neurim needed to overcome in order to market Circadin®. As the European Medicines Agency (EMA) treated Circadin® as a new active substance, Neurim was obliged to provide a complete package of clinical data as specified in Article 8(3) of the Community code relating to medicinal products for human use (Directive 2001/83/EC).

In the view of the Court of Appeal, Neurim deserved the reward of extended protection (as provided by an SPC) because it had invented a new clinical application for melatonin, but could not commercially exploit its invention until after it had obtained, submitted and waited for the EMA to review a complete package of clinical data.

Although it seemed to the court that Neurim should be awarded an SPC, prior case law of the Court of Justice of the EU (CJEU) stood in the way. Specifically, prior case law meant that:

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