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14 August 2018Big PharmaJoel Beevers and Michael Pears

Combination SPCs: shaken and stirred

The creation of supplementary protection certificates (SPCs) in the EU in the 1990s was a significant victory for innovators in the medicinal and agrochemical fields. By providing up to five years of extra patent protection for authorised medicinal and plant protection products, which require market authorisation (MA) before entry on the market, SPCs are some of the most valuable IP rights available. Their aim is to compensate patentees for the period of a patent term that is lost during the lengthy regulatory processes.

A key provision of the SPC regulation (EC 469/2009) is article 3(a), which stipulates that the “product” (ie, active ingredient or combination of active ingredients of the medicinal product) that is the subject of the SPC must be “protected by a basic patent in force”. However, despite its fundamental importance, it remains unclear what this definition actually means.

Since SPCs are governed by EU legislation, whenever national courts are unclear on how the law is to be interpreted, clarification may be sought by referring questions to the Court of Justice of the EU (CJEU). The CJEU has already handled several references on this issue (including on July 25, 2018, as discussed later), and another two are currently pending.

Spectrum of specificity

In a case in the English Court of Appeal that led to one of the two pending CJEU references (Sandoz v Searle), Thomas Mitcheson QC summed up the issue of the definition of article 3(a) as a “spectrum of specificity”. Table 1 summarises this ‘spectrum’ by reference to recent SPC case law, beginning at the top with generic terms covering the active ingredient(s) and increasing the specificity of the definition moving down the table.

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