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Supplementary Protection Certificate: Sandoz v GD Searle

In the EU, a Supplementary Protection Certificate is available if, among other things, the product in question is protected by a “basic patent in force”. In Eli Lilly v Human Genome Sciences, the Court of Justice of the European Union held that to be protected by the “basic patent”, the claim had to relate to the product implicitly but necessarily and specifically. What this decision means in practice has caused the English courts considerable concern.

In Sandoz v GD Searle, the England and Wales Court of Appeal has, again, referred the issue to the Court of Justice for the European Union, asking in this instance whether a product, not named in the patent but within the Markush formula of the claims, was a product "protected by a basic patent in force". The question in full is as follows:

Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?

In making the reference, Lord Justice Floyd, who gave the leading judgment, noted:

Like the judge, however, I am concerned with what I see as a fundamental defect with the “identification” test. The CJEU jurisprudence to date seems to take it as read that a claim can identify active ingredients with specificity. However that is not the function of claims in patents. Instead, claims are concerned with setting the limits to the monopoly. A further defect of the focus on the claim is that claims can be manipulated by skilful drafting to protect combinations, without distinguishing between genuine combinations of products which work together in a new and advantageous way so as to constitute an inventive advance, and mere collocations of products giving rise to their separate individual effects. I agree with the judge that a far better test would be to ask whether the product the subject of the SPC embodies the core inventive advance of the basic patent.

This reference follows a further reference made by the Patents Court in Teva v Gilead Sciences.

Case details at a glance

Jurisdiction: England & Wales

Decision Level: Court of Appeal

Parties: (1) SANDOZ LIMITED (2) HEXAL AG (appellants) and (1) G.D. SEARLE LLC(2) JANSSEN SCIENCES IRELAND UC (respondents)

Citation: [2018] EWCA Civ 49

Date: 25 January 2018

Link to full BAILII decision: http://dycip.com/ewcaciv49

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