CJEU hands down SPC guidance in Royalty Pharma

The Court of Justice of the European Union (CJEU) has handed down its  decision in Royalty Pharma, providing highly-anticipated guidance on supplementary protection certificates (SPCs).

In the aftermath of the CJEU’s ruling of 2011 in Medeva (C-322/10), many cases have grappled with the extent to which an active ingredient (or a combination of active ingredients) should be defined in the claims of the patent in order to be deemed ‘protected’ under article 3(a).

Case background

Royalty Pharma owns European patent EP 1,084,705, which concerns a method for lowering blood glucose levels in mammals through the administration of the enzyme dipeptidyl peptidase (DP) IV inhibitors.

Sitagliptin, which belongs to this class of active ingredients, was developed after the filing date of the basic patent by a licensee, which obtained a patent for it.

In December 2014, Royalty Pharma applied to the German Patent and Trade Marks Office (DPMA) for the grant of an SPC for the product ‘sitagliptin in all forms protected by the basic patent’, and in the alternative for ‘sitagliptin, in particular sitagliptin phosphate monohydrate’.

But the DPMA rejected the SPC, concluding that article 3(a) of regulation 469/2009 wasn’t fulfilled.

Although the product satisfied the functional definition of the basic patent as a DP IV inhibitor, said the DPMA, the basic patent didn’t contain any specific disclosure of sitagliptin and granting an SPC for a product which wasn’t provided for in the basic patent would be contrary to the regulation’s objectives.

Royalty Pharma lodged an appeal against the decision at the Federal Patent Court of Germany (Bundespatentgericht), which referred the case to the CJEU and asked whether an active ingredient must be provided in an individualised form in the basic patent.

Specific embodiments

The CJEU has confirmed that the granting of an SPC is not necessarily excluded where a product is not identified as a specific embodiment from the teaching of the basic patent.

“In the main proceedings, it is apparent ... that, if sitagliptin is not explicitly mentioned in the claims of the basic patent, it meets the functional definition used by one of the claims of that patent. In those circumstances, subject to the verifications which it is for the referring court to carry out, sitagliptin necessarily falls, as a DP IV inhibitor, [under] the invention covered by the basic patent,” said the court.

In doing so, said Beatriz San Martin, partner at Arnold & Porter in the UK, the CJEU has flatly rejected the express disclosure test.

“However, the court has stipulated that the skilled person must be able to deduce directly and unambiguously, from the specification of the patent as filed, that the product falls within the subject matter of the protection of the patent.”

The relevant date for making this assessment is the filing or priority date of the patent. If a product is invented after that date as a result of autonomous activity, it cannot form the basis of an SPC application, even if it falls within the functional definition of the basic patent.

Flat-out rejection

According to San Martin, the CJEU has flatly rejected the test—propounded by Arnold J (as he then was) in the  Teva v Gilead case at the English High Court—of whether a product “embodies the inventive advance of the basic patent”.

The CJEU ruled that the concept of inventive advance is not relevant to the interpretation of article 3(a), citing its decision in Teva UK and Others (C‑121/17) which concluded that the object of the protection conferred by a SPC must be limited to the technical characteristics of the invention covered by the basic patent.

“At last we have some clarity from the CJEU”, said San Martin, adding that the court’s decision is likely to cause the German Federal Patent Court to dismiss Royalty Pharma’s appeal denying it an SPC for sitagliptin.

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