In the latest of a series of judgments concerning the interpretation of Article 3(a) of the SPC Regulation, the Court of Justice of the European Union (CJEU) has confirmed in C-650/17 Royalty Pharma that:
- the requirement of Article 3(a) that a product must be protected by a basic patent can in principle be met by a functional claim;
- express disclosure as a specific embodiment is not necessary;
- core inventive advance is not relevant to the interpretation of Article 3(a);
- the product must be specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.
Background to the referral
Royalty Pharma is the proprietor of European Patent EP1084705 (the Patent) concerning a method for lowering blood glucose levels in mammals through the administration of inhibitors of the enzyme dipeptidyl peptidase IV (DP-IV inhibitors).
After the filing date of the Patent, a licensee of Royalty Pharma developed the DP-IV inhibitor sitagliptin.
Royalty Pharma applied to the German Patent and Trade Marks Office (Deutsches Patent- und Markenamt, the DPMA) for an SPC for sitagliptin relying on the Patent as the basic patent in force and a marketing authorisation (MA) for sitagliptin (product name ‘Januvia’).
The DPMA rejected Royalty Pharma’s SPC application on the basis that it did not comply with Article 3(a) of the SPC Regulation. It reasoned that whilst sitagliptin satisfied the functional definition of the class of active ingredients in the claims of the Patent as a DP-IV inhibitor, the patent did not contain any specific disclosure of sitagliptin. Consequently, the subject matter of protection of the Patent did not correspond to the subsequently developed medicinal product for which an MA had been granted.
Royalty Pharma appealed to the German Federal Patent Court (Bundespatentgericht). It maintained that, for the purposes of satisfying the condition in Article 3(a) of the SPC Regulation, it was not necessary for the basic patent to indicate the chemical name or the structure of the relevant active ingredient; instead a functional definition sufficed. Royalty Pharma further tried to rely on the “core inventive advance” test developed by the UK courts in interpreting the requirements of Article 3(a).
The following questions were referred to the CJEU for a preliminary ruling:
1. Is a product protected by a basic patent in force pursuant to Article 3(a) only if it forms part of the subject matter of protection defined by the claims and is thus provided to the expert as a specific embodiment?
2. Is it not therefore sufficient for the requirements of Article 3(a) if the product in question satisfies the general functional definition of a class of active ingredients in the claims, but is not otherwise indicated in individualised form as a specific embodiment of the method protected by the basic patent?
3. Is a product not protected by a basic patent in force under Article 3(a) if it is covered by the functional definition in the claims, but was developed only after the filing date of the basic patent as a result of an independent inventive step?
Relevant case law of the CJEU
The CJEU has previously grappled with the interpretation on a number of occasions. Notably, its judgment in C‑493/12 Eli Lilly v Human Genome Sciences set out that it is not necessary for the active ingredient to be identified in the claim by means of a structural formula: it is sufficient for the active ingredient to be covered by a functional description provided that the claims “relate, implicitly but necessarily and specifically, to the active ingredient”.
Further referrals sought clarification on the interpretation of this test to determine in which circumstances functional claims could be relied upon as the basis of SPC applications.
In C-577/13 Actavis v Boehringer the CJEU ruled that “Article 3(a) and (c) … must be interpreted as meaning that, where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination”. This judgment led some courts to conclude that a “core inventive advance” was relevant to interpreting the meaning of Article 3(a).
The relevance of the core inventive advance was put to the CJEU in C-121/17 Teva v Gilead, but the court merely concluded that the “subject matter of the protection conferred by an SPC must be restricted to the technical specifications of the invention covered by the basic patent.” More helpfully, the CJEU expressly confirmed that the rules governing infringement proceedings were not relevant to the interpretation of Article 3(a).
The court further held that Article 3(a) “must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination.”
The CJEU then proceeded to attempt to clarify what it meant by this by setting out a two-pronged test (the ‘Teva/Gilead test’): “For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
1. the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
2. each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”
The Royalty Pharma decision
In C-650/17 Royalty Pharma the CJEU expressly rejected “core inventive advance” as a concept relevant to the interpretation of Article 3(a).
It reformulated the first two questions to ask whether a product is protected by a basic patent in force when it is not indicated in individualised form as a specific embodiment of the method of that patent, but nevertheless satisfies a general functional definition used by one of the claims of the basic patent and necessarily comes within the scope of the invention covered by that patent.
To answer this question, the CJEU endorsed the two pronged-test Teva/Gilead test and confirmed that even where the product which is the subject of the SPC is not in individualised form as a specific embodiment of the method of the patent, the grant of an SPC is not, in principle, excluded.
The court concluded that a product must be specifically identifiable, in the light of all the information disclosed by that patent, by a person skilled in the art, based on that person’s general knowledge in the relevant field at the filing date or priority date of the basic patent and on the prior art at that date.
With regard to the third question posed in the referral, the court concluded that a product developed after the filing date of the application for the basic patent, following an independent inventive step, cannot be considered to meet the requirements of Article 3(a).
The CJEU has finally confirmed that the concept of a “core inventive advance” is not relevant to the interpretation of Article 3(a).
It is also clear that even where a product is not identified as a specific embodiment from the teaching of the basic patent, the granting of an SPC is not necessarily excluded.
However, the assessment as to whether a later-developed product arose following an independent inventive step is likely to represent challenges. It is noteworthy that sitagliptin was patented independently and therefore a determination that the product was independently inventive had already been made by a patent office. Where an independent patent has not been granted, the determination of an independent inventive step may well be less straightforward.
Moreover the judgment focused on functional definitions and makes no reference to Markush claims and it is conceivable that a further referral may ultimately be required to provide clarity on in circumstances in which such claims may form the basis of an SPC.
If you wish to know more about this decision or would like further advice, please contact Barbara Rigby or your usual Boult Wade Tennant LLP advisor.