CJEU expands on the requirements of the SPC Regulation

After the opinion of Advocate General (Wathelet) on 25 April, the Grand Chamber of the Court of Justice of the European Union (CJEU) has today handed down their decision in Teva v Gilead (Case C-121/17). A copy of the full decision is available here.

This decision is the CJEU’s response to the first of 3 pending referrals relating to Article 3(a) of Regulation 469/2009 (SPC Regulation), which requires that to be valid, the product of a supplementary protection certificate (SPC) must be “protected by a basic patent in force”. As has arisen in a number of cases, this referral seeks clarification where the product of the SPC is a combination product comprising in this case two active ingredients, tenofovir disoproxil and emtricitabine. To seek clarification, the UK Patent’s Court had (again) simply asked the question: “what are the criteria” under Article 3(a)?

The decision of the CJEU is that:

“Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 06 May 2009, concerning the supplementary protection certificate for medicinal products, 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. 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:

• 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
• each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.”

There are some immediate and stark contrasts between the CJEU’s answer compared to the AG’s opinion. For example, on the one hand there is no express dismissal of the “core inventive advance” test (as had been advocated by the Member States who made submissions). On the other hand, there is also no clear reference to a two-stage test either - ie to start with the scope of protection of a patent under the EPC and national Member State law and then add an additional requirement. Indeed, the CJEU has not adopted the AG’s proposed additional component of “specifically and precisely identifiable”. The lack of any reference or consideration at all as to any of these concepts sets apart this decision from the substantial debate of the same in the referring judgments in all three pending references under Article 3(a), the submissions made at the hearing of this case and the legal commentaries surrounding this area of law.

In contrast, the CJEU appears to have focused on and sought to clarify and extend its test of “relate necessarily and specifically”, as was set out in its earlier decision (Eli Lilly v HGS, case C-493/12). Dissecting the answer in more detail, the following points also arise:

• The CJEU’s answer is provided in the context of only combination products, something which the CJEU has been reluctant to treat as a special case in the past.

• The answer is provided with the qualifier that “even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent …”. This would suggest that where a combination of active ingredients that is “expressly mentioned in the claims” then Article 3(a) is satisfied and the fuller test is not needed. While claims expressly mentioning the active ingredients in question are more likely than not to satisfy Article 3(a), this is nonetheless at odds with the AG’s opinion which stated that “the fact that a basic patent contains a claim relating to a specifically named active ingredient may, in certain circumstances, not be sufficient”.

• The reasons for this decision include a number of references to the relevance of scope of protection under Article 69 EPC and the Protocol to the test, but there is no mention of these principles in the final answer, either as to how they apply or whether to one or both parts of the test.

• The reasons for this decision also refer to the Actavis v Boehringer (C-577/13) decision in relation to the concept of the “subject matter of the invention”. As was pointed out in the referring judgment, it is not clear why or how this differs from “core inventive advance”. In any event, the CJEU has chosen in this decision to refer simply to the “invention”. It therefore remains unclear if or how this relates to the “core inventive advance”, which the CJEU formulated as part of the test under Article 3(c) in Actavis v Sanofi (C-443/12). Indeed, there is little guidance as to how the “invention” is to be determined, including as to the CJEU’s view on the AG’s opinion that the core inventive advance test would run the risk of giving rise to confusion.

Considering the main part of the decision - ie the newly formulated and extended test (when there is no express mention of active ingredients in the claim) - this is predicated on the approach by the person skilled in the art “on the basis of the prior art at the filing date or priority date”. It is not clear why “prior art” rather than the more established concept in patent law of “common general knowledge” has been used here or whether this makes any difference. The movement from priority date to include the option of the filing date is otherwise a development from the AG’s opinion, which referred only to the priority date.

Thereafter, the test expands on each part of the “necessarily and specifically” test:

• Necessarily - is linked to the combination “falling under the invention”. As already noted above, it is not clear precisely what this means or which factors apply to it, albeit scope of protection appears to be one of them, in particular given the reference to the patent’s descriptions and drawings.

• Specifically - is linked to each of the combined active ingredients being “identifiable”. In this case, rather than referring to the patent’s description and drawings, this is said to be in the context of “all the information disclosed in the patent”. It is not clear why the wording here is different or if this makes any difference.

Overall, by failing to clarify the precise role of the scope of the protection under Article 3(a) and not even referring to the “core inventive advance” test, it is questionable whether this test can be said to advance the clarity of the test required by Article 3(a). It is even unclear to what extent the above two limbs may be considered separately, and they are linked in other parts of the decision (eg para 49).

While the CJEU opines that it does not seem possible for Gilead’s SPC to satisfy the first limb of the test, it nonetheless states that this will need to be determined by the UK Patents Court. The CJEU offers no opinion on the outcome under the second limb, again noting the need for the UK Patent Court to consider these issues including by reference to the person skilled in the art, all of the information contained in Gilead’s patent and the prior art at the filing or priority date.