News & Insights

Briefing Note on The Court of Justice of the European Union rules again on the interpretation of Article 3 SPC Regulation

Briefing Note on The Court of Justice of the European Union rules again on the interpretation of Article 3 SPC Regulation

12/12/2013 14:54:23

The Court of Justice of the European Union (the "CJEU") today gave judgment in three important and eagerly-awaited decisions concerning the interpretation of Articles 3(a) and 3(c) Regulation (EC) No. 469/2009 (the "SPC Regulation"). Links to the full judgments are incorporated into the case numbers below.

  1. Case C-443/12 Actavis Group PTC EHF, Actavis UK Ltd v Sanofi ("Actavis");
  2. Case C-484/12 Georgetown University v Octrooicentrum Nederland ("Georgetown II"); and
  3. Case C-493/12 Eli Lilly and Company Ltd v Human Genome Sciences, Inc. ("Lilly").

Judgment of the CJEU | Article 3(a)

In both Actavis and Lilly, the questions referred sought to clarify the earlier decision in Case C-322/10 Medeva, by asking the CJEU to revisit again the criteria for deciding whether a product which is the subject of an SPC application is "protected by a basic patent in force" under Article 3(a) SPC Regulation. In the Medeva case the CJEU held that the active ingredient must be "specified" in the wording of the claims.

Human Genome Sciences, Inc. ("HGS") is the holder of European Patent (UK) No 0 939 804 (the "HGS Patent") which relates to and claims a novel protein called Neutrokine-α and antibodies which bind specifically to it. The HGS Patent has been held to be valid by the UK courts (including the Supreme Court) and the European Patent Office. Of particular importance is the wording of claim 13 which claims:

"an isolated antibody or portion thereof that binds specifically to

(a) the full length Neutrokine-α polypeptide … or

(b) the extracellular domain of the Neutrokine-α polypeptide …".

Lilly wishes to market, in due course, a pharmaceutical composition containing an antibody that binds specifically to Neutrokine-α, which Lilly refers to as LY2127399 (now known as Tabalumab). Lilly sought a declaration from the UK court that any SPC granted in respect of the HGS Patent and based upon any MA for Tabalumab would be invalid. Its grounds of objection included that Tabalumab is not "protected by the [HGS] Patent" pursuant to Article 3(a) SPC Regulation because the active ingredient is not specified in the wording of the claims.

Lilly conceded that, if marketed before the expiry of the HGS Patent, Tabalumab would infringe claim 13, but argued that in order for an SPC to be granted on the basis of the HGS Patent it would have to contain a structural definition of the active ingredient.

The CJEU confirmed in the Lilly case that the infringement test is not enough to satisfy Article 3(a). What is important is the wording of the claims and the rules to be applied are those "relating to the extent of the invention", such as section 125 of the UK Patents Act, Article 69 of the European Patent Convention ("EPC") and the Protocol on the Interpretation of Article 69.

Importantly for the biotechnology industry, the CJEU held that the relevant patent claim need not specify a structural formula. Further Article 3(a) does not, in principle, preclude the grant of an SPC based on a functional claim provided that it relates "implicitly but necessarily and specifically" to the active ingredient in question.  

The CJEU observed that it could not give further guidance on the application of Article 69 EPC, since it does not have jurisdiction to interpret the provisions of that convention, but that its application is a matter to be determined by the referring national court.

No further light is shed on the interpretation of Article 3(a) in Actavis since the CJEU declined to rule on this point given the answer to the second question referred in that case.

Judgment of the CJEU | Article 3(c)

The questions referred in Georgetown II and the second question in Actavis sought to clarify, in the light of comments in Medeva, whether Article 3(c) precludes the grant of more than one SPC per patent, even where the patent claims more than one product.

The CJEU decided in Georgetown II that, in circumstances where an SPC has already been obtained for a combination product and based on a patent which complies with Article 3(a), Article 3(c) does not preclude the patentee from obtaining an SPC for one of those active ingredients which, individually, is also protected by the basic patent.

However the CJEU took a different approach in Actavis where the patentee, Sanofi, had already obtained an SPC for irbesartan (which had expired) and had obtained a further SPC for the combination of irbesartan and hydrochlorothiazide, which Actavis sought to invalidate.

The distinction drawn by the CJEU, in holding that an SPC should not be available for the combination product, seems to have been driven by a concern that each of the products in the combination should be "protected as such" by the basic patent within the meaning of Article 3(a). The CJEU also considered it unacceptable that a patentee could obtain a new SPC each time he markets a medicinal product containing the principle active ingredient (i.e. the "core inventive advance" of that patent) and another active ingredient which is not protected as such by that patent.

Yet the CJEU had not in fact considered whether the "other" active ingredient in Actavis (hydrochlorothiazide) was protected or not, as it had decided not to answer the Article 3(a) question at all in view of its decision on Article 3(c). The CJEU simply stated that it was "common ground" that hydrochlorothiazide was not "protected as such" by the basic patent.

What next?

Whilst the CJEU has provided some helpful confirmation as to what is not the appropriate Article 3(a) test, this decision once again raises more questions than it answers. In particular, the words "necessarily and specifically" do not seem to take matters any further than the Medeva case. The CJEU’s conflation of the Article 3(a) and 3(c) issues in Actavis also fails to deliver clear guidance on the circumstances in which the "one SPC per product per patent" rule ought to apply.

Thus, the correct interpretation of Article 3 as a whole still remains somewhat unclear despite these three decisions of the CJEU. Further litigation before the national courts and references to the CJEU are, therefore, to be expected and the SPC Regulation will continue to raise problems for national patent offices and courts with the task of interpreting it.

HGS (now part of GSK) was represented in these proceedings by Powell Gilbert LLP.

Please do not hesitate to contact us if you wish to discuss these issues further.