Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 14 June 2024 - is below:

CJEU

AG Opinion delivered on Art. 3(a) and 3(c) of the SPC Regulation in Joined Cases C-119/22 and C-149/22.

As mentioned in last week’s Irides update, the AG Opinion in the joined cases C-119/22 and C-149/22 concerning the correct interpretation of Art. 3 of the SPC Regulation (Regulation 469/2009) was delivered on 6 June 2024.

C-119/22 is a referral from the Finnish Market Court in Teva v Merck Sharp & Dohme concerning MSD’s product Janumet®, a combination of sitagliptin and metformin, used for the treatment of diabetes. C-149/22 is a referral from the Irish Supreme Court in Merck Sharp & Dohme v Clonmel Healthcare, concerning a different MSD product, Inegy®, a combination of ezetimibe and simvastatin used to reduce cholesterol.

The referrals concern the correct interpretation of Art. 3(a) and 3(c) of the SPC Regulation. Art. 3 of the SPC Regulation sets out of the conditions required to obtain a SPC as follows:

"A certificate shall be granted if, in the Member State in which the application […] is submitted and at the date of that application:

a) the product is protected by a basic patent in force;

b) a valid authorisation to place the product on the market as a medicinal product has been granted […];

c) the product has not already been the subject of a certificate;

d) the authorisation referred to in point (b) is the first authorisation to place the product on the market as a medicinal product".

The AG reviewed the existing CJEU case law and concluded as follows:

Art. 3(c) 

The AG first considered the previous CJEU decisions on Art. 3(c) in Actavis I (C-443/12) and Actavis II (C-577/13); the so called “core inventive advance” and “sole subject matter of the invention” tests. While expressing “a great deal of sympathy for the pragmatic and teleological reasoning of the judgments”, the AG considered Art. 3(c) not open to the purposive interpretation adopted by the Court in those decisions. Instead, the AG advocated a literal test consisting of: “(i) defining the ‘product’ for which the SPC application under review is made or for which the contested SPC has been granted; and (ii) verifying whether the patent holder had already obtained an SPC, at a prior date, for the same ‘product’.”

Art. 3(a) 

The AG noted that the decision of the Grand Chamber in Teva I (C-121/17) sought to clarify the existing CJEU case law on Art. 3(a), but required “important clarifications”. In particular, the AG opined that the correct application of the test in Teva I was that for a “product” to be regarded as “protected by a basic patent”, the product must not only (i) be expressly mentioned or at least “specifically identifiable” in the claims but also (ii) fall under the invention which is the subject matter of the patent.

The AG considered the second limb of the test did not require an assessment of patentability, but was instead an “ex post assessment of what the patent (especially the description) discloses”. For a combination product, such as is in issue in both the referred cases, this requires considering whether the patent “describes, as [an] invention, the use of A+B given their combined, synergistic effect on the human body, to solve a certain technical (medical) problem…so that the combination of A and B would be “a feature required” for the solution of that technical problem”.

The Judgment of the Court will be handed down in due course.

UPC

Court of Appeal provides commentary on opt out.

On 4 June 2024, the Court of Appeal (CoA), led by presiding Judge and Judge-Rapporteur Rian Kalden, handed down its decision in Neo Wireless v Toyota (UPC_CoA_79/2024) confirming that a valid opt-out application must be filed by or on behalf of all proprietors of all “national parts” of a European patent (as defined in the judgment).

Neo Wireless LLC (Neo US) was the owner of the European application EP 3 876 490 (EP 490) for all designated states. The German part of the then pending application was transferred in February 2023 to a different Neo entity; Neo Wireless GmBH & Co KG (Neo DE), the Defendant in these proceedings. In March 2023, Neo US filed an opt-out for EP 490 for “all EPC states”. However, the opt-out application was not filed on behalf of Neo DE, nor was the consent of Neo DE annexed or exhibited to the opt-out application. Further, Neo DE did not itself file an opt-out application with respect to the German part of the application. EP 490 was granted in May 2023.

Toyota brought a revocation action against the German part of EP 490 (held by Neo DE) before the Paris Central Division. Neo DE filed a preliminary objection on the basis that EP 490 had been validly opted-out of the jurisdiction of the UPC. Neo DE submitted that the wording of Art. 83(3) UPC Agreement (UPCA) permits the proprietor of one or more, but not all, national parts of a patent/patent application to lodge an opt-out application for all national parts of such patent/patent application, even those parts it did not own. Neo DE also argued that r. 5.1(a) the Rules of Procedure (RoP) should be ignored, since Art. 83(3) UPCA must take precedence in instances where there is a conflict between the UPCA and the RoP.

At first instance, the Paris Central Division held that the opt-out filed by Neo USA was invalid as not all proprietors of all national parts had lodged the opt-out application as required by r. 5.1(a) of the RoP/Art. 83(3) UPCA. Whilst acknowledging that the answer to the question of who must file an opt-out is unclear from the ordinary meaning of the wording of Art. 83(3) UPCA, ultimately the CoA agreed with the Paris Central Division and dismissed the appeal. The CoA held the default position in the legislature is that European patents are subject to the jurisdiction of the UPC. Therefore, in view of its meaning and purpose, Art. 83(3) UPCA should be interpreted as meaning that valid opt-out applications must be lodged by or on behalf of all proprietors of all national parts of the patent/patent application. Otherwise proprietors of other parts of the patent/patent application could be deprived from enforcing their rights in the UPC. R. 5.1(a) RoP is therefore in conformity with Art. 83(3) UPCA.