SPC Case law – France – Paris Court of Appeal – January 12, 2024
Articles 3a) and 3c) of Regulation No. 469/2009
In a decision of 12 January 2024, the Paris Court of Appeal (Docket No. 22/16673) dismissed an appeal filed by Mylan Ireland Ltd and its French subsidiary Viatris Santé (together « Mylan ») against the decision of the Paris First Instance Court (Docket No. 22/55128). More specifically, the Paris Court of Appeal confirmed the first instance decision in that SPC FR08C0033 held by Merck Sharp & Dohme LLC (« Merck ») covering the combination of sitagliptin and metformin is valid.
More specifically, MSD is the owner of European patent No. 1 412 357 (« EP 357 »). MSD is also the owner of two French SPCs:
- SPC No. 07C0041 filed on 27 August 2007, granted on 26 September 2016, expired on 23 September 2022 (with pediatric extension) and covering sitagliptin and its pharmaceutical salts; and
- SPC No. 08C0033 (« SPC 033 ») filed on 21 August 2008, granted on 17 December 2010, expired on 8 April 2023 and covering the combination of sitagliptin monophosphate and metformin hydrochloride.
In other words, SPC 033 has been filed after but granted before the SPC covering the mono-product. Mylan has been granted a marketing authorization for each of these medicinal products and has thus taken steps for price and reimbursement. In addition, Mylan responded to the warning letter sent by MSD that it considered SPC 033 to be null. MSD thus launched an action in preliminary injunction on 15 June 2022. On 20 September 2022, the Paris First Instance Court held the SPC to be valid and granted the preliminary injunction to MSD. Mylan appealed this decision.
First, the Court of Appeal, after reviewing the description of EP 357 and the claims, considered that sitagliptin and metformin were individually covered by a claim of the patent (respectively claim 15 and claim 30) and that the combination was explicitly covered by claims 25 and 30. In addition, the Court considered that the two-step test recommended by cases C-121/17 (Gilead) and C-650/17 (Royalty Pharma) to determine whether a product is protected by a basic patent within the meaning of Article 3a) of Regulation (EC) No 469/2009 (« the SPC Regulation ») only applies when the product is not specifically mentioned in the claims of said patent. Given the Court considers that the combination is explicitly mentioned and covered by the claims, the Court dismissed the application of the Gilead and Royalty Pharma test and found that SPC 033 complies with the provisions of Article 3a) of the SPC Regulation.
Second, the Court considered that Article 3c) of the SPC Regulation refers to a « certificate » and not to a « certificate application » or a « pending application ». Therefore, regardless of the fact that the SPC 033 on the combination has been filed after SPC 041 on the mono product, the Court considered that SPC 033 was the first one to cover the combination of sitagliptin and metformin. Hence, the Court considered that SPC 033 complies with the provisions of Article 3c) of the SPC Regulation.
Third, Mylan argued that EP 357 was null for insufficient disclosure of the therapeutic application of sitagliptin at the filing date. Indeed, EP357 comprises several examples of synthesis of sitagliptin and other similar compounds but does not disclose any data evidencing the medical use. However, the Court dismissed the argument as Mylan was not able to evidence that the medical use was not plausible at the filing date.
Take away message:
In this decision, the Court held that the test disclosed in the Gilead and Royalty Pharma decisions could only apply when the product was not explicitly mentioned in the claims and that the CJEU does not require the claimed combination to appear in a single claim expressly citing all the compounds in the combination. In addition, with respect to SPCs covering a combination vs SPC covering a mono product, the Court considered that one of the relevant criteria was the grant date and not the filing date. Of note, a referral in the same case regarding the validity of combination SPCs is pending before the CJEU (C-119/22). The analysis of the opinion of the Advocate General Emiliou of 6 June 2024 is available here.
SPC Case law – France – Paris Court of Appeal – January 12, 2024
Asma Bendjaballah | European patent attorney – Conseil en propriété industrielle
Bandpay & Greuter
