MSD and generics await CJEU ruling in French SPC battle over Inegy

In France, competing parties must wait for a final CJEU decision in the dispute over a supplementary protection certificate for MSD's cholesterol-lowering drug, Inegy. The Supreme Court of Paris has now suspended the case on the interpretation of Articles 3a and 3c of the current EU regulation on SPCs, pending a ruling by the highest European court.

15 February 2023 by Konstanze Richter

MSD, CJEU. Inegy The Paris Supreme Court has stayed a case concerning an SPC over cholesterol-lowering drug Inegy, pending the outcome of two CJEU appeals ©hifografik/ADOBE STOCK

In Europe, the patent market is currently awaiting the CJEU’s decision on two referrals from the Finnish Market Court and the Supreme Court of Ireland. Both address the scope of the Supplementary Protection Certificate Regulation, with regard to combination drug products.

The Finnish case concerns diabetes drug Janumet (case ID: C-119/22), while the Irish case concerns cholesterol drug Inegy (case ID: C-149/22). According to the court calendar, the oral hearing in both cases will take place on 8 March 2023.

MSD’s blockbuster Inegy is also the subject of two cases against Biogaran (case ID: 18-21.903) and Teva (case ID: 19-16.741), which the French Supreme Court has now stayed. Both companies are facing Organon, which emerged from MSD in 2020. The court in Paris has decided to stay the proceedings until the CJEU issues its rulings.

Like in the current Irish case, the French dispute concentrates on whether an SPC for a combination of active ingredients can be granted, if an SPC for one of the single agents of said combination already exists.

MSD against generics

In France, the pharma innovator MSD (now Organon) has fought with various generics manufacturers for years. In addition to proceedings against Biogaran and Teva, the company also fought against Mylan (now Viatris), Sandoz and EG Labo. All of the patent disputes are based on the national SPC for basic patent EP 07 20 599. The SPC protects the combination of ezetimibe and simvastatin, on which MSD has based its cholesterol-lowering drug Inegy.

The courts came to different conclusions in different proceedings. Some were on preliminary injunctions, while some cases discussed the merits. Often, the CJEU decisions in Gilead vs. Teva on Truvada, and Royalty Pharma vs. the German Patent and Trade Mark Office (DPMA) on sitagliptin, played a role in the outcomes.

Teva first up

The dispute began in France in 2018, when MSD filed an infringement action against generic drug manufacturer Teva. The latter launched its own combination product with ezetimibe and simvastatin, responding to MSD’s attack with a counterclaim for nullity. In a first-instance decision in October 2018, the Judicial Court of Paris declared the SPC valid and rejected the nullity suit.

Parallel proceedings saw MSD apply for a preliminary injunction against Biogaran, to prevent the generic company from marketing its own product.

In its argument, MSD had referred to the CJEU’s decision in Gilead vs. Teva on Truvada (case ID: C-121/17), published a short time earlier. Here, the European court had ruled that a compound is protected when the claims of the basic patent refer specifically to that combination of active ingredients, even if the basic patent does not expressly mention those active ingredients.

Laetitia Bénard

Furthermore, an expert or ‘person skilled in the art’ must be able to identify the combination of active ingredients, as well as the individual ingredients.

MSD awaits CJEU decision

Teva appealed against the first-instance ruling. In September 2020, the second instance found the SPC invalid. In addition to the Truvada decision, MSD had also cited the CJEU’s decision in the Royalty Pharma case (case ID: C-650/17), which it issued in April of the same year.

However, the Paris Court of Appeal noted that both rulings involved situations where the SPC on the combination product was the first and only SPC based on a basic patent. It ruled that this was not the case for the combination of ezetimibe and simvastatin. The judges also found that a person skilled in the art would not have considered that the combination of the two active ingredients constitute a product distinct from ezetimibe alone, which the basic patent protects.

Following this line of reasoning, the Paris Judicial Court and the Paris Court of Appeal handed down similar judgments in other proceedings concerning the same SPC. An example is MSD’s dispute against Mylan and Biogaran. MSD then requested that the Paris Supreme Court decide how the EU Regulation on SPCs is to be interpreted in this case, e.g. when the SPC on the combination product is added to an already-existing SPC on the mono product.

Marianne Gabriel

However, as it stands, the parties are likely to hear the answer from the CJEU instead.

Biogaran on the merits

In parallel proceedings on the merits against Biogaran, Paris Judicial Court granted MSD a stay of proceedings, pending the French Supreme Court’s judgment. In their decision of May 2021, the pre-trial judge stated the SPC should be considered valid.

Here, the judge based their reasoning on claim 17 of the basic patent explicitly mentioning the combination of ezetimibe with simvastatin.

Therefore, the pre-trial judge reasoned, one could deduce that the SPC protects the ezetimibe and simvastatin combination.

Sworn teams

From the outset, all parties relied on their core advisors, with MSD turning to Allen & Overy. The international firm has a strong reputation for patent litigation on the side of originators, with partner Laetitia Bénard representing Novartis and Bayer, among others. The two companies are currently fighting against Biogaran and Teva in France.

Francois Pochard

Traditional French IP boutique Casalonga is Biogaran’s go-to law firm. The mixed team of lawyers and patent attorneys has acted for the generic drug manufacturer in a number of cases, including the dispute against Novartis over multiple sclerosis drug fingolimod.

August Debouzy also acts for Teva in a number of patent proceedings, for example against Novartis over everolimus and against Bayer over cancer drug sorafenib.

For MSD/Organon
Allen & Overy (Paris): Laetitia Bénard (partner); associates: Charles Tuffreau (counsel), Marylis Clerc

For Biogaran
Casalonga (Paris): Marianne Gabriel, Arnaud Casalonga, Gérad Dossmann (patent attorney) (all partners)

For Teva
August Debouzy (Paris): Francois Pochard (partner); associate: Pierre-Olivier Ally (counsel)

Supreme Court Paris, Chamber of commerce, finance and economy
Vincent Vigneau (presiding judge), Philippe Mollard, Sophie Darbois, Annie Vaisette, Jocelyne Vallansan, Sylvaine Poillot-Peruzzetto, Michèle Graff-Daudret, Marie-Laure Bélaval, Carole Champalaune, Marie-Christine Daubigney, Stéphanie Barbot (judges), Olivier Douvreleur (prosecutor)