CA Paris, November 9, 2021, Eli Lilly v. Zentiva France (docket no. 21/01880)

The Paris Court of Appeal upheld a preliminary injunction prohibiting Zentiva from marketing its generic and ordering it to provide Eli Lilly with certain information. It nonetheless ordered Eli Lilly to return the damages that had been provisionally paid.

Eli Lilly and Company (a US entity) developed a cancer medication sold in France by its subsidiary, Lilly France, under the brand Alimta, the active ingredient of which is pemetrexed. Eli Lilly holds patent EP 1 313 508 (EP’508), entitled “combination containing an antifolate and methylmalonic acid lowering agent,” which expired on June 15, 2021. Patent EP’508 concerns combining the administration of Alimta with vitamin B12 and possibly folic acid to treat two types of lung cancer by reducing the active ingredient’s toxicity while maintaining its effectiveness as a treatment.

In 2018, the French subsidiary of the Czech company Zentiva, which specializes in generic medicines, obtained an authorization to market the generic version of Alimta under the name “pemetrexed Zentiva.” On April 4, 2019, Zentiva France declared it was beginning to market its generic.

Eli Lilly sued Zentiva for infringement of the French portion of its patent EP’508, asking the pretrial judge for provisional measures prohibiting Zentiva from marketing its generic and requiring it to pay damages and provide information to Eli Lilly.

Having jurisdiction to rule on the appeal of the pretrial judge’s order that Zentiva pay Eli Lilly a provisional amount of €4 million, the Court declared the appeal of the entire order admissible in the interests of the proper administration of justice.

After confirming that the alleged infringement was probable, the Court upheld the order prohibiting Zentiva from marketing pemetrexed Zentiva. According to the Court, it was probable that the patent was infringed copying, or at least by equivalence, because:

  • the generic medicine is composed of the same active ingredient as the reference medicine, and it must be administered in combination with vitamin B12 and folic acid, as recommended in patent EP’508;
  • the claims in patent EP’508, which refer only to pemetrexed disodium, not pemetrexed diarginine (the generic medicine’s salt form of pemetrexed), must be examined in light of the patent’s description, which refers in general terms to the active ingredient pemetrexed;
  • the generic medicine is designed to treat the same cancer-related illnesses with the same technical effect, and was authorized as a generic medicine of the reference medicine.

The Court also upheld the order requiring Zentiva to provide the requested information, such as the names and addresses of the manufacturers and others in possession of the products, the quantities produced and sold, the gross margin realized, and the clients’ names and addresses. The Court reversed the order, however, to the extent it added a fine to the injunction, and specified that the information would be provided within the confidential circle set up by the parties.

Furthermore, the Court reversed the order’s provision sentencing Zentiva to pay Eli Lilly a provisional amount of €4 million. The Court found that Eli Lilly had failed to show that it had suffered an amount of harm that could not seriously be disputed, and ordered it to return the €4 million in provisional damages to Zentiva.