Generic drug – infringement action – interim measures

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

The Paris Court of Appeal confirmed an interim order prohibiting Zentiva from marketing its generic and requiring it to provide Eli Lilly with certain information. It nevertheless ordered Eli Lilly to return the damages provisionally paid.

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

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

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

Jurisdiction to rule on the appeal of the pre-trial judge’s order that Zentiva pay Eli Lilly a provisional sum of 4 million euros, 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 likely that the patent was infringed in copy, or at least by equivalence, because:

  • the generic drug is composed of the same active ingredient as the reference drug, and it must be administered in combination with vitamin B12 and folic acid, as recommended in patent EP’508;
  • the claims of the EP’508 patent, which refer only to pemetrexed disodium, and not to pemetrexed diarginine (the generic salt form of pemetrexed), should be considered in light of the patent description, which refers in general terms with the active ingredient pemetrexed;
  • the generic medicine is intended to treat the same cancer-related diseases with the same technical effect and has been 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 other persons in possession of the products, the quantities produced and sold, the gross profit earned, and the names and addresses of the customers. The Court, however, reversed the order insofar as it added a fine to the injunction and specified that the information would be provided within the framework of the confidential circle set up by the parties.

In addition, the court set aside the provision of the order ordering Zentiva to pay Eli Lilly a provisional amount of 4 million euros. The Court held that Eli Lilly had not demonstrated that it had suffered harm that was not seriously contestable and ordered it to return the 4 million euros in provisional damages to Zentiva.

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