The basis of the dispute is EP 1 313 508. Eli Lilly’s patent protects the use of the disodium salt of pemetrexed in combination with vitamin B12. The drug, formulated as a so-called Swiss-type claim, forms the basis of Alimta, used in chemotherapy.
The patent expired in mid-2021, pending litigation therefore concentrates primarily on damages.
High damages awarded
In September 2020, the Judicial Court Paris had awarded Eli Lilly €28 million in the dispute against competitor Fresenius Kabi. In another dispute against Zentiva, the first instance court awarded provisional damages of €4 million to Eli Lilly in January 2021. This decision was later overturned in appeal. The court pointed out that potential damages should be dealt with in the proceedings on the merits.
In November 2019, the US company Eli Lilly and its French subsidiary Lilly France filed an suit on the merits against Viatris’ predecessor Mylan at the Judicial Court Paris. According to the claimants, Mylan’s generic drug, in which pemetrexed is used in the form of a different salt, pemetrexed diarginine, infringes their patent.
Accusation of “unfair competition”
Lilly France is also accusing the defendant of committing an “act of unfair competition” with this infringement. It is demanding provisional damages of €2.5 million and the reimbursement of costs totalling almost €255,000. To assess the actual damage caused, the claimant is also demanding the disclosure of information relating to the marketing of the generic drug between December 2014 and June 2021. This disclosure would take place within a confidentiality club.
Viatris argues that EP 508 is invalid and rejects the allegation of infringement as well as the further allegation of unfair competition. The defendant is demanding that Lilly France be excluded from any confidentiality club formed.
As Lilly France, which produces pemetrexed in France for the Eli Lilly Group, is neither the patent holder nor the licensee, Viatris believes that the French subsidiary is not entitled to claim damages.
Back to the drawing board
The court now found the French part of the patent valid and infringed, except for two claims. However, it rejected Lilly France’s claims for damages.
The judges referred to the French Intellectual Property Code, which states that only the patent holder or a licensee may file an infringement suit, and noted that Lilly France could therefore only claim damages based on the allegation of unfair competition, as it is doing. In the opinion of the court, the claimant was unable to provide any credible evidence for this allegation and it therefore dismissed the action.
However, the 3rd chamber of the Judicial Court Paris ordered Viatris to disclose information about the distribution of Pemetrexed Mylan for the period between 1st December 2014 and 15th June 2021. This information will serve Eli Lilly and Viatris as a basis for agreeing a damages sum in bilateral, out-of-court negotiations.
An appeal against this decision is possible.