Eli Lilly and Company has announced that the UK Supreme Court has decided in the litigation relating to alternative salt forms of Alimta (pemetrexed disodium) that Actavis's products directly infringe Lilly's vitamin regimen patents in the UK, France, Italy and Spain. The UK Supreme Court also affirmed the indirect infringement finding by the UK Court of Appeal. The full judgment is scheduled to be handed down on Wednesday, July 12, 2017. The ruling came in the case of Actavis v. Eli Lilly and Company.
In June of 2015, the UK Court of Appeal ruled the Alimta vitamin regimen patent would be indirectly infringed when the generic product is reconstituted or diluted in saline, but not directly infringed under the doctrine of equivalents. Following this decision, Actavis launched pemetrexed Armisarte, previously Pemetrexed Actavis, at risk. Today's announcement by the UK Supreme Court finds the Actavis product infringing, regardless of the diluent used in reconstitution or dilution.
"While we do not yet know the court's reasoning, we are pleased with the UK Supreme Court's key conclusions that confirm the Alimta vitamin regimen patent would be infringed by these generic pemetrexed products in the UK, France, Italy and Spain prior to June 2021," said Michael J. Harrington, senior vice president and general counsel for Lilly.
Harrington continued, "We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs."