London, June 26, 2015 – Eli Lilly and Company (NYSE: LLY) today announced that the Court of Appeal has ruled that the Alimta® (pemetrexed disodium) vitamin regimen patent would be indirectly infringed by a generic competitor that had stated its intent to market certain alternative salt forms of pemetrexed in the United Kingdomprior to the UK patent’s expiration in June 2021.
Specifically, the Court of Appeal held that commercialization of these alternative salt forms in the products as proposed would constitute indirect infringement by supplying an essential means for putting the patented invention into effect. The decision came in the case of Actavis v. Eli Lilly and Company.
The Court of Appeal also held there was no difference between the law in the UK and that in France, Italy and Spain as it relates to indirect infringement, and so reversed the High Court’s decision granting declarations of noninfringement over the Alimta vitamin regimen patents in those countries.
Actavis may seek permission to appeal the decision to the UK Supreme Court. In addition, Actavis has stated it may ask the High Court to decide whether a different proposed product would infringe the patent. The Court of Appeal has ruled that the High Court will need to decide whether it will hear this new claim. If the High Court decides to hear Actavis’ case on the different proposed product, Lilly will defend the case vigorously.
In Europe, the compound patents for Alimta remain in force and are expected to provide exclusivity through December 2015. This decision increases the likelihood that the vitamin regimen patents for Alimta will provide exclusivity in the UK, France, Italy and Spain through June 2021.
“We are pleased with the UK Court of Appeal’s ruling that confirms the Alimta vitamin regimen patent would be infringed by the entry of these generic pemetrexed products in theUnited Kingdom prior to June 2021. We are also pleased the ruling has cancelled the declarations of noninfringement with respect to France, Italy and Spain,” 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.”
In a separate appeal earlier this year, the Dusseldorf Court of Appeal ruled the Alimta vitamin regimen patent would not be infringed by a generic competitor that has stated intent to market pemetrexed dipotassium in Germany after the compound patent expiration in December 2015. Lilly has asked for permission to appeal this ruling.
Lilly’s vitamin regimen patents were upheld in a prior ruling by the Opposition Division of the European Patent Office. An appeal is pending before the Technical Board of Appeal of the European Patent Office.
