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German Supreme Court grants Lilly appeal to block Alimta generics

Published on 15/06/16 at 08:56am

Eli Lilly (NYSE: LLY) has announced that it has been granted an appeal by the German Federal Supreme Court, in its case against Actavis (now Allergan) relating to generic competition for Lilly’s vitamin regimen patent Alimta (pemetrexed disodium).

While the compound protection for Alimta expired in major European countries in December 2015, Lilly maintains that the patent protection for the Alimta vitamin regimen will expire in June 2021. Actavis were said to have stated an intention to market a dipotassium salt form of pemetrexed in Germany, which Lilly claimed would infringe on their 2021 expiry patent.

The blockbuster lung cancer drug generates sales of around $2.5 billion per year, so it is clear why Lilly are keen to block its rivals from engaging in generic competition. A UK high court also ruled in favour of Actavis on the same issue early this year.

Michael J. Harrington, senior vice president and senior counsel at Lilly, says: “We are pleased with the ruling by the German Federal Supreme Court granting our appeal regarding infringement of Alimta’s vitamin regimen patent in Germany. This ruling supports our continuing belief that Alimta’s vitamin regimen patent would be infringed by the entry of generic pemetrexed products, including alternative salt forms, in Europe prior to June 2021.

“We continue to emphasise 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.”

Lilly also indicates that the separate infringement proceeding and validity challenge with Hexal AG will continue unaffected by this ruling. A court granted a preliminary injunction against the German generic drugmaker in late May 2016

Sean Murray

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