UK Court Rules in Favor of Lilly in Alimta Patent Case
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Eli Lilly and Company reports that the Court of Appeal in the UK 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 Kingdom prior 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.

In a statement, Lilly reported that 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 (now called Allergan) 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.

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.

Source: Eli Lilly and Company

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