On February 12, 2016 Eli Lilly and Company (NYSE: LLY) reported that the UK High Court decided the Alimta (pemetrexed disodium) vitamin regimen patent would not presently be infringed by Actavis marketing pemetrexed trometamol in the UK, France, Italy and Spain with instructions to dilute the product only with dextrose solution (Press release, Eli Lilly, FEB 12, 2016, View Source [SID:1234509078]).

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In June of 2015, the UK Court of Appeal held that Lilly’s patent would be indirectly infringed by Actavis marketing certain alternative salt forms of pemetrexed with instructions to dilute the product with saline solution. However, the Court of Appeal left open the question of whether an alternative salt form with instructions to dilute only in dextrose solution would infringe.

The court based its decision of non-infringement on Actavis complying with its stated intentions as to how it will market its product and certain circumstances not changing over the remaining life of the patent. In its decision, the UK court accepts that it is not able to predict what will happen in the future and expressly allows either party to ask for the decision to be revisited if there is a material change of circumstances at any point in the remaining life of the patent, which expires in June 2021.

Lilly plans to seek permission to appeal today’s decision to the UK Court of Appeal.

In major European countries, the compound patents for Alimta expired in December 2015. The Alimta vitamin regimen patents expire in June 2021.

"We strongly disagree with the ruling by the UK High Court granting a declaration of non-infringement on the Alimta vitamin regimen patents under these circumstances. We plan to seek permission to appeal this ruling," said Michael J. Harrington, senior vice president and general counsel for Lilly.

In addition, Lilly has applied for permission to appeal the direct infringement aspect of the June 2015 Court of Appeal decision to the UK Supreme Court. That request is pending.

In a separate proceeding in the first quarter of 2015, 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 recently been granted permission to appeal this ruling to the Federal Supreme Court of Germany, which is scheduled to be heard mid-2016. Lilly has also recently received a preliminary injunction against a different generic competitor to restrict marketing of a copycat pemetrexed product.

In the fourth quarter of 2015, a generic competitor unilaterally withdrew its appeal in the case regarding the validity of the Alimta vitamin regimen patent before the Technical Board of Appeal of the European Patent Office (EPO). In view of the withdrawal of the appeal, the decision of the Opposition Division of the EPO finding the patents valid is final, and there cannot be further validity challenges to the vitamin regimen patents for Alimta centrally before the EPO.