Japanese Court Rules in Favor of Lilly’s Vitamin Regimen Patent
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The Japan Intellectual Property High Court has ruled in favor of Eli Lilly and Company and has confirmed the decisions of the Japan Patent Office that invalidated trials initiated by Sawai Pharmaceutical, headquartered in Osaka, Japan, regarding Lilly’s vitamin-regimen patents for Alimta (pemetrexed for injection), Lilly’s anti-cancer drug. Alimta is one of Lilly’s top-selling products with approximately $2.3 billion in 2016 sales.

In the fourth quarter of 2015, the Japan Patent Office issued written decisions upholding the validity of the Alimta vitamin-regimen patents. If the patents are ultimately upheld through all challenges, they could provide intellectual property protection for Alimta in Japan until June 2021.

Lilly also previously received a favorable ruling in the US from the US Court of Appeals for the Federal Circuit in January 2017, which upheld a federal district court’s decision that Lilly’s vitamin-regimen patent for Alimta was valid in the case of Eli Lilly and Company versus Teva Parenteral Medicines, Inc., et al., and that the patent would be infringed by generic challengers’ proposed products. If the vitamin-regimen patent is ultimately upheld through all remaining challenges, Alimta would maintain US exclusivity until May 2022. The Alimta compound patent remained in force until it expired on January 24, 2017.

Alimta was approved by the US Food and Drug Administration in 2004 and is indicated for treating mesothelioma in combination with cisplatin and for treating non-small cell lung cancer as a single agent.

Source: Eli Lilly and Company

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