Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

PHARMAPATENTS GLOBAL LTD | January 24, 2017

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the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the prescription drug component required coadministration of the other active agent. The appeal arose from ANDA litigation surrounding Eli Lilly’s ALIMTA® product, which is to be taken with folic acid and vitamin B12 to reduce side effects. Although pharmaceutical companies may welcome this decision, they should be aware of the emphasis the court place on the specific guidance and instructions provided in the product labeling.

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