Pemetrexed - USA

On Jan 12, 2017, three-judge panel of CAFC affirmed the decision of district court favoring Lilly on Method of use patent, U.S. 7,772,209 (set to expire on May 24, 2022 with PED). The said patent covers methods of administering folic acid and Vitamin B12 followed by administration of pemetrexed disodium (Alimta).

Several generic manufacturers have submitted ANDAs with Paragraph IV certifications challenging the patents on Alimta. Lilly is still asserting the ’209 patent in infringement litigation. In August 2015, a district court issued a decision in favor of Lilly in its lawsuit against Teva and APP (a subsidiary of Fresenius). Teva and Fresenius filed appeals and court held a hearing on September 9, 2016.

In a thorough opinion, the district court found, inter alia, that a skilled artisan would not have been motivated to: (1) use folic acid pretreatment with pemetrexed; (2) use vitamin B12 pretreatment with pemetrexed; or (3) use the claimed doses and schedules of folic acid and vitamin B12 pretreatments with pemetrexed. The court also found that Eli Lilly had established several secondary considerations in favor of nonobviousness. On appeal, Defendants contend that all of those findings were erroneous. Eli Lilly submits that Defendants’ arguments “amount to nothing more than an effort to reargue the facts.”

CAFC agreed with Eli Lilly and said that Defendants’ arguments fail to raise reversible error with respect to at least the findings that a skilled artisan would not have been motivated to use vitamin B12 pretreatment with pemetrexed, let alone the appropriate doses and schedules of such vitamin B12 pretreatment.