Yeda Research v. Mylan Pharm. Inc. United States Court of Appeals of the Federal Circuit, 2018 906 F.3d 1031 Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN*

In an inter partes review (IPR), the Patent Trial and Appeal Board (Board) struck down as obvious "the Copaxone patents." The Copaxone patents describe and claim COPAXONE (R) 40mg/mL, a treatment for relapsing-remitting multiple sclerosis wherein the active ingredient is glatiramer acetate (GA). The claimed treatment consists of the injection of 40mg of GA three times a week. Prior to COPAXONE (R) 40mg/mL, the Food and Drug Administration (FDA) approved COPAXONE (R) 20mg/mL, a regimen consisting of the daily injection of 20mg GA. Daily GA injections were known to subject patients to discomfort and side effects that were reduced by switching to injection three times week at the higher dosage. One prior art reference disclosed administering 40mg GA every other day, and other prior art references would have motivated a person of ordinary skill in the art (POSITA) to switch to administering the drug less frequently than once a day in order to reduce adverse side effects, and a reasonable expectation that this change in the dosing regimen would maintain efficacy while reducing side effects. The Federal Circuit affirmed, pointing out the slight difference between the prior art's disclosure of administering 40mg seven times over a two-week period versus the claimed 40mg administered six times over a two-week period. The court affirmed the Board's reliance on a reference that was published after the priority date and thus did not qualify as statutory prior art but nonetheless could be used as non-prior art evidence to support and explain an expert's opinion that a POSITA would have thought less frequent dosing worthy of investigation as of the priority date.