In Re: Copaxone Consol. Cases United States Court of Appeals of the Federal Circuit, 2018 906 F.3d 1013 Edited for Biotechnology Law Report by CHRISTOPHER M. HOLMAN*

A district court invalidated as obvious all of the asserted claims of "the Copaxone patents," and on appeal the Court of Appeals of the Federal Circuit affirmed. 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 treatment claimed in the three patents 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 pain and discomfort at the site of injection that were reduced by switching to injecting the drug three times a week at the higher dosage, with at least a one-day break between injections. The closest prior art reference, which was one of the patent owner's own prior art published patent applications, disclosed administering 40mg GA every other day (seven times every two weeks), which the court found to be only slightly different than the regimen claimed in the Copaxone patents (six times every two weeks). Other prior art included recommendations by the FDA and others that the patent owner explore the possibility of adjusting the dosage and moving to a regimen that did not require daily injections in order to reduce patient noncompliance due to the injection site reaction, and studies showing that the 40mg dose was comparable in safety and efficacy to the 20 mg dose. The Federal Circuit held that the district court had not erred in relying on a reference that was published after the priority date and thus did not qualify as statutory prior art, noting that the court had not used the reference as invalidating prior art, but instead as evidence of a person of ordinary skill in the art's (POSITA's) motivations and expectations when reading the prior art at the time of the invention. The Federal Circuit also upheld the district court's conclusion that a 40mg GA 3x/week dosage would be obvious to try, noting that there were only two tested dosage amounts in the prior art-20mg and 40mg-and that researchers were pursuing less frequent dosing regimens, while recognizing there are a limited number of days in a week on which to test frequency. The appellate court noted that the potential for FDA approval may properly be considered in determining whether one of ordinary skill would be motivated to develop a drug product, and that FDA is more likely to approve use of a dosage that has a track record.