As reported in a post last week, the Federal Circuit recently heard oral arguments in Merck KGaA v. Integra LifeSciences following remand from the Supreme Court. Since the hearing, both Merck and Integra have submitted letters to the Federal Circuit, urging the court not to decide the issue of whether Merck's use of Integra's patented compounds fell outside the 271(e)(1) FDA exemption as "research tools," in which case Merck would be liable for patent infringement.
Merck asserted in its letter that a Federal Circuit decision based on the research tool issue would be improper because Integra never argued--in the district court, Federal Circuit, or Supreme Court--that the jury verdict for Integra should be sustained on the basis that Merck used Integra's patented compounds as research tools. Integra, in its own letter, agreed with Merck, stating that while the research tool question is extremely important, it should be answered in a case in which the issue has been "squarely raised and thoroughly vetted" in the trial court.
At oral argument, Judge Rader, in particular, seemed gung ho to remand the case to the district court to determine whether Merck used Integra's compounds as research tools and therefore was not entitled to the 271(e)(1) FDA exemption. If the other two members of the panel, Judges Newman and Prost, follow the parties' advice and ignore that issue, then the Federal Circuit will limit its opinion to the narrower technical question of whether Merck's JMOL motion was properly denied by the district court.
NOTE: Thanks to Dennis Crouch for providing the parties' letters!