Amgen dodged a bullet last week when Judge William G. Young of the U.S. District Court for the District of Massachusetts denied Hoffman-LaRoche's motion to dismiss Amgen's complaint alleging infringement of its patents on erythropoeitin (EPO). Hoffman-LaRoche based its motion to dismiss on the assertion that all of the allegedly infringing activities fell under 35 U.S.C. 271(e)(1), which exempts activities reasonably related to the development of information necessary for FDA approval.
Judge Young's opinion explains that the 271(e)(1) research exemption is an affirmative defense to patent infringement, and therefore Amgen was not required to plead that Hoffman-LaRoche's activities were not protected by the exemption. Amgen's complaint survived the motion to dismiss simply because Amgen pled facts sufficient to establish importation of a patented drug in violation of section 271(a).
In dicta, Judge Young stated that even if Amgen were required to plead acts that fall outside the 271(e)(1) research exemption, the court would conclude that Amgen's complaint supported a claim of infringement. The court recognized that although many of Hoffman-LaRoche's activities fall within the research exemption, Amgen alleged that Hoffman-LaRoche is importing a drug "which is materially indistinguishable from Amgen's patented invention." According to Judge Young, "This Court cannot conclude, as a matter of law, that because Roche/Hoffman is in the process of submitting information to the FDA, that this importation of the alleged infringing drug must be solely for uses that reasonably relate to the submission of that information."
This case suggests that because the 271(e)(1) research exemption is an affirmative defense, 271(e)(1) can never be the basis for a motion to dismiss. Instead, a defendant relying on 271(e)(1) must wait at least until the summary judgment stage to dispose of the case, when it can move for summary judgment of noninfringement based on the research exemption.