On appeal, Classen argued "that this statute, as enacted and intended, and as judicially interpreted, is limited to activities conducted to obtain pre-marketing approval of generic counterparts of patented inventions, before patent expiration." Biogen and GSK argued, on the other hand, that their participation in studies evaluating risks associated with different vaccination schedules is reasonably related to their requirement under, e.g., 21 C.F.R. § 601.70 and 21 C.F.R. § 600.80, to review and report adverse information to the FDA.
The majority opinion, authored by J. Newman and joined by J. Rader, found in favor of Classen, stating:
Classen is correct, for § 271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products. The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.
The majority opinion then proceeds to review the legislative history of the Hatch-Waxman Act, which obviously focused on the then-new abbreviated approval process for generic drugs. While the majority opinion quotes from both Eli Lilly v. Medtronic and Merck v. Integra, it ignores how broadly the Supreme Court interpreted the safe harbor in those cases. Rather, according to the majority opinion, "every decision examining the statute has appreciated that § 271(e)(1) is directed to premarketing approval of generic counterparts before patent expiration."
But as the dissent by J. Moore notes, there was simply no dispute that the safe harbor applies to pre-approval activities. J. Moore wrote:
The majority cites extensively from the legislative history in an attempt to justify its construction. But these citations miss the point entirely. There is no dispute that § 271(e)(1) covers pre-approval studies, as the legislative history indicates. None of the legislative history cited by the majority, nor the cases it references, speak to the question at issue here -- whether the statute as enacted also covers post-approval activities. The question is not whether Congress intended to protect pre-approval activity -- but whether the enacted legislation covers more than just pre-approval activity. The language Congress chose to enact and that was signed by the President is plain on its face. There is no "pre-approval" limitation.
The other main issue addressed in the opinion concerns the patent-eligibility of Classen's claims under 35 U.S.C. § 101. Patently-O has an excellent discussion of that portion of the opinion.