Classen Immunotherapies v. Biogen IDEC et al., Nos. 2006-1634, -1649 (Fed. Cir. 2011)
In a 2-1 opinion today, the Federal Circuit held that the Section 271(e)(1) safe harbor "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained."
35 U.S.C. § 271(e)(1) states:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States . . . a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs . . . .
The law was passed as part of the Hatch-Waxman Act in 1984, and while the purpose of the law was to shield generic drug makers from claims of patent infringement during the generic drug development process, the Supreme Court has interpreted the law much more broadly.
For instance, in Eli Lilly v. Medtronic, 496 U.S. 661 (1990), the Court held that the safe harbor applies not only to pharmaceutical development, but also to medical device development. More recently, in Merck v. Integra, 545 U.S. 193 (2005), the Court held that the safe harbor applies not only to generic pharmaceutical development, but rather to "all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA." In addition, the Court stated, "there is simply no room in the statute for excluding certain information from the exemption on the basis of the phase of research in which it is developed or the particular submission in which it could be included." In both Lilly and Merck, the Supreme Court reached its conclusions based on the plain language of the statute, which is intentionally broad.
In this case, Classen accused Biogen IDEC and GlaxoSmithKline of infringing its patents claiming methods of immunization on the ground that both companies participated in post-approval studies "to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza . . . and risk of developing type 1 diabetes; and to determine whether timing of vaccinations influences risk." The district court granted summary judgment that these activities are within the Section 271(e)(1) safe harbor.
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 events 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, regardless of what the statute "is directed to" (whatever that means), there was no dispute in this case 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.