The Safe Harbor For FDA Submissions Expands: Did The Federal Circuit Reverse Course?

Section 271(e)(1) of the patent code, known as the "safe harbor" provision, immunizes from infringement suits various acts that are undertaken in order to submit information to the Food and Drug Administration ("FDA"). The scope of these various acts and thus of the safe harbor remains in flux. Last year, in Classen,1the Federal Circuit held that the safe-harbor clause does not shelter acts undertaken to gather "information that may be routinely reported to the FDA, long after marketing approval has been obtained." This August, however, the Federal Circuit held that Section 271(e)(1) does apply to post-approval "submissions that are required to maintain FDA approval." Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. Judge Moore, who had dissented in Classen, wrote the majority opinion in Momenta. Chief Judge Rader, who was part of the majority in Classen, wrote a fierce dissent in Momenta, arguing that the majority opinion conflicts with Classen and "will render worthless manufacturing test method patents."2 Safe Harbor for FDA Submissions

Under the FDA safe-harbor clause:3 It shall not be an act of infringement to make, use, ... or sell ... 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 or veterinary biological products.

Congress enacted this provision as part of the 1984 Hatch-Waxman Act. According to the Supreme Court, in enacting Section 271(e)(1), Congress was responding to case law4 holding that the manufacture and use of a patented invention constituted an act of infringement, "even if it was for the sole purpose of conducting tests and developing information necessary to apply for regulatory approval."5 The Federal Circuit expanded on this theme in 2008, writing that "[t]he basic idea behind this provision was to allow competitors to begin the regulatory approval process while the patent was still in force, followed by market entry immediately upon patent expiration."6 Controversy arises over whether the safe harbor protects acts that go beyond those required for seeking regulatory approval for generic drugs. Appellate cases have therefore focused on whether Section 271(e)(1) shelters otherwise-infringing activity performed while testing a medical device to obtain premarket approval,7 performing preclinical research on a drug for which no new drug application was ever filed,8...