Judge Burke faced an interesting hypothetical last week regarding the rarely invoked safe harbor provision of 35 U.S.C. § 271(e)(1). For those unfamiliar, the safe harbor provision provides that:
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into 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 or veterinary biological products.
The Sole Use Question
The issue in Wilson Wolf Manufacturing Corp. v. Sarepta Therapeutics, Inc., C.A. No. 19-2316-RGA-CJB, D.I. 28 (D. Del. Dec. 30, 2020) was whether the defendants' activities were related solely to preparing the necessary regulatory filings for its BLA product (and thus shielded from liability under the provision), or if they were partly for commercial manufacturing purposes.
At the 12(b)(6) stage, the defendant did not dispute that it had manufactured several batches of its product using the plaintiff's patented process. Nor did dispute that it had used some of those batches -- not to submit clinical data to the FDA—but to "develop, improve, and optimize its manufacturing process for commercialization purposes." Id. at 7 (quoting the complaint). This, naturally, would seem to be beyond the scope of the safe harbor provision.
The wrinkle, though, is that the FDA actually requires applicants to submit data "demonstrating 'process control to ensure a consistent product’ by 'implementing manufacturing changes needed for commercial-scale production and demonstrating product comparability prior to the initiation of clinical trials intended to provide substantial evidence of effectiveness for a marketing application.'" Id. (quoting defendant's brief).
Accordingly, the defendant argued that, since it was required to submit this data to the FDA, its activities were "'perfectly aligned' with activities undertaken for FDA purposes" and thus covered the safe harbor provision. Id.
Is There Any Safe Harbor If the FDA Requires Commercial Data?
In making this argument the defendant noted that, given the FDA guidance, it would be essentially impossible for any defendant to take advantage of the safe harbor provision at the motion to dismiss stage. All a plaintiff has to do is allege that experiments related to commercialization—which all applicants are required to submit—also serve commercialization purposes and thus are not solely for the submission of data to the FDA. Id. at 10 n.4.
Judge Burke, in denying the motion to dismiss, noted that "[t]he Court understands Sarepta’s concern[,]" but went on to opine that "every case and every pleading will turn on its unique facts" and point to some facts indicating possible commercialization. Id. Thus, for now, the Court left open the question of exactly what kind of pleading might result in a dismissal under the safe harbor provision.
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