We've discussed before how difficult it is to successfully invoke the safe harbor provision of 271 at the motion to dismiss stage. This is especially so since a plaintiff generally need not look very hard to find statements from the Defendant that they are, like, totally about to sell eleventy-billion-dollars worth of the drug in question. How then, can a defendant—with all inferences taken against them—show that the otherwise infringing product is "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 defendant in Allergan, Inc. v. Revance Therapeutics, Inc., No. 21-1411-RGA, 2022 U.S. Dist. LEXIS 129397 (D. Del. July 21, 2022), came up with an interesting answer to this question. According to the complaint, Defendants had already stockpiled a great deal of their currently unapproved BOTOX competitor (hence the title, hence the awesome picture). Defendants didn't dispute that they had done this in their motion to dismiss, but argued that they might use the product in FDA submissions in the future. Since this activity might later turn out to be protected, they argued there was no present case or controversy, and thus no subject matter jurisdiction.
Schrodinger's Botox
There's some logical appeal to the theory. Whether the activity truly infringes can't be known until either Defendants' FDA application is finally approved or they sell the product on the open market. It's clever!
It Did Not work
Judge Hall dispatched of this neat little argument quite quickly in her report and recommendation, stating:
Defendants alternatively contend that the Court lacks subject matter jurisdiction because it might in the future "utilize" the batches it is alleged to have stockpiled "to support its response to the [FDA]." According to Defendants, their past activities are therefore shielded by 35 U.S.C. § 271(e)(1), which states that it is not an act of infringement to make, use, or import a patented invention "solely for uses reasonably related to the development and submission of information" to the FDA.
That argument is also a nonstarter, for at least three reasons. First, Defendants have provided no support for the proposition that application of the statutory safe harbor implicates the Court's subject matter jurisdiction, and I am unaware of any.
Second, the FAC alleges—citing to Revance's own statements—that Revance was "actively building inventory" in preparation for "commercial launch." Viewed in the light most favorable to Plaintiffs, that allegation is sufficient to support a plausible inference that Revance did not make and import the batches in question "solely for uses reasonably related to" its FDA submission.
Third, insofar as Defendants contend that a drug manufacturer may escape infringement liability for making and importing commercial-sized drug batches with the intent to sell them if it later submits data regarding those batches to the FDA, Defendants have cited no case supporting that proposition and I am unaware of any. For those reasons, I recommend that the Court deny Defendants' request to dismiss the stockpiling claims for lack of jurisdiction.
Allergan, Inc. v. Revance Therapeutics, Inc., No. 21-1411-RGA, 2022 U.S. Dist. LEXIS 129397, at *10-11 (D. Del. July 21, 2022).
And so a novel argument, like the metaphorical cat, has died.
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