Wednesday, January 26, 2011, 8:06 AM

US Will Intervene In Another Take Care Challenge

By: Jim Lennon
The United States District Court for the Western District of Pennsylvania, yesterday, granted the Department of Justice's request to intervene in the matter of USA ex rel Alchemy Asset Services Inc. v. GlaxoSmithKline LLC et al., Civ. No. 10-680. See Order, entered January 25, 2011. One day prior, the Department of Justice filed a Notice of Intervention, "respectfully request[ing] that this Court permit the United States to intervene to address the question of the [False Marking] [S]tatute’s constitutionality pursuant to 28 U.S.C. § 2403." GSK moved to dismiss a complaint alleging its "Fiber Choice" product was falsely marked with an expired patent. GSK's motion alleged that the factual allegations were insufficient under Rule 12(b)(6) and that the False Marking Statute violates the Take Care Clause of Article II of the Constitution. In November, a magistrate judge recommended dismissal under Rule 12(b)(6) because the complaint failed to meet the heightened pleadings requirements of Rule 9(b) with respect to the "intent to deceive" prong of the claim. The magistrate did not address the constitutional challenge. Later in November the United States was granted an extension of time to decide whether to intervene regarding the constitutional challenge. Yesterday's order, granting the intervention request, sets the United States' response deadline for this Friday, January 28, 2011.

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