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…from entering the U.S., creating a significant disruption in the pharmaceutical supply chain. At the April 5 conference, two experts from the internationally recognized pharmaceutical/medical device law firm Hyman, Phelps…
…agreement’s potential financial benefits to its clients. Although the United States and 28 states declined to intervene in the case, the litigation is continuing towards trial. In a motion for…
By Serra J. Schlanger & Alan M. Kirschenbaum – Judge Rya Zobel of the Federal District Court for the District of Massachusetts has dealt another blow to the Federal health…
By Serra J. Schlanger & Alan M. Kirschenbaum – We previously reported (here and here) on two opinions handed down by Judge Rya Zobel of the Federal District Court for…
…Greek yogurt containing MPC violated several Minnesota consumer protection statutes, and failed to comply “with legal and regulatory rules” defining “yogurt.” Specifically, Plaintiff alleged that the addition of MPC was…
…. In direct contravention of the Third Circuit’s holding in K-Dur, both of Defendants’ arguments rely on superficial labels rather than the actual substance of the agreements at issue. Although…
…decision de novo, the D.C. Circuit, although not convinced by Teva’s linguistic argument, found Teva’s structural argument to be persuasive: The real issue, then, is whether the FDA is right…
…standing. [(emphasis in original)] Of course, just because FDA responds to a citizen petition after the 30-month date for obtaining tentative approval (or final approval) has passed does not necessarily…
…sharply with Teva’s 42-page opposition memorandum. With allusions to Alice in Wonderland, Teva argued that: Incredibly, [Apotex and Roxane] now take the position that FDA acted “arbitrarily and capriciously” when…
…nonanimal alternatives and to restrict the use of animal test methods for purposes of FDA approval,” and “requests that the FDA exercise this authority to promulgate a regulation mandating that…
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Federal Circuit issued its decision in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd.,…
…had not yet received final approval. Teva, in the company’s opposition brief, vigorously defended its position that there is no basis for granting en banc review. In denying FDA’s petition,…
…cases, FDA did not make a formal forfeiture determination at the time of ANDA approval and stated it would do so only if another applicant becomes eligible for approval within…
…draws no distinction between “unilateral” action and other action resulting in removal of a challenged patent from the Orange Book. This Court’s immediate review is necessary to remedy these fundamental…
…RISPERDAL (risperidone) Oral Solution – the Federal Circuit dismissed a declaratory judgment action for non-infringement notwithstanding a covenant not to sue, because the “alleged harm of indefinite delay of [ANDA]…