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In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining the zone of FDA market exclusivity periods. The case originated from Otsuka’s Citizen’s Petition asserting that  FDA had improperly approved Alkermes’s Section 505(b)(2) application for Aristada® (aripiprazole lauroxil) before expiration of the exclusivity periods for Otsuka’s Abilify Maintena® (aripiprazole) product.…
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins.” The court dismissed concerns that its holding would extend the originator’s 12-year exclusivity period by 6 months, reasoning that the FDA could signal approval of a biosimilar before the 12-year exclusivity period has run, but is that correct?…
Laboratory Developed Tests (LDTs) are tests that are intended for clinical use and designed, manufactured and used within a single laboratory. On July 31, 2014, the federal Food and Drug Administration (FDA) provided advance notice to Congress (as required by statute) of its intent to issue draft guidance for the regulatory oversight of LDTs, after its longstanding approach of “enforcement discretion” for these tests.…