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FDA Marketing Exclusivity Periods Limited To Same Active Moiety

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 … Continue reading this entry

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the … Continue reading this entry

Don't Blame Patents For High Drug Prices

Before his recent arrest, Martin Shkreli, the former CEO of Turing Pharmaceuticals, gained notoriety for increasing the price of the AIDS drug Daraprim® (pyrimethamine) from about $13.50 to about $750 per pill. He also was reported to be considering a similar price hike for benznidazole, for which his new company, KaloBios Pharmaceuticals, was going to seek … Continue reading this entry

Apotex Has Standing Despite Benicar Patent Disclaimer

In Apotex Inc. v. Daiichi Sankyo, Inc., the Federal Circuit held that Apotex has standing to seek a declaratory judgment that it does not infringe Daiichi Sankyo’s patent, even though Daiichi Sankyo has disclaimed the patent such that there can be no infringement as a matter of law. The court reached this decision because only … Continue reading this entry

Federal Circuit Finds That FDA Citizen Petition Could Give Rise To Antitrust Liability

In Tyco Healthcare Group LP v. Mutual Pharmaceutical Co., Inc., the Federal Circuit remanded-in-part for the district court to determine whether Tyco’s citizen petition to the FDA gave rise to antitrust liability. Judge Newman wrote a dissenting opinion warning against the chilling effect that antitrust liability could have on a citizen’s right to communicate with … Continue reading this entry