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Documents on Antitrust & Trade Regulation
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|What Elephant? Supreme Court Downplays Inquiry into Patent Strength in Hatch-Waxman Settlements|
Amelia Cardenas, Scott A. Cunning, Kyle Musgrove, Richard A. Ripley; Haynes and Boone, LLP;
June 19, 2013, previously published on June 17, 2013The Supreme Court held today in FTC v. Actavis that so-called “reverse payment” settlement agreements are subject to antitrust law’s “rule of reason” analysis. The Court, however, largely downplayed whether such analysis would require inquiry into what Justice Scalia...
|Federal Trade Commission v. Actavis, Inc., et al.: Supreme Court Holds that the Rule-Of-Reason Antitrust Analysis Applies to Settlement of Hatch-Waxman Disputes|
Lisa Butler, John D. Murnane; Fitzpatrick, Cella, Harper & Scinto;
June 19, 2013, previously published on June 18, 2013On June 17, 2013, the Supreme Court issued its ruling in Federal Trade Commission v. Actavis, Inc. The Court decided that, although “reverse payment settlements” in paragraph IV disputes are not immune from antitrust scrutiny, such settlements are not presumptively unlawful and instead...
|Medical Device Industry Responds to FDA's Overseas Clinical Trial Proposed Rule|
Nathan A. Beaver, Jennifer M. Forde, Antoinette F. Konski, David L. Rosen; Foley & Lardner LLP;
June 19, 2013, previously published on June 16, 2013In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices. The proposed rule would replace the current practice, which does not...
|FDA Proposes FSMA “Schedule of Target Timeframes”; CFS Demurs|
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
June 18, 2013, previously published on June 16, 2013In previous postings, we reported on the Center for Food Safety’s ("CFS’s") lawsuit seeking to compel FDA to accelerate its implementation of FSMA. In April, the presiding court ruled that FDA’s delay violated the APA and ordered FDA and CFS to attempt to set a...
|FDA’s Plan to Regulate LDTs|
Nathan A. Beaver, David L. Rosen; Foley & Lardner LLP;
June 17, 2013, previously published on June 14, 2013In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of the...
|House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action Deadlines|
Kurt R. Karst; Hyman, Phelps & McNamara, P.C.;
June 14, 2013, previously published on June 12, 2013A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of concerns and new...
|Striding Towards Greater Access of Clinical Trials Data and Results|
David B. Clissold, James E. Valentine; Hyman, Phelps & McNamara, P.C.;
June 14, 2013, previously published on June 13, 2013The pendulum has been swinging: the medical research community and public health advocates want access to clinical trials data used to support marketing applications of FDA-regulated medical products. In 2007 that pendulum picked up momentum, with the enactment of Section 801 of the FDA Amendments...
|EU and Switzerland to Sign Cooperation Agreement in Competition Matters|
Marguerite Lavendan, Francesco Liberatore, Frances Murphy; Jones Day;
June 14, 2013, previously published on June 2013The European Commission (EC) and the Swiss Competition Commission (SCC) have signed an agreement to strengthen cooperation between them and enable the exchange of information on antitrust matters. The agreement will enter into force once it has been approved by the European Parliament and the Swiss...
|Cybersecurity: FDA Risks for Medical Devices|
Seth A. Mailhot; Sheppard, Mullin, Richter & Hampton LLP;
June 14, 2013, previously published on June 13, 2013On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. The draft guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical...
|Supreme Court Agrees to Hear Case on Standing in Lanham Act False Advertising Cases|
Brendan J. O'Rourke, Erika M. Stallings, Lawrence I. Weinstein; Proskauer Rose LLP;
June 14, 2013, previously published on June 12, 2013On June 3, the U.S. Supreme Court granted the certiorari petition of Lexmark International Inc. ("Lexmark"). Lexmark sought cert to resolve a three-way split among the federal circuit courts regarding how to determine whether a plaintiff has standing to sue for false advertising under the...