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|Bill Introduced in Congress Calls for Private Enforcement of All Food Regulations and Would Weaken Preemption Defenses|
Jonathan Berman; Jones Day;
February 26, 2015, previously published on January 2015Recent years have seen a surge in private class actions alleging that food labels are misleading or misbranded. The viability of many of these cases, however, has been limited by two important provisions of the Food, Drug, and Cosmetic Act ("FDCA"). Section 310 provides that only the...
|Summary of Antares Pharma, Inc. v. Medac Pharma. Inc., 2014-1648|
Sughrue Mion PLLC;
February 17, 2015, previously published on November 17, 2014Within two years of the USPTO issuing a patent the Applicant may request the Office reissue the patent with enlarged claim scope, provided it is “for the invention disclosed in the original patent.” Antares sought and obtained a reissue of its U.S. Patent 7,776,015 (“the...
|Proposed Rule Would Allow More Physicians to Participate in Multiple ACOs|
Rick L. Hindmand; McDonald Hopkins LLC;
February 13, 2015, previously published on December 11, 2014On Dec. 1, 2014, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that would revise the Medicare Shared Savings Program (MSSP) regulations relating to accountable care organizations (ACOs). These proposed changes were published in the Dec. 8, 2014 Federal Register and...
|PTAB Denies Request to Use Covered Business Method Review for Orange Book-Listed Patents|
Jennifer L. Blackburn Ph. D., Leslie T. Grab Ph. D., Tina W. McKeon; Kilpatrick Townsend Stockton LLP;
February 6, 2015, previously published on January 16, 2015The Patent Trial and Appeals Board (PTAB) denied the request to review four Orange Book-listed patents owned by Jazz Pharmaceuticals, Inc. under the covered business method (CBM) review procedure. The CBM petitions filed by Amneal Pharmaceuticals, Par Pharmaceutical, and Roxane Laboratories...
|New Patent Eligibility Guidance: USPTO Tones Down the Rhetoric|
Jana Nelson, William L. Warren; Sutherland Asbill & Brennan LLP;
February 6, 2015, previously published on December 18, 2014On December 15, 2014, the U.S. Patent and Trademark Office issued its long-awaited Interim Guidance on Patent Subject Matter Eligibility (published in the Federal Register on December 16, link here: [(79 Fed. Reg. 74618)]). The Guidance supersedes the guidelines for determining patent eligibility...
|Federal Judge Rules That Integrated Healthcare System Comprised of Separately Owned Hospitals Incapable of Conspiring Under Section One of The Sherman Act|
Robert B. Craig; Taft Stettinius & Hollister LLP;
January 16, 2015, previously published on October 29, 2014In recent years, some competing hospital systems have achieved the benefits of merging without a change in ownership of their assets by undertaking highly integrated joint ventures so that the combination essentially becomes a single enterprise with a complete unity of interest. Such “virtual...
|FDA to Hold Webinar on Cybersecurity in Medical Devices Guidance|
Mark A. McAndrew; Taft Stettinius & Hollister LLP;
January 16, 2015, previously published on October 28, 2014On Oct. 29, 2014, the United States Food and Drug Administration (FDA) will hold a webinar on its Final Guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” According to the FDA, the webinar seeks to explain the guidance and provide a forum for...
|Amendment to Drugs and Medical Devices Law in Japan Takes Effect|
Laurie A. Clarke, Colleen Heisey, Scott T. Jones, Mark Mansour, Mitsutaka Okano; Jones Day;
December 16, 2014, previously published on December 2014A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented. The amendment mainly covers (i) establishing a fast-track authorization process for regenerative medicine products (described below), (ii) restructuring medical device regulations, and (iii)...
|Another Software Patent is Ruled Patent-Ineligible - Are Business Method and Software Patents at Risk?|
Umar R. Bakhsh, Christopher J. Chan, Malvern (Griff) U. Griffin, Srikant Viswanadham; Sutherland Asbill & Brennan LLP;
December 10, 2014, previously published on November 19, 2014On November 14, 2014, in a much-anticipated decision following the U.S. Supreme Court’s decision in Alice v. CLS Bank, a unanimous U.S. Court of Appeals for the Federal Circuit held in Ultramercial, L.L.C. v. WildTangent, Inc.1 that the claims of Ultramercial’s asserted patent were...
|FDA: Industry Must Address Cybersecurity Risks for Medical Devices.|
Theodore P. Augustinos, Sharon A. Blinkoff, Ellen Marie Giblin, Mark E. Schreiber, David S. Szabo; Edwards Wildman Palmer LLP;
November 25, 2014, previously published on October 2014On October 1, 2014 the U.S. Food and Drug Administration finalized guidance on recommendations to manufacturers for managing cybersecurity risks to better protect patient health and information. The purpose of the guidance is to encourage manufacturers to consider possible cybersecurity risks while...