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|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...
|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...
|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...
|Eurasian Economic Union|
Victoria Simonova; Dentons Canada LLP;
November 17, 2014, previously published on October 8, 2014On 29 May 2014, the presidents of Kazakhstan, Russia and Belarus signed an agreement (the "Treaty") in Astana on the Eurasian Economic Union (the "EaEU" or the "Union"). The Treaty will enter force on 1 January 2015. According to the Treaty, the Union is an...
|District Court Finds Genetic Technologies Patent Invalid Under 101 on Motion to Dismiss|
Courtenay C. Brinckerhoff; Foley Lardner LLP;
November 14, 2014, previously published on November 6, 2014Judge Stark of the U.S. District Court for the District of Delaware granted defendants’ motion to dismiss Genetic Technologies, Ltd.’s patent infringement suit with regard to claim 1 of U.S. Patent 5,612,179 on the basis that the claimed sequence analysis method is invalid under 35 USC...
|Colorado Board of Health Amends Quality Management Plan and Confidentiality Regulations|
Fred Miles; Husch Blackwell LLP;
November 12, 2014, previously published on November 3, 2014Recently, the Colorado Board of Health adopted amendments to Colorado Department of Public Health and Environment (CDPHE) regulations regarding Quality Management Plans of licensed healthcare facilities that are mandated by state statute.
|You Can’t Judge a Book By Its Cover: When Are Domestic Negotiations a “Sale” or “Offer to Sell”?|
Elizabeth Ann Lester, Peter G. Pappas; Sutherland Asbill & Brennan LLP;
November 2, 2014, previously published on October 24, 2014In Halo Electronics, Inc. v. Pulse Electronics, Inc., 2013-1472, - 1656 (October 22, 2014), the Federal Circuit concluded that there was no direct infringement when substantial activities of a sales transaction - including the final formation of a contract for sale and delivery and performance...
|Federal Circuit Judges Disagree on Use of Post Filing Date Evidence of Nonobviousness|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
October 30, 2014, previously published on October 21, 2014On October 20, 2014, the Federal Circuit issued an order denying the petition for rehearing or rehearing en banc filed in Bristol-Meyers Squibb Co. v. Teva Pharmaceuticals, USA, Inc. While the order itself may not be surprising, with two opinions concurring in the denial and two dissenting, it is...