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Documents on biotech life sciences
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|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...
|Finally Facing First Inventor to File Issues|
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
October 28, 2014, previously published on October 15, 2014It has been over three years since the Leahy-Smith America Invents Act was signed into law by President Obama, and just over eighteen months since the effective date of the first-inventor-to-file changes to 35 USC § 102. While those changes were a hot topic in March of 2013, it is only over...
|Record Setting Verdict of $73 Million in Mesh Case|
Katie Nealon; Brayton Purcell LLP;
October 19, 2014, previously published on September 18, 2014Boston Scientific, a Massachusetts-based medical device company, was ordered to pay $73 million after a jury found that it was liable for leaving a woman in severe pain following a vaginal mesh implant. The award was comprised of $23 million in compensatory damages and $50 million in punitive...
|The Dilemma of the Unintended Fiduciary|
Edward M. McNally; Morris James LLP;
October 19, 2014, previously published on October 8, 2014A recent Delaware decision highlights a trap for the unwary adviser to a business entity. The decision holds that helping a business get started may create fiduciary duties owed by the adviser, even if he or she is not acting in one of the roles that are normally thought of as creating such duties,...
|FDA Releases Framework for Overseeing Laboratory Developed Tests|
Laurie A. Clarke, Brigid C. DeCoursey, Colleen Heisey; Jones Day;
October 16, 2014, previously published on October 2014On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical devices: (i) Draft Guidance for Industry, Food and Drug...