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HTMLColorado Board of Health Amends Quality Management Plan and Confidentiality Regulations
Fred Miles; Husch Blackwell LLP;
Legal Alert/Article
November 12, 2014, previously published on November 3, 2014
Recently, 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.


HTMLYou 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;
Legal Alert/Article
November 2, 2014, previously published on October 24, 2014
In 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...


HTMLFederal Circuit Judges Disagree on Use of Post Filing Date Evidence of Nonobviousness
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 30, 2014, previously published on October 21, 2014
On 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...


HTMLFinally Facing First Inventor to File Issues
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 28, 2014, previously published on October 15, 2014
It 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...


HTMLThe Dilemma of the Unintended Fiduciary
Edward M. McNally; Morris James LLP;
Legal Alert/Article
October 19, 2014, previously published on October 8, 2014
A 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,...


HTMLRecord Setting Verdict of $73 Million in Mesh Case
Katie Nealon; Brayton Purcell LLP;
Legal Alert/Article
October 19, 2014, previously published on September 18, 2014
Boston 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...


HTMLFDA Releases Framework for Overseeing Laboratory Developed Tests
Laurie A. Clarke, Brigid C. DeCoursey, Colleen Heisey; Jones Day;
Legal Alert/Article
October 16, 2014, previously published on October 2014
On 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...


HTMLFederal Circuit Jurisdiction Over Patent Contract Disputes
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 15, 2014, previously published on October 9, 2014
In a precedential order issued in Jang v. Boston Scientific Corp., the Federal Circuit held that it has jurisdiction over the parties’ patent-related contract dispute under Gunn v. Minton even though the patents at issue have been invalidated. Despite having found Federal Circuit...


HTMLFederal Circuit Hears Arguments in Other Myriad Gene Patents Case
Courtenay C. Brinckerhoff; Foley & Lardner LLP;
Legal Alert/Article
October 13, 2014, previously published on October 7, 2014
On October 6, 2014, the Federal Circuit heard oral arguments in a case involving the claims of the Myriad gene patents that were not invalidated by the Supreme Court’s 2013 decision. The Federal Circuit is reviewing the district court’s denial of Myriad’s motion for a preliminary...


HTMLPelvic Mesh Trial News: Juries Award Significant Damages
Wendy R. Fleishman; Lieff, Cabraser, Heimann & Bernstein, LLP;
Legal Alert/Article
October 8, 2014, previously published on September 23, 2014
Thousands of injured women nationwide have filed lawsuits in state and federal courts against manufacturers of surgical pelvic mesh implants, claiming that the design of the product was defective and led to serious side effects and permanent injuries. These serious health complications include...


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