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HTMLChildren’s Hoodies Recalled This December
Stephen J. Burg; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
March 12, 2015, previously published on December 31, 2014
Parents may need to return some of their children's Christmas presents since two separate recalls announced certain hoodies pose strangulation risks.

 

HTMLValeant Recalls Children’s Contaminated Respiratory Infection Treatment
Stephen J. Burg; Burg Simpson Eldredge Hersh & Jardine, P.C.;
Legal Alert/Article
March 12, 2015, previously published on January 5, 2015
Valeant Pharmaceuticals North America LLC voluntarily recalled one lot of its ribavirin powder for solutions, Virazole, according to a notification from the U.S. Food and Drug Administration.

 

HTMLNinth Circuit Affirms Finding That Hospital’s Acquisition of Medical Group Was Anticompetitive
Robert B. Craig; Taft Stettinius & Hollister LLP;
Legal Alert/Article
March 2, 2015, previously published on February 12, 2015
The Federal Trade Commission maintained its winning streak in health care merger cases after the 9th Circuit affirmed an Idaho district court’s ruling that the acquisition of Idaho’s largest physician group by one of the state’s largest health care systems violated Section 7 of...

 

HTMLBill Introduced in Congress Calls for Private Enforcement of All Food Regulations and Would Weaken Preemption Defenses
Jonathan Berman; Jones Day;
Legal Alert/Article
February 26, 2015, previously published on January 2015
Recent 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...

 

HTMLSummary of Antares Pharma, Inc. v. Medac Pharma. Inc., 2014-1648
Sughrue Mion PLLC;
Legal Alert/Article
February 17, 2015, previously published on November 17, 2014
Within 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...

 

HTMLProposed Rule Would Allow More Physicians to Participate in Multiple ACOs
Rick L. Hindmand; McDonald Hopkins LLC;
Legal Alert/Article
February 13, 2015, previously published on December 11, 2014
On 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...

 

HTMLPTAB 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;
Legal Alert/Article
February 6, 2015, previously published on January 16, 2015
The 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...

 

HTMLNew Patent Eligibility Guidance: USPTO Tones Down the Rhetoric
Jana Nelson, William L. Warren; Sutherland Asbill & Brennan LLP;
Legal Alert/Article
February 6, 2015, previously published on December 18, 2014
On 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...

 

HTMLFDA to Hold Webinar on Cybersecurity in Medical Devices Guidance
Mark A. McAndrew; Taft Stettinius & Hollister LLP;
Legal Alert/Article
January 16, 2015, previously published on October 28, 2014
On 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...

 

HTMLFederal 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;
Legal Alert/Article
January 16, 2015, previously published on October 29, 2014
In 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...

 


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