Federal Appeals Court Rejects False Claims Act Suit Based on Drug Packaging...
Last Friday, the U.S. Court of Appeals for the Fourth Circuit affirmed the dismissal of a False Claims Act (“FCA”) case brought against Omnicare. United States ex rel. Rostholder v. Omnicare, Inc., No....
View ArticleIce Bar or V Bar on Ice?
On my last trip to Las Vegas, I captured these photos at the so-called ”Ice Bar” located in the Golden Nugget in downtown Vegas (for my digital scrapbook of trademark storytelling)......By: Winthrop...
View ArticleFDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose...
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the...
View ArticleU.S. Supreme Court Recognizes Airline Immunity for TSA Reports of Suspicious...
In Air Wisconsin Airlines Corp. v. Hoeper (Jan. 27, 2014), the U.S. Supreme Court concluded that airlines are entitled to civil immunity for reporting suspicious behavior to the TSA, provided their...
View ArticleBitcoin Does Not Need a Ban, It Needs Enlightened Regulation
If an outright ban of Bitcoin is not the correct approach, what is? More to the point, what does Bitcoin (and virtual currency in general) need to for legitimacy?...By: JD Supra Perspectives
View ArticleThe Branding Outside My Window – Anything But Obnoxious and Obtrusive
I love living in Minneapolis. The quotient for savvy and sophisticated branding is high – an opinion reinforced every time I glance out my office window....By: Winthrop & Weinstine, P.A.
View ArticleFTC Calls for National Data Security Standards as Proposed Legislation Stalls
In congressional testimony, the Federal Trade Commission’s Chairwoman, Edith Ramirez, recently reiterated the FTC’s call for stronger data security laws, while federal legislation concerning data...
View ArticleUsing Contingent Consideration to Bridge the Value Gap in Acquisitions of...
M&A activity remains in the doldrums as we enter 2014. According to FactSet Mergerstat, in 2013, 446 transactions were announced involving a U.S. buyer or target in the life sciences sector, as...
View ArticleFDA Issues Final Rule Requiring Electronic MDR Reporting
On February 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) issued a final rule titled Medical Device Reporting: Electronic Submission Requirements that will require medical...
View ArticleFDA Releases Final Guidance on “Dear Doctor” Letters That Omits Controversial...
On January 22, 2014, the FDA issued finalized guidance on the use, content and form of Dear Health Care Provider (DHCP) letters. While the finalized guidance modifies and removes certain controversial...
View ArticleChina Introduces New Health Care Sector Anti-Corruption Regulations
China Introduces New Health Care Sector Anti-Corruption Regulations As part of a concerted effort to tackle systemic commercial bribery in the country’s health care sector, China’s National Health and...
View ArticlePersonal Injury Coverage Does not Apply to Data Breach
According to a Law360 report, Sony Units Denied Coverage For Suits Tied To Cyber Attack (subscription required), a New York state judge ruled last Friday in the Zurich v. Sony insurance litigation that...
View ArticleGlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed. Cir. 2014)
The Federal Circuit issued an opinion on Monday in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. illustrating how difficult it can be to overturn a district court determination based on a question of...
View ArticleFDA's New Interpretation of the Five-Year NCE Exclusivity Provisions of...
The U.S. Food and Drug Administration (FDA) recently published its response to three citizen petitions and its draft Guidance for Industry relating to the determination of the five-year new chemical...
View Article$4 Billion Price Tag for Pleasing Plaintiffs' Bar? New Study Estimates Costs...
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in...
View ArticleFailure to Clearly List Intermediate Applications Breaks Chain of Priority -...
Addressing the issue of whether a failure to specifically reference each earlier filed patent applications will result in a loss of claim of priority to the omitted application, the U.S. Court of...
View ArticleFTC: No Need to Approve iVeriFly's Proposed Alternative COPPA Consent Method...
Under the provisions of the Children’s Online Privacy Protection Act (COPPA) Rule that invite proposals for new mechanisms for obtaining the verifiable parental consent required to collect, use and...
View ArticleNot So Fast … New Claim Construction Required Contempt Proceeding - Proveris...
Applying the TiVo standard on finding of contempt when an infringer releases a new or modified product, the U.S. Court of Appeals for the Federal Circuit vacated the district court’s contempt order,...
View ArticleFTC Cracks Down on False Advertising in Dietary Supplements
Supplements making claims regarding diabetes, genetically customized nutritional benefits, and weight loss are slammed for false advertising. Recent Federal Trade Commission (FTC) enforcement...
View ArticleBusiness Litigation Report -- February 2014
In This Issue - Firm News: ..Kathleen Sullivan Featured in December 2013 The American Lawyer Cover Story ..Quinn Emanuel Named to BTI’s 2014 “Client Service A-Team” Honor Roll Main Article: ..Overview...
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