A Guide to FDA Postmarketing Submission Requirements and Reporting...
As part of existing FDA postmarketing reporting requirements, manufacturers, packers, and distributors that are FDA applicants or that act on behalf of FDA applicants (for simplicity, “Applicants”) are...
View ArticleJudicial Notice of FDA Website Documents Can Be a Powerful Lever in a Medical...
A motion to dismiss can be a powerful tool in the hands of medical device companies to eliminate cases that should be dismissed from the outset on preemption grounds, before engaging in costly...
View Article“Sophisticated” Breach Exposes 300,000 Student Records at University of...
Officials at the University of Maryland (“University” or “UMD”) announced that UMD was the victim of a significant security breach that took place on Tuesday, February 18 (the “Breach” or “Incident”)....
View ArticleFebruary 2014: Trademark Litigation Update
Trademark Laches: An Effective Exit in the Right Circumstances. Delay-based defenses in trademark cases are rarely an effective way for a defendant to exit a case before discovery. Statute of...
View ArticleSvensson v. Retriever Sverige AB - European Union Court of Justice, February...
Plaintiff journalists wrote articles that were published in a Swedish newspaper and were freely accessible on the newspaper’s website. Defendant Retriever Sverige AB operates a website that provides...
View ArticleNews from Abroad: A Strict Approach to Priority Entitlement by the UK Court...
The Decision of the Court of Appeal in Hospira UK Generics Ltd. v. Novartis AG, [2013] EWCA Civ. 1663 was issued on 19 December 2013....By: McDonnell Boehnen Hulbert & Berghoff LLP
View ArticleDispensing Justice on Dispensing Beverage Patents and Products
After initiating an action in the Southern District of Illinois against The Coca-Cola Company (“Coca-Cola”) for patent infringement of seven patents, Beverage Dispensing Solutions, LLC (“BDS”)...
View ArticleLevick Monthly - The Tech Industry’s NSA Campaign: Trickier Than It Seems -...
In This Issue: - Cover Story - The Tech Industry's NSA Campaign: Trickier Than It Seems - Crisis & Reputation - Buckyballs: Stones Enought to Fight Back - Digital Engagement - Hack Attack? --...
View ArticleFebruary 20, 2014: Eight New IPR Filings
Intel Corporation filed five inter partes reviews against the one patent: IPR2014-00443, IPR2014-00444, IPR2014-00445, IPR2014-00446, IPR2014-00447, all challenge U.S. Pat. 7,147,759 on HIGH-POWER...
View ArticleDeceit in a Licensing Agreement
Where a technology license carries with it an obligation to pay royalties based on revenues, how does the licensor determine if the revenues are accurately reported? The sales are known to the...
View ArticleFederal Circuit Holds That Issues Of Claim Construction Must Be Reviewed...
Since 1998, when the Federal Circuit issued its en banc opinion in Cybor Corp. v. FAS Technologies, Inc., claim construction issues have been subject to de novo review on appeal. Under this standard of...
View ArticleUK Information Commissioner Reappointed
Christopher Graham, the UK Informaton Commissioner, has been reappointed for another two years. This follows from the end of his current term on 28 June 2014. It means he will have served 7 years in...
View ArticleHHS Extends Patient Access To Laboratories
On February 6, 2014, the Department of Health and Human Services (HHS) published a Final Rule amending regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the...
View ArticlePacific Coast Marine Windshields Ltd. V. Malibu Boats, LLC et. al.: Federal...
On January 8, 2014, the Federal Circuit in Pacific Coast Marine Windshields Ltd. V. Malibu Boats, LLC. et. al. confirmed that prosecution history estoppel applies to design patents. Although...
View ArticleCommercial Disparagement An Increasing Concern In The Age Of Social Media
Companies are turning to social media with increasing frequency to directly communicate with customers and potential customers. T-Mobile USA is no exception. Not only did the company release an...
View ArticleFederal Circuit: We Were Right the First Time, Claim Construction is Reviewed...
In Lighting Ballast Control LLC, v. Philips Electronics North America Corporation, [2012-1014] (February 21, 2014), the Federal Circuit en banc held that claim construction is a matter of law that is...
View ArticleFederal Circuit Holds Foreseeable Equivalents Infringe Under Doctrine of...
The Court of Appeals for the Federal Circuit held Wednesday that the doctrine of equivalents covers alternatives that were foreseeable at the time of application but not literally claimed. As a result,...
View ArticleWeek in Review - February 21, 2014
R u liable 4 your employee's txt msg? In some situations, the answer may be “yes.” Two courts reviewed employee texting issues this week. The first court reviewed whether an employer can be liable for...
View ArticleDraft Framework for Interstate Medical Licensure Compact Released
A significant barrier to the interstate practice of telehealth is closer to being broken down. The Federation of State Medical Boards ("FSMB") recently completed and distributed a draft Interstate...
View ArticleHIPAA Housekeeping - Don't Forget Your Annual Report of Small Breaches
If you are a "covered entity" under the Health Insurance Portability and Accountability Act ("HIPAA") and suffer a breach of protected health information, one of your first reactions should be to count...
View Article