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FDA to Strengthen Oversight of Certain In Vitro Diagnostic Devices

In the wake of a new Medicare reimbursement framework, FDA plans stricter regulation of some in vitro diagnostic devices. On July 31, 2014, the U.S. Food and Drug Administration (FDA; Agency) announced its intent to...more

A second patent in a chain falls to obviousness-type double patenting challenge

The court had previously determined that The Kennedy Trust’s U.S. Patent No. 7,846,442 (the “parent patent”) was invalid for obviousness-type double patenting (“ODP”) to U.S. Patent No. 6,270,766 (“the grandparent“). At issue...more

Prior claiming in Australia…has news of its demise been greatly exaggerated? Is prior claiming still applicable to the remaining...

Prior claiming was a ground of invalidity under the Patents Act 1952 (1952 Act). It prevented grant of a patent claiming subject matter already claimed by another patent. Prior claiming was superseded by the broader concept...more

DC Development Activities May Be Impacted By Petition to FWS

On July 28, 2014, the Center for Biological Diversity petitioned the U.S. Fish & Wildlife Service (FWS). The petition, if granted, could have ramifications for development and other activities in the District of...more

In The New Landscape of TCPA Litigation, No Industry Is Safe

In recent years, the number of private actions filed under the Telephone Consumer Protection Act (the “TCPA” or the “Act”) has risen sharply, but perhaps more concerning is that litigants are using the Act to target an...more

Weeks II: Innovator Liability Finds a Sweet Home in Alabama

Last week, the Supreme Court of Alabama confirmed its January 2013 holding that manufacturers of brand drugs can be liable for injuries caused by generic drugs. Weeks v. Wyeth, Inc., No. 1101397, slip op. (Ala. Aug. 15,...more

Domestic Cat Genome Sequenced

Earlier this month, an international effort* led by Stephen J. O'Brien at the Oceanographic Center, Nova Southeastern University, Ft. Lauderdale, Florida reported the complete genomic sequencing of the domestic cat, Felix...more

HUD Notice Has Potential To Encourage Broad PHA Renewable Energy Rollout

In an effort to support President Obama's July 2013 Climate Action Plan, the U.S. Department of Housing and Urban Development (HUD) has issued Notice PIH-2014-18 (HA). The notice offers guidance on federal incentives for...more

Court protects privacy in ruling on warrantless searches of cellphones

Every now and then The Nine agree on something. Among the unanimous rulings the U.S. Supreme Court issued in the final stretch this year was Riley v. California, which held that law enforcement officials may not make a...more

Lean Six Sigma - It’s not just for manufacturing

Motorola developed Six Sigma in 1986 to provide techniques and tools for process improvement. It subsequently used Six Sigma in all of its manufacturing operations. The name comes from the world of statistical modeling, where...more

Here Comes the Sunshine Act

The Centers for Medicare and Medicaid Services (CMS) released a guide for physicians to prepare for the Dispute Resolution period of the Physician Payments Sunshine Act. The CMS guide is available on the CMS Open Payments...more

Court Allows ESA Claims Involving Oversight of Pesticides to Move Forward

In Center for Biological Diversity v. Environmental Protection Agency, No. 11-cv-00293-JCS, plaintiffs alleged that the Environmental Protection Agency (EPA) violated section 7 of the Endangered Species Act by failing to...more

Zelda Williams and Social Media Decency

Social media commentators can be feral. This is largely due to a psychological phenomenon known as the online disinhibition effect. The relative anonymity of social media communications, for some, opens the door for cruel and...more

Financial Services Update: Crypto-currencies in Australia – specifically bitcoin

While the use of crypto-currencies such as Bitcoin have increased in popularity in Australia there has very little legal clarification provided by regulators or legislators in relation to its legal status....more

Massive Data Breach Affects 4.5 Million Patients in 29 States

Community Health Systems, Inc. (the “Company”), one of the largest hospital organizations in the country, announced via a public filing (Form 8K) made yesterday with the Securities and Exchange Commission (“Report”) that the...more

Hospital Operator Reports 4.5 Million Patients’ Data Stolen in Cyberattack

The Tennessee-based acute-care hospital chain Community Health Systems, Inc. (CHS), reported on August 18 that information on approximately 4.5 million patients was stolen from the company. CHS is one of the largest hospital...more

What?? The Target Company Does Not Own its IP!?

We have been working on a number of private company mergers and acquisitions transactions this year where the technology and the intellectual property of the target company (the “Target”) are the key value drivers for the...more

4.5 Million Patients’ Information Stolen by Hackers

Community Health Systems Inc. (“CHS”), a Tennessee-based hospital provider, has reported it was the target of data hackers who were able to obtain identification information belonging to approximately 4.5 million CHS...more

Reasonable Doubt: Data Privacy, Cybersecurity, and the FTC

Today’s cybersecurity environment demands that every business establish effective corporate data privacy and consumer information security systems and practices. But, unfortunately, no single cybersecurity law exits to...more

Gone but not forgotten…is the archaic ground of prior claiming relevant to “whole of contents” novelty?

This is one of two related articles on aspects of prior claiming. Prior claiming was a ground of invalidity under the Patents Act 1952 (1952 Act). It prevented grant of a patent claiming subject matter already claimed by...more

CFPB Issues Consumer Advisory on the “Wild West” of the Virtual Currency Economy

The Consumer Financial Protection Bureau (“CFPB”) recently issued a consumer advisory summarizing the purported risks of virtual currencies, and announced that it would begin collecting complaints from the public regarding...more

Stefan Hankin on Online Harassment [Video]

In this LEVICK Daily video interview, Stefan Hankin, the Founder and President of Lincoln Park Strategies, examines an upcoming U.S. Supreme Court decision regarding online harassment and how it will impact the bounds of...more

Community Health Systems' HIPAA Breach: Significant Lessons for Health Care and Non-Health Care Companies

On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more

Video Recordings Act 1984 (Exempted Video Works) Regulations 2014

The Department for Culture, Media & Sport has published regulations (“Regulations”) that amend the Video Recordings Act 1984 (“Act”)....more

FDA Requests Comments and Issues Notice of Public Hearing Related to Implementation of GDUFA

On August 19, 2014, the U.S. Food and Drug Administration (FDA) issued in the Federal Register a request for comment and notice of public hearing on a variety of topics relating to its implementation of the Generic Drug User...more

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