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New draft regulation on resolution of disputes between electronic communication operators

The Italian Communication Authority (AGCOM) published a new consultation on a draft regulation relating to the resolution of disputes between electronic communication operators....more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

DC District Court Strikes Down 340B Orphan Drug Rule

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

Complaint Filed Against HHS Alleges Medicare LCDs Deprive Beneficiaries of Necessary Clinical Laboratory Services

On April 18, 2014, California Clinical Laboratory Association (“CCLA”) and “Jane Doe” (collectively, “Plaintiffs”) filed a lawsuit against HHS for equitable relief in the United States District Court for the District of...more

Supreme Court Denies Certiorari in Stem Cell Funding Case

In an order issued earlier today, the Supreme Court denied certiorari in Sherley v. Sebelius, ending the efforts by two adult stem cell researchers to prevent the National Institutes of Health (NIH) from funding research...more

OCR's Breach Settlement the First Ever Involving Less than 500 Patients

OCR started 2013 with a bang by announcing that it had reached “the first settlement involving a breach of unprotected electronic protected health information (ePHI) affecting fewer than 500 individuals” with the Hospice of...more

First OCR Settlement Involving a “Small” Breach Focuses on Mobile Device Security

In what is best understood as a follow-up to both the recent settlement with MEEI and the release of its mobile device security guidance, HHS OCR recently released details of a settlement reached with the Hospice of Northern...more

Intellectual Property Newsletter - December 2012

In This Issue: ..News From the Bench: - Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents. - The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more

Posting Copyrighted Image Has Consequences

Any organization with a website should take care that it is not posting anyone else’s copyrighted content without permission. If a court finds that the unauthorized use of another’s copyrighted content was done intentionally,...more

Intellectual Property Bulletin - Summer 2012

In This Bulletin: Final Patent Rules Provide Few Surprises; CFAA is Losing Ground as a Tool to Fight Trade Secret Misappropriation; Quick Updates: You Are Not Your IP Address; The Federal Circuit Addresses the Abstract...more

First State HIPAA Enforcement Action against a Business Associate Returns $2.5 Million Payout

In February, we alerted you to the first HIPAA enforcement action taken against a business associate. The action was pursued by the Minnesota Attorney General against Accretive Health, a service provider that was involved in...more

Protecting Your Company’s Digital Information From Departing Employees 4th Circuit Weighs in on Liability Under the Computer Fraud...

This past Thursday, July 26th, the US Court of Appeals for the Fourth Circuit issued an opinion addressing liability under the federal Computer Fraud and Abuse Act (CFAA) for departing employees who access and copy computer...more

In Re Electronic Privacy Information Center

Petition For A Writ of Mandamus To Enforce This Court's Mandate

EPIC Files Mandamus Petition to Compel Action on the Airport Body Scanner Program EPIC has filed a mandamus petition with the Federal Court of Appeals in Washington, DC to require the beginning of a public comment...more

Supreme Court confirms that generic drug manufacturers can challenge brand-name use-code descriptions in patent litigation

The Hatch-Waxman Act Congress designed the Hatch-Waxman Act (codified at 21 U.S.C. § 355(b), (j), (l) and 35 U.S.C. §§ 156, 271, and 282) to inspire medical innovation by giving medical-device and pharmaceutical patent...more

Alaska Medicaid Settles HIPAA Security Case for $1,700,000

The U.S. Department of Health and Human Services Office of Civil Rights (OCR) has announced the first HIPAA enforcement action OCR has taken against a State agency, and the resolution agreement and related corrective action...more

Protecting Your Rights: New gTLD Applications

In June 2011, the Internet Corporation for Assigned Names and Numbers (ICANN) approved a program to expand the Internet's domain name system by introducing new generic top-level domain names. The new gTLD application period...more

FRAND Defence in German Courts: Remedy Against Standard-Essential Patents?

Standard setting is considered an inevitable process nowadays. It enables the interoperability of products and services from different vendors. The telecommunication sector, for example, is heavily penetrated by standards,...more

Copyright Owners Using DMCA To Take Down URLs

At a conference held June 18 at Stanford University Law School – The 9th Annual Stanford Ecommerce Best Practices Conference - it was reported that copyright holders are increasingly using the Digital Millennium Copyright...more

The Impending Domain Name Explosion: Why Brand Owners Must Pay Attention on "Reveal Day" June 13

After years of preparation and a decidedly rocky start to ICANN’s New gTLD Program due to a glitch in the gTLD application system, the applications are in, and ICANN will soon begin evaluating the TLD candidates. First,...more

"Suggestion" of Mootness or, alternatively, Motion for Remand in AMP v. USPTO

One of the interesting and unresolved issues in the Association for Molecular Pathology v. U.S. Patent and Trademark Office case ("Myriad") involves whether the Federal Circuit, or any U.S. court, has jurisdiction to hear the...more

Why You Should Care That .Com Can Be .Anything

Time to panic? The Internet is about to change dramatically. Ever since Al Gore invented the Internet (or so I’ve heard), users have relied on a limited number of top-level domains, or “TLDs.” A top-level domain is the...more

G2 Compliance Report -- Keeping the Whistle Away From the Whistleblower: The Laboratory Compliance Officer’s Role in Qui Tam...

Do you, as a laboratory compliance officer, want to spare your employer the disruption, expense, and burden of a government enforcement action? The answer, of course, is “yes.” The most effective and efficient way of doing so...more

A Sea Change in the Safe Harbor

To the delight of content owners everywhere, the Second Circuit Court of Appeals has become the first court in the country to rule that Internet Service Providers (ISPs) can be liable for copyright infringement even if they...more

ACTA: The Public Revolt

The Anti-Counterfeiting Trade Agreement (ACTA) is the latest and most far-reaching attempt to harmonize intellectual property enforcement and strengthen anti-counterfeiting efforts across the globe. As of May 2012, the...more

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