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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The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more
On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more
May 15, 2014 -- David Schoenbrod, professor at New York Law School, talks about the recent ruling at the United States Supreme Court preserving the Environmental Protection Agency's power to regulate power plant pollution...more
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
The Federal Circuit’s recent decision in Fresenius USA, Inc. v. Baxter Int’l, Inc., illustrates the potential value of challenging a patent's validity through administrative proceedings in the U.S. Patent & Trademark Office...more
The California Supreme Court ruled this week that an electronic database, maintained in a geographic information system (GIS) file format, is a public record subject to disclosure in that format under the California Public...more
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
Full text copy of Supreme Court's dismissal of lawsuit challenging federal wiretapping program.
On Tuesday, February 26, 2013, a divided Court dismissed a challenge to the FISA Amendments Act, which permits federal...more
The Court of Appeals for the Second Circuit sent shockwaves through the pharmaceutical industry with its decision in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative convicted of a...more
Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more
On December 3, 2012, the United States Court of Appeals for the Second Circuit issued an opinion that stands to transform the regulatory landscape in which pharmaceutical and medical device companies operate. In recent...more
In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more
A recent decision by the U.S. Court of Appeals for the Second Circuit may significantly curtail enforcement efforts relating to the so-called “off-label” use of drugs approved by the Food and Drug Administration for specific...more
In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more
The intersection of domain names and the First Amendment is not new. Indeed, in the early days of the domain name system, courts considered the issue of whether a domain name registrar could prohibit the registration of...more
Uitspraak van het CBB in beroep en in hoger beroep. SURFnet is geen aanbieder van een openbaar elektronisch communicatienetwerk of een openbare elektronische communicatiedienst. Of sprake is van het aanbieden van een openbaar...more
In another significant Patent Term Adjustment (PTA) case decided last week (Novartis AG v. Kappos, Civ. Action No. 10-cv-1138 (Nov. 15, 2012)), the U.S. District Court for the District of Columbia found that Novartis could...more
Below is a complete text-version of the attached -- Mass. Treasurer Steven Grossman's Letter to Sen. Reid and Sen. Kyl objecting to the Draft iGaming Prohibition Bill expected to be dropped during the Lame Duck session of...more
It is important to weigh enforcement risks with perspective. The Justice Department’s biggest FCPA enforcement year was approximately $1.4 billion in 2010.
The Justice Department doubled that amount in the off-label...more
In a history-making decision, the Supreme Court today in National Federation of Independent Business v. Sebelius upheld the Patient Protection and Affordable Care Act (PPACA) as constitutional under the taxation clause of the...more
The Supreme Court of the United States delivered its much-anticipated and historic ruling in National Federation of Independent Business v. Sebelius today, holding the major provisions of the Patient Protection and Affordable...more
We are living in an age of retrenchment with regard to patent law, where thirty years of Federal Circuit precedent, from the court created by Congress to harmonize U.S. patent law to great public benefit, is being...more
When the Supreme Court upheld the constitutionality of the Patient Protection and Affordable Care Act, those hoping to benefit from the portion of the law known as the Biologics Price Competition and Innovation Act (the...more
In Christopher et al. v. Smithkline Beecham Corp.,--- S.Ct. ----, 2012 WL 2196779, U.S., June 18, 2012 (NO. 11-20412, C.D.O.S, 6646, the Supreme Court rejected the Department of Labor's interpretation of its own regulations...more
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