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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

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

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

Schoenbrod: SCOTUS Ruling Helps EPA Deal With a "Stupid Statute" [Video]

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

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

Fresenius v. Baxter: The Importance of Timing in Patent Litigation

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

State Supreme Court Rules Geographic Information System File is a Public Record Subject to Disclosure in that Format -...

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

FDA Emphasizes Patient-Specific Prescriptions

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

Capper, Dir of National Intelligence, et al v. Amnesty International USA et al

SCOTUS Dismisses Federal Wiretapping Challenge

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

Does Misdemeanor Misbranding Survive Caronia?

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

Court’s Ruling about Off-Label Drug Promotion Defies Reason

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

Second Circuit Holds that Criminal Penalties for Pharmaceutical Sales Representative’s Off-Label Promotion Violate the First...

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

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

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

‘Off-Label’ FDA Cases Can Run Afoul of First Amendment, Appeals Court Holds

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

"Second Circuit Vacates Conviction Based on Off-Label Promotion, Deals Blow to Government Theory in Drug Marketing Cases"

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

Domain Names and the First Amendment: The Latest Word

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

CBb 22 juni 2012, CR 2012/187 (SURFnet/OPTA) m.nt. P.M. Waszink en H.P. Wiersema

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

District Court Denies Equitable Tolling, Fifth Amendment Taking in Novartis Patent Term Adjustment Case

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

State Treasurer and Chairman of the Massachusetts State Lottery Commission Letter to Sen. Reid & Sen Kyl Objecting to Draft...

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

Off-Label Marketing: Fines and Industry Exclusion

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

Affordable Care Act Survives Supreme Court Review Largely Unscathed, Clearing Way for Biosimilars

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

Pathway for Follow-on Biologics Survives the Supreme Court

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

Eli Lilly & Co. File Amicus Brief in AMP v. Myriad

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

A Look At Abbott’s Citizen Petition Against The Biologics Price Competition And Innovation Act

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

Supreme Court Rejects Agency Interpretation; Pharmaceutical Reps Exempt From Overtime

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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