Solicitors General Insights: The Art of Oral Advocacy With Michigan and New Jersey — Regulatory Oversight Podcast
NLRB Authority in Jeopardy, Pregnant Worker Protections, Non-Compete Order Rescinded, EEOC Right-to-Sue Rule - #WorkforceWednesday® - Employment Law This Week®
Work This Way: A Labor & Employment Law Podcast | Reverse Discrimination in the Workplace with Jennie Cluverius and Fay Edwards of Maynard Nexsen
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Mid-Year Labor & Employment Law Update: Key Developments and Compliance Strategies
FTC and Florida Focus on Non-Competes, SCOTUS to Rule on Pension Withdrawal Liability - #WorkforceWednesday® - Employment Law This Week®
Podcast - Diamond Alternative Energy, LLC v. EPA: The Intersection of Constitutional and Environmental Law
Sittenfeld v. United States – Campaign Contributions as Crimes?
The Briefing: The Supreme Court Dodges the Discovery Rule Question—What That Means for Copyright Enforcement
(Podcast) The Briefing: The Supreme Court Dodges the Discovery Rule Question—What That Means for Copyright Enforcement
Legal Implications of the Supreme Court's Ruling on Universal Injunctions
Solicitors General Insights: The Tale of Two Washingtons — Regulatory Oversight Podcast
The Presumption of Innocence Podcast: Episode 65 -The Power of Interpretation: Constitutional Meaning in the Modern World
SCOTUS Clean Air Act Cases: What’s New?
(Podcast) The Briefing: Sinking the Rogers Test? What Pepperdine’s Lawsuit Could Mean for Hollywood
The Briefing: Sinking the Rogers Test? What Pepperdine’s Lawsuit Could Mean for Hollywood
The Presumption of Innocence Podcast: Episode 64 - Cages We Built: The Making of Mass Incarceration in America
Rewriting the Rules: The Supreme Court's Landmark Decision on Clean Water Act Permits
(Podcast) The Briefing: No CTRL-ALT-DEL For the Server Test
Purdue Pharma (Purdue) has filed a petition for a writ of certiorari challenging a recent Federal Circuit decision upholding the invalidation of several Purdue patents on grounds of obviousness....more
This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry. Since the Supreme Court’s Actavis decision in mid-2013, potentially anti-competitive agreements are...more
This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more
Generic and branded pharma companies alike are waiting with baited breath to see if the U.S. Supreme Court will take up the issue of personal jurisdiction in Hatch-Waxman patent cases this term. After a broad ruling from the...more
The Supreme Court has been asked to review whether the safe harbor established by 35 U.S.C. § 271(e)(1) encompasses a generic drug manufacturer’s bioequivalence testing performed only as a condition of maintaining FDA...more
Patent settlement agreements were traditionally deemed outside the purview of antitrust scrutiny unless the patent holder’s conduct fell outside the legitimate scope of the patent’s exclusionary power. This all changed when...more
The FDA recently announced that it would once again delay promulgation of its proposed rule for generic drug labeling obligations. This action followed introduction of a spending bill that would have blocked funding for the...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
In the first decision by a federal appeals court interpreting the U.S. Supreme Court’s landmark ruling in FTC v. Actavis, the Third Circuit recently held in King Drug Co. of Florence v. SmithKline Beecham Corp. that so-called...more
Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more
Case Name: Shire Development, LLC v. Watson Pharms., Inc., 787 F.3d 1359 (Fed. Cir. June 3, 2015) (Circuit Judges Prost, Chen, and Hughes presiding; Opinion by Hughes, J.) (Appeal from S.D. Fla., Middlebrooks, J.) - Drug...more
Case Name: Teva Pharms. USA, Inc., v. Sandoz, Inc., Fed. Cir. Nos. 2012-1567, -1568, -1569, -1570, 2015 U.S. App. LEXIS 10229 (Fed. Cir. June 18, 2015) (Circuit Judges Moore, Mayer, and Wallach presiding; Opinion by Moore,...more
An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, would allow...more
Earlier this month, the Generic Pharmaceutical Association (GPhA) held a press conference to announce the release of a study of the effects of reverse settlement payment agreements in ANDA litigation. ...more
On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more
On June 24, 2013, in a 5-4 decision, the U.S. Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett held that state-law design-defect claims based on the inadequacy of a generic drug’s labeled warnings are pre-empted...more
Patent rights and antitrust law contain inherently antagonistic policies: While antitrust law is aimed at preventing monopolies and promoting competition, patent law explicitly rewards inventors with a time-limited right to...more
On June 17, 2013, in FTC v. Actavis, Inc., the U.S. Supreme Court ruled that plaintiffs may bring antitrust suits against so-called “reverse payment” or “pay-for-delay” settlements, under which pioneer and generic...more
The old adage "Bad cases make bad law" is invoked when the facts of a case lead a court to rule in favor of the particular entities before it rather than applying the law consistently. (Although anyone familiar with recent...more
In a 5-4 decision, the U.S. Supreme Court rejected the notion that a manufacturer’s option to stop selling its product resolves preemption concerns raised by conflicting state and federal laws....more
Yesterday, the Supreme Court issued its ruling in the much-anticipated Mutual Pharms. Co. v. Bartlett, No. 12-142 (on appeal from the First Circuit Bartlett v. Mutual Pharms. Co., 678 F.3d 30 (1st Cir. 2012)). As we...more
One of the most controversial antitrust issues for the pharmaceutical industry during the last decade has been the treatment of patent settlements in which a patent-holding branded manufacturer made payments to its generic...more
In a significant victory for generic drug companies, the Supreme Court today issued its decision in Mutual Pharmaceutical Co. v. Bartlett, reversing the decision of the First Circuit, which had affirmed a multimillion dollar...more
On June 17, 2013, the U.S. Supreme Court determined that the Federal Trade Commission’s (FTC) antitrust challenge to a reverse payment settlement agreement between drug manufacturers, otherwise known as a “pay-for-delay”...more
For over a decade, the antitrust enforcers at the Federal Trade Commission have challenged the type of patent settlement where a brand-name drug manufacturer pays a prospective generic manufacturer to settle patent...more