"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more
4/13/2018
/ Biopharmaceutical ,
Clinical Trials ,
Expanded Access Programs (EAPs) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Legislative Agendas ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Preemption ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Oversight ,
Right to Try ,
Terminal Illness Treatments
Agreements among companies to not hire each other’s workers are more risky than ever. The DOJ’s Assistant Attorney General for the Antitrust Division, Makan Delrahim, stated on January 19 that the division has criminal cases...more
4/5/2018
/ Antitrust Division ,
Antitrust Provisions ,
Antitrust Violations ,
Corporate Counsel ,
Employer Liability Issues ,
Enforcement Actions ,
Fast-Food Industry ,
Franchise Agreements ,
Franchises ,
Hiring & Firing ,
Joint Venture ,
Legislative Agendas ,
No-Poaching ,
Proposed Legislation
Senators Mike Lee (R-UT), Ted Cruz (R-TX) and Ben Sasse (R-NE) recently introduced a bill that would extend a limited state action immunity to state licensure boards only if states implement reforms that reduce occupational...more
The Sedona Conference’s recent updates to The Sedona Principles provide important guidance on how parties to litigation should handle e-discovery. In particular, the new edition of the Principles set forth best practices...more
To prevail in a product-hopping case, a plaintiff must be prepared to establish both monopoly power and anticompetitive effects.
On September 28, a unanimous panel of the U.S. Court of Appeals for the Third Circuit...more
10/6/2016
/ Anti-Competitive ,
Appeals ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Pharmaceutical Industry ,
Prescription Drugs ,
Product Hopping ,
Sherman Act ,
Summary Judgment ,
Warner Chilcott
On January 13, 2016, the Federal Trade Commission (FTC or the Commission) released an overview of the pharmaceutical patent settlements filed with the Commission in Fiscal Year 2014 (October 1, 2013 – September 30, 2014). The...more
The Teladoc decision reinforces that state boards that are composed of market participants need to reassess how they are supervised if they seek shelter from antitrust scrutiny under the state action doctrine....more
In a split decision, the U.S. Court of Appeals for the First Circuit affirmed the certification of a class of indirect purchasers who allege that they paid inflated prices for the heartburn drug Nexium. In re Nexium Antitrust...more
On December 22, 2014, the Federal Trade Commission (FTC or the Commission) released an overview of pharmaceutical patent settlements filed with the Commission in Fiscal Year 2013 (October 1, 2012–September 30, 2013). The FTC...more
The Supreme Court has a renewed interest in the state action doctrine. After declining to clarify what types of state action are exempt from federal antitrust scrutiny for years, the Supreme Court agreed to hear its second...more
A United States district court judge sitting in the District of New Jersey has held that only patent litigation settlements involving monetary payments from branded to generic pharmaceutical manufacturers are subject to the...more
Earlier this year, the Supreme Court issued its decision in FTC v. Phoebe Putney Health System, Inc., 133 S.Ct. 1003 (2013), which held that the state action antitrust immunity doctrine applies only when the state legislature...more
On Tuesday, the United States Supreme Court reined in the state action immunity doctrine, which exempts municipalities from scrutiny under the federal antitrust laws when they act pursuant to a “clearly articulated state...more