In a recent lawsuit, the State of Ohio has accused certain pharmaceutical benefit managers, or “PBMs,” of violating state antitrust laws. According to the complaint, the PBMs have leveraged their market dominance to enrich...more
In a recently unsealed opinion, a court in the District of New Jersey has declined to certify a direct-purchaser class in In re Lamictal ("Lamictal") on numerosity grounds. It joins the growing number of courts in recent...more
The Tenth Circuit recently became the first federal court of appeals to address an antitrust challenge to a relationship central to modern pharmaceutical drug markets: the price negotiations between drug companies and...more
Missouri resident Elliot Conrad Dale recently filed an antitrust lawsuit against GlaxoSmithKline (“GSK”), claiming GSK employed a “device hopping” scheme to ensure uninterrupted patent and regulatory protection for its...more
On April 13, 2021, the Court of Appeals for the Fifth Circuit issued its long-anticipated decision in Impax v. FTC, marking the first time an appellate court has weighed in on the merits of a so-called reverse payment case...more
Stop me if you’ve heard this one before: the FTC is suing pharmaceutical manufacturers Endo and Impax over an alleged “reverse payment” agreement to reduce competition in the market for Opana ER, an oxymorphone extended...more
On June 9, the United States Court of Appeals for the Fifth Circuit heard oral argument in Impax Laboratories, Inc., Etc. v. Federal Trade Commission. The appeal by pharmaceutical manufacturer Impax marks the first time a...more
Yesterday we discussed 2019’s most significant developments in challenges to reverse-payment settlements. Today we continue our analysis of recent trends in pharmaceutical antitrust actions with a discussion of cases...more
2019 witnessed a number of developments in challenges to reverse-payment settlements. In its first decision on a pay-for-delay settlement since the Supreme Court’s seminal 2013 decision in FTC v. Actavis, the FTC took an...more
Recently, Judge Goldberg in the Eastern District of Pennsylvania certified two classes of plaintiffs asserting antitrust claims based on alleged “product hopping” by the manufacturer of branded tablets treating opioid...more
European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more
5/22/2017
/ Antitrust Provisions ,
Antitrust Violations ,
Competition Authorities ,
Department of Justice (DOJ) ,
Drug Pricing ,
EU ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Mylan Pharmaceuticals ,
Pharmaceutical Industry ,
Popular ,
South Africa
Last Monday Sanofi brought an antitrust suit against Mylan, alleging that Mylan engaged in illegal conduct to suppress competition in the epinephrine auto-injector (“EAI”) market, which is dominated by Mylan’s billion-dollar...more
Last Wednesday, the Second Circuit Court of Appeals partially vacated the judgment of the district court in In re Actos End-Payor Antitrust Litigation. In doing so, the Second Circuit allowed only plaintiffs’ claims that...more
2/15/2017
/ Abbreviated New Drug Application (ANDA) ,
Anti-Competitive ,
Antitrust Litigation ,
Causation ,
Corporate Counsel ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Method Claims ,
Motion to Dismiss ,
Patents ,
Pharmaceutical Industry ,
Product Exclusivity
On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit. In In re Aggrenox Antitrust Litigation, 3:14-md-02516 (D. Conn.), three...more
8/25/2016
/ Anti-Competitive ,
Antitrust Litigation ,
Antitrust Violations ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Generic Drugs ,
Patents ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Reverse Payments ,
Rule-of-Reason Analysis
As we have previously reported, generic drug manufacturers have come under scrutiny from state and federal regulators for recent generic drug price hikes. These investigations have expanded to include Turing Pharmaceuticals...more
Drug company Turing Pharmaceuticals made headlines recently when it reportedly raised the price of Daraprim, used commonly by AIDS patients to fight life-threatening infections, from $13.50 to $750 per tablet. Amidst...more
10/19/2015
/ Anti-Competitive ,
Attorney General ,
Duty to Deal ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Monopolization ,
Mylan Pharmaceuticals ,
Patent Litigation ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Popular ,
Retailers ,
Reverse Payment Settlement Agreements ,
SCOTUS ,
Wholesale
In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more
7/17/2014
/ Draft Guidance ,
Enforcement ,
Federal Trade Commission (FTC) ,
Financial Conduct Authority (FCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Off-Label Promotion ,
Off-Label Use ,
Pharmaceutical Industry ,
Securities and Exchange Commission (SEC)