News & Analysis as of

Cymbalta Withdrawal Cases May Soon Have an MDL

Eli Lilly & Co., the producer of the popular antidepressant Cymbalta (duloxetine), is facing a spate of litigation over injuries associated with the drug. Plaintiffs allege that Cymbalta can cause severe withdrawal symptoms,...more

Preliminary Injunction Order in Actavis Casts a Skeptical Eye Toward the “Hard Switch”

Last week, we briefly reported on the injunction granted by the U.S. District Court for the Southern District of New York in the New York Attorney General’s “product hopping” suit against Actavis and its subsidiary, Forest...more

Lupin Appeals Fine Imposed by European Commission in “Pay-For-Delay” Crackdown

In July of this year, the European Commission imposed fines on French pharmaceutical company Servier and five generic drug makers, including Lupin Ltd., totaling €427.7 million. The fines were the result of a five-year...more

For the First Time PTAB Upholds Validity of Pharma Patents

On December 9, 2014, the Patent Trial and Appeal Board (“PTAB”) upheld the validity of three Supernus Pharmaceutical’s patents relating to once-daily formulations of doxycycline. The trio of decisions is significant because...more

Preliminary Injunction Precludes Actavis from Pulling Current Version of Namenda off the Market

Yesterday, Judge Robert Sweet granted the New York Attorney General’s request to block Actavis and its New York-based subsidiary Forest Laboratories LLC from pulling Namenda, a dementia drug commonly used to treat...more

Celltrion Healthcare Co. v. Kennedy Trust for Rhematology Research (S.D.N.Y. 2014); Hospira Inc. v. Janssen Biotech Inc. (S.D.N.Y....

Earlier this month, Judge Paul Crotty, U.S. District Court Judge for the Southern District of New York handed down rulings in two separate cases related to the biosimilars law (the Biologics Price Competition and Innovation...more

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

Growth Of The 340b Program: Past Trends, Future Projections

The 340B program provides certain healthcare providers (referred to as “covered entities”) access to deeply discounted pharmaceuticals for outpatient use. Congress created the program in 1992 to help uninsured and vulnerable...more

December 2014: Life Sciences Litigation Update: MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft®...

MDL Court Strikes Plaintiffs’ Experts’ Testimony on Human Causation in Zoloft® Products Liability Litigation. This summer, the U.S. District Court presiding over a multi-district products liability litigation issued a pair of...more

340B State of Affairs – Study Reveals Benefits to Vulnerable, Chronically Ill Patients

The 340B provider community received welcome news from a recent study published by Health Affairs, which published a long-awaited report analyzing 12 months of outpatient prescription data to identify trends in 340B contract...more

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing...more

Public Outcry Over Generic Price Hikes Spurs Criminal Investigations

Drug manufacturers Impax Laboratories and Lannett Company have come under public scrutiny and, more recently, criminal investigation for their recent generic drug price increases. The companies disclosed in recent SEC filings...more

EP Committee Study on Legislative Areas of the TTIP Addresses Nanomaterials

The European Parliament (EP) Committee on Environment, Public Health, and Food Safety (ENVI) has posted a study entitled ENVI Relevant Legislative Areas of the EU-US Trade and Investment Partnership Negotiations (TTIP). The...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

Beginning to Close the POM Circle? – POM Wonderful and Drug Advertising: JHP Pharmaceuticals

Earlier this year, in POM Wonderful LLC v. Coca-Cola Co.,[1] the Supreme Court examined the interaction between the Lanham Act’s prohibition against false advertising and the FDCA’s prohibition against food, drug and...more

The Era of Generic Biologic Drugs Has Officially Begun: An Update on U.S. Biosimilars  [Video]

Paul A. Calvo, Ph.D., director at the intellectual property law firm Sterne, Kessler, Goldstein & Fox, P.L.L.C., discusses the success of generic biologic manufacturers at the FDA and in the courts as the era of generic...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Takeda Pharm. Co., Ltd. v. Mylan Inc.

Nature of the Case and Issue(s) Presented: The issue here concerns whether the owner of a pharmaceutical patent may simultaneously assert a claim for infringement under § 271(e)(2), and a claim pursuant to the Declaratory...more

Do You Offer or Accept Copayment Coupons? OIG says YOU are Responsible for Compliance with Federal Law

In recent years, copayment coupon programs have become standard promotional practices for both large and small pharmaceutical manufacturers. Copayment coupons are typically offered to commercially insured patients in order...more

Depomed, Inc. v. Actavis Elizabeth LLC

Nature of the Case and Issue(s) Presented: Depomed sued Actavis for infringing seven patents related to a dosage form capable of being retained in the stomach, allowing for the delayed-release of gabapentin in the small...more

Fresenius Kabi USA, LLC v. Dr. Reddy’s Labs., Ltd.

Nature of the Case and Issue(s) Presented: Plaintiff filed suit alleging infringement of claims 1, 16, 36, and 37 of each of the patents-in-suit. The patents-in-suit all claim pharmaceutical compositions containing propofol...more

Hospira, Inc. v. Burwell

Nature of the Case and Issue(s) Presented: Precedex is commonly used as a sedative. Specifically, the FDA has approved Precedex for two uses: (i) sedation of initially intubated and mechanically ventilated patients during...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Canadian Competition Bureau chief takes a tough stance on pay-to-delay agreements

The Canadian Competition Bureau intends to take a tough approach to so-called “pay-to-delay” settlements, potentially anti-competitive agreements in which generic drug manufacturers agree to delay the launch of a low-cost...more

Curtailing Access to Combat Abuse - New DEA Regulations Focus on Prescription Medication Collection

The Drug Enforcement Administration’s (DEA) new regulations aimed to cut down on prescription drug abuse will soon allow patients to return unused pharmaceuticals to authorized locations. The new rules go into effect October...more

304 Results
|
View per page
Page: of 13