As the nation’s largest pharmacy chains grapple with accusations of under-staffing, threats to patient safety and crack downs from regulators, Harris Beach’s Pharmacy Law attorneys are tracking developments.
CVS Health...more
New York’s recent addition of Section 203-f to Labor Law declares unenforceable any provisions in existing and future employment agreements requiring an employee to assign to the employer those inventions developed entirely...more
11/20/2023
/ Employees ,
Enforcement ,
Intellectual Property Protection ,
Inventions ,
Jurisdiction ,
Labor Code ,
New York ,
Pre-Employment Agreements ,
Severance Agreements ,
Technology Sector ,
Trade Secrets
In 2021, the Federal Circuit determined that Amgen’s biotech antibody patents lack enablement, i.e., the specification did not teach one of ordinary skill in the art how to make and use the invention without undue...more
After New York Governor Kathy Hochul created a new Pharmacy Benefits Bureau within the Department of Financial Services specifically charged with regulating and licensing Pharmacy Benefit Managers (PBMs), the Bureau recently...more
The use of the word “about” in a patent claim as part of a numeric range might permit the patent holder to preclude competitor formulations falling outside the approximate range, as illustrated in a fairly recent decision Par...more
The U.S. Supreme Court’s recent unanimous decision clears the way for state regulation of Pharmacy Benefit Managers (“PBMs”). Rutledge v. Pharm. Care Mgmt. Ass’n, 141 S. Ct. 474 (2020). At issue before the High Court was...more
2/3/2021
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Popular ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
In a recent decision, New Jersey Appellate Court applied the expert admissibility standard from the New Jersey Supreme Court’s landmark decision In re Accutane Litig., 234 N.J. 340 (2018) as a basis for reinstating two...more
In a recent decision, the Federal Circuit affirmed Delaware District Court’s finding of invalidity based on failure to define the scope of the invention and to meet the written description requirements of 35 USC § 112. IBSA...more
In responding to the question of law certified by the United States Court of Appeals for the Third Circuit pursuant to Rule 2:12A-3, the New Jersey Supreme Court answered in the affirmative that a claim under the New Jersey...more
In a recent decision, the issue before the Federal Circuit was the meaning of the term “product” in a patent term extension statute. Biogen Int'l GmbH v. Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020). Section 156 of...more
The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued by Long Island counties Nassau and Suffolk (County Plaintiffs) in their capacities as...more
In an effort to reduce waste and plastic pollution, Governor Andrew Cuomo has signed legislation banning single-use carryout plastic bags in New York state. However, the initiative may prove poorly timed, given the state of...more
In a second criminal case against a pharmaceutical distributor and its executives this year, the Department of Justice has accused Ohio-based Miami-Luken and its former President and Compliance Officer of conspiring to...more
9/6/2019
/ Controlled Substances ,
Criminal Prosecution ,
DEA ,
Department of Justice (DOJ) ,
Distributors ,
Drug & Alcohol Abuse ,
Government Investigations ,
Internal Controls ,
Opioid ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Unjust Enrichment
Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more
5/28/2019
/ CCO ,
CEOs ,
Compliance ,
Controlled Substances ,
Controlled Substances Act ,
Corporate Executives ,
Criminal Conspiracy ,
Criminal Investigations ,
DEA ,
Deferred Prosecution Agreements ,
Drug Distribution ,
New Guidance ,
Opioid ,
Personal Liability ,
Pharmaceutical Industry ,
Pharmacies ,
Unlawful Distribution
Recent actions by the United States Department of Justice (DOJ) clearly demonstrate its focus on ensuring the effectiveness of both a corporation’s compliance program and its compliance officer....more
The claim that the MMR vaccine caused autism was meritless on its face, held the U.S.D.C., Eastern District of New York (Doe v. Merck & Co, Inc.). The action filed on behalf of “Baby Doe” stemmed from Merck-manufactured...more
4/16/2019
/ Administrative Proceedings ,
Causation ,
Civil Conspiracy ,
Compensatory Damages ,
Court of Federal Claims ,
Declaratory Rulings ,
Department of Health and Human Services (HHS) ,
Design Defects ,
Dismissals ,
Exhaustion Doctrine ,
Food and Drug Administration (FDA) ,
Fraud ,
Injunctive Relief ,
Lack of Jurisdiction ,
Manufacturer Liability ,
National Childhood Vaccine Act of 1986 ,
Preemption ,
Res Judicata ,
Vaccinations
Frederick (Rick) Fern and the New York City Harris Beach Life Science Practice Group were successful in securing a summary judgment for medical device manufacturers Curlin Medical Inc., Moog Inc., and distributor B. Braun...more