On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more
The US Supreme Court has held that companies can be forced, as a condition of doing business in a state, to agree to be sued in that state’s courts — even if the lawsuit has nothing to do with that state. In its June 27,...more
6/29/2023
/ Commerce Clause ,
Constitutional Challenges ,
Due Process ,
Foreign Corporations ,
General Jurisdiction ,
Mallory v Norfolk Southern Railway Co ,
Out-of-State Companies ,
Personal Jurisdiction ,
Registration Requirement ,
SCOTUS ,
State of Incorporation ,
Statutory Interpretation
On January 30, 2023, the Court of Appeals for the Third Circuit issued a precedential decision rejecting a policy of the Department of Health and Human Services (HHS) in implementing the 340B Program. Under that policy, HHS...more
Last fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
Under the Affordable Care Act, group health plans and health insurance issuers are required to provide health insurance coverage based on recommendations made by healthcare coverage professionals. The covered categories...more
This fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
This fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
This fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
This fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
This fall, after returning from a year of telephone arguments, the U.S. Supreme Court significantly changed its argument format. The biggest change was the addition of an untimed round of questioning at the end of each...more
On April 23, 2021, President Biden signed into law the “Ensuring Innovation Act,” which modifies section 505 of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 355, by codifying the regulatory approach used by...more
On December 27, 2020, the President signed into law the “Consolidated Appropriations Act, 2021” (the “Act”). Included within this omnibus legislation are several provisions (in Division BB, Title III, Subtitle C) that affect...more
The Federal Circuit Thursday issued a decision that narrows the venue options available to patent owners bringing suit against generic drug manufacturers under the Hatch-Waxman Act. In a unanimous decision, the court held...more
11/9/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue
Subtitle F of the recently enacted U.S. CARES Act substantially reforms the regulatory framework for non-prescription drugs, representing the most significant update of the review process for over-the-counter (OTC) drugs...more
On December 4, 2017, the Supreme Court heard oral argument in the much anticipated case, Christie v. NCAA, in which the Court is considering New Jersey’s bid to permit sports gambling at the state’s casinos and race tracks. A...more
Summary -
In Star Athletica, LLC v. Varsity Brands, Inc., 580 U.S. ___ (2017), the Supreme Court clarified the test for whether artistic features of a useful article are separable and therefore copyright eligible. The...more
4/3/2017
/ Cheerleaders ,
Copyright ,
Copyright Infringement ,
Copyrightable Subject Matter ,
Fashion Design ,
Fashion Industry ,
Graphic Designs ,
SCOTUS ,
Section 101 ,
Separability ,
Sports Apparel ,
Star Athletica v Varsity Brands ,
The Copyright Act ,
Uniforms ,
Utilitarian Function
New Jersey’s years-long battle to allow sports gambling received a significant boost from the U.S. Supreme Court last week, which issued an order inviting the Solicitor General to file a brief in the case (known to Court...more
A common question under Section 11 of the Securities Act of 1933 is whether and under what circumstances an issuer’s statement of opinion or belief may give rise to liability. The Supreme Court recently held in Omnicare, Inc....more