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Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

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

You May Have Already Agreed to Be Sued in Pennsylvania and Georgia: The Supreme Court Makes Jurisdiction Easier For State-Court...

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

Federal Court of Appeals Rejects HHS Stance on Section 340B Contract Pharmacies

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

Extra Time in the Supreme Court

​​​​​​​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

10/17/2022  /  SCOTUS

Federal District Court Ruling May Jeopardize Insurance Coverage of More Than 50 Recommended Procedures, Screenings, and Treatments

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

Extra Time in The Supreme Court: Updated February 2022

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

3/22/2022  /  Oral Argument , SCOTUS

Extra Time in the Supreme Court: Updated January 2022

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

1/25/2022  /  Oral Argument , SCOTUS

Extra Time in the Supreme Court: Updated December 2021

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

1/25/2022  /  Oral Argument , SCOTUS

Extra Time in the Supreme Court: Updated November 2021

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

11/12/2021  /  Oral Argument , SCOTUS

Extra Time in the Supreme Court: October 2021

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

11/1/2021  /  Oral Argument , SCOTUS

Congress Passes Legislation Codifying FDA’s “Active Moiety” Approach to Exclusivity Determinations

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

Congress Enacts Amendments Affecting The Regulation Of Generic Drugs And Biosimilars

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

Federal Circuit Narrows Venue for Patent Infringement Suits Under the Hatch-Waxman Act

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

U.S. CARES Act Enables Long-Awaited OTC Drug Regulatory Modernization: Key Highlights

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

Christie v. NCAA: Will New Jersey’s Bet on Sports Gambling Pay Off?

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

Supreme Court Broadens Copyright Eligibility For Design Elements, Including Artwork On Clothing

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

Place Your Bets: Will the Trump Administration Support New Jersey’s Push to Expand Sports Gambling?

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

Supreme Court Clarifies Liability Standard for Statements of Opinion in Securities Offering Registration Statements

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

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