The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The US Court of Appeals for the Eleventh Circuit reversed and remanded a district court’s ruling, holding that waiver of sovereign immunity for claims related to a federal contracting program means the defendant, a sovereign...more
A unanimous Supreme Court held May 23 that a party’s waiver of its arbitration right does not require showing prejudice to an opposing party, because the Federal Arbitration Act (“FAA”) prohibits arbitration-specific rules....more
Addressing a “narrow question of statutory interpretation,” the US Court of Appeals for the Fourth Circuit reversed the district court’s dismissal of a trademark case for lack of subject matter jurisdiction, holding that a...more
In Cal. Spine & Neurosurgery Inst. v. Blue Cross of Cal., 2020 U.S. App. LEXIS 20533 (9th Cir. June 20, 2020), the Ninth Circuit held that a surgical provider's complaint sufficiently alleged that Blue Cross of California...more
Brillman v. New England Guaranty Ins. Co., 2020 VT 16 (Feb. 21, 2020) - In this insurance coverage decision, the Vermont Supreme Court determined that the “date of loss,” which starts the clock running on the one-year...more
The Supreme Court of the United States issued the following decision this morning: Thacker v. TVA, No. 17-1201: The Tennessee Valley Authority (“TVA”) is a federally-created and Government-owned corporation that...more
On April 29, 2019, the Supreme Court of the United States decided Thacker v. Tennessee Valley Authority, No. 17-1201, holding that the “sue-and-be-sued” clause that waives the Tennessee Valley Authority’s (TVA) sovereign...more
Federal Circuit Determines Time-Barred Petitioner Joined to an IPR Has Appellate Standing - In Mylan Pharmaceuticals Inc. v. Research Corporation Tech., Appeal Nos. 2017-2088, -2089, -2091, the Federal Circuit held that a...more
Federal Circuit Summary - Before Dyk, Reyna, and Taranto, per curiam. Petition for Writ of Mandamus from the District Court for the Eastern District of New York. Summary: In a case pending before TC Heartland was...more
• In Sheppard, Mullin, Richter & Hampton, LLP v. J-M Manufacturing Company, Inc., the Supreme Court of California held that an attorney-client engagement agreement that is arguably tainted by an unwaived or inadequately...more
Federal Circuit Summary - Before Reyna, Bryson, and Hughes. Appeal from the Northern District of California. Summary: Breach of a duty of disclosure to a standards-setting organization may constitute implied waiver,...more
Federal Circuit Summary - Before Newman, Lourie, and Reyna. Appeals from the Patent Trial and Appeal Board. Summary: A party did not waive SAS-based relief in an IPR appeal when it requested remand for consideration of...more
Federal Circuit Sheds Some Light on How SAS May Impact Pending Appeals from the PTAB — Court Terminates Appeals of Partially-Instituted IPRs and Remands Back to the PTAB to Consider Non-Instituted “Claims and Grounds” in...more
On November 15, 2017, the United States Court of Appeals for the Federal Circuit resolved a split among district courts on the question whether the United States Supreme Court’s TC Heartland decision constituted a change in...more
In a big win for the tech industry and app developers, and for other companies seeking to enforce arbitration agreements through web-based interactions, last week the Second Circuit Court of Appeals held that the plaintiff in...more
Legislative Update - Governor Brown recently signed into state law the following employment law bills (among others): SB 358—Referred to as the California Fair Pay Act, this law is directed at closing the pay...more