BT Raleigh

The Effect of Supreme Court Decision in SEC v. Jarkesy on HHS-OIG Powers The U.S. Supreme Court’s highly anticipated decision in SEC v. Jarkesy has made waves this summer, creating significant implications for government agencies and calling into question whether or not agencies can impose civil monetary penalties (CMPs). The ruling came the same week as the decision in Loper Bright Enterprises v. Raimondo, where the Supreme Court overturned the Chevron doctrine and ruled that courts are no longer required to give deference to federal agencies where there is statutory ambiguity.

HHS-OIG Highlights Fraud, Abuse Concerns With Manufacturer Offering Financial Assistance to Treat Infertility Side Effects The Office of Inspector General of the U.S. Department of Health and Human Services (HHS-OIG) has issued Advisory Opinion No. 24-06, an unfavorable opinion regarding proposed financial assistance from the manufacturer of a gene therapy product for certain qualifying patients who may need fertility services after receiving such gene therapy treatment.

Federal Circuit Finds Prior Sale of Product Made By Secret Process Continues to Bar Patent on Process Post-AIA In Celanese Int’l Corp. v. Int’l Trade Comm’n, the U.S. Court of Appeals for the Federal Circuit affirmed a finding by the International Trade Commission (ITC) that certain claims of three Celanese patents were invalid because Celanese sold products made using the patented process more than one year before filing patent applications. Although it had long been settled law under the 1952 Patent Act that such sales would invalidate a corresponding process patent, Celanese argued that Congress had changed the law when it passed the America Invents Act (AIA) in 2011. The Federal Circuit disagreed.

The Gloves Are Off: DOJ Whistleblower Pilot Program Set to Shore Up ‘Gaps’ in Private Payer Healthcare Enforcement On Aug. 1, 2024, the U.S. Department of Justice (DOJ) introduced its highly anticipated Corporate Whistleblower Pilot Program, meant to fill gaps in current federal agency whistleblower programs. One such gap relates to the healthcare industry and private insurance payers, as the False Claims Act (FCA) – the federal government’s primary civil enforcement tool for redressing fraud against the United States government – imposes liability only for fraud perpetrated against federal payers such as Medicare and Medicaid.

We are excited to share that Best Lawyers has named 2 Barnes and Thornburg Raleigh attorneys to ‘The Best Lawyers In America®’ 2025 List. This recognizes the outstanding achievements of legal professionals who have demonstrated unparalleled expertise and dedication in their fields. Congratulations! https://lnkd.in/gEitbCEH

Federal Circuit Clarifies Scope of § 73(d)(3)(i) Estoppel in Interrelated USPTO Proceedings In Softview LLC v. Apple Inc., the U.S. Court of Appeals for the Federal Circuit clarified the scope of estoppel under 37 C.F.R. § 73(d)(3)(i) concerning interrelated proceedings at the U.S. Patent and Trademark Office (USPTO), vacating and remanding the lower decisions of the Patent Trial and Appeal Board (PTAB). Softbank appealed PTAB’s decisions to reject all claims in multiple parallel reexamination proceedings regarding U.S. Patent No. 7,461,353 (the ’353 patent) concerning mobile device displays. Importantly, 18 claims (out of 319) of the ‘353 patent had been invalidated in a parallel inter partes review (IPR) proceeding. The PTAB’s decisions on Softbank’s reexamination appeal relied directly on the IPR invalidity decision.

HHS-OIG Draws Legal Boundaries for Patient, Caregiver Support Provided by Biotech Company The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-05, a favorable opinion regarding the federal Anti-Kickback Statute (AKS) and civil monetary penalty laws against beneficiary inducements (CMP) as applied to travel, lodging, meals, and other travel expense assistance to patients and caregivers provided by a biotechnology company, and an unfavorable opinion regarding the company’s provisions of fertility preservation services.

A Question of Patent Invalidity Must Be ‘Substantial’ to Defeat Preliminary Injunction, Appeals Court Says The U.S. Court of Appeals for the Federal Circuit recently issued a precedential decision affirming a district court’s decision to maintain a preliminary injunction against an accused patent infringer. The appeals court in Natera, Inc. v. NeoGenomics Lab'ys, Inc. restated the established three-part test for preliminary injunctions: likelihood of success, irreparable harm, and public interest. For patent cases, the Federal Circuit has split the likelihood of success part of the test into two subparts: infringement and invalidity.

Federal Appeals Court Tackles Patent Prior Art and Public Disclosure In Sanho Corp. v. Kaijet Technology Int’l Ltd., the U.S. Court of Appeals for the Federal Circuit addressed the scope of the prior art exception in U.S. law that deals with conditions for patentability, which provides “[a] disclosure shall not be prior art to a claimed invention under subsection [102](a)(2) if . . . the subject matter disclosed had, before such subject matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor.” In this case, the court affirmed a decision by the U.S. Patent Trial and Appeals Board (PTAB) that the prior art in question, a private but non-confidential sale of the invention by the inventor, did not qualify for the exception.

AI Coming to the EU: EU Artificial Intelligence Act’s Recent Publication, Next Steps The European Union’s Artificial Intelligence Act, Regulation (EU) 2024/1689, was published on July 12 in the Official Journal of the European Union. This marks the establishment of the first comprehensive horizontal legal framework for regulating AI systems across the EU. The EU AI Act will enter into force on Aug. 1, 2024, with the majority of its provisions becoming enforceable on Aug. 2, 2026. While the compliance timeline may appear extended, the process of developing an AI compliance program is intricate and time-intensive. It is imperative for businesses to commence their compliance efforts promptly to ensure they are adequately prepared to meet the regulatory requirements.