United States: Healthcare

Biotech companies conducting early-stage biologics trials outside the United States face complex intellectual property challenges that can significantly impact their ability to secure U.S. market exclusivity. Foreign clinical trial registrations, contractor disclosures, and misaligned regulatory timelines create prior-art risks and patent forfeiture scenarios that many companies fail to anticipate. This analysis examines how strategic patent filing coordination with foreign Phase I development can preserve

Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.

On September 8, 2026, the U.S. Department of Labor's Employee Benefits Security Administration (EBSA) issued Field Assistance Bulletin No. 2026-03 (Bulletin 2026-03), narrowing near-term enforcement of the Mental Health Parity and Addiction Equity Act (MHPAEA) to three priority areas and confirming nonenforcement of the 2024 Final Rule's newer provisions pending litigation. The administration has also stopped defending that rule in court and promised a substantially revised proposal by December 31, 2026.

The U.S. Department of Justice recently secured a $32 million settlement with Dompé U.S. Inc. over allegations that the pharmaceutical company violated the Anti-Kickback Statute by paying Medicare beneficiaries' co-pays through patient assistance foundations to induce purchases of its drug Oxervate.

On October 1, the Health Resources and Services Administration (HRSA) published 10 approved rebate plans covering 18 Medicare-negotiated drugs, setting a January 1, 2027, start. As we warned in The 340B Squeeze (September 28), this is the first of three federal pricing changes that will land on a single outpatient claim. Health systems have about one quarter to get ready, and litigation could still change the picture.

As pharmacies enter the fourth quarter, we expect pharmacy benefit managers (PBMs) to intensify audit activity, pursue audit recoupments and increase efforts to suspend or terminate pharmacies from their networks. Pharmacy owners should prepare for heightened scrutiny of purchasing records, copayment collection, dispensing practices and compliance with provider agreements as the year closes. The potential consequences extend beyond repayment demands, as an adverse audit finding can threaten the pharmacy’s continued network participation and ability to serve its patients.

Healthcare organizations are increasingly adopting AI tools for administrative tasks like scheduling, billing, and claims processing. While these technologies promise efficiency gains, the vendor agreements governing them require careful scrutiny to address data rights, HIPAA compliance, vendor responsibilities, and hidden costs that may not be apparent in initial discussions.

Ultragenyx Pharmaceutical has received FDA approval for FAYUVI, a groundbreaking one-time gene therapy designed to halt or slow the progression of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. This marks the first-ever treatment capable of addressing the underlying cause of this ultra-rare, fatal neurodegenerative disorder that has previously had no disease-modifying therapeutic options.

After hearing arguments in April 2026, a Seventh Circuit panel declined to overturn a lower court ruling dismissing a union fund’s challenge to an Arkansas rule affecting pharmacy benefit managers (PBMs). The case is Central States Southeast & Southwest Areas Health & Welfare Fund et al. v. McClain, Case Number 25-2727, U.S. Court of Appeals for the Seventh Circuit.