United States: Patent

Recent U.S. court decisions have produced significant consequences for Japanese companies doing business with the United States, spanning tariff refund mechanisms, jurisdictional challenges, and substantial patent verdicts. This advisory examines six critical developments that could reshape legal strategies for Japanese exporters and technology companies operating in the American market.

Global investment in generative AI reached $25.2 billion in 2023, transforming how major technology companies acquire AI capabilities and fundamentally reshaping the due diligence process. The buyer's playbook has evolved from simply counting patent assets to investigating six critical pillars: proprietary data ownership, patent characterization, technical authenticity, regulatory compliance, cybersecurity resilience, and training data rights.

The economic impact of sports and fitness markets continues to surge, with franchise valuations and technological innovation reaching unprecedented levels. From wearable devices to performance analytics, intellectual property has become a strategic weapon in an industry where companies compete as aggressively as the athletes themselves. Wolf Greenfield examines the patents, trademarks, trade secrets, and licensing issues shaping this rapidly evolving landscape.

Researchers routinely use AI tools like AlphaFold and Schrödinger's software without scrutinizing license agreements that contain restrictions on commercial use, confidentiality, and mandatory disclosure requirements. These overlooked terms can create significant legal obstacles when translating academic innovations into commercial products, affecting everything from sponsored research agreements to patent filings and university spinouts.

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

As businesses rapidly adopt artificial intelligence, machine learning, and predictive analytics across their operations, many overlook critical intellectual property considerations. Recent federal court decisions reveal the nuanced distinction between simply automating existing processes with AI versus creating patentable innovations that improve how AI systems themselves operate.

The European Union has published the final text of its comprehensive pharmaceutical legislation reform, introducing significant changes to regulatory data protection, orphan drug exclusivity, and antimicrobial resistance measures.

Effective April 5, 2026, the USPTO introduced a "pre-order" procedure for ex parte reexaminations, allowing patent owners to respond within 30 days of service of a request, and before the Office decides whether a Substantial New Question of patentability (SNQ) exists.

The UPC Court of Appeal has endorsed a more holistic approach to assessing inventive step in patent disputes, marking a significant development in European patent law. This analysis examines how the UPC's methodology compares with the EPO's problem-solution approach and the practices of national courts like those in the UK and Germany.