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The health care and life sciences sector is entering a period of accelerated transformation shaped by new technologies, shifting regulatory frameworks, and evolving market demands. ��������; Lardner LLP’s “Health Care & Life Sciences Top Trends for 2026” provides timely insights into how organizations can capitalize on emerging opportunities while navigating a complex environment of heightened enforcement, policy uncertainty, and rapid innovation. The report surveys enforcement priorities under President Trump’s second administration, developments in antitrust, changes in federal program oversight, and evolving legal landscapes in digital health, telehealth, medical devices, and pharmaceuticals. Across the many topics covered, two chapters offer particularly important takeaways for stakeholders in precision medicine and personalized therapeutics, where intellectual property protection is critical to safeguarding innovation and achieving commercial success.

The chapter on “Health Care Patent Practice: Changes at the USPTO for 2026” signals a possible shift in how medical diagnostics and artificial intelligence-driven health technologies will fare in patent examination. Under newly appointed USPTO Director John Squires, there are early signs of a more expansive view of patent eligibility under 35 U.S.C. § 101, which could benefit innovations in medical diagnostics, AI-enabled medical devices, and precision medicine applications. Director Squires has emphasized that broad patent eligibility is vital for U.S. competitiveness, job creation, and safeguarding technological leadership. His initial actions, such as reversing § 101 rejections for machine learning-related inventions, point to potential easing of eligibility constraints that have historically made it difficult to protect diagnostic inventions and software-enabled medical tools. If sustained, this philosophy could mean that precision medicine technologies, often blending advanced analytics, patient-specific biological data, and medical decision support, have a better chance of obtaining robust patent protection. Alongside changes to inter partes review rules, continuation practice fees, and pilot examination programs, these developments suggest that patent strategy should be revisited in light of new pathways for protecting inventions that personalize diagnosis and treatment.

Austin J. Kim’s chapter, “Patent Protection in the Age of Artificial Intelligence: An Examination of the Potential Role of AI-Generated Data in Diagnostics and Therapeutic Inventions,” addresses the intersection of AI and patent law in biomedical innovation. As AI becomes embedded in every stage of medical research, from modeling protein structures and analyzing diagnostic imaging to discovering therapeutic targets and tailoring treatments to individual patients, its outputs are increasingly valuable for advancing precision medicine. However, patenting these inventions remains challenging because diagnostics and therapeutics operate within unpredictable biological systems that demand more than theoretical proof. For diagnostic inventions, filings need to detail why the approach is non-conventional compared to prior technologies, avoiding claims that merely recite correlations or abstract ideas. For therapeutic inventions, patents require credible evidence of efficacy, which can be difficult to provide early in development. Mr. Kim proposes leveraging AI-generated data to strengthen patent applications by using simulations, predictive modeling, and generative datasets to show technical improvements over existing methods, support broader claims, or demonstrate likely therapeutic effects. While the USPTO has yet to take a clear position on the acceptability of in silico data for patents, such data, accompanied by well-crafted descriptions, model validations, and prophetic examples, can help innovators in precision medicine secure IP protection when conventional clinical data is limited.

Reviewing ��������; Lardner’s full 2026 Trends publication is worthwhile for several reasons. It offers a panoramic view of the enforcement environment which can be critical for compliance planning in regulated health care and life sciences markets, and details policy changes that could reshape reimbursement, coverage, and investment strategy.