Navigating the Legal Landscape: How the Supreme Court’s Latest Term Impacts the Medical Technology Industry

MedTech Industry faces Legal Scrutiny: Upcoming Event to Tackle Key Issues

Washington, D.C. – Legal professionals and industry executives in the medical technology sector are preparing for a crucial online session scheduled for november 18, 2025. Akin Gump Strauss hauer & Feld LLP, in collaboration with AdvaMed, will host a Continuing Legal Education (CLE) session addressing recent Supreme Court decisions and emerging legal challenges.

Supreme Court and trade Policy in Focus

The event will delve into significant rulings from the previous Supreme Court term, specifically those with implications for the medical technology industry. Attendees can anticipate a detailed overview of forthcoming cases and a unique analysis of a prominent tariff case, presented by one of the lead advocates involved. According to recent data from the U.S. Trade representative, trade disputes involving medical devices have increased by 15% in the last year, highlighting the importance of staying informed.

Who Should attend This Critical Session?

This event is designed for a targeted audience including legal counsel, compliance officers, and executives working within the MedTech industry. Representatives involved in international transactions, in-house legal teams at MedTech companies, and trade compliance professionals will benefit from the insights shared. The session aims to empower participants to proactively navigate evolving trade policies and mitigate potential risks.

Event Details at a Glance

The online session will take place from 11:00 AM to 12:00 PM ET on November 18, 2025. Akin Gump is accredited as a CLE provider in California, New York, and Texas, with reciprocity available in several other states, including Alaska and Florida. HereS a quick overview of the key details:

Category	Details
date	November 18, 2025
Time	11:00 AM – 12:00 PM ET
Location	Online
CLE sponsor	Akin Gump Strauss Hauer & Feld LLP
CLE Credit Hour	1.0

Did You Know? The medical technology industry contributed over $170 billion to the U.S. economy in 2023, according to a recent report by Deloitte, making legal and trade compliance especially vital.

Registration and Pricing Data

AdvaMed members can attend the session free of charge, while non-members will be required to pay a registration fee of $149. Interested individuals can verify their company’s AdvaMed membership status here.

Pro Tip: CLE credits are a crucial element of maintaining professional development.Confirm the accreditation status with your state bar before attending to ensure eligibility.

Meet the Speakers

Participants will hear from prominent legal experts including Pratik Shah, Partner and Head of Supreme Court & Appellate Practice at Akin Gump Strauss hauer & Feld LLP, and Kelly Cleary. Their expertise will provide valuable insights into the complex legal landscape facing the MedTech industry.

The Growing Importance of Legal expertise in MedTech

The medical technology sector is characterized by rapid innovation and stringent regulatory requirements. Keeping abreast of legal developments is no longer solely a function of legal departments; it’s become a critical component of strategic decision-making for all levels of an organization. Successfully navigating patent disputes, trade regulations, and compliance mandates will determine a company’s ability to thrive in this dynamic market.

Frequently Asked Questions About the Event

what are your thoughts on the increasing legal complexities within the medical technology field? Share your comments below, and don’t forget to share this article with your network!

What specific inventive concepts, beyond biomarker identification, are now considered essential for securing patent protection for novel diagnostic tests?

Patent Eligibility & the Biotech Sector

The Supreme Court’s recent rulings have significantly reshaped the legal terrain for medical technology companies, particularly concerning patent law. A key area of focus has been the ongoing debate surrounding patent eligibility of biotechnological inventions. While Amgen Inc.v. Sanofi, 593 U.S. _ (2021), clarified that simply discovering a naturally occurring phenomenon isn’t patentable, the line remains blurry.

* Impact on Diagnostics: Companies developing novel diagnostic tests, especially those based on naturally occurring biomarkers, face increased scrutiny. Demonstrating a “significant” inventive concept beyond merely identifying the biomarker is crucial for securing patent protection.

* Gene Editing Technologies: The legal status of patents covering CRISPR and other gene editing technologies continues to evolve. Disputes over interference and priority remain common, requiring careful patent prosecution strategies.

* Software-Based Medical devices: The Court’s stance on abstract ideas impacting software patents extends to digital health and medical device software. Companies must demonstrate how their software implements an inventive concept to overcome the Alice/Mayo framework.

Data Privacy & HIPAA Compliance

The increasing reliance on health data and artificial intelligence (AI) in medical devices has brought data privacy issues to the forefront. While the Supreme Court hasn’t directly addressed HIPAA in its latest term, related rulings on data access and privacy have implications.

* Data Security Breaches: The potential for significant financial penalties and reputational damage from data breaches necessitates robust cybersecurity measures. Companies must adhere to the HIPAA Security Rule and implement best practices for data protection.

* Telehealth & Interstate Data Transfer: The expansion of telehealth raises complex questions about interstate data transfer and compliance with varying state privacy laws. Understanding these nuances is vital for national telehealth providers.

* AI and Algorithmic Bias: The use of AI in medical diagnostics and treatment raises concerns about algorithmic bias and potential discrimination. Companies must ensure their AI algorithms are fair, transparent, and validated across diverse patient populations.

FDA Regulation & Preemption

The Supreme Court’s decisions on federal preemption continue to influence the regulatory landscape for medical devices overseen by the Food and Drug Governance (FDA).

* Medical Device Litigation: The Court’s rulings on preemption determine the extent to which state law claims (e.g., product liability) are preempted by federal regulations. This impacts the potential for litigation against medical device manufacturers. riegel v. Medtronic, Inc., 552 U.S. 312 (2007) remains a key precedent.

* 510(k) Clearance & liability: Companies relying on the 510(k) clearance pathway must be aware of potential liability risks if their devices are found to be substantially different from predicate devices.

* Off-Label Use & Promotion: The FDA’s authority to regulate off-label promotion of medical devices remains a contentious issue.Companies must carefully navigate the legal boundaries of permissible marketing activities.

Antitrust Concerns in the Medical Device Market

Increased consolidation within the medical device industry has drawn scrutiny from antitrust regulators. The Supreme Court’s rulings on antitrust law have implications for mergers, acquisitions, and competitive practices.

* Merger review: The department of Justice (DOJ) and Federal Trade Commission (FTC) are increasingly challenging mergers that coudl reduce competition in the medical device market.

* Pay-for-Delay Agreements: Agreements between pharmaceutical and medical device companies to delay the entry of generic or biosimilar competitors are subject to antitrust scrutiny.

* Exclusive Dealing Arrangements: Exclusive contracts between medical device manufacturers and healthcare providers can raise antitrust concerns if they foreclose competition.

Practical Tips for Medical Technology Companies

* Proactive Patent Strategy: Develop a robust patent portfolio that covers not only core inventions but also incremental improvements and option embodiments.

* Data Privacy Compliance Program: Implement a comprehensive data privacy compliance program that addresses HIPAA,state privacy laws,and emerging regulations.

* Regulatory Due diligence: Conduct thorough regulatory due diligence before launching new medical devices or expanding into new markets.

* Antitrust Compliance Training: Provide antitrust compliance training to employees involved in pricing, marketing, and competitive strategy.

* **Stay Informed