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Intellectual Property Protection Medical Devices Life Sciences

Gardner Law

Why Every Manufacturer Needs a Robust Information Security Program

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Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more

Ropes & Gray LLP

New Horizons: Implications of the UK-India Trade Agreement for Life Sciences and Innovation

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The UK and India have announced one of the “biggest and most economically significant” bilateral trade agreements the UK has signed since Brexit, following years of discussions. This marks a significant milestone for the UK...more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

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The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Goodwin

US Emerging as Top Global Medtech Destination

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For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more

Husch Blackwell LLP

Structuring the Right Deals for Growth in Life Sciences

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Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more

Polsinelli

Federal Circuit Refuses to Rehear Case Involving Orange Book Listing of Device Patents

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Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

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This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Dickinson Wright

Part 3: Key Takeaways from Claim Examples in the 2024 AI Patent Eligibility Guidance

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This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more

American Conference Institute (ACI)

[Event] 2nd Annual Life Sciences AI Summit - February 20th - 21st, New York, NY

Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more

Wilson Sonsini Goodrich & Rosati

The Life Sciences Report – January 2025

This latest edition features an interview with retiring longtime Wilson Sonsini IP partner Vern Norviel and articles on MedTech and pharma trends for 2025, the eligibility of life sciences companies for qualified small...more

Mintz - Venture Capital & Emerging Companies...

MintzTech Connect Industry News: Spotlight on Surgimatix, Inc

Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more

A&O Shearman

Balancing innovation and public health: third-party interests in the UPC's landmark ruling of Edwards Lifesciences vs. Meril

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In a landmark decision (UPC_CFI_15/2023) delivered on November 15, 2024, the Unified Patent Court's Local Division in Munich (UPC, LDM) ruled in favor of Edwards Lifesciences Corporation in a patent infringement case against...more

Goodwin

Four Steps to Maximize AI Innovation in Medtech

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Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

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On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

Husch Blackwell LLP

Closing the Gap: Medical Device Innovation, Frontline Healthcare Workers, and the Role of AI

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The recent, rapid advancement of the development of artificial intelligence and machine learning (AI) has revolutionized various industries. It is unsurprising then, that at this year’s South by Southwest Conference (SXSW),...more

Seyfarth Shaw LLP

Medical Device Companies Settle Trade Secrets Dispute for $8,000,000

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Aegis Spine Inc. has agreed to pay $8,000,000 to fellow spinal implant manufacturer Life Spine Inc., following Life Spine’s suit in the Northern District of Illinois alleging Aegis had misappropriated Life Spine’s trade...more

Knobbe Martens

Recent Developments in Medical Casts

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On October 5, 2023, the World Intellectual Property Organization published Cast21’s PCT application related to its alternative cast device – a 3D-printed exoskeleton created from a medical-grade resin.  Cast21’s device seeks...more

ArentFox Schiff

ArentFox Schiff Issues the First Global Definitive Legal Guide for Industries Navigating AI

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Artificial intelligence promises to transform the way we live and work and its impact will undoubtedly stretch to every business sector across the globe. This next generation of technology brings exciting possibilities and...more

ArentFox Schiff

Legal Implications of AI in the Life Sciences Industry

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Artificial intelligence (AI) is rapidly transforming the life sciences industry, with significant advancements in various areas. These innovations bring new legal challenges related to intellectual property, data protection,...more

Knobbe Martens

Navigating the Regulatory Landscape: FDA Approval and Patent Protection for Software as a Medical Device

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Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device involves navigating complex and evolving...more

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Ankura

eDiscovery and Life Sciences Industry - Challenges and Solutions

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The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

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