News & Analysis as of

Intellectual Property Protection Medical Devices

Offit Kurman

Patents and the FDA: Four Critical Considerations Medical Device Companies Must Know to Successfully Introduce New Products into...

Offit Kurman on

The intersection of patent strategy and FDA regulatory strategy is a critical consideration for medical device companies. A well-integrated approach can create powerful barriers to entry, strengthen intellectual property (IP)...more

Ropes & Gray LLP

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

Ropes & Gray LLP on

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?

Troutman Pepper Locke on

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

WilmerHale

Standard-Essential Patent Licensing Comes to Medtech

WilmerHale on

Connected technology products are a part of daily life. Connectivity standards – such as 5G and Wi-Fi – provide a common language that allows products from different manufacturers to communicate with each other. ...more

MoFo Life Sciences

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

MoFo Life Sciences on

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

Goodwin on

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

Husch Blackwell LLP on

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

Polsinelli on

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

Gardner Law

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...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...

Haug Partners LLP on

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

Dickinson Wright on

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

Sheppard Mullin Richter & Hampton LLP

Ceramtec GMBH v. Coorstek Biocermanics LLC

This case examines the application of trademark functionality doctrine in the medical device industry, specifically addressing whether the pink color of ceramic hip components can be protected as a trademark. The case...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

Foley & Lardner LLP

AI in Drug Discovery: 2025 Outlook

Foley & Lardner LLP on

Looking forward to the 2025 prediction season, a survey of the emerging AI-powered drug discovery landscape has been making the rounds—and with good reason. The survey, summarized by Stanford’s Chris Bradbury, is likely the...more

A&O Shearman

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

A&O Shearman on

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

Goodwin on

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

Fuerst Ittleman David & Joseph

Compounded GLP-1 Drugs: is the Party Over? These Are the Legal and Regulatory Issues for Game Changing Weight Loss Products and...

Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more

Goodwin

FDA Approvals of AI Medical Devices Rise Rapidly

Goodwin on

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a record high of 221 last year, according to data tracing back to 1995....more

A&O Shearman

District Court Denies Regeneron’s Motion For Preliminary Injunction To Block Amgen’s Eylea Biosimilar

A&O Shearman on

On September 23, 2024, Judge Kleeh of the Northern District of West Virginia denied Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) motion for a preliminary injunction against Amgen Inc. (“Amgen”) related to Amgen’s filing of...more

Gardner Law

Kickbacks and Consequences: Lessons from the Innovasis Settlement

Gardner Law on

On May 29, 2024, the U.S. Department of Health and Human Services’ Office of Inspector General (HHS OIG) announced a $12 million settlement with Innovasis Inc., a medical device manufacturer, and two of its senior executives...more

WilmerHale

AI-Powered Medical Devices Bring Patent and Regulatory Pitfalls

WilmerHale on

Artificial intelligence and machine learning are transforming the medical device industry. Simultaneously, companies are working to gain Food and Drug Administration approval and obtain intellectual property protection for...more

Bracewell LLP

USPTO Lights the Way for AI Inventions to Shine

Bracewell LLP on

The murky world of artificial intelligence-enabled inventions requires illumination. Did the USPTO’s recent guidance provide this much-needed illumination, or merely leave a trail of breadcrumbs? Some say the guidance is...more

116 Results
 / 
View per page
Page: of 5

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide