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AI-Powered Medtech: What Companies Need to Know About Regulatory and IP Risks

As the medtech AI market surges toward $615 billion by 2034, companies must navigate complex licensing, regulatory, and intellectual property challenges. Understanding these key issues is essential to unlocking the full potential of AI-driven healthcare innovation.

The global market value for medical technology utilizing artificial intelligence (AI) is projected to reach about $615 billion by 2034.

According to recent market reports, the global market value for medical technology utilizing artificial intelligence (AI) was estimated to be around $19 billion in 2023, with projections for significant growth to reach about $615 billion by 2034, a compound annual growth rate of over 35%.

The medtech AI market is experiencing a remarkable surge in adoption, driven by advancements in AI algorithms, increasing healthcare data availability, and rising demand for improved diagnostics and treatment options. Factors like personalized medicine, early disease detection, improved patient outcomes, and cost-efficiency are key drivers for the growth of this market. As of August 2024, FDA has authorized 950 artificial intelligence and machine learning (AI/ML) medical devices.

To read the rest of this article by Duane Morris partner Driscoll Ugarte, originally published in MC+CI Qmed, please visit the publication website.

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FDA Releases Draft AI Guidance – A New Era for Biotech, Diagnostics and Regulatory Compliance

The U.S. Food and Drug Administration’s recent release of two draft guidance documents on the use of artificial intelligence in drug development, biologics and medical devices has sparked both excitement and skepticism. As AI increasingly permeates these fields, the regulatory landscape is just beginning to take shape—and these proposed guidelines take a step in that direction by raising awareness of important questions about the future of AI innovation in life sciences. For therapeutic, medical device and diagnostics companies—whether already implementing AI or just beginning to explore its potential—the message is clear: The landscape is evolving, and future success will require thoughtful consideration of compliance, patient safety and privacy protection from the earliest stages of AI adoption.

Read the full Alert on the Duane Morris LLP website.

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Federal Circuit Court Affirms Delisting of Patents Claiming Device Components of Drug Product Without Active Ingredient

In Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC (No. 2024-1936), the Federal Circuit affirmed the District Court of New Jersey’s order to delist from the FDA Orange Book Teva’s five patents claiming just device components of a drug product without reciting any active ingredient.

Read the full Alert on the Duane Morris LLP website.

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Promoting Intimate Health and Wellness Products and Treatments: What Spas Need to Know

The global market for intimate wellness products is expected to grow to $81.4 billion by 2028, up from $51.9 billion in 2021, according to recent market research reports. Once taboo, or the topic of hush-hush conversations, intimate wellness brands are increasingly crossing over into mainstream wellness marketing, collaborating with well-known fashion and beauty brands and major retailers, expanding concepts of self-care for Gen Z consumers who are more inclusive and willing to explore individual concepts of pleasure.

To read the full article by Duane Morris associate Kelly Bonner, please visit the WellSpa360 website (registration required).

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FDA’s Final Guidance on Decentralized Clinical Trials Published

On September 18, 2024, the U.S. Food and Drug Administration (FDA) issued final Guidance on recommendations for conducting decentralized clinical trials (DCTs) for drugs, devices or biological products. Instead of using traditional clinical trial sites, DCTs hold some or all trial activities remotely at locations convenient for trial participants by, for example, using telehealth appointments, outsourcing visits to local healthcare providers, or conducting laboratory tests at outside facilities.

Read the Alert on the Duane Morris LLP website.

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FDA’s Latest Draft Guidance on Medical Device PCCPs Incorporates FD&C Act Changes

The U.S. Food and Drug Administration (FDA) recently issued draft Guidance informing medical device manufacturers how to structure a predetermined change control plan (PCCP) to describe appropriate, intended future device modifications. The Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research in consultation with the Center for Drug Evaluation and Research and the Office of Combination Products in the Office of the Commissioner worked together to prepare this Guidance.

Read the full Alert on the Duane Morris LLP website.

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House Oversight Committee Gives Pharmacy Benefit Managers Deadline to Correct Congressional Record of Allegedly Fraudulent Statements

On August 28, 2024, the U.S. House Committee on Oversight and Accountability issued letters to executives of three of the nation’s largest pharmacy benefit managers (PBMs), accusing them of providing false testimony before Congress. Each letter outlines the allegedly false statements and the evidence that the statements contradict. They also outline the statutory penalties for perjury before Congress—namely, monetary fines and imprisonment for up to five years. The letters give the PBMs until September 11, 2024, to correct the Congressional Record.

Read the Alert on the Duane Morris LLP website.

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Artificial Intelligence in Medtech

Given the vast amounts of data available, including raw measurements, diagnostic information, treatment plans, and regulatory guidelines, the biomedical technologies sector stands to gain immensely from artificial intelligence (AI), particularly machine learning (ML).

ML, at its core, learns from training datasets to identify patterns, which can then be applied to new input data to make direct inferences. For instance, if specific body scans frequently result in a particular diagnosis, ML can be used to quickly provide that diagnosis when similar scans are encountered, thus aiding in disease diagnosis.

Read the full article by Duane Morris partner Agatha H. Liu, PhD on the MD+DI website. 

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Patent Primogeniture: Obviousness-Type Double Patenting Immunity for First-Filed, First-Issued and Later-Expiring Patent in a Family

Recently, the relationship and intersection between obviousness-type double patenting (ODP) and any awarded Patent Term Adjustment (PTA) and/or Patent Term Extension (PTE) has received significant attention. The United States Court of Appeals for the Federal Circuit held in In re Cellect, 81 F.4th 1216 (Fed. Cir. 2023), that PTA and PTE, being codified in separate statutes, are treated differently for the purposes of determining the requisite expiration dates in an ODP analysis.

The Federal Circuit’s recent holding in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 2024-1061, 2024 WL 3763599 (Fed. Cir. Aug. 13, 2024), raises the issue of when a claim can be used as a reference claim in an ODP analysis. In particular, the court addressed the question of whether “a first-filed, first-issued, later-expiring claim [can] be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date”. Id. at *4.

Read the Alert on the Duane Morris LLP website.

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The opinions expressed on this blog are those of the author and are not to be construed as legal advice.

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