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In the weeks leading up to FDA’s October 14, 2021 Transparency of AI/ML Enabled Medical Devices Workshop (Workshop) we took a brief look at the history of FDA’s regulation of medical device software and the agency’s more recent efforts in regulating digital health. In this post, we will provide an overview of the topics discussed at the Workshop and our impressions of the agency’s likely next steps.
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In our last post, we took a brief look back through history at FDA’s approach to regulating medical device software and found that there is little distinction from the agency’s approach to hardware devices. Recently, however, FDA has announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems (including its own internal data systems) and changing the way the agency handles pre-market reviews of and compliance activities for software as a medical device (SaMD) and SaMD manufacturers. In this post, we will review FDA’s digital health improvement highlights from the past few years and take a quick look at the agenda for the transparency of AI/ML-enabled medical devices workshop scheduled for October 14, 2021.
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In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series detailing the history behind FDA’s regulation of software and then reporting our impressions of FDA’s presentations and statements from various attending stakeholders following meeting. In this part, we briefly summarize FDA’s traditional approach to regulating software and how software development quickly revealed the limitations of the original regulatory framework established in the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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When It Isn’t Better Late Than Never: ALJ Reins in on Redesigns First Disclosed in the Last Week of Fact Discovery

September 21, 2021 | Blog | By Michael Renaud, Adam Rizk, Matthew Karambelas, Tianyi Tan

In a recent IAM article, Levelling the playing field in ITC patent cases by identifying redesigns to a set deadline, we commented on best practices for ITC complainants to protect their interests against the nascent uptick of redesign submissions at the tail end of fact discovery. Although reasonable minds can differ as to whether the uptick in motion practice is coincidence or a more troubling sign that some respondents are using late redesign disclosures as a vehicle to put complainants at a disadvantage in fast-paced Section 337 proceedings, such late disclosures undoubtedly prejudice complainants’ ability to fully review and assess such disclosures for possible infringement.
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In what appears to be a case of first impression, on August 23, 2021 U.S. District Judge John Z. Lee of the United States District Court for the Northern District of Illinois denied a biosimilar applicant’s motion to dismiss a patent infringement suit brought under the Biosimilar Price Competition and Innovation Act (“BPCIA”) against a foreign parent corporation that did not file or sign the relevant abbreviated Biologics License Application (“aBLA”).
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Life Sciences Newsletter — September 2021

September 1, 2021 | Article | By Adam Lenain, William Whelan, Susan Berson, Jonathan L. Kravetz, Terri Shieh-Newton

This edition covers return-to-work challenges, insight on patenting AI innovations, FDA guidance on medical devices, transactional and IP activity in the life sciences, and recent Mintz work for life sciences clients.
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PTAB statistics show interesting trends for Orange Book and biologic patents in AIA proceedings

August 24, 2021 | Blog | By Peter Cuomo, Joe Rutkowski, Nana Liu

The PTAB recently published the first update to its 2019 study of AIA trials involving petitions challenging Orange Book-listed patents and biologic patents through June 2021. Highlights of these pharmaceutical patent challenge statistics include, e.g., the number of these petitions filed, the number of instituted trials, and the trial outcomes since fiscal year 2013.
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AI in Biotech and Synthetic Biology: What Can Be Protected? What Should Be Kept Secret?

August 11, 2021 | Blog | By Joshua Berk, Lily Zhang, Terri Shieh-Newton

Machine learning (ML), bioinformatics, artificial intelligence (AI), and other computational tools have become ubiquitous in the biotech and synthetic biology industries because such technology allows for rapid processing of a large amount of complex data to produce advancements in therapeutics and diagnostics. As the landscape becomes increasingly more competitive, it is important for companies, particularly in the aforementioned industries, to obtain patent protection for their AI-related technology.
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On June 24, 2021, the Food and Drug Administration (FDA) issued the long-awaited Remanufacturing of Medical Devices Draft Guidance, which describes the agency’s current thinking on activities that meet the definition of remanufacturing and a process for determining whether an act done to an original equipment manufacturer’s (OEM’s) legally marketed finished device is considered remanufacturing (the “Draft Remanufacturing Guidance”).
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This alert covers the New York City Economic Development Corporation’s RFP seeking proposals for projects supporting new ventures and technology development in NYC’s life sciences community.
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On April 16, 2021, Food and Drug Administration (FDA) published twin notices in the Federal Register effectively reversing a move by the Trump administration Department of Health and Human Services (HHS) on January 15, 2021 purporting to exempt 91 medical device types from the premarket notification requirement under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. HHS’s actions on January 15, signed by then-HHS Secretary Alex Azar, sought to make permanent FDA’s grant of temporary enforcement discretion for the 91 device types for the duration of the COVID-19 public health emergency.
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This 90-minute webinar explored the processes, considerations, and other factors behind the incubation and launch of new companies by some of today’s leading venture capital firms. Panelists discussed common sources of ideas for new companies, de-risking of translational science, ideal initial management, and financing a new entity.
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Recent transactions from our Life Sciences practice
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FDA Issues New Guidance on Drug Naming

December 17, 2020 | Blog | By Karen K. Won

Last week, the Food and Drug Administration (“FDA”) issued a pair of Guidance for Industry documents outlining best practices for developing proprietary names (i.e. brand names) for prescription and nonprescription human drug products. 
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An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

November 5, 2020 | Blog | By Joanne Hawana

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the quality of different subsets of tests. Since then, there have been some important policy developments affecting diagnostic and antibody testing. There also has been significant growth in the number of tests authorized by the Food and Drug Administration for point-of-care uses in various patient settings such as clinics, emergency departments, and physician offices. Read on for an update about these developments.
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As the COVID-19 pandemic continues to upend our daily lives, the promise of a vaccine offers hope that life may, in the not-too-distant future, return to some version of normalcy. The path to getting a safe, accessible vaccine to market, however, presents a variety of its own challenges. As we’ve been exploring in our Bioethics in a Pandemic blog series, the pandemic has presented a host of bioethics issues pertinent to the vaccine development and distribution process. Mintz's Bridgette Keller recently shared her insights into how bioethics can (and should!) influence research and development at the M2D2 Challenge Awards. A video of her presentation is now available to view online.
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Life Sciences Newsletter — October 2020

October 19, 2020 | Article | By Adam Lenain, William Whelan, Susan Berson, Jonathan L. Kravetz, Terri Shieh-Newton

The October Mintz Life Sciences Newsletter brings the latest developments in life sciences, legal insights, and industry activity.
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The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating COVID-19 symptoms. Although the regulatory action was announced in the FDA’s daily pandemic update on October 2, 2020, the warning letter issued by the Office of Prescription Drug Promotion (OPDP) is dated September 22, 2020. From our perspective, this public FDA action is notable for two distinct policy reasons.
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