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FDA Cracks Down on Unauthorized and Counterfeit COVID-19 Diagnostic Tests
May 9, 2022 | Blog | By Benjamin Zegarelli
As the COVID-19 public health emergency drags into its third year, we continue to keep track of efforts by the Food and Drug Administration (FDA) to combat fraud in the form of fake cures, counterfeit diagnostic tests, and other products claiming to prevent, treat, or detect infection by SARS-CoV-2 that are marketed without required FDA authorization. Our previous posts provided updates on joint and separate efforts by FDA and the U.S. Federal Trade Commission (FTC) throughout the pandemic to detect and eliminate these illegal products. In this post, we focus on FDA’s recent enforcement activities concerning COVID-19 diagnostic tests and the agency’s increasingly aggressive pursuit of entities offering counterfeit or unauthorized tests.
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Financing Options for Life Sciences Companies in 2022
March 21, 2022 | Blog
Public and private life science companies have multiple options available for capital-raising. Here are a few to be considered.
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Minimizing Stockholder Litigation Risks
February 18, 2022 | Blog
In 2021, approximately on quarter of all federal securities fraud class action lawsuits filed nationwide were against life sciences companies and their officers and directors. These considerations are for directors and officers of life sciences companies looking to manage disclosures and mitigate risk before a suit ever gets filed.
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Benefits of and Best Practices for Protecting Artificial Intelligence and Machine Learning Inventions as Trade Secrets
February 10, 2022 | Blog | By Marguerite McConihe, Meena Seralathan
We previously discussed which portions of an artificial intelligence/machine-learning (“AI/ML”) platform can be patented. Under what circumstances, however, is it best to keep at least a portion of the platform a trade secret? And what are some best practices for protecting trade secrets? In this post, we explore important considerations and essential business practices to keep in mind when working to protect the value of trade secrets specific to AI/ML platforms, as well as the pros and cons of trade secret versus patent protection.
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Prior Daubert Orders and Discovery Lessons Out of N.D. Cal.
February 4, 2022 | Blog | By Peter Snell, Robert Sweeney
A recent order from the Northern District of California in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., No. 19-cv-06593 (Jan. 27, 2022) (“Edwards”), provides guidance regarding the ability (or inability) to use a prior Daubert ruling to discredit an expert witness at trial when such a ruling arose within the context of a different case. In addition, the order highlights a pitfall that can arise when an opposing party produces deficient damages-related discovery but is not pressed to supplement its discovery through a motion to compel.
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Written Description Requirement Challenges: Federal Circuit Decision Sheds Light on How Expert Testimony Can Help
January 21, 2022 | Blog | By Brad M Scheller, Meena Seralathan
Earlier this month, in Novartis Pharms. Corp., Inc. v. Accord Healthcare, Inc., et al., No. 2021-1070, the Federal Circuit issued a helpful decision concerning the not-often-discussed written description requirement. The panel specifically addressed whether sufficient written description can exist for claim limitations that are not explicitly or directly disclosed in the specification (including negative claim limitations). This new ruling provides patent owners with a useful guide for successfully navigating similar written description challenges in patent infringement cases. For example, Patent Owners seeking to combat written description requirement challenges should proffer expert witnesses who can clearly articulate how they understand the patent description in relation to the claims and what portions of that description support the same.
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Life Sciences CEO Interview: Joe Payne, President and CEO of Arcturus Therapeutics
November 1, 2021 | Blog
Joe Payne, CEO of Arcturus Therapeutics, discusses his company’s focus on developing next-generation mRNA vaccines and therapies, his current areas of focus as head of the company, the importance of moving forward through the pandemic, and the most frequently asked question he gets about the company.
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Coverage of FDA’s AI/ML Medical Devices Workshop - Part 3: A Summary of the Panel Discussions
October 20, 2021 | Blog | By Lara Compton, Benjamin Zegarelli
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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Coverage of FDA’s AI/ML Medical Devices Workshop - Part 2: FDA’s Recent Digital Health Initiatives
October 12, 2021 | Blog | By Benjamin Zegarelli, Lara Compton
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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Coverage of FDA’s AI/ML Medical Devices Workshop - Part 1: The History of FDA Software Regulation
October 4, 2021 | Blog | By Benjamin Zegarelli, Lara Compton
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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N.D. Ill. Finds that a Foreign Parent Corp. May be Sued Under BPCIA Without the U.S. Subsidiary that Signed and Filed aBLA
September 21, 2021 | Blog | By Thomas Wintner, Adam Samansky, Joe Rutkowski
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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Are You a Medical Device Servicer or Remanufacturer? FDA’s New Guidance May Help…Or Not
July 21, 2021 | Blog | By Benjamin Zegarelli, Cody Keetch
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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Mintz Life Sciences Deal Activity (April – June 2021)
June 30, 2021 | Article
New York City Offers Up to $20 million to Projects Selected from Life Sciences Innovation Infrastructure RFP
June 24, 2021 | Alert | By Ilse P. Johnson
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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FDA Reverses 11th Hour HHS Action to Exempt Certain Devices from 510(k) Premarket Requirement
April 20, 2021 | Blog | By Benjamin Zegarelli
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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Mintz Life Sciences Deal Activity (January – March 2021)
March 31, 2021 | Article
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