Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

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A Tip for Improving Your “Improved” Jepson Claim: Include Written Description Support

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As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). Authorized by Congress in March 2022, the new agency will bring together industry, academia, and government through public-private partnerships for high-risk, high-reward endeavors intended to drive breakthroughs in biomedicine and health. ARPA-H seeks to capitalize and expand on recent advances in biomedicine to revolutionize the prevention and treatment of cancer, infectious diseases, and Alzheimer’s and other diseases, and potentially to uncover cures. Its impact on Americans could be profound.  Read the <a href="https://govcon.mofo.com/topics/us-government-launches-billion-dollar-biomedical-agency">full blog post</a>.

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Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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U.S. Government Launches Billion-Dollar Biomedical Agency

New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

As part of the Biden Administration’s ongoing efforts to spur innovation and research, it has championed the creation of a new sub-agency within the Department of Health and Human Services, the Advanced Research Projects Agency for Health (ARPA-H). 


U.S. Government Launches Billion-Dollar Biomedical Agency

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Brandy Guarda, Regulatory Analyst in Washington, D.C., contributed to the drafting of this post.On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised" target="_blank">COVID-19 Test Policy Guidance</a> to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations (EUAs). The agency will prioritize EUA reviews for:<ul><li>Diagnostic tests that are likely to have significant benefits for public health (such as those that employ new technologies);</li><li>Diagnostic tests that are likely to fulfill an unmet need (such as diagnosing infection with a new variant or subvariant); </li><li>Supplemental EUA requests for previously authorized tests when the request is intended to fulfill a condition of authorization or includes a modification that will significantly benefit public health or fulfill an unmet need; and </li><li>Tests for EUA requests from (or supported by) a U.S. government stakeholder, such as tests funded by the Biomedical Advanced Research and Development Authority or the National Institutes of Health’s Rapid Acceleration of Diagnostics. </li></ul>Note: There has been no movement on the draft <a href="https://content.govdelivery.com/accounts/USFDA/bulletins/301f58f" target="_blank">Transition guidances</a> since comments closed in March 2022, but we continue to monitor closely for any updates on this guidance. We recommend that test developers work with counsel to evaluate these new EUA guidelines and how their diagnostic tests may fit into the remaining prioritization categories. It will be essential to develop persuasive cover letters for FDA that hone in on the most innovative aspects of their tests and how they will advance public benefit, and to highlight these features of tests in early correspondence with the agency.

FDA Updates COVID-19 Test Policy

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FDA Updates COVID-19 Test Policy

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On September 27, 2022, the U.S. Food and Drug Administration (FDA) updated its COVID-19 Test Policy Guidance to encourage test developers to pursue full marketing authorization as opposed to Emergency Use Authorizations (EUAs).

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On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced by the industry. This guidance marks the final version of two previous iterations of this guidance—the first was released in 2017 titled “Clinical and Patient Decision Support Software” and was replaced by the draft issued on September 27, 2019. FDA’s substantially revised final guidance reflects the industry’s concerns and questions voiced during the comment period of the 2019 draft guidance. The final guidance does away with the risk-based framework detailed in the 2019 draft guidance, and instead provides additional details regarding FDA’s interpretation of each statutory criterion for non-device classification along with more than thirty specific demonstrative examples of device and non-device CDS functions.  Interpretation of Section 520(o)(1)(E) CriteriaIn the 2022 final guidance, FDA provides additional clarification of its interpretation of each of the four criteria in Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act. In order for a software function to be excluded from the device definition by the provision, and considered a non-device CDS function, it must meet all four criteria. 1. Not intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition systemSoftware functions that are intended to acquire, process, or analyze medical images, signals from in vitro diagnostic devices (IVDs), or patterns or signals from signal acquisition systems will remain devices subject to FDA oversight. The final guidance provides additional clarification regarding the definitions of “medical image,” “signal,” and “pattern.” <ul><li>Medical Image: FDA generally considers the term “medical image” to include images generated by medical imaging systems for medical purposes, such as x-ray, CT, ultrasound, and MRI images. Images that were not originally acquired for medical purposes but are now being processed or analyzed for a medical purpose are also considered medical images.</li><li>Signal: FDA interprets the term “signal” to include signals that typically require use of an IVD or a signal acquisition system that measures a parameter from within, attached to, or external to the body for a medical purpose. This often includes, but is not limited to, use of sensors, collection of samples or specimens, or use of radiological imaging systems. </li><li>Pattern: FDA interprets the term “pattern” in this context to refer to multiple, sequential, or repeated measurements of a signal or from a signal acquisition system. For example, for an electrocardiogram (ECG), an electrical signal is acquired from the body and processed to create an ECG waveform and QRS complex. For continuous glucose monitors, a photometric or electrochemical signal generated by an assay and instrument is processed to generate glucose measurements over time. These repeated measurement outputs are considered patterns.  </li></ul>FDA considers software functions that assess or interpret the clinical relevance of a signal, pattern, or medical image to fail this first criterion because they acquire, process, or analyze the data. For example, software functions that process or analyze an electrochemical or photometric response generated by an assay and instrument to generate a clinical test result do not meet the first criterion.2. Intended for the purpose of displaying, analyzing, or printing medical information about a patient or other medical informationFDA interprets “medical information about a patient” to mean the type of information that is normally communicated “between HCPs in a clinical conversation or between HCPs and patients in the context of a clinical decision, meaning that the relevance of the information to the clinical decision being made is well understood and accepted.” This includes software functions that display, analyze, or print patient-specific information like demographic information, symptoms, test results, and/or other medical information such as peer-reviewed clinical studies or clinical practice guidelines. In the final guidance, FDA identified sampling frequency as an important consideration in determining if information is considered “medical information” or a “signal” or “pattern.” FDA considers a “single discrete test or measurement result that is clinically meaningful (e.g., a blood glucose lab test result)” to be medical information, while a more continuous sampling of the sample information (e.g., continuous glucose monitor readings) would be considered a pattern or signal. FDA clarified that it “recognizes there is a continuum between a single sample and a continuous sample” and included more detailed examples for reference. 3. Intended for the purpose of supporting or providing recommendations to an HCP about prevention, diagnosis, or treatment of a disease or conditionFDA interprets this criterion to refer to software that provides condition, disease and/or patient-specific recommendations to a health care provider (HCP) “to enhance, inform and/or influence a health care decision but is not intended to replace or direct the HCP’s judgment.” In the final guidance, FDA expands on this criterion, adding two factors for consideration in determining whether a software function is being used to support or provide recommendations to an HCP: (1) the level of software automation and (2) the time-critical nature of the HCP’s decision-making. Both factors will be considered in determining whether a software function is being used to enhance, inform, and/or influence, or rather to substitute, replace, or direct the HCP’s judgment.In the final guidance, FDA dives into a discussion about automation bias in the context of CDS functions and the errors of commission or omission that may result if software provides an HCP user with a single, specific output or solution, especially in time-critical circumstances that require urgent action. FDA highlights instances involving time-critical decision-making and cases where software provides that a specific preventive diagnostic or treatment directive is failing this criterion because it is not intended to support or provide recommendations. Examples include software that provides a specific diagnostic or treatment course, a specific follow-up directive, or time-critical alarms and alerts intended to trigger potential clinical intervention to assure patient safety. The focus of this criterion is the preservation of HCP decision-making and judgment. Software functions that meet this criterion are those that provide evidence-based tools and make recommendations based on analysis of patient-specific information that an HCP may incorporate into its holistic decision-making process.  4. Intended for the purpose of enabling an HCP to independently review the basis for the recommendations that the software presents, and not intended that the HCP should rely primarily on any of those recommendations to make a clinical diagnosis or treatment decision regarding an individual patientThere were many questions from stakeholders in the industry regarding this fourth criterion and the requirements for satisfying independent review. In response, the new final guidance recommends that software or labeling:<ul><li>Include the purpose or intended use of the product, including intended HCP users and intended patient populations</li><li>Identify the required input medical information, with plain language instructions on how the inputs should be obtained, their relevance, and data quality requirements</li><li>Provide a plain language description of the underlying algorithm development and validation that forms the basis for the CDS implementation, including:</li><ul><li>Summary of the logic or methods relied upon to provide the recommendations,</li><li>Description of the data relied upon, and</li><li>Description of the results from any clinical studies conducted to validate the algorithm/recommendations.</li></ul></ul>In addition, FDA recommends the software outputs provide the HCP users with relevant patient-specific information and other known/unknown factors for consideration by the HCP in applying its judgment. In response to industry comments and questions regarding the difficulties associated with software complexity and proprietary information, FDA clarified that regardless of the complexity or proprietary nature of the software, the outputs or labeling “should provide adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation.” Relevant sources should be identified, available, and communicated in a way that is understandable to the intended users.  Device and Non-Device CDS Function ExamplesThe final guidance provides many specific examples of types of software that may be considered non-device CDS functions assuming they meet the requirements of the fourth criterion. These include, for example:<ul><li>Software functions that match patient-specific medical information to reference information routinely used in clinical practice to facilitate assessments of specific patients, like a software function that uses patient diagnosis and other medical information to provide an HCP with current practice treatment guidelines for common conditions such as influenza, hypertension, and hypercholesterolemia; </li><li>Software functions that analyze family history, prior mammogram results, and BRCA1 status from the medical record and recommend that an HCP consider increased mammography frequency or supplemental breast ultrasound for the patient;</li><li>Software functions that analyze the type of arthritis diagnosis in a patient record and identify prioritized treatment options available for that condition; and</li><li>Software functions that interpret daily results of a basic metabolic panel for a hospitalized patient and recommend several options for IV fluids that may be beneficial to ensure proper hydration and to prevent acidosis.</li></ul>The final guidance also provides examples specifically intended to clarify FDA’s interpretation of the fourth criterion—independent HCP review—as well as 34 separate examples of device software functions on which FDA intends to focus its regulatory oversight.Patient/Caregiver Decision SupportThe final guidance eliminates software functions that support or provide recommendations to patients or caregivers from the CDS function exclusion and will regulate that software as medical devices. FDA stated its intention to be consistent with existing policies in the regulation of CDS intended for non-HCPs and “will update existing policies, as appropriate, with additional examples as CDS for non-HCPs continues to evolve.”

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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FDA Releases Foundational Digital Health Guidance

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On September 27, 2022, the U.S. Food and Drug Administration (FDA) issued its long-awaited final clinical decision support (CDS) software function guidance. This final guidance presents a significant departure from the previous draft version issued three years prior, including updates to address concerns voiced by the industry. This guidance marks the final version of two previous iterations of this guidance—the first was released in 2017 titled “Clinical and Patient Decision Support Software” and was replaced by the draft issued on September 27, 2019. 

FDA Releases Foundational Digital Health Guidance

For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. However, test developers must act fast. The Food and Drug Administration is asking for notifications of intent to develop monkeypox diagnostic tests by October 13, 2022. On August 4, 2022, HHS Secretary Becerra declared a <a href="https://www.hhs.gov/about/news/2022/08/04/biden-harris-administration-bolsters-monkeypox-response-hhs-secretary-becerra-declares-public-health-emergency.html" target="_blank">Public Health Emergency</a> acknowledging the ongoing rapid transmission of monkeypox and the necessity of an urgent response. In a public health emergency, FDA requires in vitro diagnostic tests, including laboratory developed tests, to undergo premarket review to ensure the accuracy and reliability of such testing. To speed the availability of these tests, FDA has unique authorities during an emergency to issue emergency use authorizations (“EUAs”) under an expedited review process created by section 564 of the Federal Food, Drug, and Cosmetic Act. On September 7, 2022, Secretary Becerra signed a section <a href="https://www.hhs.gov/about/news/2022/09/07/hhs-secretary-becerra-issues-564-declaration-to-expand-the-availability-of-testing-for-monkeypox.html" target="_blank">564 Declaration</a> allowing FDA to use its EUA authority for in vitro diagnostics to more rapidly expand testing availability.To aid developers in preparing EUA submissions, on September 13th FDA issued a final guidance: <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-monkeypox-tests-address-public-health-emergency" target="_blank">Policy for Monkeypox Tests to Address the Public Health Emergency</a>. As noted in the guidance, “FDA intends to prioritize review of EUA requests for high-throughput diagnostic tests, tests with home specimen collection, or rapid all from experienced developers with high manufacturing capacity.” Significantly, FDA requested interested parties send an intent to submit an EUA by October 13, 2022. It should be noted that FDA does not expect EUA requests for certain validated diagnostic LDTs that are developed and performed in a single lab, that uses PCR, and when the only sample type is a lesion swab sample from a potential monkeypox lesion.FDA also issued an EUA template and summary template for molecular diagnostic tests, which are available for download on <a href="https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/monkeypox-emergency-use-authorizations-medical-devices">Monkeypox Emergency Use Authorizations for Medical Devices</a>. For general FAQs and regular updates, FDA is maintaining a Frequently Asked Questions page available here: <a href="https://www.fda.gov/medical-devices/monkeypox-and-medical-devices/faqs-testing-monkeypox">FAQs on Testing for Monkeypox</a>.Since issuing the declaration, FDA has issued one emergency use authorization for a <a href="https://www.fda.gov/media/161454/download" target="_blank">multiple target, Real-Time PCR test</a>. This test is joined on the market by the CDC-developed, FDA-cleared non-variola Orthopoxvirus (“NVO”) assay. FDA has further clarified that there are no current shortages of monkeypox tests, test kits, nor reagents, especially the CDC NVO assay.In addition, leadership from FDA’s CDRH Diagnostics Office (OHT7) will now host a weekly virtual town hall for monkeypox test developers beginning September 21, 2022 (12:05 - 1:00 p.m. ET). The webinar, in a similar format to the virtual town hall for COVID-19 test developers, will include announcing updates, addressing previously emailed questions, and answering live questions. Now that the town hall for COVID-19 test developers occurs on a monthly basis, there will be a monthly combined town hall addressing both COVID-19 and monkeypox updates and questions beginning on September 28, 2022 (12:05 - 1:00 p.m. ET). For monkeypox virtual town hall details, please visit the Virtual Town Hall Series - Monkeypox Test Development and Validation.MoFo’s FDA + Healthcare Regulatory and Compliance practice is following these developments closely and assisting developers in the preparation of their notifications and submissions. We look forward to assisting test developers as they respond to this unfolding public health emergency.

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New Opportunities for Test Developers: Monkeypox Diagnostics

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For in vitro diagnostic test developers, the monkeypox public health emergency presents an urgent public health need for testing as well as a unique opportunity for rapid regulatory review of testing products. 

New Opportunities for Test Developers: Monkeypox Diagnostics

Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the Companies Act 2006. This statute sets out various duties for directors of companies.Read the <a href="https://www.mofo.com/resources/insights/220901-key-considerations-for-early-stage-companies" target="_self">full client alert</a>.

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Simon Arlington is a partner based in the Corporate Group focusing on M&A and private equity.

Simon Arlington

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Associate

Michelle Luo is an associate in the firm’s London office and a member of the Technology Transactions, Intellectual Property and Global Privacy Groups.

Michelle Si-Ting Luo

Michelle Luo

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Key Considerations for Early-Stage Companies in the Alternative Protein Industry

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Companies in the UK are regulated by many statutes, ranging from those dictating how much tax they need to pay, to those centred on how they treat their employees. At a corporate level, the main statute that companies should be familiar with is the Companies Act 2006.

Key Considerations for Early-Stage Companies in the Alternative Protein Industry

Agtech

United Kingdom

On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. APHIS concluded that a new genetically engineered tomato produced by Norfolk Plant Sciences is unlikely to pose an increased plant pest risk compared to a conventional tomato, and is therefore not subject to regulation under the SECURE rule. This means that these tomato plants, which have been engineered to produce deep purple tomatoes with enhanced nutritional quality, may be legally imported, moved interstate, or “released” into the environment (including, for example, in a field trial) in the United States without a permit from APHIS.Notably, this finding also means that subsequent genetic transformation events involving the same combination of plant species, trait, and mechanism of action (“PTMOA”) as Norfolk Plant Sciences’ purple tomatoes are also no longer regulated under the SECURE rule. Thus, other subspecies and varieties of Solanum lycopersicum that have been modified to produce the same trait by the same mechanism of action—even if by different transgenic events—are now exempt under § 340.1(c) of the SECURE rule. More information on this so-called PTMOA exemption is available in APHIS’s “Guide for Requesting a Confirmation of Exemption from Regulations under 7 CFR part 340” (published August 31, 2022; document ID BRS-GD-2020-0001). This approach is different from the “event-by-event” regulation that was previously required, and represents the first time that APHIS has made an RSR determination under its new rules.Additional information about the contours of the SECURE rule and the genetic engineering that Norfolk Plant Sciences used to produce their purple tomato is provided below.About the SECURE RuleThe SECURE rule (7 CFR part 340) governs how APHIS regulates certain organisms developed using genetic engineering, with the goal of protecting U.S. agriculture from plant pest risks under the Plant Protection Act of 2000 (7 U.S.C. §§ 7701 et seq.). It replaced the previous version of 7 CFR part 340, which had been in place largely unchanged since APHIS’s biotechnology regulations were established in 1987, in phases between May 18, 2020 and October 1, 2021.The new regulations completely overhauled and streamlined the regulatory process for assessing the plant pest risk of organisms developed using genetic engineering, taking into account advances in scientific understanding, and focusing more on the properties of the engineered organism and less on the method(s) used to produce it.The revised regulations exempt certain types of modifications from regulation; such exemptions are self-determined, though developers may voluntarily request confirmation from APHIS that a given exemption applies. This exemption/confirmation process replaced the previous “Am I Regulated?” process on June 17, 2020, and APHIS has since issued 15 confirmation letters as of this writing, with the earliest in April 2021.However, no plant had made it through the new RSR process until now. The RSR process is an option for instances in which no SECURE rule exemptions apply to a given engineered plant, but the developer feels that the plant nonetheless does not pose an increased plant pest risk and should therefore not be regulated by the SECURE rule. The RSR process replaced the previous “petition” process for requesting deregulation from 7 CFR part 340 due to low likelihood of posing a plant pest risk.The RSR process became available for corn, soybean, cotton, potato, tomato, and alfalfa on April 5, 2021, and for all other plant species on October 1, 2021. APHIS received Norfolk Plant Sciences’ RSR request on August 4, 2021 and responded on September 6, 2022 (both the request and the response documents are available under RSR number 21-166-01rsr). As of this writing, Norfolk Plant Sciences’ tomato is the only RSR request publicly available on APHIS’s website.Under the RSR process, APHIS reviews “the biological properties of the plant; and the trait (or new characteristic); and the mechanism of action (or how the genetic modification causes the new trait to occur)” in order to evaluate plant pest risk. There are two potential steps to this process, depending on what APHIS determines during the first step. In Step 1, APHIS identifies whether the engineered plant poses a plausible pathway to increased plant pest risk compared to a “comparator” plant. If APHIS finds no such pathway, the RSR process concludes, and APHIS notifies the requestor that the plant in question is not subject to regulation under the SECURE rule. This was the outcome for Norfolk Plant Sciences’ tomato.On the other hand, if APHIS does determine that the engineered plant may plausibly pose an increased plant pest risk, there are several potential next steps. First, the developer may accept that the plant is regulated under the SECURE rule, and then either request a permit before moving or releasing the plant, or take no further action and not move or release the plant. Alternatively or additionally, the developer may request that APHIS proceed to Step 2 of the RSR process, which entails a more involved review, subsequent publication in the Federal Register, and solicitation and review of public comments before a final determination. As of this writing, no plant has gone through this second step of the RSR process.About the Purple TomatoAs described in its RSR request, Norfolk Plant Sciences created its purple tomato plant by Agrobacterium-mediated insertional mutagenesis of the “MicroTom” tomato variety, and subsequent crossing into other tomato varieties. The plants are engineered to increase expression of their natural anthocyanin pigments, which is what causes the fruits to have a deep purple color and also enhances their nutritional value.Specifically, the inserted DNA contains two transcription factors from the snapdragon plant (Antirrhinum majus), which serve to activate production of the tomato’s native anthocyanin biosynthesis pathway, causing increased anthocyanin production. Each of these two transcription factor genes, called Del and Ros1, is expressed from the T-DNA under a native tomato promotor that causes fruit-specific expression. The T-DNA also includes the nptII selectable marker with a promotor and terminator from Agrobacterium tumefaciens, which have a decades-long history of safe use and consumption.Complete genome sequencing revealed that the T-DNA was inserted at a single site in chromosome 4, accompanied by several small deletions. Phenotypic evaluation of the transformed plants revealed that they grew effectively the same as non-transgenic tomatoes, except that they produce deep purple fruit with significantly higher anthocyanin content. Photos of the plants and fruit are available in the published RSR request.APHIS considered the information disclosed in Norfolk Plant Sciences’ RSR request, alongside “publicly available resources, and APHIS’ familiarity with tomato and knowledge of the trait, phenotype, and mechanism of action” and “did not identify any plausible pathway by which [the] modified tomato, or any of its sexually compatible relatives, would pose an increased plant pest risk relative to a comparator tomato” (21-116-01 RSR Response, page 1). As such, APHIS concluded that these purple tomatoes are not subject to regulation under the SECURE rule.Other Regulatory AgenciesIt is important to note that deregulation from APHIS’s SECURE rule does not mean that the plant is wholly removed from U.S. federal regulatory oversight. For example, regulations implemented by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and/or other arms of USDA (such as Plant Protection and Quarantine (PPQ) import and export regulations, and/or Agricultural Marketing Service (AMS) labeling requirements) may still apply. Along those lines, Norfolk Plant Sciences’ RSR request states that Norfolk Plant Sciences submitted a food and feed safety and nutritional assessment of the Purple Tomato to FDA under the voluntary <a href="https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=NewPlantVarietyConsultations&sort=BNF_No&order=DESC&type=basic&search=">Biotechnology Notification Consultation program</a>, which was received as BNF number 178. As of this writing, FDA has not yet published a completed consultation for Norfolk Plant Sciences’ purple tomato.ConclusionThis regulatory review is an important milestone for regulation of genetically engineered plants in the United States. It is the first public test of the SECURE rule’s RSR process since its implementation more than a year ago, when it became one of the most scientifically progressive such review processes in the world, at least on paper. The deregulation of Norfolk Plant Sciences’ purple tomatoes shows that USDA-APHIS is embracing its new product-focused regulations. Although the review took more than a year—significantly longer than the 180 days promised by APHIS for Step 1—the process will likely become more efficient as the agency and developers become more familiar and comfortable with the new system. It will be interesting to see how the exemption and review processes grow and possibly become more streamlined with additional use.

Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

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Purple Tomato Is First Genetically Engineered Plant to Be Deregulated Through USDA’s New Regulatory Status Review Process

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On September 7, 2022, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) announced the completion of the first Regulatory Status Review (RSR) of a genetically engineered plant under the SECURE rule. 