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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FDA Releases Foundational Digital Health Guidance | MoFo Life Sciences

Brigid DeCoursey Bondoc

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.”

FDA Releases Foundational Digital Health Guidance

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