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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Because No One is Immune to the Law

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In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon go

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Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6) | MoFo Life Sciences

Stephan Kreß

Robert Grohmann

In Part 2 of our <a target="_blank" href="https://lifesciences.mofo.com/topics/Software-as-a-Medical-Device-in-Europe--New-Regulatory-Regime-About-to-Enter-into-Force--Part-1-of-6.html?utm_source=linkedin_elevate&utm_medium=social">series of consecutive articles</a> on the reformed regulatory framework under the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation 2017/745</a> (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition of “medical device” and the importance of the intended purpose of healthcare-related standalone software in determining the regulatory requirements of companies offering such software in the EU.<h4>Introduction: The Relevance of the Intended Purpose</h4>As is already the case under the current <a target="_blank" href="https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:en:PDF">EU Medical Device Directive 93/42/EEC</a> (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains the critical factor when determining the obligations regarding regulatory compliance with the European medical devices regime. The intended purpose establishes whether standalone software is considered a medical device in the first place.[1]In particular with regard to so-called health apps or other apps related to biological functions or wellbeing (e.g., related to fitness, diet, sleeping habits, or mental health), no bright line can be drawn between normal software and MDSW. For example, an app that allows the user to monitor his or her food habits for weight control purposes will qualify as normal software, while the same app might qualify as medical device if the monitoring is intended to be used for prevention of diseases such as metabolic disorders. A standalone software application that is claimed by its manufacturer to be a natural method of birth control and in which the user enters certain parameters (first day of menstruation, body basal temperature, etc.) in order to obtain the fertility window, should qualify as a medical device as it is intended to prevent pregnancy or facilitate conception.The following table highlights some of the distinctions:<table border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="312" valign="top" style="width: undefined%; height: auto;">Medical purpose</td><td width="312" valign="top" style="width: undefined%; height: auto;">Non-medical purpose</td></tr><tr><td width="312" valign="top" style="width: undefined%; height: auto;">Prevention or diagnosis of disease or injury</td><td width="312" valign="top" style="width: undefined%; height: auto;">Patient medical education (e.g., giving general health tips)</td></tr><tr><td width="312" valign="top" style="width: undefined%; height: auto;">Treatment or alleviation of disease or injury (e.g., giving instructions to alleviate symptoms such as tinnitus)</td><td width="312" valign="top" style="width: undefined%; height: auto;">Monitoring of general fitness (e.g., physical exercise tracker), general health, and general wellbeing (e.g., wellness diary)</td></tr><tr><td width="312" valign="top" style="width: undefined%; height: auto;">Decision support or decision-making (e.g., with regard to therapeutic measures)</td><td width="312" valign="top" style="width: undefined%; height: auto;">Communication or simple search functions (e.g., finding a certain healthcare specialist)</td></tr><tr><td width="312" valign="top" style="width: undefined%; height: auto;">Control of conception</td><td width="312" valign="top" style="width: undefined%; height: auto;">Storing and displaying medical data (e.g., weight or body fat) without any change or analysis</td></tr></tbody></table> In this regard, we want to focus on three changes introduced by the MDR that are particularly noteworthy.<h4>1. Expansion of the Definition of “Medical Device”</h4>The MDR broadens the scope of medical purposes that are covered by adding new specifications to the list of relevant medical purposes. The full list of medical purposes under Article 2(2) of the MDR thus reads as follows (emphasis added to highlight the changes compared to the MDD):<ul><li>Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease;</li><li>Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;</li><li>Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;</li><li>Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations; or</li><li>Control or support of conception.</li></ul>For standalone software, in particular, the addition of prediction and prognosis of disease can become relevant, e.g., for software providing healthcare professionals with information on a patient’s future health prospects or likely individual outcomes of a certain therapy. The importance of this addition also becomes palpable when looking at current COVID-19 apps. Based on a person’s recent contacts, such apps often make a prognosis with regard to the risk of the user developing COVID-19, while the app would not be in a position to actually diagnose the infection.<h4>2. Expansion of Relevant Material and Product Life Cycle Approach</h4>The MDR comprehensively includes further material to be considered when assessing the medical purpose. Under current law, according to Article 1(2)(g) of the MDD, “intended purpose” means the use for which the device is intended according to “the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.” In this regard, Article 2(12) of the MDR now also lists sales materials and statements to emphasize that any such information in whatever form given will be relevant. It also includes the specifications made by the manufacturer in the clinical evaluation (regarding the increased importance of the clinical evaluation, as we will describe in Part 4 of this series, available from March 5, 2021), which will require manufacturers to put even greater care on the framing of the intended purpose.In line with the new product life cycle-focused approach of the MDR, it further intends to prohibit any attempts by the manufacturers to expand the intended purpose after the conformity assessment has been carried out. Article 7(d) of the MDR stipulates this expressly and prohibits the use of text, names, trademarks, pictures, or signs in the labelling; instructions for use; or making available, putting into service, and advertising of devices that are not in compliance with the intended purpose for which the conformity assessment was carried out.<h4>3. The Intended Purpose Is Not the Only Factor Qualifying a Product as Medical Device</h4>The MDR introduces in its Annex XVI groups of products (e.g., contact lenses) that irrespective of their intended purpose qualify as medical devices. While these product groups currently are not relevant with regard to standalone software, this may change as Annex XVI will likely be expanded over time.<h4>Concluding Remarks</h4>Even though the changes introduced to the regulation of software by the MDR may seem subtle at first glance, developers and stakeholders in the fields of digital health, fitness, and wellbeing should be aware that more products might be regulated in the foreseeable future. The MDR will make inevitable a careful assessment of the intended purpose of apps and other software products, which must cover every part of their documentation and advertisement. Framing the purpose of MDSW correctly will not only determine the applicability of the MDR but also potentially limit the scope of use for which an app can be marketed. Only a proactive and consistent approach in this regard will prevent any interference by the competent authorities and secure a smooth transition into the future market under the MDR. [1] Software also falls under the MDR’s framework if the software is intended for controlling or influencing the performance of medical devices or is an “accessory for a medical device” within the meaning of Article 2(2) of the MDR. In this series, however, we focus on standalone software.

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