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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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

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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. 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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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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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

The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses by detecting patterns in clinical data associated with disease, improving surgical outcomes through preoperative and intraoperative surgical guidance, and enabling the development of personalized diagnostics and therapeutics. Medical device companies should look to build a robust patent portfolio for their ML inventions. This raises the question of how to build a patent portfolio for ML inventions in the medical device field. ML involves the training of mathematical models to draw conclusions from data, such as medical images or other clinically relevant data. While mathematical models by themselves are not eligible for patenting, their application to achieve practical results is patentable. Broadly speaking, patents for ML‑based inventions fit into three broad categories. <ul><li>Applications of ML. This category includes patents directed to novel results achieved using ML. Examples of ML applications in the medical device field include automatic identification of anatomical structures in imaging, automatic diagnoses from patient data, and patient recovery tracking. Patents in this category are often the most valuable, both because of their breadth of coverage and because infringing activity can be readily detected, often from advertising materials and use of the product. </li><li>Structure of the ML model. The structure of the ML model refers to the structure of the mathematical algorithm itself and how it processes data. Although mathematical algorithms by themselves are not eligible for patenting, the application of a novel ML model to a practical application can be patented. Patents in this category are often less valuable because their scope is narrower and detection of infringement is more difficult.</li><li>ML model training. This category includes patents directed to the process for training an ML model to achieve its purpose. Training of an ML model is critical to how well it performs and thus can be one of the most important aspects of developing an ML solution. However, infringement of patents in this category is often very difficult to detect because the process for training is typically not advertised or apparent from the use of the product.</li></ul>Although patents directed to the applications of ML are typically the most valuable, medical device companies should also pursue patents to ML model structure and training because these patents contribute to the benefits that a robust patent portfolio provides, including:<ul><li>Deterring others from practicing the invention. Patents, of course, can be used to prevent others from making and using an invention. However, patents that are unlikely to ever be asserted still serve as a deterrent from copying and as a roadblock to the ability of competitors to innovate their own products. </li><li>Providing freedom to operate. Filing a patent application ensures that an invention is in the public space and thereby cannot be patented by anyone that invents the same thing later. Preventing others that create the same invention at a later date from patenting the invention ensures a company’s ability to practice its own technology. This is an important countervailing consideration to keeping an ML invention as a trade secret since trade secret protections do not protect against independent invention and patenting.</li><li>Advertising to investors. This benefit is most relevant to emerging companies looking for investments or acquisitions. Patents can serve as advertisements of the technical capabilities and sophistication of a company. They provide investors with the ability to “look under the hood” and make their own independent assessment of the value of the underlying ML technology.</li></ul>Given the increasing importance of ML in the medical device market, robust patent portfolios protecting ML innovations can help ensure that medical device companies reap the benefits of their valuable innovations.

The Importance of Patents for ML-Based Medical Device Inventions

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Christopher Gloria is a partner in the firm’s Patent Group. Mr. Gloria’s practice concentrates on domestic and international patent prosecution, IP due diligence, and IP litigation support including patent infringement and validity determinations.

Christopher Gloria

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The Importance of Patents for ML-Based Medical Device Inventions

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The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies.

Our Federal Circuitry blog recently discussed the Court's decision in <a href="https://cafc.uscourts.gov/opinions-orders/19-2054.OPINION.8-11-2022_1990706.pdf" target="_blank">Hologic, Inc. v. Minerva Surgical, Inc.</a>, No. 19-2054.You should read this case if: you want to know how the Federal Circuit will treat assignor estoppel post-MinervaYou have to feel a little sorry for a party that beats the incredible odds of getting Supreme Court review only to end up with the same result. That’s what happened in our case of the week. Unless you’ve been living under a rock (or the proverbial equivalent of a rock in patent-land—the MPEP maybe), you’re no doubt aware of one of the few relatively recent Supreme Court patent cases: <div><a href="https://www.supremecourt.gov/opinions/20pdf/20-440_9ol1.pdf" target="_blank">Minerva Surgical, Inc. v. Hologic, Inc. </a>(And once again, here’s where a few readers shed a tear for what could have been in American Axle.) As a recap, the Supreme Court granted cert to decide whether the doctrine of assignor estoppel found any support in patent law. Assignor estoppel precludes an assignor of a patent from later challenging that patent’s validity. At least initially, smart money was on the “no” side, as nothing in the U.S. Code expressly provides for assignor estoppel, and this is supposedly a textualist Supreme Court.</div>

Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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Brian Matsui co-chairs Morrison Foerster’s Appellate and Supreme Court practice. Brian is a go-to appellate advocate for sophisticated clients in complex appeals nationwide. 

Brian R. Matsui

Brian Matsui is a partner in Morrison Foerster’s Appellate and Supreme Court practice. For nearly 20 years, Brian has been a go-to appellate advocate for sophisticated clients in complex appeals nationwide. Clients turn to Brian for his substantial experience in patent appeals in the Federal Circuit. He has argued more than 10 times in that Court, winning appeals from both district courts and the Patent Trial and Appeal Board. Brian excels at applying significant legal principles to complex technologies in a way that distills them for the Court. He has done so for companies in a myriad of industries, including mobile device manufacturers, pharmaceutical companies, medical device companies, memory manufacturers, movie studios, and software companies.

Brian Matsui

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Last Week in the Federal Circuit (August 8 – August 12): Taking a round Trip on the Assignor Estoppel Express

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For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the defendant in Minerva. Below we provide our usual weekly statistics and a detailed discussion of our case of the week—our highly subjective selection based on whatever case piqued our interest.

Research assistant Nicole Gebert contributed to this article.<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html">Part 1</a> of this article discussed the background and purpose of the <a href="https://eur-lex.europa.eu/eli/reg/2017/746/oj" target="_blank">EU In Vitro Diagnostic Regulation (EU) 2017/746</a> (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system, conformity assessments, and the role of notified bodies. This was followed by <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a>, where we discussed clinical evidence, post-market surveillance, and transition periods. We will now focus specifically on requirements for medical device software (MDSW) as an IVD (IVD-MDSW) and the delimitation between the application of the <a target="_blank" href="https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745">EU Medical Device Regulation (EU) 2017/745</a> (MDR) and application of the IVDR to a software device.<h2>Qualification as IVD-MDSW</h2>As already mentioned in<a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank"> part 1</a> of this article, the expanded IVDR definition of “in vitro diagnostic medical devices” in Article 2 (2) now explicitly includes software.IVD-MDSW usually occurs in the following forms:<ul><li>Software itself as an IVD</li><li>Software as an accessory for an IVD</li><li>Software driving or influencing the use of an IVD</li></ul>The first stage in determining whether the software is an IVD-MDSW subject to the IVDR is to confirm that the software is a medical device (MDSW).<ul><li>The Medical Device Coordination Group (MDCG) guideline <a href="https://ec.europa.eu/docsroom/documents/37581?locale=en" target="_blank">MDCG 2019-11</a> clarifies that MDSW is software intended to be used alone, or in combination, for a purpose as specified in the definition of “medical device” in the MDR or IVDR (for more information on the intended purpose of MDSW under the MDR, see part 2 our <a href="https://lifesciences.mofo.com/topics/Software-as-Medical-Device-in-Eu--New-Reg-Enter-into-Force--Part-2-of-6.html" target="_blank">MDR blog series</a>). In general, software that processes, analyses, creates, or modifies medical information will qualify as MDSW if it is intended to have a medical purpose. Software for non-medical purposes, or for general purposes, even when used in a healthcare setting, or software intended for well-being purposes, is not covered by the MDR and IVDR. Software that merely used to store, archive, or performs simple searches on medical data does not qualify as MDSW.</li></ul>Second, the software must meet the following criteria to qualify as IVD-MDSW:<ul><li>The MDSW provides information within the scope of the definition of IVDs; </li><li>MDSW creates information based on data obtained by an IVD only; or</li><li>The intended purpose of the MDSW is substantially driven by data sources coming from IVDs.</li></ul>In accordance with the second step, an MDSW that analyses maternal parameters such as age, concentration of serum markers, and information obtained through various IVD assays, as well as fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered an IVD-MDSW as the intended purpose is substantially driven by IVD data.MDSW that does not fulfill this second step is covered exclusively by the MDR. This includes, for example, MDSW that assesses the level of risk to initiate care processes that help reduce intensive care unit (ICU) transfers, readmissions, adverse events, and the duration of stay, by considering risk assessment parameters like respiratory rate, heart rate, blood pressure, and SpO2, by default, and can be configured by the user to include other parameters as well, including results from in vitro medical diagnostic devices. This MDSW would fall under the MDR as (i) the data is obtained from both IVDs and medical devices, and (ii) the data obtained from the IVD is not critical to the output, so the information derived from the medical device is more relevant to the intended purpose.<h2>Risk Classification of IVD-MDSW According to the IVDR</h2>In <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article, we discussed the adoption of a new classification system. We also pointed out that the IVDR does not contain software-specific classification rules, like Rule 11 of Annex VIII to the MDR. Therefore, the classification of MDSW under the IVDR requires consideration of all classification and implementation rules of Annex VIII to the IVDR.The classification system of the IVDR considers the intended purpose of the device and the inherent risks, and groups devices into four different risk classes (classes A to D) in ascending order of their risk intensity. For example, software for the interpretation of automated readings of line immunoassay for the confirmation and determination of antibodies to HIV-1, HIV-1 group O, and HIV-2 in human serum and plasma, may be a device intended to be used for determining the infectious load of a life-threatening disease where monitoring is critical in the process of patient management under rule 1 of Annex VIII to the IVDR and would thus be classified in class D. At the same time, the IVD-MDSW referred to above, which uses maternal parameters and information obtained through fetal ultrasound examination to evaluate the risk of trisomy 21, may be considered a device that is intended for screening for congenital disorders in the embryo or fetus under Rule 3 (l) of Annex VIII to the IVDR and should thus be in class C.However, given the close nature of the MDR and the IVDR, there are of course similarities in the regulation of MDSW. Very similar to the risk assessment under the software-specific rule 11 of Annex VIII to the MDR (i.e., which effectively provides for class IIa ranking as a default result and therefore requires notified body review of most MDSW), the risk assessment of MDSW under the IVDR will in most cases result in a class B ranking (or higher) and therefore also require the IVD-MDSW to undergo an conformity assessment by a notified body. This is because IVDs, including IVD-MDSW, which are not covered by any specific classification rule, fall under class B by default (Rule 6 of Annex VIII of the IVDR).<h2>Technical Documentation for IVD-MDSW</h2>Before placing IVDs on the market, most manufacturers will need to get their technical documentation assessed by a notified body (see <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-1-of-3.html" target="_blank">part 1</a> of this article for IVDR conformity assessment routes). The IVDR stipulates several software-specific requirements for the technical documentation in Annex II:<ul><li>The device description and specification should include a description of any software that drives the device or influences use of the device (Annex II 1.1.k).</li><li>For IVDs that incorporate software, the design information should include a description of any software to be used with the device, as well as an overview of the entire system. If the IVD uses software for objective data interpretation, or if the software is independent of any other device, a description of the data interpretation methodology, namely the algorithm, should be included (Annex II 3.1).</li><li>The documentation should further contain evidence of software validation as used in the finished device, as well as address all hardware configurations and, where applicable, operating systems identified in the labeling (Annex II 6.4, EN ISO/IEC 62304 is considered the state of the art approach).</li></ul>Several guidelines for IVDR technical documentation submissions have been issued by notified bodies and should be taken into consideration when dealing with the respective notified body (e.g., TÜV Rheinland, BSI).<h2>Introduction of a Unique Device Identification Requirement for IVD-MDSW</h2>The IVDR, like the MDR, introduces the Unique Device Identification (UDI) system. Annex VI Part C 6.2 of the IVDR addresses the UDI assignment for software specifically. In accordance with the IVDR, software that is commercially available on its own (i.e., standalone IVD-MDSW), as well as software that constitutes an IVD device, shall be subject to UDI requirements. These requirements are identical for MDSW under the MDR and for IVD-MDSW under the IVDR. More details on how to identify software devices can be found in <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe--New-Regulatory-Regime-About-To-Enter-Into-Force--Part-5-of-6.html" target="_blank">part 5</a> of our blog series on the MDR.<h2>IT Security</h2>Among the many novelties introduced, the IVDR and the MDR aim to ensure that devices placed on the EU market are suitable for the new technological challenges associated with cybersecurity risks.IVDs must thus be designed and manufactured in a way that removes or reduces risks associated with the possible negative interaction between software and the IT environment in which it operates and interacts (Annex I Chapter II 13.2.d). Manufacturers must establish, implement, document, and maintain a risk management system. Particularly with the complexity of software development, software configuration, and interdependencies between software components, IVD-MDSW is afflicted with security vulnerabilities. It is therefore considered more reasonable that software as such is subject to foreseeable misuse. Manufacturers should foresee or evaluate the potential exploitation of those vulnerabilities.Manufacturers must also develop and manufacture IVD-MDSW in accordance with the state of the art, while taking into account the principles of development lifecycle and risk management, including information security, verification, and validation. Manufacturers also need to set out minimum requirements concerning IT network characteristics and IT security measures, including protection against unauthorized access (Annex I Chapter II (16) IVDR).Further information can be found in the MDCG Guidance on Cybersecurity for medical devices (<a href="https://ec.europa.eu/health/system/files/2022-01/md_cybersecurity_en.pdf" target="_blank">MDCG 2019-16</a>).<h2>Performance Evaluation of IVD-MDSW</h2>Although the IVDD already required a performance assessment, it was only implied, not explicitly stated, and primarily concerned with the analytical performance of the device. Under the IVDR, any software that qualifies as an IVD must meet all clinical evidence and performance evaluation principles explicitly outlined in Article 56 (1) and Annex XIII of the IVDR. The MDCGs Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software (<a href="https://ec.europa.eu/health/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eva_md_software_en_0.pdf" target="_blank">MDCG 2020-1</a>) aims to provide the framework for the determination of the appropriate level of clinical evidence required for MDSW to fulfill the requirements set out in the IVDR (and MDR).Although the definition of clinical evaluation in the MDR and performance evaluation in the IVDR are not identical, sufficient clinical evidence is expected in both cases to demonstrate compliance with the relevant general safety and performance requirements.When collecting clinical evidence for IVD-MDSW, three key elements should be taken into account:<ul><li>Scientific validity;</li><li>Analytical performance; and</li><li>Clinical performance.</li></ul>Part A of Annex XIII applies primarily to the pre-market phase and defines performance evaluation as a three-step process: (i) drafting a performance evaluation plan, (ii) collecting data to demonstrate scientific validity and analytical and clinical performance, and (iii) evaluating and documenting the data in a performance evaluation report.Part B of Annex XIII concerns the post-market phase and outlines the requirements for post-market performance follow-up. This concept was not included in the IVDD, but is in line with the practice of many manufacturers to conduct a periodic “state of the art” review.<h2>Concluding Remarks</h2>Under the IVDR, IVD-MDSW is subject to several software specific requirements. As most IVD-MDSW will likely end up in class B or higher, manufacturers will also need to undergo notified body review in order to be able to place IVD-MDSW on the market. Therefore, it can be expected that a number of manufacturers will make use of the transition periods discussed in <a href="https://lifesciences.mofo.com/topics/eu-in-vitro-diagnostic-regulation-entered-into-force--part-2-of-3.html" target="_blank">part 2</a> of this blog series. However, as discussed in more detail in <a href="https://lifesciences.mofo.com/topics/Software-as-medical-device-in-Europe-new-regulatory-regime-to-enter-into-force-part-6.html" target="_blank">part 4 of our blog series on MDSW under the MDR</a>, in particular MDSW manufacturers should be aware of the implications that come along with the use of transition periods as the IVD-MDSW may not undergo any significant changes to its design or intended purpose in order to benefit from such transition periods.

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in the digital, high-tech, life sciences, and pharmaceutical industries.

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Counsel

Robert advises companies from the technology and life sciences sectors on a wide range of commercial, intellectual property (IP) and regulatory matters. His clients range from multinational corporations to startups and scaleups.

Robert Grohmann

Robert Grohmann is counsel at Morrison Foerster’s German office in Berlin. As a member of the technology transactions group, he focuses on advising domestic and foreign companies and startups in all areas of technology and IP law, including patent and software licensing, employee inventions law, as well as know-how protection. Moreover, Mr. Grohmann’s expertise encompasses the judicial and extra-judicial representation in matters of trademark law, design law, and competition law.

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EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)

FDA Clinical Decision Support Software vs. EU’s Medical Device Regulation

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Research assistant Nicole Gebert contributed to this article.
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulati

EU: IN VITRO DIAGNOSTIC REGULATION ENTERED INTO FORCE (PART 3 OF 3)