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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Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
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Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016

Quality Management System Regulation (QMSR) – Harmonizing the Quality System Regulation (QSR) with ISO 13485:2016 | MoFo Life Sciences

Brigid DeCoursey Bondoc

Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.The U.S. Food and Drug Administration (FDA) issued the much-anticipated <a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">proposed rule</a> “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820) with the international standard specific for medical device quality management systems set by the International Organization for Standardization, ISO 13485:2016.  QSR has been the core regulation for device manufacturing in the United States since its implementation over 20 years ago.  Medical device establishments have come to have an increasingly international presence, necessitating significant efforts to comply with different requirements.  In order to reduce compliance costs for industry and harmonize domestic and international requirements, FDA first signaled its <a target="_blank" href="https://www.fda.gov/media/123488/download">intent</a> to align its QSR with the ISO 13485:2016 in December 2018, and estimated that a proposed rule would be issued in fall 2019.  After delays likely caused by FDA’s shift in priorities to focus on the COVID-19 response, the agency finally published the proposed rule last month.  The long-awaited and long-delayed proposed rule, if finalized, will rename 21 CFR Part 820 as “Quality Management System Regulation” (QMSR), and will harmonize the U.S. good manufacturing practices with international standards.  The proposal projects to save medical device establishments hundreds of millions of dollars in compliance costs. Many expected that FDA would rewrite QSR in order to align the U.S. regulatory framework with the ISO standard.  To the surprise of many, FDA performed a gap analysis and now proposes to incorporate ISO 13485 by reference rather than re-writing the regulation in its entirety.  ISO 13485 was first introduced in 1996, around the same time when FDA significantly revised Part 820, establishing the current QS regulation.  ISO 13485 went through many revisions since its first issuance, and its most current version has become more closely aligned with the requirements in part 820.  Notably, the 2016 updates to ISO 13485 included several requirements mandated by FDA under its QSR, such as document control and records management, particularly as both relate to protecting confidential information.  This alignment, as well as the agency’s commitment to global regulatory harmonization of medical device regulatory processes, prompted FDA to further explore incorporating the Quality Management System (QMS) requirements of ISO 13485:2016 into Part 820.  However, this “incorporation by reference” approach only applies to the current 2016 version of ISO 13485 and “[a]ny future revisions to this standard would need to be evaluated” before being incorporated.  As before, the proposed rule will only apply to finished devices, although FDA reiterates that it has the legal authority to apply the quality system requirements to manufacturers of components or parts of finished devices when needed.  The proposed QMSR, a nine-page document, is a “gap regulation” that is intended to be read in conjunction with ISO 13485.  Specifically, the proposed rule addresses FDA-specific requirements by adding necessary requirements and definitions that are absent from ISO 13485 and removing redundant or inconsistent regulations from Part 820.  For example, the proposed rule removed the term “device master record” (DMR) because (1) the concept is covered by ISO 13485’s Clause 4.2.3 on medical device files (MDF) and (2) under the QSR, the DMR is part of the design history file, which is inconsistent with the ISO standard.  Below are some key sections of the new proposed rule.Inspection.The proposed rule does not impact FDA’s authority to conduct inspections under section 704 of the Food Drug and Cosmetic Act (“FD&C Act”) (21 U.S.C. § 374).  However, FDA intends to replace its current inspection approach for medical devices, the Quality System Inspection Technique (QSIT), with an inspection approach that will be consistent with the requirements of the proposed Part 820 as finalized.  Similar to the current QSIT inspection approach, these inspections would involve the collection of information to support observations noted during the inspection and included on FDA Form 483, as appropriate and necessary.  FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485 or the revised Part 820.  In addition, manufacturers with a certificate of conformance to ISO 13485 are not exempt from FDA inspections.  Firms will need to participate in the Medical Device Single Audit Program (MDSAP) to avoid routine FDA inspections.Supplementary Provisions.  To fill the gap with ISO 13485, the proposed rule seeks to add (1) control of records (proposed section 820.35) and (2) device labeling and packaging controls (proposed section 820.45) to ensure consistency and alignment with other requirements in the FD&C Act and its implementing regulations.  For control of records, the agency plans to add the following requirements: <ul style="text-align: left;"><li>First, signature and date requirements will be required for records subject to Clause 4.2.5 of ISO 13485 (Control of Records).  </li><li>Second, information required by Part 803 (Medical Device Reporting) must be captured on certain records of complaints and servicing activities.  </li><li>Third, firms need to document in their records the Unique Device Identification (UDI) for each medical device or batch of medical devices in accordance with Part 830.  </li><li>Fourth, FDA proposes to retain the clarification from current Part 820 (section 820.180) about confidentiality of records FDA receives to remind firms that FDA protects such records in accordance with Part 20.</li></ul>For device labeling and packaging, ISO 13485 only states that “defined operations for labeling and packaging shall be implemented” without specifically addressing the inspection of labeling by the manufacturer.  Given that many device recalls are related to labeling and packaging, FDA proposes to supplement the ISO standard by retaining requirements from the current Part 820 (i.e., Subpart K).  If finalized, regulated industry must meet the requirements in ISO 13485 7.5.1 (Control of Production and Service) and the proposed section 820.45.Table 1—High-Level Summary of 21 CFR Part 820 Proposed Rule Differences and Additions<table style="text-align: left;" border="1" cellspacing="0" cellpadding="0"><tbody><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Current part 820 </td><td width="229" valign="top" style="width: undefined%; height: auto;">ISO 13485 requirements </td><td valign="top">Proposed rule</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart D—Document Controls</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 4. Quality Management System</td><td valign="top">Differences addressed in 820.35</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart M—Records</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 4. Quality Management System</td><td valign="top">Differences addressed in 820.35</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart K—Labeling and Packaging Control</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 7. Product Realization</td><td valign="top">Differences addressed in 820.45</td></tr><tr><td width="165" valign="top" style="width: undefined%; height: auto;">Subpart N—Servicing</td><td width="229" valign="top" style="width: undefined%; height: auto;">Clause 7. Product Realization</td><td valign="top">Differences addressed in 820.35</td></tr></tbody></table>Risk Management.  Compared to the current QSR, which only explicitly addresses risk management activities in relation to design validation, the ISO standard has a greater emphasis on risk management activities and risk-based decision-making throughout the quality management system (QMS) processes.  Risk management for device manufacturers is the essential systematic practice of identifying, analyzing, evaluating, controlling, and monitoring risk throughout the product lifecycle to ensure that the devices they manufacture are safe and effective.  FDA expects the explicit integration of risk management throughout the clauses of ISO 13485 will send a clear message to manufacturers that it is necessary to “integrate risk management activities throughout their QMS and across the total product lifecycle.”On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting.  While most industry stakeholders embraced the agency’s proposal, some have complained that the implementation period is too quick, saying that two years, rather than one, is a more appropriate timeframe.  Stay tuned for more detailed coverage about industry concerns in our next blog.Comments on the proposed rule can be submitted in the Federal Register (<a target="_blank" href="https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments">Docket No. FDA-2021-N-0507</a>) until May 24, 2022, and the proposed rule is expected to be effective one year after finalization.<div style="position: absolute;left: -10000px;top: 0px;width: 1px;height: 1px;overflow-x: hidden;overflow-y: hidden;text-align: left;" id="_mcePaste"> <p style="background-image: initial;background-position-x: initial;background-position-y: initial;background-size: initial;background-repeat-x: initial;background-repeat-y: initial;background-attachment: initial;background-origin: initial;background-clip: initial;background-color: white;vertical-align: baseline;" class="MsoNormal"> </div>

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