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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After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of plants produced through modern biotechnology and compare that regulatory regime to the EU’s proposed regulation.

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The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation? | MoFo Life Sciences

Liz Freeman Rosenzweig Ph.D.

Brigid DeCoursey Bondoc

Michael Ward Ph.D.

After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">recent post</a>. Here, we provide a brief overview of U.S. regulation of plants produced through modern biotechnology and compare that regulatory regime to the EU’s proposed regulation.Update: As of July 5th, the final proposal is publicly available on <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52023PC0411" target="_blank">Eur-Lex</a>.Overview of U.S. Regulation of Plants Produced through Modern BiotechnologyThe U.S. regulation of plants produced through modern biotechnology (including, e.g., gene-edited plants) is similar in many respects but also differs considerably from the EU Commission’s proposed risk-based regulatory approach. In general, both reflect the growing international trend towards loosening regulations for gene-edited plants that are closely related to conventional breeding. However, the way this is overseen in the United States does not exactly correspond with the new EU developments.Federal regulation of plants produced through modern biotechnology in the United States is distributed across three federal agencies in an often overlapping manner, with each agency’s regulations reflecting implementations of different statutes, the various motivations and definitions of which do not always align.The United States regulates plants produced through modern biotechnology with the <a href="https://www.usda.gov/topics/biotechnology/how-federal-government-regulates-biotech-plants" target="_blank">Coordinated Framework for the Regulation of Biotechnology</a>, which was established in 1986 as a collaborative approach across the following U.S. agencies: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the Department of Agriculture (USDA).The EPA regulates the sale, distribution, and use of pesticides, including Plant Incorporated Protectants (PIPs) that <a href="https://www.epa.gov/pesticides/epa-finalizes-rule-accelerate-use-plant-incorporated-biotechnologies-protect-against" target="_blank">could not have been developed through conventional breeding</a>. PIPs are plant-produced pesticidal substances, such as a plant protein that inhibits fungal growth, and the genetic material that can cause a plant to produce that substance. They may or may not be genetically edited.The FDA, in parallel, regulates the safety of food, including animal feed and food additives — <a href="https://www.fda.gov/food/food-new-plant-varieties/new-plant-variety-regulatory-information" target="_blank">regardless of whether they have been genetically edited</a>.The USDA’s regulation <a href="https://www.ams.usda.gov/rules-regulations/be/regulated-entities" target="_blank">includes mandatory labeling/disclosure administered by the Agricultural Marketing Service</a> (USDA-AMS) and regulation of importation, transportation, and environmental release of plants and plant pests developed using genetic engineering that may pose a risk to plant health by the Animal and Plant Health Inspection Service (USDA-APHIS).Of these U.S. regulations, the most comparable to the proposed EU NGT regulation is USDA-APHIS’s Revised Biotechnology Regulations (previously known as the SECURE rule), which were revised in May 2020. Key Differences in U.S. and Proposed EU RegulationThe SECURE rule contains <a href="https://www.ecfr.gov/current/title-7/subtitle-B/chapter-III/part-340" target="_blank">several exemptions</a>, which in many ways sound quite similar to the EU’s category 1 plants—though there are also key differences.Notably, exemptions from USDA-APHIS’s Revised Biotechnology Regulations are self-determined, though developers may voluntarily reach out to USDA-APHIS for confirmation of an exemption.  Additionally, while the proposed EU regulations require all exempt plants to be listed in a single public database, engineered plants that are exempt from the USDA-APHIS requirements can be released or otherwise enter the U.S. market without explicit disclosure by USDA-APHIS. While USDA-APHIS maintains a publicly available database of voluntary requests for confirmation of exemption under the Revised Biotechnology Regulations, companies that self-determine if an exemption applies do not appear in any federal database. Thus, unlike in the proposed EU regulations, USDA-APHIS’s Revised Biotechnology Regulations do not require notification procedures or publication in a database if an exemption applies.Both the proposed EU regulations and USDA-APHIS’s regulations are risk-based approaches.  Notably, however, USDA-APHIS’s analyses are driven wholly by plant pest risk.  In contrast, the EU’s risk assessment as currently written considers a broader array of types of potential risks, such as risks to human health.  In the United States, the FDA would consider human health risks for plants that are intended for human or animal consumption—but, as <a href="https://lifesciences.mofo.com/topics/purple-tomato-is-first-genetically-engineered-plant-to-be-deregulated-through-usda-s-new-regulatory-status-review-process" target="_blank">we have summarized separately</a>, the FDA and USDA do not share implementing regulations, and the USDA-APHIS exemptions do not apply to FDA review.Focusing just on comparing the discrete USDA-APHIS Revised Biotechnology Regulations exemptions themselves with the EU’s proposed category 1 criteria, the acceptable modifications in the EU’s category 1 plants sound much like the USDA-APHIS’s §§ 340.1(b)(1)-(3) exemptions on a technical level (e.g., substitutions, deletions, and changes corresponding to alleles present in a relevant gene pool). However, a major difference is that the §§ 340.1(b)(1)-(3) exemptions are currently limited to single modifications, while the EU criteria include up to 20 modifications (e.g., up to 20 nucleotide insertions, deletion of any number of nucleotides, some types of targeted insertions and substitutions; targeted inversions, etc.; see brief discussion below and <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">our separate post</a> for the full list of criteria). (USDA-APHIS’s Revised Biotechnology Regulations also have other specific exemptions for certain microbial pesticides and PIPs and various narrow situations not discussed here).For example, a gene-edited plant that has a single, targeted modification may qualify for an exemption under § 340.1(b) if that same plant could have been created through conventional breeding — and it would seemingly also be considered a category 1 plant in the EU, assuming its sequence shares “similarity with the targeted site that can be predicted by bioinformatic tools,” which is not an explicit factor under USDA-APHIS’s Revised Biotechnology Regulations.  In contrast, a plant with multiple targeted edits that resulted in substitution of, say, 3 total bases could still seem to equally fall under the EU’s category 1, but would likely not qualify from a current exemption to USDA-APHIS’s Revised Biotechnology Regulations, as USDA-APHIS has clarified that “[i]n general, multiple modifications made simultaneously in the same plant developed using genetic engineering will not qualify for an exemption under § 340.1.”Although the EU’s category 1 NGT plants in some respects encompass a wider baseline set of exemptions, USDA’s <a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/confirmations/responses/cr-table" target="_blank">list of exempt genetically modified plants</a> is designed to grow over time. For example, the EU’s category 1 exempts plants with up to 20 genetic modifications of the types referred to in <a href="https://eur-lex.europa.eu/resource.html?uri=cellar:c88fe9ac-1c06-11ee-806b-01aa75ed71a1.0001.02/DOC_2&format=PDF">Annex I</a>, provided they meet the sequence similarity restrictions outlined in <a href="https://lifesciences.mofo.com/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu">our EU proposal overview</a>. In contrast, as noted above, in the United States, a plant with multiple targeted genetic changes (much less 20) would not immediately qualify for a § 340.1(b) exemption, unless the modifications were all present together in the gene pool. However, new plants that have the same plant-trait-mechanism-of-action (PTMOA) combination as a plant that USDA-APHIS has previously reviewed and deregulated do qualify for a permit exemption (and these can contain, theoretically, any number of changes), as well as plants that USDA-APHIS determined not to regulate prior to the implementation of its Revised Biotechnology Regulations. Further, plants that are produced by crossing exempt plants are also exempt from USDA-APHIS’s Revised Biotechnology Regulations, even if they wouldn’t meet an individual exemption if the modifications were produced as simultaneous edits. The EU Commission plans to produce a first monitoring report no sooner than three years after the first products have been notified and authorized. The criteria for category 1 NGT plants and their exemptions from Annex I of the proposal are not set in stone and could be changed, e.g., new exemptions could be added, so it is possible that the EU exemptions could, in practice, expand similarly to USDA-APHIS’s Revised Biotechnology Regulations exemptions.The EU’s rules for category 2 plants also seem facially similar to USDA-APHIS’s Revised Biotechnology Regulations permitting and <a href="https://www.mofo.com/resources/insights/220912-purple-tomato-first-genetically-engineered-plant-to-be-deregulated" target="_blank">Regulatory Status Review (RSR) provisions</a> for non-exempt plants, in that they have simplified requirements in comparison to the respective legacy approaches but still require a risk assessment and some level of monitoring. However, the RSR provisions in USDA-APHIS’s Revised Biotechnology Regulations directly broaden the pipeline of exemptions, while the EU categories do not seem as elastic. On the other hand, USDA-APHIS’s Revised Biotechnology Regulations provisions apply broadly to importation, interstate movement, and environmental release, while the EU’s category 2 provisions are mostly aimed at plants produced for food or feed.More broadly, as the EU adopts a single risk-based regulatory approach to gene-edited plants, U.S. regulation remains fragmented across federal agencies. For example, even if a gene-edited, plant-based food falls under one of the USDA permit exemptions described above, that food must still undergo FDA’s <a href="https://www.fda.gov/food/food-new-plant-varieties/consultation-programs-food-new-plant-varieties" target="_blank">Voluntary Plant Biotechnology Consultation Program</a>, or else risk FDA enforcement action.[1]Finally, consumer transparency surrounding gene-edited plants differs significantly between the United States and EU. Both EU and USDA regulations do not require labeling of food that could “occur naturally” (i.e., food that is “<a href="https://www.ecfr.gov/current/title-7/subtitle-B/chapter-I/subchapter-C/part-66" target="_blank">found in nature</a>” in the United States) or be obtained through “conventional breeding.” However, because the USDA does not define these terms, the <a href="https://www.ams.usda.gov/rules-regulations/national-bioengineered-food-disclosure-standard" target="_blank">mandatory label disclosure for U.S. bioengineered food</a> encompasses more food products than the EU’s labeling requirements, which limit labeling to gene-edited plants that do not meet the broad requirements for category 1 NGTs.Overall, the new EU proposal would bring regulations to plants developed using NGTs that are much more in line with U.S. regulations, but exactly how the regulations would cover an individual NGT-produced plant may still differ. It will be interesting to see how the various regulations continue to morph and whether they become streamlined in practice.Elena Klonoski, a summer associate in our Boston office, contributed to the drafting of this post.[1] Edward L. Rubin & Joanna K. Sax, <a href="https://arizonalawreview.org/pdf/60-3/60arizlrev539.pdf" target="_blank">Administrative Guidance and Genetically Modified Food</a>, 60 Ariz. L. Rev. 539, 561 (2018).

The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?

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