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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Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year.

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New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023 | MoFo Life Sciences

Abby C. Burrus Ph.D.

Deborah A. Pohlmann Ph.D.

Liz Freeman Rosenzweig Ph.D.

Brigid DeCoursey Bondoc

William F. Tarantino

Michael Ward Ph.D.

Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year.The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S., the USDA and EPA each issued final rules that will affect a wide variety of gene-edited plants. We detail two of these final rules below. For further international context of the growing momentum around genetically engineered plants, see the following: <a href="/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu" target="_self" dir="ltr">Considerations on NGTs in the EU</a>, <a href="/topics/the-eu-s-new-proposal-for-plants-developed-using-new-genomic-techniques-how-does-it-compare-to-u-s-regulation-" target="_self">Comparing the EU’s Proposal to U.S. Regulation</a>, <a href="/topics/crispr-s-next-10-years-from-lab-to-plate" target="_self">Industry Specialists Considering CRISPR’s Future</a>.I. After a long wait, EPA finally overhauled its regulation of PIPs in 2023 with a controversial updateOn May 31, 2023, the EPA published a <a href="https://www.federalregister.gov/documents/2023/05/31/2023-11477/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies" target="_blank" dir="ltr">final rule</a> (88 FR 34756) regarding <a href="https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/overview-plant-incorporated-protectants" target="_blank">Plant-Incorporated Protectants (PIPs)</a>, following both an initial proposal on October 9, 2020, and a period of public comments that ended on December 8, 2020. This final rule came into effect July 31, 2023, and has already been met with some controversy in the industry.This regulation follows on the heels of massive revisions between 2020 and 2021 to USDA APHIS’s SECURE rule, <a href="/topics/purple-tomato-is-first-genetically-engineered-plant-to-be-deregulated-through-usda-s-new-regulatory-status-review-process" target="_self" dir="ltr">redesigning APHIS’s assessment (and exemption therefrom) of various genetically engineered plants</a>.              i. PIP relevance to the EPAThe EPA <a href="https://19january2021snapshot.epa.gov/regulatory-information-topic/regulatory-information-topic-pesticides_.html" target="_blank" dir="ltr">regulates pesticides broadly</a> under the Federal Insecticide, Fungicide, and Rodenticide Act (<a href="https://www.epa.gov/enforcement/federal-insecticide-fungicide-and-rodenticide-act-fifra-and-federal-facilities" target="_blank">FIFRA</a>) and the Federal Food, Drug, and Cosmetic Act (<a href="https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act" target="_blank">FFDCA</a>). PIPs refer to pesticides produced by plants as well as the genetic material necessary for the plants to produce those pesticides. EPA is authorized to regulate PIPs produced through genetic engineering (rather than native production by a plant).While the EPA regulates the PIPs and their genes in plants, the edited plants themselves are not regulated by the EPA. Rather, branches of the USDA and <a href="https://www.fda.gov/food/food-new-plant-varieties/new-plant-variety-regulatory-information" target="_blank">FDA</a> likely regulate the actual plants.              ii. Which PIPs receive which regulation?The EPA’s previous regulations, 40 CFR 174.71 (66 FR 37772; July 19, 2001), exempted PIPs that were transferred solely through conventional breeding methods, and the <a href="https://www.federalregister.gov/documents/2020/10/09/2020-19669/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies" target="_blank" dir="ltr">2020 proposed rule</a> (85 FR 64308) offered that PIPs may be exempt from FIFRA registration and FFDCA tolerance requirements in cases where, in addition to meeting EPA safety requirements, the PIPs could have been transferred through conventional breeding methods: i.e., in cases where the PIPs are equivalent to pesticides (or genes) from sexually compatible plants.The <a href="https://www.epa.gov/pesticides/epa-finalizes-rule-accelerate-use-plant-incorporated-biotechnologies-protect-against" target="_blank" dir="ltr">final rule</a> largely incorporated the proposed exemptions and further delineated which PIPs remain exempt or will be newly exempt. (Note, however, that these are only exemptions from FIFRA; other regulations may still apply. Developers of exempt PIPS must still comply with<a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174/subpart-B/section-174.21#p-174.21(d)" target="_blank"> recordkeeping and eligibility determinations requirements</a> to maintain the exemption.)The <a href="https://www.federalregister.gov/documents/2023/05/31/2023-11477/pesticides-exemptions-of-certain-plant-incorporated-protectants-pips-derived-from-newer-technologies" target="_blank" dir="ltr">final rule</a> exempts PIPs that fall into the following two categories:              1) “PIPs created through genetic engineering from a sexually compatible plant” (i.e., by insertion of genetic material from a sexual compatible species or through modifying existing genetic material) (quote from final rule summarizing <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174/subpart-B/section-174.26#p-174.26(a)(1)" target="_blank" dir="ltr">40 CFR 174.26(a)(1)-(2)</a>); and             2) PIPs that are characterized as “loss-of-function” (quote from final rule summarizing <a href="https://www.ecfr.gov/current/title-40/chapter-I/subchapter-E/part-174/subpart-B/section-174.27" target="_blank">40 CFR 174.27</a>).From a scientific perspective, changes from the 2020 proposed rule focused on clarifying the boundaries of the exempted PIPs. For example, the first category was revised to account for “regulatory regions inserted as part of the native gene,” in addition to the coding sequence. Further, as proposed, the first category would have only exempted pesticides with the same sequence found in a native compatible plant; the final rule also exempts some instances of PIPs having identified polymorphisms.In the final rule, the first category exempts modified genetic material and the insertion of genetic material into a recipient plant, so long as the genetic material is native to a plant that is sexually compatible with the recipient plant. Additionally, any inserted regulatory regions of genes must be identical to the native plant’s corresponding regulatory regions.The second category, “<a href="https://www.epa.gov/system/files/documents/2023-05/final-rule-may2023.pdf#:~:text=EPA%20regulates%20the%20modified%20genetic%20material%20that%20confers,The%20loss-of-function%20PIP%20exemption%20is%20based%20on%20function." target="_blank">loss-of-function</a>” PIPs, which was elevated from a sub-category in the proposed rule to its own category in the final rule, exempts protectants that are derived from the <a href="https://www.epa.gov/system/files/documents/2023-07/Clarification-Exemption-Examples-PIPs-Rule.pdf" target="_blank">reduction or elimination</a> of a gene’s activity, regardless of the genetic modification method or the particular modification used to accomplish the reduction or elimination. According to a list of “<a href="https://www.epa.gov/system/files/documents/2023-07/Clarification-Exemption-Examples-PIPs-Rule.pdf" target="_blank">hypothetical examples</a>” from the EPA, this category does not apply to PIPs in which, for example, the editing downregulates a first inhibiting gene, which then allows increased expression of another, “secondary” gene that possesses the actual pesticidal activity.PIP developers may decide for themselves whether exemption applies to their PIP(s) under the second category (loss-of-function), but instances of the first category still require <a href="https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0" target="_blank">EPA confirmation of exemption</a>. Further, edits to multiple genes may be exempt as long as each individually meets an exemption criterion.<a href="https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/pesticides-exemptions-certain-plant-incorporated-0" target="_blank">Additional information about the final rule</a>, including background, clarification, and submission support, is available from the EPA.II. USDA-AMS continued expanding the list of available plant products on the marketOn November 29, 2023, the AMS published a <a href="https://www.federalregister.gov/documents/2023/11/29/2023-26059/national-bioengineered-food-disclosure-standard-list-of-bioengineered-foods" target="_blank" dir="ltr">final rule</a> (88 FR 83305) that expanded the USDA’s List of Bioengineered (BE) Foods (“the List”) associated with the labeling requirements of the National Bioengineered Food Disclosure Standard (NBFDS). <a href="https://www.ams.usda.gov/rules-regulations/be/bioengineered-foods-list" target="_blank">The List</a> originated from the <a href="https://www.congress.gov/114/plaws/publ216/PLAW-114publ216.pdf" target="_blank">2016 Public Law 114–216</a>, which amended the <a href="https://www.govinfo.gov/content/pkg/COMPS-10259/pdf/COMPS-10259.pdf" target="_blank">Agricultural Marketing Act</a> of 1946. The Nov. 29 final rule that updated the List came into effect on December 29, 2023; regulated entities must be in compliance by June 23, 2025.The List identifies, albeit non-exclusively, “crops or foods that are available in a bioengineered form throughout the world and for which regulated entities must maintain records” under the NBFDS. A <a href="https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard" target="_blank" dir="ltr">“BE”</a> food is considered to be a food containing genetic material modified through in vitro recombinant DNA techniques that could not have been modified as such by nature or conventional breeding alone.This final rule follows a June 2022 proposed rule, altering the List as follows:<ul><li>Adding “sugarcane (Bt insect-resistant varieties)” to the List; and</li><li>Amending the previously listed “squash (summer)” line to “squash (summer, coat protein-mediated virus-resistant varieties).”</li></ul>This effort helps establish and disseminate reasonable presumptions of what foods are considered “BE.” However, as reiterated in the <a href="https://www.federalregister.gov/documents/2018/12/21/2018-27283/national-bioengineered-food-disclosure-standard" target="_blank" dir="ltr">final rule</a>, even if foods are not on the List, if a regulated entity has actual knowledge that a food or food ingredient is “BE” as defined by the NBFDS, the entity is required to comply with the regulations.In 2024, we may see further changes to the U.S. and international GE plant regulatory landscape; please follow our blog for future updates on this and related topics.

New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023

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