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.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Resources

Editors

230315-new-mofo-life-sciences-logo.jpg

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.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

Patent Strategy + Prosecution

Patent Prosecution | Patent Firm

Band 1: Intellectual Property: Patent Prosecution, California

Tier 1: Patent Strategy & Management

Recommended: Patent Prosecution

Patent Strategy Firm Of The Year

 Intellectual Property: Patents: Prosecution

Recommended for Patent Prosecution in California and DC Metro Area

Highly Recommended: Patent Prosecution, California

Patent Prosecution, US 

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>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

Life Sciences: IP/Patent Litigation

Life Sciences

Global: Life Sciences

Asia-Pacific Region: Life Sciences

Healthcare: Life Sciences

China Healthcare and Life Sciences: Foreign Firms

US: Biotechnology Law

Japan: Life Sciences

China: Life Sciences: International Law Firm

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech Blog

MOFO TECH

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

SOCIALLY AWARE

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

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

Navigating U.S. Regulatory Requirements for Genetically Modified Microorganisms Using Interactive Tool

LinkedIN

On September 12, 2024, Morrison Foerster, in collaboration with Bayer Co.Lab, hosted a pivotal panel discussion under the title “MoForum Charting the Biotech Startup Journey” at Morrison Foerster’s Berlin office.The event provided an in-depth exploration of the biotech startup ecosystem, particularly focusing on the journey from foundation and early-stage funding to growth, scaling, and successful exits. The event was a tremendous success, drawing attention to the vibrant biotech scene in Berlin and Germany and providing valuable insights into the challenges and opportunities faced by startups in this dynamic sector.Wolfgang Schönig, a partner at Morrison Foerster specializing in Life Sciences Transactions and Licensing, led through the evening. He was joined by an esteemed panel of industry leaders, including Ruth Shah (Head of Bayer Co.Lab Berlin), Anela Vukoja (Principal at Apollo Health Ventures), Elisa Kieback (Co-founder and CTO of T-knife Therapeutics), Stefanie Urlinger (Chief Scientific Officer of Cimeio Therapeutics), Nikita Sharma (Principal at Versant Ventures), and Jan‑Philipp Kruse (Senior Director at Lilly Ventures).Key Takeaways from the Panels DiscussionThe panel discussion was segregated into four different chapters curated along the lifecycle of a Biotech company. The topics covered in the discussion and key take aways include:<ul><li>Chapter 1: Foundation and Early-stage Funding The discussion highlighted the critical role of technology transfer and the need for streamlined processes to facilitate the transition from academic research to commercial ventures. Panelists emphasized the importance of public funding in setting attractive incentives for private investments. Key takeaways included the need for academia to be measured by tech transfer impact and the importance of creating good data to attract private investments.</li><li>Chapter 2: Growth and Scaling Insights from this session underscored the necessity of shifting from an academic to a commercial mindset for successful growth and scaling. The panelists discussed the challenges of attracting growth funding and the strategic importance of establishing a U.S. presence to attract more risk-tolerant investors. Critical aspects covered included the need to professionalize processes, particularly regarding quality and compliance, and the importance of having a clear focus and a lean operational model.</li><li>Chapter 3: Partnering and Internationalization This segment of the discussion focused on the significance of forming partnerships with Big Pharma and the advantages of operating across multiple biotech hubs, including the United States and Germany. The panelists shared their experiences and strategies for successful international expansion. Key points included the benefits of different ecosystems and the importance of new ways to collaborate.</li><li>Chapter 4: Achieving Successful Exits The final chapter dealt with exit strategies, highlighting various scenarios and the importance of aligning these with the goals of stakeholders. The discussion provided insights into managing stakeholder relationships throughout the exit process to ensure the continuation of innovation. The panelists discussed the different opinions on exit scenarios and the critical milestone of bringing innovation forward.</li></ul>ConclusionThe MoForum on Charting the Biotech Startup Journey offered invaluable insights and fostered discussions that underscored the collaborative spirit necessary to drive innovation in the biotech sector. Morrison Foerster and Bayer Co.Lab are proud to have facilitated this engaging and informative event.Watch this spot for further information on the German and Berlin Biotech scene.<div data-reactroot=""><img class="rich-text-embed-image" alt="Panelist group 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltdf181cb90a577444/66e9d0b98dc03a91091b5170/Panelists-life-sciences-blog.jpg?format=auto&amp;quality=60"/></div><div data-reactroot=""><img class="rich-text-embed-image" alt="Group photo 1" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blte90deeae9321508c/66e9d2f4a924ba3445df2574/panel-discussion-life-sciences.jpg?format=auto&amp;quality=60"/></div><div data-reactroot=""><img class="rich-text-embed-image" alt="Terrace photo" src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltc4e0b9d4966489b2/66e9d2dd44a1ad887c36a4c1/crowd-terrace-life-sciences.jpg?format=auto&amp;quality=60"/></div>

grohmann_robert_blog_150x150.png

grohmann_robert_common_640x280.jpg

grohmann_robert_heroretina_2700x1160.jpg

grohmann_robert_mobileretina_750x1040.jpg

grohmann_robert_social_600x600.jpg

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.

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.

MoForum: Bayer Co.Lab Edition – Charting the Biotech Startup Journey

Research assistant Sarah Baumann substantially contributed to this article.On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two categories: NGT-1 plants and NGT-2 plants. The MEPs endorsed the European Parliament’s draft that would make NGT-2 crops subject to risk assessment, authorization prior to market approval, and mandatory labelling. Please read the previous <a href="/topics/commission-plans-liberalization-of-new-genomic-techniques-ngts-in-the-eu" target="_blank">blog post on NGT plants</a> for more details.However, MEPs also agreed on an amendment proposed by the European Parliament’s Committee on the Environment, Public Health, and Food Safety (ENVI), which concerns the issue of patentability of NGT plants. The amendment provides a ban on any patenting of “NGT plants, plant material, parts thereof, genetic information and process traits contained therein.” The proposal aims to free farmers and breeders from legal uncertainty and dependence on corporations. The ban would apply retroactively.MEPs have also called upon EU member states to submit a report by June 2025 on the impact of patents on breeders’ and farmers’ access to diverse plant reproductive material. The draft requires member states to submit a proposal to update the EU’s existing intellectual property rules to bring them in line with the patent ban.The European Parliament approved the proposal by a majority of 307 votes to 263. It will now be negotiated with EU member states in the European Council. However, a ban on all NGT patents is not yet supported by all Council members. It is therefore not clear whether this proposal will come into force at all.If the proposal is adopted, the patent ban would have to be implemented by amending Directive 98/44/EC (the “Biotech Directive”). However, the Biotech Directive has already been implemented in the national law of the EU member states and in the Implementing Regulations of the European Patent Convention (EPC). The ENVI proposal is therefore inconsistent with the European Patent Convention and the case law of the European Patent Office (EPO). The EPC rules can be amended by a vote of the Administrative Council of the European Patent Office to bring them in line with EU law. If the law were to come into force, the EPO would also have to adjust its practices regarding NGT plants.The European Parliament published a document with the amendments that the MEPs have agreed on: <a href="https://www.europarl.europa.eu/doceo/document/TA-9-2024-0067_EN.pdf" target="_blank">TA (europa.eu)</a>. You can find more information on the Parliament’s <a href="https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2023/0226(COD)&l=en" target="_blank">website</a>.

freeman-rosenzweig_liz_blog_150x150.png

freeman-rosenzweig_liz_common_640x280.jpg

freeman-rosenzweig_liz_heroretina_2700x1160.jpg

freeman-rosenzweig_liz_mobileretina_750x1040.jpg

freeman-rosenzweig_liz_social_600x600.jpg

Associate

Dr. Liz Freeman Rosenzweig focuses her practice on patent prosecution and intellectual property and regulatory counseling in the areas of life sciences and agricultural biotechnology, including AgTech

Liz Freeman Rosenzweig Ph.D.

Liz Freeman Rosenzweig

230510-microscope.jpg

230510-microscope

On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two categories: NGT-1 plants and NGT-2 plants. 

February 2024 Update on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU

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.

burrus_abby_blog_150x150.png

burrus_abby_common_640x280.jpg

burrus_abby_heroretina_2700x1160.jpg

burrus_abby_mobileretina_750x1040.jpg

burrus_abby_social_600x600.jpg

Patent Agent

Abby Burrus focuses her work on patent drafting and prosecution for companies in the life sciences industry. Prior to joining MoFo, Abby earned her Ph.D. in organismic and evolutionary biology from Harvard University. As a doctoral researcher, she examined the evolution, development, and molecular control of plant glands and produced interdisciplinary analyses in plant research. 

Abby C. Burrus Ph.D.

Abby Burrus

pohlmann_deborah_blog_150x150.png

pohlmann_deborah_common_640x280.jpg

pohlmann_deborah_heroretina_2700x1160.jpg

pohlmann_deborah_mobileretina_750x1040.jpg

pohlmann_deborah_social_600x600.jpg

Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.
Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technolo

Deborah A. Pohlmann Ph.D.

Deborah Pohlmann

bondoc_brigid_blog_150x150.png

bondoc_brigid_common_640x280.jpg

bondoc_brigid_heroretina_2700x1160.jpg

bondoc_brigid_mobileretina_750x1040.jpg

bondoc_brigid_social_600x600.jpg

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

In re Lumber Liquidators Chinese Laminate Litigation

Maxus Energy Corporation

In re Hydroxycut Personal Injury and Class Action Litigation

Los Angeles World Airport (LAWA)

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al

Fitbit Force Recall 

William F. Tarantino

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