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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USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

Patent Term Extension for Medical Devices

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In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024, struck down the 2020 USDA Animal and Plant Health Inspection Service (APHIS) rule codified at 7 C.F.R. § 340 regarding GE plants. The court vacated APHIS’s 2020 rule, formerly known as the SECURE (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient) rule, which had been adopted to streamline USDA oversight of plants developed using genetic engineering.Summary judgment ruling on December 2, 2024On December 2, 2024, Judge James Donato issued a summary judgment ruling in <a href="https://www.bloomberglaw.com/document/X1M9DNOB0000N" target="_blank">National Family Farm Coalition et al. v. Tom Vilsack et al.</a>, vacating a 2020 update to APHIS’s biotechnology regulations (<a href="https://www.federalregister.gov/documents/2020/05/18/2020-10638/movement-of-certain-genetically-engineered-organisms" target="_blank">7 C.F.R. § 340</a>), which had exempted many GE plants from USDA regulation and streamlined the deregulation process for others. The three main exemptions under the now vacated 2020 rule are codified at 7 CFR § 340.1(b)(1)–(3) and relate to a genetic change caused by cellular repair of a targeted, single double-stranded break; a targeted single base pair substitution; and the introduction of certain types of known sequences from the plant’s gene pool, respectively.The November 2024 updates to the 2020 rule are not explicitly included in the vacaturIn late 2023, <a href="https://www.mofo.com/resources/insights/231115-comment-morphing-us-biotechnology-regs" target="_blank">APHIS proposed five additional exemptions</a> to be incorporated into the 2020 rule. After a review of public comments, <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-announces-final-notice-additional-exemptions-movement-organisms" target="_blank">two new exemptions were finalized, effective November 13, 2024</a>, and APHIS immediately began to inform developers about their function and effects, including at a November 14, 2024, stakeholder meeting. However, following the December 2 ruling, the new exemptions, which APHIS termed “Additional Modification 1” (AM1) and “Additional Modification 2” (AM2), are now in jeopardy.The <a href="https://www.aphis.usda.gov/biotech-exemptions" target="_blank">November 2024 exemptions are defined as follows</a>:<ul><li>AM1: An indel or contiguous deletion of any size, made at a targeted location, with or without insertion of DNA if generated without using a repair template, or without insertion of DNA if generated using a repair template.</li><li>AM2: A plant with up to twelve (12) modifications, made simultaneously or sequentially, if each modification individually qualifies for exemption and occurs in a different gene.</li></ul>The parties briefed the court regarding these new exemptions prior to the summary judgment ruling. However, the court did not rule on the 2024 updates, and addressed only the 2020 final rule in its December 2 opinion. The parties have been ordered to brief the court by January 13, 2025, as to the impact of the vacatur on the November 2024 exemptions.Thus, as of December 2, the 2020 rule and its exemptions have been vacated. The new exemptions under the 2024 revisions, however, appear to remain in place, at least for now, though it is unclear whether or how APHIS can process requests related to these new exemptions given the status of the 2020 rule.What happens to plants that were approved or exempted under the 2020 rule?APHIS confirmed in a December 4, 2024, <a href="https://www.aphis.usda.gov/news/program-update/aphis-acknowledges-new-court-ruling-vacating-updates-biotechnology-regulations" target="_blank">announcement</a> that “Regulatory Status Review responses, Confirmation Request responses, and active permits that USDA issued prior to December 2, 2024, remain valid.” However, it is uncertain how the ruling will impact both developers who did not engage in a voluntary confirmation of exemption or Regulatory Status Review (RSR) and were proceeding with development under a self-determined exempt status, and developers  with pending confirmation or RSR requests.The ruling does not affect applicable parallel regulatory oversight by the FDA, EPA, or other (e.g., non-APHIS) branches within the USDA.How did this happen?Judge Donato granted partial summary judgment in favor of the plaintiffs, a group of 29 farming and organic non-profit and public-interest groups, finding that APHIS’s adoption of the rule was arbitrary and capricious under the Administrative Procedure Act (APA). The plaintiffs argued in a lawsuit filed on July 6, 2021, that the 2020 rule failed to comply with federal statutes, including the Plant Protection Act (PPA).APHIS adopted the now-vacated rule after nearly 15 years of attempts to update its regulations under part 340 of the PPA for better efficiency in regulation and better reflection of the advances made in gene editing and crop breeding. The 2020 rule introduced regulatory exemptions for certain GE plant modifications, including targeted DNA breaks repaired without a template (part 340(b)(1)), targeted single base pair substitutions (part 340(b)(2)), and insertion of a gene from the plant’s gene pool (part 340(b)(3)). The effect of the rule was to remove certain categories of GE crops from oversight by USDA‑APHIS’s Biotechnology Regulatory Services, including some types of GE plants that could be created by conventional breeding techniques and those that the agency determined do not pose a plant pest risk. This change decreased the regulatory burden and facilitated entry for smaller developers.One issue in the December 2 ruling was how APHIS dealt with “noxious weeds” in the 2020 rule. The 2020 rule did not incorporate APHIS’s authority to regulate noxious weeds into its regulation of GE crops, despite previous proposed rules by APHIS that sought to evaluate GE plants for noxious-weed risk. Citing Transportation Division of the International Association of Sheet Metal, Air, Rail, & Transportation Workers v. Federal Railroad Administration (Transp. Workers), 988 F.3d 1170 (9th Cir. 2021), Judge Donato held that APHIS’s failure to explain the agency’s reversal of its position on additional risk assessments for noxious weeds was arbitrary and capricious.Judge Donato also took issue with the categorical exemptions, which treat the risk of conventionally bred plants as the baseline in determining the scope of regulatory oversight. His reasoning relied heavily on <a href="https://nap.nationalacademies.org/read/10258/chapter/1" target="_blank">a 2002 National Academy of Sciences publication</a> that concluded that risks associated with crop cultivars that could have been developed through conventional breeding “should not be assumed to be acceptable.” Despite APHIS’ position in the briefing that it had carefully assessed the risks of conventionally-bred plants over the past 30 years, Judge Donato categorized the 2020 rule as being in direct conflict with APHIS’s own experts.What’s next?The case may not be immediately appealable as the summary judgment order did not rule on all the plaintiffs’ claims. Plaintiffs also challenged the rule under the Endangered Species Act and the National Environmental Policy Act. The court asked the parties to jointly propose a status conference date to address the remaining claims. USDA could immediately appeal if the district court certifies the summary judgment ruling under Federal Rule of Civil Procedure 54(b), which allows a district court to certify for appeal an order granting summary judgment on an issue that is separate and distinct from other claims in the case. Even if such certification were to occur, expedited review by the Ninth Circuit would not be guaranteed.In the meantime, the vacatur of the 2020 rule reverts the core USDA biotechnology regulations to their pre-2020 framework. Under the pre-2020 system, APHIS regulated GE organisms based on the use of plant pests in the genetic engineering process, rather than the plant pest risks of the final edited products, to which the 2020 rule had shifted focus. Developers could petition APHIS under the old rule for a determination that a GE organism was unlikely to pose a plant pest risk, a process known as a petition for non-regulated status, or obtain an indication of non-regulated status under the legacy “Am I Regulated” (AIR) procedures.APHIS has <a href="https://www.aphis.usda.gov/news/program-update/aphis-acknowledges-new-court-ruling-vacating-updates-biotechnology-regulations" target="_blank">acknowledged</a> the court ruling and plans to provide more detailed guidance to stakeholders in the coming days, but as of this writing, the USDA has not announced any intent or capacity to enforce the old framework.Of note, in March 2018, then-Secretary of Agriculture Sonny Perdue <a href="https://www.usda.gov/media/press-releases/2018/03/28/secretary-perdue-issues-usda-statement-plant-breeding-innovation" target="_blank">stated</a> that the USDA had no plans to regulate plants that could be developed through conventional breeding techniques, provided they were not plant pests or created using plant pests. The incoming Trump administration may seek to retain this approach. However, the vacatur of the 2020 rule’s categorical exemptions undoes much of the groundwork to automatically exempt many such plants from USDA review, assuming the legacy regulations are back in place in the interim.If APHIS moves to propose a new rule to address the court’s ruling, the process would likely be subject to customary procedural requirements, including notice and comment procedures, before finalization.This is a developing story.We are closely monitoring developments in this case and USDA’s forthcoming guidance, and will continue to share updates. Alice Carli, a law clerk in our Los Angeles office, contributed significantly to the drafting of this post. Caressa Tsai, a law clerk in our San Francisco office, also contributed to the drafting of this post.

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.

Michael Ward Ph.D.

Michael (Mike) Ward is global head of the Life Sciences + Healthcare Group, head of the Patent Group, co-chair of the firm’s Intellectual Property Group, and co-chair of our global Food + Agriculture Group.

Michael Ward

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.

William F. Tarantino

Krista deBoer’s practice involves the full range of environmental, climate, and green claims issues. As a partner in MoFo’s Class Actions + Mass Tort practice group, Krista represents clients in environmental and toxic tort litigation, Proposition 65 litigation, and consumer class actions 

Krista S. deBoer

Krista deBoer

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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

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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

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New DCMA Defective Pricing Pilot Team Will Possess Audit Resolution Authority

Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene Editing (GE) Decree. Together, these changes reflect major updates to Uruguay’s intellectual property (IP) system broadly.Plant regulation and IP are particularly important in Uruguay, and the country is often on the shortlist of top target destinations for IP filings in agriculture, as it has the capacity to grow food for its own population as well as much of the rest of the world.For further information, read our more detailed <a href="https://www.mofo.com/resources/insights/240808-updates-in-uruguay-accession" target="_self">client alert</a>.Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.

Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

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Updates in Uruguay – Accession to the PCT and Announcement of a New GMO Regulatory Framework

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Earlier in 2024, Uruguay announced two major updates in the patent and regulatory spheres that are likely to encourage outside investment in Uruguayan industry, particularly for agbiotech: Uruguay is acceding to the Patent Cooperation Treaty (PCT) and is also rolling out a new Gene Editing (GE) Decree. 

After overhauling its <a href="https://www.aphis.usda.gov/biotechnology" target="_blank">biotechnology regulations</a> for <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?_gl=1*1ko2alj*_ga*MTQxNjc1MjY0LjE3MTg3NDExMTY.*_ga_3HVRG7GH76*MTcyMTI4MjEwOC4xNy4xLjE3MjEyODIxNjQuMC4wLjA." target="_blank">plants developed</a> using <a href="https://www.mofo.com/resources/insights/231115-comment-morphing-us-biotechnology-regs" target="_blank">genetic engineering</a>, the United States Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS) is again reevaluating its regulatory procedures, both by opening the door to major regulatory changes for microbes developed through genetic engineering and by surveying the results of its previous changes for plant regulation.In July, APHIS requested public comment regarding modified microbe regulation and released a biotechnology regulation enforcement summary. Comments are due September 3, 2024. In June, APHIS released its biotechnology regulation impact report for 2023. These announcements, which highlight the morphing U.S. regulatory landscape for genetically engineered plants and microbes, are described in detail below.Invitation for Public Comment on Modified Microbe RegulationOn July 2, 2024, APHIS <a href="https://www.aphis.usda.gov/news/program-update/aphis-invites-public-comment-request-information-options-reducing-regulations" target="_blank">announced</a> the opening of a 60-day public comment period on a Request for Information (RFI) that explores options to reduce the regulatory burden for modified microbes (available now in the <a href="https://www.regulations.gov/document/APHIS-2024-0002-0001" target="_blank">Federal Register</a>). APHIS requests comments from the public regarding pathways to commercialization, including needs, ideas, and concerns, regarding possible risk-based deregulation of modified microbes and other potential regulatory and non-regulatory pathways to commercialization.Comments should be received on or before September 3, 2024, and can be submitted either electronically through the <a href="https://www.regulations.gov/" target="_blank">Federal eRulemaking Portal</a> (Docket No.: <a href="https://www.regulations.gov/document/APHIS-2024-0002-0001" target="_blank">APHIS-2024-0002</a>) or mailed in.APHIS BRS InvestigationsSeparately, on July 9, 2024, APHIS <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-posts-investigative-enforcement-services-annual-enforcement-data-0" target="_blank">released</a> its Enforcement Services Annual Enforcement Data Report overviewing how it enforced its regulations in the 2023 fiscal year. For example, the Report summarized enforcement data regarding regulatory correspondence to parties involved in an alleged violation, charging a stipulated penalty, and referring the case to the USDA or U.S. Department of Justice for further action.Among this data, APHIS included a section on enforcement relating to its Biotechnology Regulatory Services (BRS), which included initiation of one case by APHIS’s Investigative and Enforcement Services (IES). This summary is notable as it is one of the first published reports of enforcement and associated penalties from the revised biotechnology regulations for plants produced through genetic engineering.APHIS Releases 2023 Impact Report – Safe Biotechnology ProductsIn June, APHIS <a href="https://www.aphis.usda.gov/news/agency-announcements/aphis-releases-2023-impact-report" target="_blank">issued</a> its 2023 Impact Report noting its accomplishments last year. One of the areas of focus was on safe biotechnology products, through which APHIS promoted crops that help achieve climate goals and are healthier to eat, while ensuring that these products are safe to eat and grow. The full report can be found on the <a href="https://www.aphis.usda.gov/sites/default/files/aphis-impact-report-2023.pdf" target="_blank">USDA website</a>.The activities described in the report represent robust use of APHIS’s revised regulations for engineered plants. The report also shows that the agency is gaining momentum and becoming increasingly nimble at administering its now four-year-old revised regulations.Many if not all of these topics and more will likely be discussed live with the public at APHIS’s annual stakeholder meeting, which is scheduled for <a href="https://www.aphis.usda.gov/biotechnology/meetings" target="_blank">November 14, 2024, and the agency is soliciting topics for discussion by email</a>.For further information, read our more detailed client alert. Marley Macarewich, a summer associate in Morrison Foerster’s San Francisco office, contributed significantly to this post.

Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

Brigid Bondoc

Microbes, Biotech Investigations, and Impacts: Midsummer Regulatory Updates from USDA-APHIS

In July, APHIS requested public comment regarding modified microbe regulation and released a biotechnology regulation enforcement summary. Comments are due September 3, 2024. In June, APHIS released its biotechnology regulation impact report for 2023.

MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now <a href="https://soundcloud.com/user-496742723/03-27-lifescience-podcast01-v1" target="_blank">available</a>. The podcast features interviews with legal experts who share insights and advice you just might need when your life sciences are on the line.The special guest for Episode 1 was Jim Krenn, a MoFo partner whose practice is focused on major corporate transactions for emerging and established companies in the life sciences. Jim, Nate, and Kate discuss strategies to maximize and protect the value of trade secrets, how investing in compliance early pays dividends as companies mature, and where companies may face government scrutiny on the journey from startup to public company.Trade secrets play a central role in raising capital, selling a company, and going public, and the rise of cyber breaches and sophisticated intellectual property theft has pushed investors to look closely at how trade secrets are safeguarded. Jim maps out strategies for maximizing the value of trade secrets at key stages and discusses with Nate and Kate how to protect a critical asset for many life sciences companies.Early-stage companies often focus on development and growth, but an appropriate compliance function is important to control present and future downside risk. Jim explains the decision dynamics at play, and Kate discusses how increased scrutiny on life sciences companies makes good compliance a winning value proposition.Outside scrutiny on company systems peaks when the time comes to take a company public or consider a merger or acquisition. Interested parties pore over compliance functions at this stage, particularly in the highly regulated life sciences industry. Nate and Kate discuss corresponding risks for company insiders.

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Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

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Nathaniel (Nate) Mendell is a partner in Morrison Foerster’s Investigations + White Collar Defense and Privacy + Data Security practice groups and was the former Acting U.S. Attorney for the United States Attorney’s Office for the District of Massachusetts. 

Nathaniel Mendell

Nathaniel R. Mendell

Co-Chair of Emerging Companies + Venture Capital Practice

Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.

Jim Krenn

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MoFo partners Kate Driscoll and Nate Mendell launched the MoFo life sciences podcast When Your Life Sciences Are on the Line this week, and Episode 1 is now available. 

When Your Life Sciences Are on the Line: Protecting Your Company’s Most Valuable Asset: Trade Secrets

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>.

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

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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

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance and Enforcement Group for a 2024 preview, and here is what our team of former government officials from the U.S. Department of Justice (DOJ), Food and Drug Administration (FDA), and Department of Health and Human Services (HHS), former in-house compliance counsel, privacy lawyers, and veteran defense attorneys have offered up.Read the full <a href="https://www.mofo.com/resources/insights/240109-2024-regulatory-compliance-and-enforcement-predictions" target="_blank">client alert</a>.

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense practice. Adam formerly served as an Associate Deputy Attorney General for the U.S. Department of Justice (DOJ) and as the U.S. Attorney for the Southern District of California. 

Adam L. Braverman

Adam L. Braverman is a partner in Morrison Foerster’s Investigations + White Collar Defense group. He represents companies and their executives in internal and government investigations, white collar criminal defense matters, and parallel civil litigation related to allegations of bribery, government procurement fraud, COVID-19 and CARES Act fraud, anti-money laundering violations, and matters involving organized crime.