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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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.

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Food Traceability Final Rule OverviewOn November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its <a href="https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods" target="_blank">Final Rule: Requirements for Additional Traceability Records for Certain Foods</a> (“Final Rule”) in the Federal Register. The Final Rule establishes additional traceability recordkeeping requirements for subject entities that manufacture, process, pack, or hold foods that are included on the <a href="https://www.fda.gov/food/food-safety-modernization-act-fsma/food-traceability-list" target="_blank">Food Traceability List</a> (FTL). FDA’s ultimate goal in these efforts is to reduce the time it takes to respond to foodborne illness outbreaks. These additional recordkeeping requirements are intended to enable FDA to quickly and efficiently track down potentially hazardous foods and ultimately reduce the number of people who are exposed and get sick.The Final Rule identifies critical tracking events (CTEs) along the supply chain where records containing key data elements (KDEs) must be created and maintained for foods on the FTL. KDEs will vary for different CTEs but will contain information needed to effectively trace a product based on the CTE performed. CTEs include: <ul><li>Harvesting</li><li>Cooling (before initial packing)</li><li>Initial packing of raw agricultural commodities (other than food obtained from fishing vessel)</li><li>First land-based receiving of food from fishing vessel</li><li>Shipping</li><li>Receiving</li><li>Transforming</li></ul>The Final Rule also requires subject entities to establish and maintain a traceability plan, which details how the traceability program records are maintained, how traceability lot codes are assigned, and other key information needed to understand the records. Five Takeaways from the FDA WebinarOn Wednesday, December 7, 2022, FDA held an informational <a href="https://www.fda.gov/food/workshops-meetings-webinars-food-and-dietary-supplements/webinar-food-traceability-final-rule-12072022" target="_blank">webinar</a> on the recently released Food Traceability Final Rule issued pursuant to the FDA Food Safety Modernization Act (FSMA). <ol><li>All entities subject to the Final Rule must comply with its requirements by January 20, 2026. Because of the need for all entities to share information to achieve effective traceability, the compliance date for all entities is the same. To prepare for compliance with the Final Rule, FDA recommends that subject entities begin talking to their supply chain partners to better understand existing recordkeeping systems and efficient communication pathways. </li><li>While the rule does not require subject entities to keep electronic records, for many companies the requirement to [describe the requirement to produce records to FDA in three days] will likely require a sophisticated and interoperable software solution to comply. The Final Rule does not prescribe software specifications or requirements for recordkeeping, and it is the responsibility of the subject entities to meet the requirements under the Final Rule with whatever technology they choose to use. FDA will not be validating or endorsing software systems. </li><li>FDA anticipates updating the Food Traceability List (FTL) every five years. Updates to the FTL will be made through notice and comment rulemaking, and industry stakeholders will have opportunities to submit information for FDA to consider when contemplating updates. Any deletions of foods on the FTL will be effective immediately after the Final Rule updating the list is in effect, and any additions to the FTL will be effective two years after the Final Rule. </li><li>FDA has begun the implementation planning phase for the Final Rule and is planning on incorporating stakeholder engagement throughout the process. It is actively working on ways for stakeholders to submit traceability information to it and is contemplating a database that allows subject entities to upload information. FDA intends to issue additional guidance in the future.</li><li>In implementing and enforcing the Final Rule, FDA anticipates that education of industry stakeholders will go hand in hand with regulation. It understands that this is a new paradigm and that the industry will have questions going forward. It has stated it will continue to update the FAQs as more questions are received and emphasized that industry stakeholders may continue to submit questions to FDA’s Food and Cosmetics Information Center (FCIC) through its online <a href="https://cfsan.secure.force.com/Inquirypage/" target="_blank">inquiry page</a>. </li></ol>

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FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar

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On November 21, 2022, the U.S. Food and Drug Administration (FDA) officially published its Final Rule: Requirements for Additional Traceability Records for Certain Foods (“Final Rule”) in the Federal Register.  The Final Rule establishes additional traceability recordkeeping requirements for subject entities that manufacture, process, pack, or hold foods that are included on the Food Traceability List (FTL).

FDA Final Food Traceability Rule: Overview and Key Takeaways from FDA’s Food Safety Modernization Act Webinar

This article is Part B of the fifth alert in our series of alerts focussed on the alternative protein industry. While Part A provided an overview of financing options in the industry, this Part B considers a variety of key financing options in more detail, including important considerations for nascent companies.Read the <a href="https://www.mofo.com/resources/insights/221207-financing-options-in-the-alternative-protein-industry" target="_self">full client alert</a>.

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Simon Arlington is a partner based in the Corporate Group focusing on M&A and private equity.

Simon Arlington

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Michelle Luo is an associate in the firm’s London office and a member of the Technology Transactions, Intellectual Property and Global Privacy Groups.

Michelle Si-Ting Luo

Michelle Luo

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Financing Options in the Alternative Protein Industry

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This article is Part B of the fifth alert in our series of alerts focussed on the alternative protein industry. While Part A provided an overview of financing options in the industry, this Part B considers a variety of key financing options in more detail, including important considerations for nascent companies.

Financing Options in the Alternative Protein Industry

This is an excerpt from a longer piece. For more information on the history and landscape of PVPs on transgenic plants, <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/blt97cae3869531ab98/638e0c0ab660b4108abd0411/221205-usdas-pvp-system-embraces-transgenic-and-gene-edited-plants.pdf" target="_blank">read more</a>.Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants. PVP certificates (PVPs), which have been available in the U.S. since the enactment of the Plant Variety Protection Act of 1970 (PVPA; 7 U.S.C. §§ 2321-2582), have historically been associated with traditional breeding. However, there are actually numerous granted PVPs covering transgenic plant varieties, and the USDA is now also granting PVPs to gene edited plants. This article describes a recently granted PVP for a gene edited plant, contextualizing this example PVP in the broader landscape of PVP certificates that are directed to plant varieties created using modern biotechnology.As of this writing, there have been at least 1,952 granted PVPs covering transgenic plant varieties since 1998, when the USDA started collecting this information (Figure 1a). This represents roughly 20% of all PVPs granted during this time frame. PVPs covering transgenic varieties are identifiable by an affirmative answer in field 18 in the PVP ST-470 application form (Figure 1b). These transgenes are often used to confer traits that do not usually occur in a crop’s gene pool, such as herbicide tolerance or insecticidal protein synthesis.Figure 1a<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltffce86eee8e0fe31/638f828d035f1065512a8764/221206-figure1a.jpg?format=auto&amp;quality=60" alt="figure1a"/></div>Figure 1a: PVP grants covering transgenic plant varieties by year. Data source: USDA, AMS, S&T, Plant Variety Protection Office, July 2022. The raw data consists of all PVP varieties where the answer to the question “Does the variety contain any transgenes?” is “Yes.” The bar graph was generated by filtering this raw data for records with an issue date, then sorting by issue year.Figure 1b<div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/bltf36b755087f71e6a/638f82b1c1672c63e5e71d77/221206-figure1b.jpg?format=auto&amp;quality=60" alt="figure1b"/></div>Figure 1b: Field 18 of a PVP certificate, indicating the presence of inserted nucleic acids. Source: <a href="https://apps.ams.usda.gov/CMS/AdobeImages/201800533.pdf" target="_blank">PVP application form</a> for rape variety ‘KSR4652’. Note that the USDA changed the language in this field around 2018; an earlier version referred to “transgenes” rather than “biotechnology events” (for an example of the previous language, see field 18 in the <a href="https://apps.ams.usda.gov/CMS/AdobeImages/201700290.pdf" target="_blank">PVP application form</a> for rape variety ‘Cara’). According to the USDA, AMS, S&T, and Plant Variety Protection Office, this change was due to industry pressure for the field to be written more broadly, in order to better encompass newer methods of genetic modification (personal communication, July 2022). USDA-AMS, for its part, views the use of “transgenes” and “biotechnology events” in this context as synonymous, and it collects the information in field 18 in order to assist the National Laboratory for Genetic Resource Preservation in handling seed deposits after expiration (USDA, AMS, S&T, and Plant Variety Protection Office; personal communication, July 2022).In addition to PVPs on transgenic varieties, which contain foreign DNA by definition, the USDA has also recently begun granting PVPs on gene edited plant varieties. Gene editing is a form of modern biotechnology used to make precise genetic changes, but which does not necessarily entail insertion of foreign DNA.For example, the USDA recently granted a PVP certificate to GreenVenus, LLC for the ‘GVR-108XL’ lettuce variety, which was created using gene editing without transgene insertion. Thus, in contrast to the PVPs discussed above, field 18 in this Certificate is marked as “No.” The table below summarizes the bibliographic information of the ‘GVR-108XL’ lettuce PVP, including links to relevant documents.<table><tbody><tr><td>PVP certificate</td><td>No. <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">202000361</a></td></tr><tr><td>Crop</td><td>Lettuce (Lactuca sativa L.)</td></tr><tr><td>Variety name</td><td>‘GVR-108XL’</td></tr><tr><td>Applicant and owner</td><td>GreenVenus, LLC</td></tr><tr><td>Filing date</td><td>August 24, 2020</td></tr><tr><td>Issue date</td><td>May 13, 2022</td></tr><tr><td>Related applications</td><td>1) US Provisional Patent <a href="https://patentcenter.uspto.gov/applications/62925853" target="_blank">62/925,853</a> (filed October 25, 2019);2) International patent application <a href="https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2021080761" target="_blank">PCT/US2020/54082</a> (published April 29, 2021)</td></tr></tbody></table>GreenVenus, LLC’s romaine lettuce variety ‘GVR-108XL’ has edits to five polyphenol oxidase (PPO) genes, which are enzymes responsible for damage-related browning in fruits and vegetables, and negatively affect the shelf life of products such as pre-cut salads. As described in the publicly available description and data included with the published <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">PVP application</a>, the genetic edits in ‘GVR-108XL’ lettuce lower the activity of PPOs to delay browning, without the presence of transgenes in the plant’s genome. These edits were accomplished using a nuclease and guide RNAs to target multiple PPO genes. The nuclease and guide RNAs were originally introduced on a T-DNA using Agrobacterium-mediated transformation. This foreign DNA was integrated into the lettuce genome, thereby producing a transgenic lettuce plant that mediated its own gene editing. Once the transgenic nuclease and guide RNAs accomplished the desired edits to the PPO genes, the transgenic DNA was segregated out in subsequent generations by traditional breeding. The final ‘GVR-108XL’ lettuce plants thus include the PPO edits, but do not include foreign DNA (for more information, see pg. 8 and Exhibit B of the <a href="https://apps.ams.usda.gov/CMS/AdobeImages/202000361.pdf" target="_blank">‘GVR-108XL’ PVP application</a>).Options for plant IP protection and changes to PVPsAlthough this post focuses on PVPs, it is useful to keep in mind that PVPs are one of three non-mutually exclusive forms of IP available for plants in the United States. The other two forms are utility patents and plant patents. Utility patents can have any number of claims, and can cover many different aspects a plant, including but not limited to plant lineages, parts, cells, varieties, and even sometimes traits. Plant patents are restricted to asexually propagated plants, and contain only one claim, which is limited to the particular plant described in the plant patent and clones thereof. Somewhat similarly, PVPs are limited to the protected variety, but have slightly broader coverage than plant patents in that they contain provisions regarding essentially derived varieties (EDVs). This means that permission must be granted by the Certificate holder in order to sell varieties deemed to be “essentially derived” from the protected variety, so long as the protected variety is not itself an EDV. Read a more <a href="https://chinaipr.com/2020/04/02/essentially-derived-varieties-and-the-role-of-leading-cases-in-chinese-plant-variety-protection/" target="_blank">in-depth discussion of EDVs</a>.What do we expect going forward?We expect the number of PVPs granted on plants produced using biotechnology—whether transgenic or not—to only increase going forward. Given the recent updates to USDA’s regulatory process for assessing plants developed using genetic engineering under the SECURE rule, which we have summarized in a <a href="https://www.mofo.com/resources/insights/220912-purple-tomato-first-genetically-engineered-plant-to-be-deregulated" target="_blank">previous post</a>, and the increasing technological ease with which such edits may be made, it is likely that there will be an increase in development of such plants in the US. This is likely to be particularly true for certain “simple” types of gene editing, such as targeted DNA breaks that are repaired without a template, and targeted single base pair substitutions, both of which are <a href="https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/regulatory-processes/exemptions" target="_blank">exempt</a> from regulation under the SECURE rule.Not only will significantly more GE plants likely be produced going forward, but the recent expansion in PVP coverage to also include asexually reproduced plants (summarized in a <a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants" target="_blank">previous post</a>) means that nearly all such plants are now potentially eligible for PVP coverage. We expect that the combination of these two factors will lead to a significant increase in both the number and proportion of PVPs granted on transgenic and gene edited plant varieties—though it remains to be seen how closely USDA will publicly track each of these categories.As these technological and regulatory changes continue to settle in, it will be interesting to see how the industry adapts to the new regulatory atmosphere, and how use of the various forms of plant IP available in the United States continues to morph in parallel.

USDA’s PVP System Embraces Transgenic and Gene Edited Plants

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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Scientific Specialist

Christopher Lew is a scientific specialist in the Intellectual Property Group. The scientific specialist team conducts patent and non-patent literature searches for patentability, freedom to operate, 

Christopher D Lew

Christopher Lew

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

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

USDA’s PVP System Embraces Transgenic and Gene Edited Plants

Plant Variety Protection (PVP) is a form of intellectual property protection administered through the United States Department of Agriculture (USDA) for new varieties of plants. PVP certificates (PVPs), which have 

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This is the first such consultation completed by the agency and, while not a formal approval process, means that FDA has no further questions about UPSIDE’s conclusions that (1) its production process is safe and (2) its cultured chicken cell products are as safe as comparable foods, like traditionally produced chicken leg meat.Human food produced using animal cell culture technology is subject to an interagency regulatory framework between FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and USDA’s Food Safety and Inspection Service (FSIS). <a href="https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell" target="_blank">Under the agencies’ formal agreement</a>, both agencies agreed to a regulatory framework in which CFSAN regulates the initial steps of cell collection, cell banking, and cell differentiation. Once the cells are removed from their sealed growth environments at the harvest stage, FSIS oversees their further processing, labeling, and packaging.To market its product, UPSIDE will still need to meet additional FDA requirements, such as food facility registration, and will need a grant of inspection from FSIS for the manufacturing establishment. The product itself also must bear a USDA mark of inspection. USDA has yet to issue any guidance or regulations addressing product labeling, so many questions remain regarding how cell-cultured foods can be marketed. If <a href="https://www.federalregister.gov/documents/2021/09/03/2021-19057/labeling-of-meat-or-poultry-products-comprised-of-or-containing-cultured-animal-cells" target="_blank">FSIS’s advance notice of proposed rulemaking</a> is any indication, the agency’s eventual rulemaking on these issues will be hotly contested by industry and other interest groups.UPSIDE submitted a <a href="https://www.fda.gov/media/163262/download" target="_blank">Premarket Notice for Integral Tissue Culture Poultry Meat</a> to FDA on October 1, 2021, and amended it multiple times in response to FDA’s requests for further information and points of clarification. FDA was particularly interested in the genetic engineering method UPSIDE uses to immortalize its cell lines, and its ability to maintain single-species lines free from microbial or chemical contamination. The consultation process spanned over a year and covered every step of the cell culture process, including (1) how the cells are isolated, (2) how the cell bank is maintained and monitored, (3) how the cells are multiplied and differentiated, and (4) how the cell material is harvested.<div class="embedded-entry redactor-component block-entry" type="entry" data-sys-entry-uid="blt55bed3bf86d934f6" data-sys-entry-locale="en-us" data-sys-content-type-uid="image_content" sys-style-type="block"><div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt42e24a20d96e86cd/637ce41176567a10a7cbb880/cultured-animal-cells-flowchart-what-fda-evaluated-in-first-pre-market-consultation.png?format=auto&amp;quality=60" alt="cultured animal cells flowchart what fda evaluated in first pre market consultation"></div></div>FDA invites additional consultations from cultured meat producers looking to enter the U.S. market. “FDA is ready to work with additional firms,” and <a href="https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development" target="_blank">intends to release new guidance</a> on its process for regulating animal cell cultured foods by the end of 2022. Cultured meat and other novel food producers should rejoice: FDA is committed to supporting innovation in the food supply. We are very much looking forward to browsing the cell cultured aisle of the local supermarket and cannot wait to be able to sample the cell cultured products of our clients!

FDA Clears the Path to Lab-Grown Meat

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

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Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.

Owen Grayson Hosseinzadeh

Owen Hosseinzadeh

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FDA Clears the Path to Lab-Grown Meat

De Novo Classification Final Rule to Take Effect Next Year

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On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken.

Innovation, agriculture, and technology took center stage at San Diego’s first AgTech Hackathon. The event took place October 21 – 23 in the city of Escondido, a key farming hub in San Diego County looking to attract agtech startups to the region. The event brought together entrepreneurs, farmers, investors, students, and community leaders to collaborate and develop innovative agtech ideas into viable business pitches.MoFo was a proud sponsor of the event, and Partner Matthew Ferry served as a judge in the pitch competition that culminated the weekend. Prior to the competition, Matthew Ferry and scientific analyst Dr. Edith Pierre-Jerome presented on the Top Three IP Issues for AgTech Startups, including:#3. Not understanding the different IP areas applicable to your business.Intellectual property takes many different forms. Classic forms of IP, such as patents, copyrights, trademarks, and trade secrets, are all forms of intellectual property protection that can be used strategically to protect different aspects of a business. Here are the main differences between them:Patents provide exclusive rights to inventions. There are three types of patents within the United States:<ul><li>Utility patents, which protect a new and useful process, machine, manufacture, or composition of matter;</li><li>Design patents, which protect a new, original, and ornamental design of a functional item; and</li><li>Plant patents, which protect the invention or discovery of a new and distinct plant varieties </li></ul>Copyrights protect original works of authorship fixed in a tangible medium of expression, like a book or this blog post.Trademark rights protect words, phrases, or designs that denote a product or service and help consumers associate the product or service with its source.Trade secret rights protect information that derives value from not being generally known and is subject to reasonable efforts to maintain secrecy.Plant Variety Protection (PVP) certificates are a plant-specific form of IP protection that, similar to patents, provide exclusive rights to new sexually reproduced, tuber propagated, and, as of 2020, asexually reproduced plant varieties. Unlike patents, PVP certificates are issued by the USDA Plant Variety Protection Office, offer use exemptions for noncommercial purposes, and cover Essentially Derived Varieties. For more information, see <a href="https://lifesciences.mofo.com/topics/planting-the-seeds-of-change">Planting the Seeds of Change | MoFo Life Sciences</a>.#2. Employees, contractors, and founders failing to assign IP to the company.In the United States, a patentable invention or discovery belongs to the inventor until ownership is assigned to another person or entity. This is true (generally) even if the inventor was an employee or founder of the company.Without owning the IP, the company may not be able to stop others from practicing the invention and may have unclear rights in its own freedom to operate. As a company matures and seeks to attract investment, investors will often look to make sure all the intellectual property meant to be owned by the company is actually owned by the company. This may not be the case if the inventor did not assign their rights to the company in writing.Assignment to the company should happen early on since it is often difficult to track down inventors the more time passes.#1. Publishing inventions before filing for patent protection.Inventors are often their own worst enemy when it comes to obtaining a patent. AgTech startups may want to publish whitepapers, sell prototypes, or gain traction for their market by publishing and presenting their discoveries. But they should beware of doing so without first consulting IP counsel. Once the subject matter is published or publicly used, the inventor may no longer be able to obtain patent protection in many foreign jurisdictions and has a strict one-year deadline to seek a patent within the U.S. Matthew Ferry also shared his thoughts on MoFo’s support of the AgTech industry:“For more than two decades, MoFo’s global Food + Agriculture practice has helped shape the food and agribusiness sector. We pride ourselves on delivering innovative, business-minded solutions to help our clients feed a rapidly growing global population.We have unparalleled technology experience, with a top-tier patent group that has a deep technological understanding of critical areas driving the industry. Our collaborative team offers full life cycle counseling from farm to table to help companies and investors navigate the future of food across the supply chain.With a growing population demanding an increased supply of healthier foods and global climate change altering where and how we can grow it, the innovations being developed by the AgTech community have never been more vital.”

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Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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Edith Pierre-Jerome

Top Three IP Issues for AgTech Startups