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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In October 2023, the <a href="https://www.upov.int/portal/index.html.en" target="_blank">International Union for the Protection of New Varieties of Plants (UPOV)</a> published a long-awaited <a href="https://www.upov.int/edocs/expndocs/en/upov_exn_edv.pdf" target="_blank">updated Explanatory Note on Essentially Derived Varieties (EDVs)</a>. The UPOV Convention outlines a popular sui generis form of IP protection for plant varieties and was first established in 1961; EDVs have been a provision of the UPOV Convention since 1991. However, the bounds of what can constitute an EDV have often been difficult to devise in practice, and stakeholders have long been requesting clarification from UPOV, particularly in light of modern breeding techniques that may incorporate, for example, gene editing. This new guidance represents UPOV’s response to these concerns.What Are EDVs?The legal concept of an “essentially derived” variety serves to effectively extend the reach of a Plant Variety Right (PVR; often also used synonymously with Plant Breeders’ Rights, or PBRs) issued under a PVR scheme that is based on the 1991 UPOV Convention. Thus, in order to understand the concept of EDVs, it is first necessary to understand what a PVR is.PVR certificates are a form of IP protection that are separate from patents and are designed specifically for new plant varieties. PVRs protect against unauthorized commercial activity or use of a protected variety, with <a href="https://www.upov.int/databases/en/#QS13" target="_blank">over 150,000 total active titles worldwide as of 2022</a>. The most common legal framework for PVR protection is outlined in the <a href="https://upovlex.upov.int/en/convention" target="_blank">UPOV Convention</a>. Each UPOV <a href="https://www.upov.int/members/en/" target="_blank">Member jurisdiction</a> ultimately provides and implements its own PVR laws and regulations that are consistent with the UPOV Convention to which they are signatory, but UPOV’s “Explanatory Notes” (which provide non-binding guidance for understanding and implementing various terms or provisions of the UPOV Convention) can influence how a Member implements and interprets its PVR laws.There are two current versions of the UPOV Convention, 1978 and 1991, which have some differences in PVR requirements and the scope of protection. One key difference is that the 1991 UPOV Convention introduces the concept of EDVs and provides coverage to the certificate owner of a protected variety over varieties essentially derived from the protected variety (i.e., EDVs).The core definition of an essentially derived variety (EDV) comes from Article 14(5)(b) of the 1991 Act of the UPOV Convention (emphases added):A variety shall be deemed to be essentially derived from another variety (“the initial variety”) when:(i) it is predominantly derived from the initial variety, or from a variety that is itself predominantly derived from the initial variety, while retaining the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety(ii) it is clearly distinguishable from the initial variety and(iii) except for the differences which result from the act of derivation, it conforms to the initial variety in the expression of the essential characteristics that result from the genotype or combination of genotypes of the initial variety.By way of example, the <a href="https://www.ams.usda.gov/services/plant-variety-protection" target="_blank">U.S. Plant Variety Protection</a> law (which is administered by the U.S. Department of Agriculture and is in line with the 1991 UPOV Convention) provides a non-exhaustive list of how EDVs can be made, including by: 1) the selection of a natural or induced mutant or of a somaclonal variant, 2) the selection of a variant individual from plants of the initial variety, 3) backcrossing, 4) transformation by genetic engineering, and 5) other methods. (7 USC 57 §2401 (a)(4)(A)).The third and most recent EDV Explanatory Note was published on October 27, 2023, and was prepared to address the fact that the previous EDV Explanatory Note, which was published in April 2017, no longer reflected breeders’ common practices in understanding EDVs and was insufficient to address the development of new breeding technologies (e.g., gene editing). The updated guidelines provide additional guidance for two key terms used in the definition of an EDV: “predominantly derived” and “essential characteristics.” Each of these is outlined below.Predominantly DerivedThe Explanatory Note explains that “predominant” derivation means that more of the genome of the initial variety is retained than would be retained by normal crossing and selection with different parents. This definition reinforces that a variety should only be considered predominantly derived from the initial variety if it retains almost the whole genome of its initial variety. Varieties with a single parent (“mono-parental” varieties) are considered per se predominantly derived from their initial varieties. Mono-parental varieties include varieties that are the result of mutations, gene editing, and the like. The Explanatory Note also states that there is no upper limit on the number of characteristic differences between an initial variety and a variety predominantly derived from the initial variety. Thus, predominant derivation is primarily defined by the genetic similarity between the derived and initial varieties rather than changes in characteristics.Essential CharacteristicsRegarding “essential characteristics,” the Explanatory Note reinforces that these are characteristics that contribute to the “principal features, performance, or value” of a variety. Examples of essential characteristics include morphological, physiological, agronomic, industrial, biochemical, and commercial attributes of a variety. In addition, the Explanatory Note states that a “predominantly derived” variety can still be an EDV of an initial variety even if it doesn’t completely share the essential characteristics of the initial variety, as long as the missing essential characteristics are missing as a result of the act of derivation. The Explanatory Note also allows for essential characteristics to evolve over time.Concluding ThoughtsThis third EDV Explanatory Note appears to elevate the importance of genetic similarity between an EDV and the initial variety and opens the possibility that essential characteristics may not always be 100% shared between an EDV and the initial variety. This new guidance therefore may provide more latitude for creative “essential characteristics” arguments, but, on the other hand, may also narrow the options for “predominantly derived” arguments. On a practical level, these guidelines will most likely impact both traditional breeders of multi-parental varieties and gene editors who make targeted genetic changes in an initial protected variety to produce a new variety. This Note appears to increase the avenues for such edited varieties to be considered EDVs of their initial varieties, which means that, while a developer producing such an edited plant could still seek their own PVR protection for their edited (i.e., derived) variety (assuming it meets all the requirements for protection, e.g., distinctness, uniformity, and stability), depending on how the updated guidance reads on the technical changes in the derived variety, the developer of the derived variety may still face freedom-to-operate concerns regarding the PVR holder of the initial variety. That being said, and as noted above, UPOV Notes are non-binding guidance; it remains to be seen how various jurisdictions with EDV provisions on the books (e.g., the U.S. and many others) will react and how such issues may play out in infringement disputes.Overall, these updates should make the concept of EDVs more straightforward to apply to varieties produced by new breeding technologies. For more updates on plant variety rights, see our other recent <a href="https://www.mofo.com/resources/insights/240131-us-plant-variety-protection-office">post on PBRs in the U.S., Canada, and Japan</a>, and subscribe to our blog.

UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

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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

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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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Cory Ellison is a patent agent in the San Francisco office of Morrison & Foerster. Dr. Ellison’s practice involves patent application drafting, patent prosecution, matters pertaining to plant variety 

Cory Ellison Ph.D.

Cory Ellison

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Dr. Edith Pierre-Jerome focuses her practice on patent drafting and prosecution in areas related to molecular and cellular biology, biochemistry, microbiology, and plant genetics.

Edith A. Pierre-Jerome Ph.D.

Edith Pierre-Jerome

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UPOV Updates Explanatory Note on Essentially Derived Varieties (EDVs)

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In October 2023, the International Union for the Protection of New Varieties of Plants (UPOV) published a long-awaited updated Explanatory Note on Essentially Derived Varieties (EDVs). 

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

Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.Read the <a href="https://media2.mofo.com/v3/assets/blt5775cc69c999c255/bltbc857834ffd7f479/64a89947ade08c2fe3cb214e/230705-top-considerations-for-transactions.pdf" target="_self">full article</a>.

Top 10 Considerations for Transactions Involving Alternative Protein Companies

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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

Dr. Sarah Bloch focuses her work on patent drafting and prosecution. Sarah has experience in IP due diligence inquiries, with an emphasis on biotechnology, agriculture, and the food industry.
Sarah ha

Sarah E. Bloch Ph.D.

Sarah Bloch

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Top 10 Considerations for Transactions Involving Alternative Protein Companies

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Matthew Ferry and Sarah Bloch authored an article for the Daily Journal discussing the top ten aspects alternative protein companies should consider when planning for and negotiating research and commercial agreements.

After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see <a href="https://www.arc2020.eu/wp-content/uploads/2023/06/ARC2020_-1.-Draft-NGT-proposal.pdf" target="_blank">Proposal</a>). Although the official presentation is scheduled for July 5, 2023, the document was leaked and reveals a significant reversal away from the existing legislation on genetically modified organisms (GMOs), especially in the 2001 GMO Directive (see <a href="https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32001L0018" target="_blank">Directive 2011/18/EC</a>) and the 2003 Regulation on genetically modified food and feed (see <a href="https://eur-lex.europa.eu/eli/reg/2003/1829/oj" target="_blank">Regulation 1829/2003/EC</a>). A new risk-based approach leads away from strict authorization procedures and labeling requirements.A. Overview of the planned framework: Introduction of two categories of NGT plantsThe new regulation is applicable to NGT plants and their food and feed. According to Article 3(2) of the Proposal, “‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis, cisgenesis, intragenesis, or a combination thereof, on the condition that the NGT plant does not contain any genetic material originating from outside the breeders’ gene pool that temporarily may have been inserted during the development of the NGT plant.”  “Breeders’ gene pool” has been defined to mean “the total genetic information available in one species and other taxonomic species with which it can be cross-bred, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses.”The regulation follows a risk-based approach. Risk profiles associated with NGT plants are very diverse, from plants with risk profiles similar to conventionally bred plants to plants with various types and degrees of hazards and risks that might be similar to those of plants obtained by established techniques of genetic modification. The Proposal therefore adjusts the level of regulatory oversight according to this variety of potential risks posed by NGT plants and products (Recital 12). The Commission plans to introduce two categories of NGT plants (category 1 and category 2 NGT plants), in which category 1 plants are subject to less stringent requirements than category 2 plants.Category 1 plants are considered “equivalent” to conventional plants, and must differ from the recipient or parent plant by no more than 20 genetic modifications of the following types:(1) Substitution or insertion of no more than 20 nucleotides;(2) Deletion of any number of nucleotides;(3) Targeted (a) insertion of a contiguous DNA sequence or (b) substitution of an endogenous DNA sequence with a contiguous DNA sequence, where the contiguous sequence is in the breeders’ gene pool and the modification does not interrupt an endogenous gene (though the definition of NGT does not include temporary insertion of genetic material from outside the breeders’ gene pool during development of the new plant);(4) Targeted inversion of a sequence of any number of nucleotides; or(5) Any other targeted modification of any size, on the condition that the resulting DNA sequences already occur (possibly with modifications as accepted under points 1 and/or 2) in a species from the breeders’ gene pool.Further, these 20 or fewer modifications must be in DNA sequences that share “sequence similarity” with the targeted site. The sequence similarity must be able to be “predicted by bioinformatic tools,” though the degree of required similarity is not clear.Thus, the technical scope of “equivalence” is theoretically quite broad, though one will still be required to show that the modified sequence is “predictable” and shares some (presumably relatively high) sequence identity.  Overall, these acceptable modifications seem largely designed to include methods that have a long history of safe use (such as random mutagenesis and subsequent selection, which often result in, for instance, the first and second types of modifications listed above), and modern targeted editing, such as CRISPR, can be used to make any of the above modifications.     1. No authorization or labeling duties for category 1 NGT plantsFor NGT plants that could also occur naturally or be produced by conventional breeding and not harbor traits that can have a negative impact on sustainability, this regulation would provide a procedure to determine that the genetic modifications made and traits achieved are indeed of such a nature (a “notification procedure”), thereby classifying them as category 1 NGT plants. Category 1 NGT plants need to fulfill the criteria of equivalence to conventional plants set out in Article 5 and Annex I of the Proposal, i.e., when it differs from the recipient/parental plant by no more than 20 genetic modifications.Category 1 NGT plants defined in this way will not be subject to the rules and requirements of the EU GMO legislation, unless the new legislation doesn’t introduce new rules (Recital 11). Category 1 NGT plants will also be subject to any regulatory oversight that applies to conventionally bred plants (Recital 23). Despite the fact that category 1 NGT plants will not be subject to the rules and requirements of the EU GMO legislation, they would remain subject to the prohibition of use of GMOs in organic production to meet the demands of the sector (Recital 17).The most striking change in the legal situation is that category 1 NGT plants in the future will no longer have to be authorized before they are placed on the market or used for any other purpose. Articles 6 and 7 of the Proposal provide for a notification procedure to a national authority to prove that the respective NGT plant, or food or feed produced from such plants, meets the requirements for classification as category 1.According to Art. 7(2) of the Proposal, for example, to place a NGT plant on the market, the notification must include:(a) The name and the address of the notifier;(b) The designation of the NGT plant;(c) A description of the trait(s) and characteristics which have been introduced or modified;(d) The information necessary to demonstrate that the plant is a NGT plant; and(e) An identification of the parts of the notification that the applicant requests to be treated as confidential.In addition, it should be noted that there will be no labeling requirement for category 1 plants. The EU Commission explicitly states that labeling can be done “on a voluntary basis” (Recital 29).All recognized – and thus approved – category 1 NGT plants must be entered in a publicly accessible database (Art. 10). Individual Member States may not restrict or even prohibit the deliberate release or placing on the market of category 1 NGT plants and the respective free movement of goods (Art. 9).     2. Authorization requirements for category 2 plants are less strictFor all other NGT plants (category 2 NGT plants), the Proposal provides for a simplification of the authorization procedures of the current GMO legislation, in particular, a risk assessment adapted to the risk profile of the plant (Articles 15 and 22). Given the wide variety of NGT plants, food, and feed, the type and amount of information necessary for the risk assessment will vary on a case-by-case basis (Annex II). Factors to be considered are, inter alia:(a) The trait(s) introduced;(b) The function of the modified or inserted genome sequence(s);(c) The function of any gene disrupted by the insertion of a cisgene/intragene or parts thereof:(d) Prior experience with the consumption of similar plants or their products; and(e) Prior experience with the cultivation of the same plant species or plant species exhibiting similar traits or in which similar genome sequences have been modified, inserted, or disrupted.This, however, only applies to NGT plants for food and feed. Category 2 NGT plants created for uses other than food or feed will only need a notification sent to the national authority (Article 16). However, it is mandatory to label category NGT2 plants and any products obtained from them (Article 26).B. The EU Commission’s reasoningThe Proposal is part of the European Green Deal, a set of proposals to make the EU’s climate, energy, transport, and taxation policies fit for reducing net greenhouse gas emissions by at least 55% by 2030. With a liberalization of the legal situation for NGTs, the Commission hopes that the agricultural sector can also contribute to the targeted greenhouse gas reduction and the EU’s Farm to Fork Strategy, aiming to reduce the environmental and climate impact of food production and consumption in the EU.The EU Commission considers the existing GMO legislation not fit for the purpose of certain plant applications of new genomic techniques and too strict for NGT organisms. The existing authorization procedures and risk assessment requirements can therefore be disproportionate or inadequate (Recital 7).C. OutlookThe Proposal is to be presented by the EU Commission on July 5, 2023. It will then have to go through the regular EU legislative process. The timetable for EU lawmakers is currently tight and quite challenging. After all, new elections to the EU Parliament are due in June 2024. In order not to interrupt the implementation of the project and unnecessarily postpone it, it is hoped there will be a speedy implementation within the next year.The ambitious goals of the Commission are an important sign that could lead to Europe becoming a location for innovation. An overhaul of the outdated strict legal NGT framework will lead to increasing research into future technologies and enhance the competitiveness of the EU agri-food sector, while maintaining a high level of protection of human and animal health and the environment.For a comparison of the EU proposal to U.S. regulation, please see our recent <a href="https://lifesciences.mofo.com/topics/the-eu-s-new-proposal-for-plants-developed-using-new-genomic-techniques-how-does-it-compare-to-u-s-regulation-">blog post</a>.Update July 2023: The EU Commission has officially presented the <a href="https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2023:411:FIN" target="_blank">Proposal on New Genomic Techniques</a>. In addition, the Commission has published accompanying <a href="https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_3568" target="_blank">Q&A</a> on the proposal. The leak discussed in this blog post corresponds to the actual official EU Commission proposal. The legal assessment therefore remains. However, please note that some article numbers and recital numbers have changed.Two minor changes in the central definition of category 1 NGT plants in Annex 1 should be highlighted here. They do not necessarily extend and reduce the scope of category 1 NGT plants, but lead to more legal certainty when categorizing NGT plants:<ol><li>Originally, a targeted insertion or substitution of DNA was not allowed to result in an intragenic plant. The official proposal now states that the targeted insertion or substitution must not interrupt an endogenous gene. The shift to “does not disrupt an endogenous gene” provides more technical guidance as to where to make such edits.</li><li>To be considered an NGT plant in category 1, the plant must be considered “equivalent to conventional plants." Defining this equivalence, the leaked draft stated: “An NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than [20] genetic modifications (…), in predictable DNA sequences. A predictable DNA sequence is any DNA sequence that shares sequence similarity with the targeted site.” Now the official proposal clarifies the meaning and method of similarity prediction: “A NGT plant is considered equivalent to conventional plants when it differs from the recipient/parental plant by no more than 20 genetic modifications (…), in any DNA sequence sharing sequence similarity with the targeted site that can be predicted by bioinformatic tools.”</li></ol>Research assistant Tim Stripling substantially contributed to this article.***For more information, read our previous client alert, <a href="https://www.mofo.com/resources/insights/210525-novel-genomic-techniques" target="_blank">The European Commission’s Take on Novel Genomic Techniques (NGTs) in Light of CJEU’s Ruling in Case C-528/16</a>

After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration.

Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU

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

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

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

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

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.What is a CRADA?<a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> are the basis for research collaboration between federal agencies and private sector businesses and organizations. CRADAs are derived from the Stevenson-Wydler Technology Innovation Act of 1980, Public Law 96–480, 94 Stat. 2311 (Oct. 21, 1980), as amended by the Federal Technology Transfer Act of 1986, Public Law 99–502, 100 Stat. 1785 (Oct. 20, 1986) (FTTA). CRADAs are different than grants and procurement contracts in that CRADAs emphasize collaboration between federal laboratories and non-federal parties to undertake joint research as opposed to the transfer of funding.How are rights in inventions developed under CRADAs allocated?The allocation of rights in inventions developed under CRADAs are generally subject to a different and more flexible set of rules (described in 15 U.S.C. § 3710(a)) than those prescribed in the Bayh-Dole Act (35 U.S.C. §§ 200–212), which generally applies to inventions developed with federal government funding under grants and contracts. In contrast, the government generally has wide latitude in negotiating certain aspects of CRADAs, including, in particular, with respect to rights in inventions and subsequent patents related thereto. Overall, the allocations will depend on inventorship: was the invention made in whole or in part by a government employee or solely by a collaborator’s employee?Inventions made by government employee(s) under a CRADAWhere inventions are made either in whole or in part by a government employee (i.e., either government inventions or joint inventions), the government may either assign or license the invention to the collaborator (for reasonable compensation, if appropriate; see 15 U.S.C. § 3710(b)(1)).The collaborator also has the option for an exclusivelicense in a pre-negotiated field of use (see 15 U.S.C. § 3710(b)(1)). Assignments or licenses to the collaborator of government-developed or jointly developed inventions are subject to the government’s retention of a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have it practiced throughout the world by or on behalf of the government. Further, where the government either assigns or grants an exclusive license to the collaborator, the government retains “march-in” rights to force a license to a third party in “exceptional circumstances” (i.e., where necessary to meet health or safety needs or public use requirements) or if collaborator fails to comply with domestic manufacturing requirements, where applicable. Alternatively, if the collaborator has a non-exclusive license, the government could simply give a license to a third party.Inventions made by collaborator’s employee(s) under a CRADAIn contrast, where CRADA inventions are made solely by a collaborator’s employee(s), the collaborator may retain title, but must provide the government with a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced the invention throughout the world for government purposes (see 15 U.S.C. § 3710(b)(2)). While negotiating the terms of the CRADA, the collaborator may want to thoroughly describe all background IP (including any patents) related to the research project and clearly exclude the background IP from the rights scheme that applies to CRADA-subject inventions.USDA CRADA policy and templatesThe USDA Agricultural Research Service (ARS) provides a number of template agreements, including a template CRADA, on its <a href="https://www.ars.usda.gov/ott/templates-agreements/" target="_blank">website</a>.Some CRADA terms are more open to negotiation than others. For instance, collaborators will not be able to negotiate out terms required under the licensing requirements of 35 U.S.C. § 209, which apply to both joint inventions and government inventions licensed by a collaborator and are outlined in Section 7.1 of the USDA template. Under this statute, wholly government inventions and joint inventions (by the government and the collaborator) are treated the same.Key takeawaysOverall, <a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> can offer collaborators potential advantages over competitors by, for example, facilitating confidential access to USDA’s research capacity, license negotiations, and global network of partners, while also helping USDA scientists contribute more directly to economic development and facilitating licensing of USDA technologies. Potential collaborators should be aware that they have some degree of latitude in negotiating CRADAs and should take care to consider the implications of inventorship on title of resulting IP, among other considerations. Our government contracts and IP teams have negotiated CRADAs with USDA in the past and can provide assistance with CRADA negotiations. Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/government-contracts-public-procurement" target="_blank">Government Contracts + Public Procurement</a> or <a href="https://www.mofo.com/capabilities/patent-strategy-prosecution" target="_blank">Patent Strategy + Prosecution</a> teams if you have any questions or if you are interested in learning more about how MoFo could help your company navigate CRADAs with USDA.

Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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Dr. Bu Yin has nearly 10 years of experience in life sciences patent application drafting, global portfolio management, and strategic counseling. Dr. Yin frequently counsels on issues relating to pate

Bu Yin Ph.D.

Bu Yin

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.

IP Implications of USDA Research Collaborations

On April 3, 2023, the U.S. Plant Variety Protection Office (PVPO) held a preparatory session for the International Union for the Protection of New Varieties of Plants (UPOV) Technical Working Party for Vegetables (TWV) and Technical Working Party for Agricultural Crops (TWA) virtual meetings in May. This session was to provide an opportunity for feedback and comments on the UPOV Test Guidelines and the PVPO Exhibit C forms.In regard to the UPOV Test Guidelines, the PVPO will be submitting comments received on the PVPO Hemp (Cannabis) form to the UPOV Technical Working Party. As of April 3, 2023, there were no plans for the PVPO to submit comments on any of the other crops that will be discussed in the May meetings.In regard to the PVPO Exhibit C forms, the PVPO is currently in the process of aligning Exhibit C forms for all crops with the UPOV Test Guidelines. The Exhibit C forms are being updated on an as-requested basis, which means that only those forms that have been updated are currently available on the PVPO website. You can contact the Office (via <a href="mailto:AMS.PVPOForms@usda.gov">AMS.PVPOForms@usda.gov</a>) to request specific forms, ask about the status of specific forms, or ask other form-related questions. Over time, all of the forms will be updated.The PVPO stated that some older characteristics, which have been important for variety searches in the past, will be retained on the updated Exhibit C forms. In addition, the PVPO will retain quantitative traits in the updated Exhibit C forms.There is a new “area of adaptation” section on the updated Exhibit C forms, which will include options for both field-grown varieties and greenhouse-grown varieties. Over time, the PVPO will be updating its dashboard to display varieties by their area of adaptation, to facilitate variety searching. This dashboard will eventually replace the current certificate management system.If you have any comments on Exhibit C forms, they can be submitted to the Plant Variety Protection Office via email (<a href="mailto:pvpomail@usda.gov">pvpomail@usda.gov</a>), and the Examiner who handles the crops will review. MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team will continue to monitor developments related to the PVPO and will post future updates on our blog.