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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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.

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Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU | MoFo Life Sciences

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>

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

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