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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On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to

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Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants

Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants | MoFo Life Sciences

Liz Freeman Rosenzweig Ph.D.

Cory Ellison Ph.D.

Michael Ward Ph.D.

On January 6, 2020, the Plant Variety Protection Office (PVPO) released the final version of its much-anticipated rule to open Plant Variety Protection (PVP) to asexually reproduced plants. Publication of this rule means that the PVPO is now accepting applications for all species of asexually reproduced plants for the first time.Extending PVP rights to all asexually reproduced plants means that breeders of plants, such as fruit trees, which are typically propagated asexually rather than by seed, may now obtain PVP certificates for their varieties in the United States. This addition is also notable for breeders of hemp—the regulated production of which was legalized by the 2018 Farm Bill—because hemp can be reproduced both asexually and by seed.The 2018 Farm Bill Extended PVPA Protection to Asexually Reproduced PlantsThe new PVPO rule was prompted by the 2018 Farm Bill (Public Law No: 115-334, Sec. 10108), which dramatically expanded the scope of the U.S. Plant Variety Protection Act (PVPA) to include protection for asexually reproduced plant varieties. Prior to this amendment, the PVPA had been limited to sexually reproduced plants (i.e., seed-bearing plants) and tuber‑propagated plants. Although the Farm Bill was passed over a year ago, the PVPO needed time to revise the Plant Variety Protection Regulations (7 C.F.R. part 97; “Regulations”), which guide the implementation of the PVPA, prior to accepting applications for asexually reproduced plant varieties. A draft rule proposing such revisions was published for comment in the Federal Register in July 2019 (84 Fed. Reg. 33176, 33178), and comments closed in September 2019. In the intervening period, the PVPO revised the draft into a final rule, which was reviewed and approved by the PVPO Administrator and the Secretary of Agriculture before being released on January 6, 2020.The 2018 Farm Bill included the following amendments to the PVPA: 1) the sections on rights provided (7 U.S.C. § 2402), infringement (7 U.S.C. § 2541), and false marking and cease and desist orders (7 U.S.C. § 2568) were revised to include language for asexually reproduced plants and 2) the definitions section (7 U.S.C. § 2401(a)) was revised to provide a definition for the term “asexually reproduced.” Specifically, the PVPA now defines “asexually reproduced” as “produced by a method of plant propagation using vegetative material (other than seed) from a single parent, including cuttings, grafting, tissue culture, and propagation by root division.” (2018 Farm Bill, Public Law No: 115-334, Sec. 10108, 132 Stat. 4906 (Dec. 20, 2018).)In implementing these changes, the PVPO’s new rule demonstrates how the Office will handle PVP applications for asexually reproduced plants. Many of the changes merely broaden the Regulations’ existing language to include asexually reproduced plants. For instance, with regard to the publication of pending applications, amended § 97.19(c) states that information relating to pending applications shall show the “name of the crop” rather than the “name of the kind of seed.” Notably, however, there are two key areas that Applicants interested in obtaining PVP protection for their asexually reproduced varieties should be sure to understand: 1) the testing requirements and 2) the deposit requirements (discussed in detail below).Distinctness, Uniformity, and Stability (DUS) TestingAs is the standard for sexually reproduced and tuber-propagated plants, the PVPO will not conduct its own DUS trials for asexually reproduced plants. Rather, Applicants will perform DUS testing themselves and provide their data to the PVPO using new Exhibit C forms that the Office has developed for asexually reproduced plants. These new Exhibit C forms are based on the Test Guidelines Table of Characteristics from the International Union for the Protection of New Varieties of Plants (UPOV). The PVPO’s new forms are available on the PVPO website and through the <a target="_blank" href="https://www.ams.usda.gov/services/plant-variety-protection">ePVP online application system</a>. Additionally, the PVPO may also accept DUS reports from other countries on a case-by-case basis.Deposit RequirementsFor PVP applications directed to seed-reproduced and tuber-propagated varieties, the PVPO currently requires Applicants to submit a biological deposit of the candidate variety. When the PVPA was extended to asexually reproduced plants, the PVPO had planned to require deposits for asexual reproduced species as well. However, in response to feasibility concerns raised in the public comment period, the final rule provides for a three-year delay in enforcement of the deposit requirement for asexually reproduced plants. Thus, deposits of propagating material for asexually reproduced plants will not be required until January 6, 2023. In the intervening period, the PVPO will examine the technical feasibility of making deposits for asexually reproduced plants.Therefore, from January 6, 2020, until January 6, 2023, Applicants are not required to make a biological deposit for PVP applications for asexually reproduced plants, though they may do so voluntarily. However, Applicants who choose to not make deposits during this period are required to submit declarations stating that: 1) propagating material will be maintained at a specific physical location that the PVPO can inspect (7 C.F.R. § 97.7(d)(2)(i) 2020) and 2) the propagating material will be provided within three months of a request by the PVPO (7 C.F.R. § 97.7(d)(2)(ii) 2020).The final rule envisions that, after January 6, 2023, deposits will be required for PVP applications for asexually reproduced plants within three months of notice of certificate issuance. As with sexually reproduced and tuber-propagated plants, Applicants seeking protection for asexually reproduced plants will be required to submit a declaration stating that the deposit will be maintained for the duration of the certificate.Although deposits are currently envisioned to become required and enforceable after January 6, 2023, Applicants may request waivers that, if granted by the PVPO, will allow for delayed submission of the deposit. Two types of waivers will be available for asexually reproduced plants:<ol><li>Waiver for “good cause, such as delays in obtaining a phytosanitary certificate” (7 C.F.R. § 97.7(d) 2020); and</li><li>Waiver to withhold deposit due to technical infeasibility.</li></ol>If a technical infeasibility waiver is granted by the PVPO, the Applicant will further be required to:<ol><li>Make the same two § 97.7(d)(2)(i)-(ii) declarations noted above; and</li><li>Submit a deposit within three months of notice that the technical infeasibility has been resolved.</li></ol>Overall, Applicants should be prepared to submit deposits of propagating material for asexually reproduced plants, although such deposits will not be formally required until January 6, 2023. During the intervening time, as noted above, the PVPO is reviewing the technical feasibility of making deposits for asexually reproduced plants. Following this review period, the PVPO may modify the deposit requirements outlined above.PVP Certificates vs. Plant PatentsPrior to the PVPA amendment, intellectual property protection on asexually reproduced plants in the United States was already available in the form of plant patents under 35 U.S.C. § 161. Plant patents continue to be available, but PVP certificates offer broader protection in terms of so-called “essentially derived varieties” (EDVs). That is, in addition to covering the variety owned by the titleholder, PVP certificates also require the titleholder’s permission before commercialization of any variety that has been “essentially derived” from the titleholder’s variety (7 U.S.C. § 2541). In contrast, plant patents cover only the exact plant set forth in the issued patent and clones thereof. Thus, the option to obtain PVP rights expands the scope of protection available for breeders of asexually reproduced plants in the United States. Furthermore, with the addition of asexually reproduced plants, the U.S. PVP system is now more aligned with analogous systems in other UPOV countries, allowing breeders to streamline their international portfolios.While PVP certificates provide broader protection for breeders than do plant patents, they do present some drawbacks. Specifically, the PVPA contains exemptions to infringement for seed-saving, research, and breeding (7 U.S.C. §§ 2543-44), while plant patents do not. Furthermore, unlike PVP applications, plant patent applications do not formally require a deposit. Finally, plant patents are more economical than PVPs. Indeed, PVP certificates require both a $3,000 deposit fee and a $5,150 application fee, while the official fees for a plant patent are likely to total less than half of that amount.Moving ForwardIn addition to incorporating the inclusion of asexually reproduced plants, the PVPO’s revised Regulations updated the fee schedule and modernized administrative procedures. The full text of the new rule is available at the <a target="_blank" href="https://www.federalregister.gov/documents/2020/01/06/2019-27636/regulations-and-procedures-under-the-plant-variety-protection-act">PVPO’s website</a>. Given the cost and the potential technical complications of the deposit requirement, it remains to be seen how popular PVPs for asexually reproduced plants will be. However, the opportunity to obtain PVPs for asexually reproduced plants—particularly considering the EDV protection provided—is a significant step forward for plant intellectual property in the United States.

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