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.

Social

Search

Subscribe

Life Sciences and Healthcare Group

Life Sciences Podcast

Patent Counseling + Prosecution

FDA Regulatory + Life Sciences Compliance

FDA + Healthcare Regulatory and Compliance 

Life Sciences Transactions + Licensing

Life Sciences IP Litigation

Resources

Editors

230315-new-mofo-life-sciences-logo.jpg

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.

poon_meghan_blog_150x150.png

poon_meghan_common_640x280.jpg

poon_meghan_heroretina_2700x1160.jpg

poon_meghan_mobileretina_750x1040.jpg

poon_meghan_social_600x600.jpg

Partner

Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

With 80+ Ph.D.s, more than 100 advanced degrees, and multi-lingual capabilities, including Chinese and German, we offer clients around the world a patent prosecution and counseling practice that is unrivaled in its depth of industry and technical experience.

Patent Strategy + Prosecution

Patent Prosecution | Patent Firm

Band 1: Intellectual Property: Patent Prosecution, California

Tier 1: Patent Strategy & Management

Recommended: Patent Prosecution

Patent Strategy Firm Of The Year

 Intellectual Property: Patents: Prosecution

Recommended for Patent Prosecution in California and DC Metro Area

Highly Recommended: Patent Prosecution, California

Patent Prosecution, US 

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>

schonig_wolfgang_blog_150x150.png

schonig_wolfgang_common_640x280.jpg

schonig_wolfgang_heroretina_2700x1160.jpg

schonig_wolfgang_mobileretina_750x1040.jpg

schonig_wolfgang_social_600x600.jpg

Our life sciences and healthcare clients, from emerging innovation drivers to iconic brands, rely on our unrivaled depth of knowledge and technological experien

Life Sciences: IP/Patent Litigation

Life Sciences

Global: Life Sciences

Asia-Pacific Region: Life Sciences

Healthcare: Life Sciences

China Healthcare and Life Sciences: Foreign Firms

US: Biotechnology Law

Japan: Life Sciences

China: Life Sciences: International Law Firm

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

favicon.ico

favicon-16x16.png

favicon-32x32.png

apple-touch-icon.png

MoFo Favicons

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.

life-sciences-featured-image.jpg

life-sciences-featured-image

Announcements

Welcome to Mofo Life Sciences

Blog - Terms of Use

Cookies

Blog - Privacy Policy

Blog - Blog Disclaimer

Blog - Attorney Advertising

morrison-foerster-blog-logo.png

Brings together legal insights and in-depth analyses on trends and complex issues shaping the global technology industry.

MoFo Tech Blog

MOFO TECH

Equips our clients with the most up-to-date and relevant information on employment and labor law issues.

Employment Law Commentary

EMPLOYMENT LAW COMMENTARY

Stay on top of emerging issues and stay informed of developments related to the law and business of social media.

Socially Aware

SOCIALLY AWARE

In-depth analysis of developments and trends impacting government contracting.

Government Contracts Insights Blog

GOVERNMENT CONTRACTS INSIGHTS

Provides insights and reports on the most current class actions lawsuits and product liability issues that affect consumer-facing companies.

Class Dismissed Blog

CLASS DISMISSED

MoFo Life Sciences

  Linkedin

MoFo LinkedIN

Life Sciences Blog - RSS

Stay Connected

Never miss a post from MoFo Life Sciences. Enter your email below to stay up-to-date.

Because No One is Immune to the Law

Morrison Foerster - Footer

Blogs -  Home Button

Home

Blog - Topics

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

USPTO Discontinues Accelerated Examination Program in Favor of Expanding Track One Program

Subject Matter Eligibility of AI Medical Treatments

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

Federal Circuit Vacates and Remands in Long-Pending Dispute over CRISPR IP

The Future of Food: Exploring the World of Cell-Cultivated Cuisine (Blog Post)

LinkedIN

The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical challenges and infeasibilities.” The <a href="https://www.ams.usda.gov/content/usda-announces-delay-germplasm-deposit-requirement-asexually-reproduced-varieties-protected" target="_blank">announcement</a> specified that any future requirements for a deposit will not be applied retroactively. As of this writing, there are no hints of a date for such potential future requirements.This change is now reflected in the requirements for a Plant Variety Protection (PVP) certificate <a href="https://www.ams.usda.gov/services/plant-variety-protection/pvpo-requirements" target="_blank">listed on the PVPO website</a>:“The deposit of propagating material for asexually reproduced plant varieties is not required. The applicant must sign a declaration that the propagating material will be maintained at a specific location, subject to PVPO inspection, and if requested by PVPO, the applicant has three months to provide the propagating material or risk losing protection.”The availability of PVP rights for asexually reproduced plants is still relatively new in the United States, as the PVPO only started accepting applications for asexually reproduced plants as of January 6, 2020. Initially, the deposit requirement was delayed until January 6, 2023, due to feasibility concerns. With no viable solutions at the end of the three-year delay, the decision to waive the deposit requirement provided a timely resolution. Now—more than three months out from the initial expected date for deposit requirements for asexually reproduced plants, and more than three years out from the entrance of asexually reproduced plants into the PVP system to begin with—there is less uncertainty on how such deposits may be handled. Although deposits for asexually reproduced plants may still be required at some point in the future, the lack of retroactive application of such future requirements represents at least a reliable interim reprieve for producers of these plants.The prior uncertainty surrounding deposit requirements for asexually reproduced plants was likely a deterrent for many potential applicants considering PVP protection, especially since a deposit is not formally required to obtain a plant patent for asexually reproduced varieties. Without the cost and technical challenges associated with a deposit, PVPs for asexually reproduced plants may soon enjoy more widespread popularity.For more on PVPs for asexually reproduced plants read our previous blog post on the topic: <a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants" target="_blank">Plant Variety Protection Office Now Accepting Applications For Asexually Reproduced Plants</a><a href="https://lifesciences.mofo.com/topics/pvp-office-now-accepting-applications-for-asexually-reproduced-plants">.</a>Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team if you have any questions regarding this change or PVPs. We regularly monitor these developments and will post future updates on our blog.

USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants

pierre-jerome_edith_blog_150x150.png

pierre-jerome_edith_common_640x280.jpg

pierre-jerome_edith_heroretina_2700x1160.jpg

pierre-jerome_edith_mobileretina_750x1040.jpg

pierre-jerome_edith_social_600x600.jpg

Patent Agent

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

freeman-rosenzweig_liz_blog_150x150.png

freeman-rosenzweig_liz_common_640x280.jpg

freeman-rosenzweig_liz_heroretina_2700x1160.jpg

freeman-rosenzweig_liz_mobileretina_750x1040.jpg

freeman-rosenzweig_liz_social_600x600.jpg

Associate

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

ellison_cory_blog_150x150.png

ellison_cory_common_640x280.jpg

ellison_cory_heroretina_2700x1160.jpg

ellison_cory_mobileretina_750x1040.jpg

ellison_cory_social_600x600.jpg

Sr Patent Agent

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

230315-life-sciences-blog.jpg

USDA PVP Office Waives Deposit Requirement for Asexually Reproduced Plants

230315-life-sciences-blog

The U.S. Department of Agriculture (USDA) Plant Variety Protection Office (PVPO) has waived the deposit requirement for asexually reproduced plants until further notice due to “continued and ongoing technical 

Agtech

Intellectual Property

United States

Update: USDA announced on March 23, 2023 that the Interagency Working Group on Competition and Intellectual Property in Seeds and Other Agricultural Inputs was officially <a href="https://www.ams.usda.gov/press-release/usda-launches-interagency-working-group-competition-and-intellectual-property-seeds" target="_blank">launched</a>. On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “<a href="https://www.ams.usda.gov/sites/default/files/media/SeedsReport.pdf" target="_blank">More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs</a>,” which was prepared in consultation with the U.S. Patent and Trademark Office (USPTO), Department of Justice (DOJ), and Federal Trade Commission (FTC). The report is a response to President Biden’s Executive Order issued on July 9, 2021, titled “<a href="https://www.whitehouse.gov/briefing-room/presidential-actions/2021/07/09/executive-order-on-promoting-competition-in-the-american-economy/" target="_blank">Promoting Competition in the American Economy</a>,” which promotes a whole-of-government approach to competition and includes initiatives across federal agencies. One of these initiatives directed the USDA, in consultation with the USPTO, to prepare a report on concerns and strategies for ensuring “that the intellectual property (IP) system, while incentivizing innovation, does not also unnecessarily reduce competition in seed and other input markets beyond that reasonably contemplated by the Patent Act.” The report was prepared after a 90-day comment period, a public listening forum, and input from multiple interested parties.While many commenters agreed that fair protection of IP was critical to continued innovation and investment in seed systems, concerns were raised that the current system and practices for protecting and enforcing IP rights for plant innovations may not promote fair competition. There were several primary areas of concern, including the following:<ul><li>Difficulties in accessing information on existing IP rights associated with a particular plant variety. Commenters noted the various IP systems for protecting plant-related innovations and the lack of a consolidated source of information.</li><li>Application of patent standards on the examination of plant-related innovations. Concerns were raised around incomplete searching of non-patent sources.</li><li>Use and enforcement of IP rights for plant-related inventions, and the increased use of licenses that override research and breeding exemptions.</li><li>Commenters licensing IP from larger firms were concerned about the effects of consolidation on their choice of products and the competitive market environment.</li></ul>In addition to these concerns, many commenters called for greater investment in public infrastructure around seed systems and plant breeding. The decades of underinvestment in public infrastructure were stated to have significantly reduced public infrastructure capacity, as well as farmer choice and the availability of varieties tailored to local circumstances. In addition, decentralized variety development capacity has been lost, which has resulted in vulnerable supply chains.The report identifies three key topic areas to address these challenges:<ol><li>Provide and enforce robust and reliable IP rights that enhance innovation and promote fair competition;</li><li>Ensure that IP owners can exercise their rights within the scope of fair competition provided by law; and</li><li>Rebuild critical national infrastructures for variety development and the provision of seed and other planting stock to create resilient seed supply chains.</li></ol>In order to deliver on these recommendations, the USDA will:<ul><li>Establish a new Farmer Seed Liaison who will coordinate information sharing and work to reduce confusion for all parties operating in the complex seed system;</li><li>Form a working group with the USPTO to promote fair competition in the seed market, which will also work with the DOJ and FTC; and</li><li>Enhance transparency to farmers; for example, by expanding the FarmerFairness.gov portal, which enables farmers and seed businesses to report tips and complaints related to seed markets.</li></ul>The USDA-USPTO Working Group on Competition and Intellectual Property has created the following joint initiatives:<ol><li>Exploring joint USPTO-USDA opportunities for collecting broader stakeholder input from researchers, plant breeders, farmers, and others in the seed and agricultural input markets;</li><li>Pursuing additional opportunities to enhance the quality of the patent examination process for innovations related to agricultural products and processes, including for prior art search capabilities and additional training and guidance for patent examiners;</li><li>Collaborating on new programs to enhance the transparency of IP information for agriculture-related innovations and assess the availability and viability of patented and off-patented germplasm; and</li><li>Considering and evaluating new proposals for incentivizing and protecting innovation in the seed and agricultural-related space, including the broader adoption of research or plant breeders’ exemptions when U.S. utility patents cover seeds. </li></ol>The USPTO will be hosting a series of outreach events and listening sessions on these topics, and invites public participation in the process.Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/plant-intellectual-property" target="_blank">Plant IP</a> team if you have any questions on the USDA-USPTO Working Group or the joint initiatives included in this report. We regularly monitor these developments and will post future updates on our blog.

ward_michael_blog_150x150.png

ward_michael_common_640x280.jpg

ward_michael_heroretina_2700x1160.jpg

ward_michael_mobileretina_750x1040.jpg

ward_michael_social_600x600.jpg

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

bendix_claire_blog_150x150.png

bendix_claire_common_640x280.jpg

bendix_claire_heroretina_2700x1160.jpg

bendix_claire_mobileretina_750x1040.jpg

bendix_claire_social_600x600.jpg

Dr. Claire Bendix’s work focuses on patent preparation, patent prosecution, and matters pertaining to plant variety protection both in the United States and abroad. She also has experience in conducti

Claire L. Bendix Ph.D.

Claire Bendix

221205-pvp-blog-image.jpg

USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace

221205-pvp-blog-image

On March 6, 2023, the U.S. Department of Agriculture (USDA) released its report on “More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs,” 

USDA and USPTO Promoting Fair Competition and Innovation in the Seed Marketplace

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

221005-veggies-blog.jpg

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

221005-veggies-blog

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

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

Regulatory

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

arlington_simon_blog_150x150.png

arlington_simon_common_640x280.jpg

arlington_simon_heroretina_2700x1160.jpg

arlington_simon_mobileretina_750x1040.jpg

arlington_simon_social_600x600.jpg

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

Simon Arlington

luo_michelle_blog_150x150.png

luo_michelle_common_640x280.jpg

luo_michelle_heroretina_2700x1160.jpg

luo_michelle_mobileretina_750x1040.jpg

luo_michelle_social_600x600.jpg

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

Michelle Si-Ting Luo

Michelle Luo

Financing Options in the Alternative Protein Industry

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

Financing Options in the Alternative Protein Industry

Financing

Startup