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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Because No One is Immune to the Law

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This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California.  The law bans the manufacture, sale, and distribution of four food additives used in over 12,000 different food products: brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. 

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Golden State Crackdown—Unpacking California’s Landmark Food Safety Act | MoFo Life Sciences

Claudia M. Vetesi

Brigid DeCoursey Bondoc

Lena Gankin

Marcus Grimes

Update: On November 2, FDA <a href="https://www.fda.gov/food/cfsan-constituent-updates/fda-proposes-rule-revoke-regulation-allowing-use-brominated-vegetable-oil-bvo-food" target="_blank">issued a proposed rule</a> to revoke the regulation authorizing the use of brominated vegetable oil (BVO) in food. FDA is basing the proposed rule on studies it conducted that FDA says demonstrate adverse health effects in animals approximating real-world human exposure levels. Comments on the proposed rule can be submitted until January 17, 2024.This month, California Governor Gavin Newsom signed into law the California Food Safety Act—a bill targeted at enhancing food safety within California.  The law bans the manufacture, sale, and distribution of four food additives used in over 12,000 different food products: brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3. The History and the AdditivesThe California Food Safety Act makes California the first state in the country to ban the use of brominated vegetable oil, potassium bromate, propylparaben, and Red Dye No. 3 in food products.  But these types of bans are not novel.  All four ingredients are currently banned in the European Union.[1] <ul dir="ltr"><li dir="ltr">Brominated vegetable oil (BVO), which can be added to beverages to keep citrus flavor from separating, has also been banned in Japan in part over allegations about neurologic symptoms in people who drink large amounts of citrus soda.[2] While BVO is regulated as a food additive, the U.S. Food and Drug Administration (FDA) has stated that over the years, many beverage makers have reformulated their products to replace BVO with alternative ingredients, and few beverages sold in the United States today contain the additive.[3]  In May 2022, the FDA published a study suggesting that high levels of BVO had negative effects on rodents and the FDA is currently working on a proposed rule to remove authorization for the use of BVO as a food ingredient.[4]</li></ul><ul dir="ltr"><li dir="ltr">Potassium bromate, which can be added to baked goods to help dough strengthen and rise, allegedly has harmful effects on the respiratory and nervous systems when consumed in large quantities. In addition to the European Union, potassium bromate is currently prohibited in China, South Korea, Sri Lanka, Canada, Brazil, Peru, India, Colombia, and Singapore.[5]</li></ul><ul><li dir="ltr">Propylparaben, which is used in food preservation, has been allegedly linked to reproductive health concerns. In addition to the European Union, propylparaben is currently prohibited in Japan, China, Sri Lanka, and Singapore.[6]</li></ul><ul dir="ltr"><li>Red Dye No. 3, which is a color additive providing a bright, cherry-red color, has been banned for use in cosmetics and externally applied drugs in the United States since 1990, when the FDA determined that it “causes a carcinogenic response in rats.”[7] The European Union restricted its use in food to only candied cherries and cocktail cherries in 1994.  Australia and New Zealand also restrict its use to just cocktail cherries and frosting.[8]  In October 2022, 24 scientists and consumer and health groups, including the Washington, D.C.-based nonprofit watchdog and consumer advocacy group, the Center for Science in the Public Interest, called on the FDA to ban the use of Red Dye No. 3 in foods.</li></ul>The Law and the ImpactThe California Food Safety Act passed the state legislature on September 12, 2023, almost unanimously with only six no votes. The law will go into effect on January 1, 2027, allowing manufacturers time to reformulate products without the prohibited food additives.  California Governor Gavin Newsom dubbed the law a “positive step forward” while the FDA reviews the additives and considers additional regulations.[9] The National Confectioners Association (NCA), however, has accused California lawmakers of “making decisions based on soundbites rather than science.”[10]  The NCA further cautioned that this is a “slippery slope” and it could create confusion around food safety and increase food costs for consumers.[11] Violations of the California Food Safety Act will be punishable by a civil penalty of up to $5,000 for the first violation and up to $10,000 for each subsequent violation.While it is too soon to tell the impact that the law will have on California’s grocery store aisles, manufacturers may need to change their operations to accommodate the new California Food Safety Act.  Given that these additives have been banned in several countries, it is likely the change will not be a complex one, but California’s law could kickstart a trend among other states. For example, a similar bill to ban the same four additives, plus titanium dioxide, was introduced by New York’s legislature in March 2023.[12] And California’s new law could signal a trend that may influence the FDA’s rulemaking on food additives. On the class action side, the law could further usher in a wave of “healthy” food lawsuits, where plaintiffs challenge the ingredients in and labeling of food products. Morrison Foerster will continue to monitor the impact of the California Food Safety Act and any FDA actions on food additives and is available to provide legal guidance to clients on the potential regulatory, advertising, and class action litigation matters.[1] <a href="https://www.msn.com/en-us/health/nutrition/california-ban-on-4-food-additives-sparks-outrage-slippery-slope/ar-AA1hWCxi" target="_blank">https://www.msn.com/en-us/health/nutrition/california-ban-on-4-food-additives-sparks-outrage-slippery-slope/ar-AA1hWCxi</a>.[2] https://www.foodnetwork.com/healthy/articles/brominated-vegetable-oil-dangers-side-effects.[3] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">https://fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo</a>.[4] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">Id.</a>[5] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo" target="_blank">Id.</a>[6] <a href="https://www.fda.gov/food/food-additives-petitions/brominated-vegetable-oil-bvo">Id.</a>[7] 55 Fed. Reg. 3520 (Feb. 1, 1990), available at <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf</a>.[8] <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">Id.</a>[9] <a href="https://www.govinfo.gov/content/pkg/FR-1990-02-01/pdf/FR-1990-02-01.pdf">Id.</a>[10] <a href="https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/">https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/</a>.[11] <a href="https://candyusa.com/news/nca-statement-on-california-governor-newsom-signing-bill-ab-418-to-ban-certain-food-ingredients/">Id.</a>[12] https://legislation.nysenate.gov/pdf/bills/2023/S6055A.

Golden State Crackdown—Unpacking California’s Landmark Food Safety Act

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