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

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

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. This is especially true in the life sciences, where data can be imperative for securing a patent but difficult to obtain as a result of long development cycles, clinical trial periods, and financial limitations. The submission of post-filing-date data can be a mechanism by which additional evidence in support of patentability can be provided once prosecution has begun.The United States Patent Office (USPTO) has long allowed post-filing-date data in the form of an affidavit or declaration to provide objective evidence to demonstrate non-obviousness (e.g., by showing unexpected results) or for establishing enablement. To be accepted, the presented data must be commensurate in scope with the claims sought to be patented. For a showing of enablement, the objective evidence also must be consistent with the supporting teachings of the specification.Last week, the European Patent Office confirmed that post-published evidence may be used to support a technical effect in the assessment of inventive step in the <a href="https://documents.epo.org/projects/babylon/eponet.nsf/0/C620B61029205275C125897B002BEDCF/$File/G2_21_Decision_%20of_the_Enlarged_Board_of_Appeal_of_23_March_2023_EN.pdf" target="_blank">decision of the Enlarged Board of Appeal in G 2/21</a>. The decision states that evidence submitted to prove the technical effect may not be disregarded solely because it had not been public before the filing date. However, for post-published data to be considered to establish inventive step, the skilled person must be able to derive the technical effect as being encompassed by the teaching and embodied by the originally disclosed invention.Recent guidelines implemented by the Chinese National Intellectual Property Administration (CNIPA) in January 2021 also allow post-filing data to be considered in support of both inventive step and sufficiency of disclosure, if the technical effect to be proved by the supplementary data is obtainable by the disclosure of the specification. The Japan Patent Office’s Examination Guidelines also permit submission of post-filing data of experimental results to address inventive step, enablement, and written description, but such data may not be a substitute for the detailed description of the invention. Accordingly, in our experience, post-filing data in Japan is allowed as evidence if it supports and reinforces data already present in the originally filed specification.While jurisdictions differ on whether and how post-filing data can be considered, data generated after filing may still be submitted in some cases when it is not possible to include at filing. However, to increase the likelihood that post-filing data will be considered, applicants should ensure that their patent specification includes teachings that provide a nexus between the claimed subject matter and the technical effect achieved. While this may not always require actual working examples, at least some in vitro data may be required and—for the case of therapeutic methods—in vivo animal model data may be necessary or helpful.

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Dr. Elizabeth (Liz) Newman focuses her work on patent  drafting and assisting prosecution. She also has experience in IP due diligence  inquiries, including freedom-to-operate analyses, with an emphas

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Karen Potter is a partner in Morrison & Foerster’s Life Sciences Patent group. Her practice focuses on patent preparation, prosecution, and strategic counseling for start‑up, emerging, and established

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Karen Potter

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Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

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In a “first to file” patent system as exists in the United States and in most countries throughout the world, timing of when to file a patent application is critically important but must be balanced by patentability requirements such as nonobviousness and enablement. 

Recent Updates on Use of Post-filing Data as Evidence to Support Patentability

Update 5/1/2023: FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023.In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced <a href="https://www.fda.gov/media/165420/download" target="_blank">draft guidance</a> relating to the naming and voluntary nutrient statements of PBMA products. [1]This new draft guidance is meant to address criticism from both sides of industry about the lack of clarity from FDA regarding the labeling of PBMAs. FDA’s draft guidance was informed by a September 2018 Request for Information on plant-based dairy product labeling that elicited over 13,000 public comments, as well as research demonstrating that, while most consumers understand PBMAs do not contain milk, they are generally less informed about the nutritional differences between milk and its plant-based alternatives.The draft guidance proposed clarifications on several issues that have been the subject of substantial industry debate. There is no “standard of identity” for plant-based milk alternatives in federal law, so plant-based milks must bear the common or usual name of the food. The draft guidance acknowledges that, for many plant-based milks, the common or usual name of the product includes the word “milk.” If finalized, the draft guidance would clarify that, while a standard of identity has been established for milk, that standard of identity does not preclude another food from using “milk” in the label. However, the use must not be misleading, and FDA proposed several recommendations to ensure plant-based milk product labels are not misleading, including the following:<ul><li>PBMAs that include “milk” in the product name should include a qualifying word naming the plant source of the product (e.g., “soy milk”). When multiple plant sources are used, the guidance recommends that both sources be used in the name or the statement of identity, with the most predominant source included first (e.g., “walnut and cashew milk” or “soy and nut milk blend”).</li><li>Names that qualify the terms “beverage” or “drink” with the plant source of the food would also be okay.</li><li>The name not merely should say “plant-based milk/beverage/drink,” but should identify the plant source.</li></ul>FDA’s draft guidance, if finalized, would also settle another debate among stakeholders by clarifying that PBMAs do not need to use the term “imitation” in their labeling. While the draft guidance acknowledged that some plant-based milk alternatives may meet the FDA definition for an “imitation” milk product, the guidance does not recommend labeling such products as “imitation,” and said FDA would not take action against them as being misbranded.In addition, the draft guidance recommended that products that have a different nutritional composition than milk bear what FDA called “voluntary nutrient statements,” i.e., an additional statement on the label describing how the nutrient content differs from milk. FDA based this draft recommendation on research showing that consumers may not understand the nutritional differences between PBMAs and milk, and what FDA described as “the potential public health concern of underconsumption of certain nutrients otherwise provided by milk.” FDA’s draft recommendations include the following:<ul><li>The statement should communicate clearly to consumers when a PBMA is lower in nutrients in comparison to milk. For example, a PBMA label could read “Contains lower amounts of [nutrient name(s)] than milk.”</li><li>For any nutrient listed in USDA’s Food and Nutrition Service non-dairy beverages criteria that is lower in the PBMA product, the label bears the voluntary nutrient statement.</li><li>The voluntary nutrient statement should appear on the principal display panel near and visually connected to the product, if space allows, and the draft guidance provides several visual examples of disclaimers on product containers.</li><li>PBMAs may also make truthful and not misleading statements about nutrients that are not in the nutrient criteria list or that appear in higher amounts than the nutrient criteria list. For example, a PBMA label could read “Contains 50% more calcium than milk.”</li><li>Voluntary nutrient content statements are recommended for products called “beverage” or “drink” and not just for products that use “milk” in the name.</li></ul>The draft guidance goes to great pains to call the recommended nutrient statements “voluntary,” whereas in a guidance like this FDA would typically be providing clarifications as to what statements it considers necessary to avoid FDA considering the product misbranded. FDA may be concerned about the First Amendment implications of treating these statements as required. Nonetheless, we recommend clients seek counsel before deciding not to include a voluntary nutrient statement.Moreover, while the disclosures are “voluntary,” plaintiff’s counsel is likely to be monitoring whether companies are adding them and may challenge the failure to do so through consumer protection claims. Recent litigation has focused on whether reasonable consumers would be deceived when plant-based alternative products use names commonly associated with dairy and meat products. For example, in 2018, the Ninth Circuit ruled that Blue Diamond’s almond milk products were not in violation of False Advertising Law (FAL) in part because the defendant “accurately labels and advertises its almond milk product.” Painter v. Blue Diamond Growers, 757 F. App’x 517, 518 (9th Cir. 2018). Moreover, several cases have extended First Amendment protections to plant-based alternative products that use names commonly associated with dairy or meat products. SeeTurtle Island Foods v. Strain, 594 F. Supp. 3d 692 (M.D. La. 2022) (finding no evidence that Louisiana’s plant-based labeling limitations were necessary to prevent consumer confusion, and the state failed to address why a less restrictive alternative, such as a disclaimer, would not be sufficient to advance the government interest); Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017) (although “a state can propose a definition for a given term, . . . it does not follow that once a state has done so, any use of the term inconsistent with the state’s preferred definition is inherently misleading,” particularly where that definition is inconsistent with common usage).The recommendations in the draft guidance are made as the PBMA industry continues to grow, with sales reaching approximately $2.4 billion in 2020 and plant source variety continuing to diversify the marketplace. FDA is still soliciting and reviewing comments on the guidance, and its recommendations will not represent FDA’s views until finalized.We are also watching how Congress reacts to this draft guidance. FDA has already received substantial congressional interest in the guidance, including the introduction of legislation by Sens. Tammy Baldwin (D-WI), Jim Risch (R-ID), Susan Collins (R-ME), and Peter Welch (D-VT) to prevent PBMAs from using the term “milk” in their labeling. There is a long history of congressional action on behalf of food and agriculture constituencies, including actions to prevent the launch of a GE salmon product and added sugar disclosures.Morrison Foerster will continue to monitor the FDA’s guidance on PBMAs. Our regulatory and class action litigation teams work seamlessly to advise clients on product labeling and advertising decisions.Annel Becerra Rodriguez, an associate in our San Francisco office, contributed to the writing of this post.[1] The draft guidance applies only to alternative milk products and not other plant-based dairy alternatives such as cheese, yogurt, or kefir alternatives.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

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Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.