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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Patent-Eligibility Considerations & Prosecution Strategies for AI-Based Life Sciences Patent Applications

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

Recentive: Raising the Patent-Eligibility Bar in AI-Related Inventions

April 2025 Update on Regulation of New Genomic Techniques in the EU

In Patent Prosecution, You Have the Right to Remain Silent. Anything You Say Can and Will Be Used Against You in the Court of Law

On May 3, 2023, New York Governor Kathy Hochul signed into <a href="https://www.nysenate.gov/legislation/bills/2023/A3007" target="_blank">law</a> an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. Here are four key points from the new law:1. How does the enacted legislation differ from the initial proposal? The original proposed legislation gave DOH broad authority to both review and approve material transactions and allowed DOH to define what transactions are material. See our previous blog post <a href="https://lifesciences.mofo.com/topics/states-extend-scope-of-regulatory-oversight-of-health-care-entities" target="_blank">here.</a> The enacted legislation pulls back on this authority and does not grant DOH the ability to approve transactions and also excludes “de minimis” transactions from review. De minimis transactions in this context are those that result in a healthcare entity increasing its total gross in-state revenues by less than $25 million.[1]2. Definition of “Material Transactions.” The law defines “material transactions” as any of the following:(1) a merger with a healthcare entity(2) an acquisition of one or more healthcare entities, including, but not limited to, the assignment, sale, or other conveyance of assets, voting securities, membership or partnership interest, or the transfer of control(3) an affiliation agreement or contract formed between a healthcare entity and another person(4) the formation of a partnership, joint venture, accountable care organization, parent organization, or management services organization for the purpose of administering contracts with health plans, third-party administrators, pharmacy benefit managers, or healthcare providers as prescribed by the commissioner by regulation.[2]3. Exclusions from Review. In addition to de minimis transactions mentioned above, the law excludes the following transactions from review: clinical affiliations of healthcare entities formed with the intent to facilitate collaboration between the entities (i.e., collaboration on clinical trials), transactions already subject to the Certificate of Need (CON) process, or an insurance entity approval process under the New York Public Health or Insurance Laws.4. Notice Requirements. The notice and review process will be further defined in regulations promulgated by DOH. Written notices must have information including, but not limited to, name and address of the transaction parties, copies of the definitive agreements, locations impacted by the transactions, closing date, and description of the purpose of the transaction, including anticipated impacts on cost, quality, and access in the impacted markets.[3] Upon receipt of a transaction notice, DOH will submit the notice to various bureaus of the Office of the New York Attorney General and post a summary of the proposed transaction on its website with an opportunity for public comment. 5. Noncompliance Consequences. DOH may impose a civil penalty of $2,000 for each day that a transaction is out of compliance. This penalty may be increased up to $5,000 for subsequent violations that pose a “serious threat to the health and safety” of individuals.[4] Each day that the violation continues is a separate violation and the penalty may extend until and unless a notice is filed.ConclusionAlthough the law is less onerous than what had been originally proposed, it does impose obligations on a broad array of entities, including management services organizations, in an attempt to monitor investments and other activities in the healthcare industry. [1] NY Pub. Health L. § 4550(4)(b).[2] NY Pub. Health L. § 4550(4)(a).[3] NY Pub. Health L. § 4552(1).[4] NY Pub. Health L. § 4552(4); NY Pub. Health L. § 12.

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On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions” at least 30 days before closing. This new law will require healthcare entities, such as management service organizations, physician practices, and other similar entities, to submit notice and supporting documentation to DOH when engaging in mergers, acquisitions, and other transactions in New York. 

New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways

On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) <a href="https://www.federalregister.gov/public-inspection/2023-09985/using-artificial-intelligence-and-machine-learning-in-the-development-of-drug-and-biological" target="_blank">announced</a> the publication of a new discussion paper titled “<a href="https://www.fda.gov/media/167973/download" target="_blank">Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products</a>.” The discussion paper aims to facilitate a discussion with stakeholders on the use of artificial intelligence and machine learning (AI/ML) in drug development, including the development of medical devices intended for use with drugs. The discussion paper covers three main topics: the landscape of current and potential uses of AI/ML; considerations for the use of AI/ML; and next steps and stakeholder engagement.Here are five key takeaways:1. FDA Acknowledges that AI/ML Applications Exist for Each Stage of Drug Development. AI/ML may have applications for use in all stages of drug development, from drug discovery to pharmaceutical manufacturing. AI/ML has been applied to real‑world data (RWD) and data from digital health technologies (DHTs) to support drug development.  The first section of the discussion paper summarizes the different ways in which AI/ML can be used in drug discovery, clinical and nonclinical research, postmarketing surveillance, and advanced pharmaceutical manufacturing. 2. FDA Is Growing Its Own Experience with AI/ML for Drug Development. In recent years, the FDA has seen a growth in drug and biological product submissions that reference AI/ML. In response, FDA has taken a number of actions, including establishment of the CDER AI Steering Committee, the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program, and the Model‑Informed Drug Development (MIDD) Pilot Program. For postmarket safety surveillance, the CDER Sentinel System, CBER Biologics Effectiveness and Safety (BEST) system, and CDRH National Evaluation System for health Technology (NEST) efforts, are exploring AI/ML approaches to improve existing systems.3. FDA Understands Development of Standards and Practices for Use of AI/ML Is Critical. The U.S. government and international community have expressed an increased commitment to facilitating AI innovation and adoption. Regulators and standards organizations have developed and issued standards to facilitate the advancement of ethical AI. For example, in August 2019, the National Institute for Standards and Technology (NIST) released the “U.S. Leadership in AI: A Plan for Federal Engagement in Developing Technical Standards and Related Tools.” In addition, in October 2021, the FDA, Health Canada, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) jointly published 10 guiding principles to inform the development of Good Machine Learning Practices (GMLP) for medical devices using AI/ML.4. FDA Has Identified Key Questions on AI/ML in Drug Development. The FDA aims to initiate a discussion with stakeholders on the following three key areas and provides specific questions to solicit feedback.Human-Led Governance, Accountability, and Transparency<ul><li>In what specific use cases or applications of AI/ML in drug development are there the greatest need for additional regulatory clarity?</li><li>In your experience, what are the main barriers and facilitators of transparency with AI/ML used during the drug development process (and in what context)?</li><li>How are pre-specification activities managed, and changes captured and monitored, to ensure the safe and effective use of AI/ML in drug development?</li></ul>Quality, Reliability, and Representativeness of Data<ul><li>What additional data considerations exist for AI/ML in the drug development process?</li><li>What are some of the key practices utilized by stakeholders to help ensure data privacy and security?</li><li>What processes are developers using for bias identification and management?</li></ul>Model Development, Performance, Monitoring, and Validation<ul><li>What practices and documentation are being used to inform and record data source selection and inclusion or exclusion criteria?</li><li>In what context of use are stakeholders addressing explainability, and how have you balanced considerations of performance and explainability?</li><li>What are some examples of current tools, processes, approaches, and best practices being used by stakeholders for: selecting model types and algorithms for a given use, determining when to use specific approaches for validating models and measuring performance in a given context, evaluating transparency and explainability, and increasing model transparency, etc.?</li></ul>5. FDA Wants Your Feedback. The FDA is soliciting feedback on the opportunities and challenges in using AI/ML in drug and medical device development. The FDA includes a series of questions for feedback in the discussion paper, and a workshop with stakeholders is planned to provide an opportunity for further engagement. <a href="https://www.regulations.gov/docket/FDA-2023-N-0743" target="_blank">Comments must be submitted by August 9, 2023 (Docket No. FDA-2023-N-0743). </a>

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

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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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FDA on Use of AI/ML in Drug Development: Five Key Takeaways

Recent Digital Health-Related FDA Announcements

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On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products.

Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.What is a CRADA?<a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> are the basis for research collaboration between federal agencies and private sector businesses and organizations. CRADAs are derived from the Stevenson-Wydler Technology Innovation Act of 1980, Public Law 96–480, 94 Stat. 2311 (Oct. 21, 1980), as amended by the Federal Technology Transfer Act of 1986, Public Law 99–502, 100 Stat. 1785 (Oct. 20, 1986) (FTTA). CRADAs are different than grants and procurement contracts in that CRADAs emphasize collaboration between federal laboratories and non-federal parties to undertake joint research as opposed to the transfer of funding.How are rights in inventions developed under CRADAs allocated?The allocation of rights in inventions developed under CRADAs are generally subject to a different and more flexible set of rules (described in 15 U.S.C. § 3710(a)) than those prescribed in the Bayh-Dole Act (35 U.S.C. §§ 200–212), which generally applies to inventions developed with federal government funding under grants and contracts. In contrast, the government generally has wide latitude in negotiating certain aspects of CRADAs, including, in particular, with respect to rights in inventions and subsequent patents related thereto. Overall, the allocations will depend on inventorship: was the invention made in whole or in part by a government employee or solely by a collaborator’s employee?Inventions made by government employee(s) under a CRADAWhere inventions are made either in whole or in part by a government employee (i.e., either government inventions or joint inventions), the government may either assign or license the invention to the collaborator (for reasonable compensation, if appropriate; see 15 U.S.C. § 3710(b)(1)).The collaborator also has the option for an exclusivelicense in a pre-negotiated field of use (see 15 U.S.C. § 3710(b)(1)). Assignments or licenses to the collaborator of government-developed or jointly developed inventions are subject to the government’s retention of a nonexclusive, nontransferable, irrevocable, paid-up license to practice the invention or have it practiced throughout the world by or on behalf of the government. Further, where the government either assigns or grants an exclusive license to the collaborator, the government retains “march-in” rights to force a license to a third party in “exceptional circumstances” (i.e., where necessary to meet health or safety needs or public use requirements) or if collaborator fails to comply with domestic manufacturing requirements, where applicable. Alternatively, if the collaborator has a non-exclusive license, the government could simply give a license to a third party.Inventions made by collaborator’s employee(s) under a CRADAIn contrast, where CRADA inventions are made solely by a collaborator’s employee(s), the collaborator may retain title, but must provide the government with a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced the invention throughout the world for government purposes (see 15 U.S.C. § 3710(b)(2)). While negotiating the terms of the CRADA, the collaborator may want to thoroughly describe all background IP (including any patents) related to the research project and clearly exclude the background IP from the rights scheme that applies to CRADA-subject inventions.USDA CRADA policy and templatesThe USDA Agricultural Research Service (ARS) provides a number of template agreements, including a template CRADA, on its <a href="https://www.ars.usda.gov/ott/templates-agreements/" target="_blank">website</a>.Some CRADA terms are more open to negotiation than others. For instance, collaborators will not be able to negotiate out terms required under the licensing requirements of 35 U.S.C. § 209, which apply to both joint inventions and government inventions licensed by a collaborator and are outlined in Section 7.1 of the USDA template. Under this statute, wholly government inventions and joint inventions (by the government and the collaborator) are treated the same.Key takeawaysOverall, <a href="https://www.ars.usda.gov/ARSUserFiles/ott/New%20Website/Office%20of%20Technology%20Transfer%20(OTT)/Templates/CRADAs.pdf" target="_blank">CRADAs</a> can offer collaborators potential advantages over competitors by, for example, facilitating confidential access to USDA’s research capacity, license negotiations, and global network of partners, while also helping USDA scientists contribute more directly to economic development and facilitating licensing of USDA technologies. Potential collaborators should be aware that they have some degree of latitude in negotiating CRADAs and should take care to consider the implications of inventorship on title of resulting IP, among other considerations. Our government contracts and IP teams have negotiated CRADAs with USDA in the past and can provide assistance with CRADA negotiations. Please reach out to MoFo’s <a href="https://www.mofo.com/capabilities/government-contracts-public-procurement" target="_blank">Government Contracts + Public Procurement</a> or <a href="https://www.mofo.com/capabilities/patent-strategy-prosecution" target="_blank">Patent Strategy + Prosecution</a> teams if you have any questions or if you are interested in learning more about how MoFo could help your company navigate CRADAs with USDA.

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Tina is a partner in Morrison & Foerster’s Government Contracts practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmace

Tina Reynolds

Tina is co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She counsels a wide variety of government contractors on compliance with federal acquisition and ethics regulations. She drafts and negotiates contracts on their behalf and has been involved with numerous internal investigations and compliance reviews, and with bid protest, contract claims, and False Claims Act litigation. She also advises on M&A transactions involving government contractors.

Tina D. Reynolds

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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

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Many stakeholders in the AgTech industry are interested in collaborating with or obtaining funding from the United States Department of Agriculture (USDA), but are unsure what implications such collaborations may have on their intellectual property (IP) obligations, opportunities, and strategy. Here, we summarize key IP implications of entering into a Cooperative Research and Development Agreement (CRADA) with the USDA.

IP Implications of USDA Research Collaborations

On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Substantiaton-NPO.pdf" target="_blank">notices of penalty offenses</a> to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional foods, placing them on notice that they could incur significant civil penalties if they fail to adequately substantiate product claims. The <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Sample-cover-letter-substantiaton.pdf" target="_blank">cover letters</a> suggest that the recipients consult FTC staff’s recently issued <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Products-Compliance-Guidance.pdf" target="_blank">Health Products Compliance Guidance</a>. The letter to the recipient companies also provides a copy of a <a href="https://www.ftc.gov/system/files/attachments/penalty-offenses-concerning-endorsements/notice-penalty_offenses-endorsements.pdf" target="_blank">previously approved notice of penalty offenses</a> regarding the use of endorsement and testimonials. Notices of penalty offenses allow the agency to seek civil penalties up to $50,120 per violation against companies that engage in conduct they know has been found unlawful in a previous FTC administrative order. The FTC warned that it will not hesitate to use its authority to target violators with large civil penalties. Companies receiving this warning from the FTC include companies that sell cosmetics, personal care products, food, drugs, devices, and dietary supplements.The FTC requires that companies substantiate product claims with reliable evidence. The Notice of Penalty Offenses Concerning Substantiation of Product Claims stated that the following acts or practices in the advertising and promotion of products are deceptive or unfair and unlawful under Section 5(a)(1) of the Federal Trade Commission Act:<ul><li>Making an objective product claim without having a reasonable basis at the time the claim is made consisting of competent and reliable evidence;</li><li>Making a claim regarding the health benefits or safety of a product without having as substantiation competent and reliable scientific evidence that has been conducted and evaluated in an objective manner by qualified persons, and that is generally accepted in the profession;</li><li>Representing expressly or implicitly that a product is effective in the cure, mitigation, or treatment of any serious disease (e.g., heart disease, cancer, arthritis, erectile dysfunction) without having and relying on at least one human clinical trial that (1) is randomized, (2) is well controlled, (3) is double-blinded (unless demonstrated that blinding cannot be effectively implemented given the nature of the intervention), (4) is conducted by persons qualified by training and experience to conduct such studies, (5) measures disease end points or validated surrogate markers, and (6) yields statistically significant result;</li><li>Misrepresenting the level of type of substantiation for a claim; and</li><li>Representing that a product claim has been scientifically or clinically proven unless, at the time of representation, the advertiser possesses and relies upon evidence sufficient to satisfy the relevant scientific community of the claim’s truth.</li></ul>The initial distribution of the notice is limited to those companies making health claims or those likely to make health claims considering their product types. However, the FTC stressed that the notice is not limited to health claims and will apply to any entity making claims about the efficacy or performance of its products. While it does not suggest a company has engaged in deceptive or unfair conduct, inclusion on the list demonstrates at the very least that the FTC is aware of the company and the company’s products.Morrison Foerster’s regulatory and class action litigation teams work seamlessly to advise clients on compliance and product claims. Please contact the authors if you have questions.

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims

FTC Issues Notice of Penalty Offenses on Substantiation of Product Claims