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

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

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

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

AI + Robotics

Agtech

Antitrust

Asia

Bioinformatics

Biotech

Blockchain

Cell + Gene Therapy

CFIUS

Corporate + Venture Capital

COVID-19

Data Analytics

Digital Health

Employment

European Union

Financing

Global

Healthcare

Intellectual Property

Licensing + Commercial

Litigation

Medical Devices + Diagnostics

Pharma

Privacy + Data Security

Product Liability + Class Action

Rare Disease

Regulatory

Startup

United Kingdom

United States

Topics

Blog - Editors

Blog - About

About

Blog - Subscribe

Meghan McLean Poon Ph.D.

More

What is “Healthy?” Are Fats In?

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

USPTO Fee Changes for 2025

An InSECURE Future: Court Ruling Guts USDA Regs on Genetically Engineered Plants

Uspto Withdraws Consideration of Controversial Change to Terminal Disclaimer Practice

Owen Grayson Hosseinzadeh, Law Clerk in San Diego, contributed to the drafting of this post.On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken. This is the first such consultation completed by the agency and, while not a formal approval process, means that FDA has no further questions about UPSIDE’s conclusions that (1) its production process is safe and (2) its cultured chicken cell products are as safe as comparable foods, like traditionally produced chicken leg meat.Human food produced using animal cell culture technology is subject to an interagency regulatory framework between FDA’s Center for Food Safety & Applied Nutrition (CFSAN) and USDA’s Food Safety and Inspection Service (FSIS). <a href="https://www.fda.gov/food/domestic-interagency-agreements-food/formal-agreement-between-fda-and-usda-regarding-oversight-human-food-produced-using-animal-cell" target="_blank">Under the agencies’ formal agreement</a>, both agencies agreed to a regulatory framework in which CFSAN regulates the initial steps of cell collection, cell banking, and cell differentiation. Once the cells are removed from their sealed growth environments at the harvest stage, FSIS oversees their further processing, labeling, and packaging.To market its product, UPSIDE will still need to meet additional FDA requirements, such as food facility registration, and will need a grant of inspection from FSIS for the manufacturing establishment. The product itself also must bear a USDA mark of inspection. USDA has yet to issue any guidance or regulations addressing product labeling, so many questions remain regarding how cell-cultured foods can be marketed. If <a href="https://www.federalregister.gov/documents/2021/09/03/2021-19057/labeling-of-meat-or-poultry-products-comprised-of-or-containing-cultured-animal-cells" target="_blank">FSIS’s advance notice of proposed rulemaking</a> is any indication, the agency’s eventual rulemaking on these issues will be hotly contested by industry and other interest groups.UPSIDE submitted a <a href="https://www.fda.gov/media/163262/download" target="_blank">Premarket Notice for Integral Tissue Culture Poultry Meat</a> to FDA on October 1, 2021, and amended it multiple times in response to FDA’s requests for further information and points of clarification. FDA was particularly interested in the genetic engineering method UPSIDE uses to immortalize its cell lines, and its ability to maintain single-species lines free from microbial or chemical contamination. The consultation process spanned over a year and covered every step of the cell culture process, including (1) how the cells are isolated, (2) how the cell bank is maintained and monitored, (3) how the cells are multiplied and differentiated, and (4) how the cell material is harvested.<div class="embedded-entry redactor-component block-entry" type="entry" data-sys-entry-uid="blt55bed3bf86d934f6" data-sys-entry-locale="en-us" data-sys-content-type-uid="image_content" sys-style-type="block"><div data-reactroot=""><img src="https://media2.mofo.com/v3/images/blt5775cc69c999c255/blt42e24a20d96e86cd/637ce41176567a10a7cbb880/cultured-animal-cells-flowchart-what-fda-evaluated-in-first-pre-market-consultation.png?format=auto&amp;quality=60" alt="cultured animal cells flowchart what fda evaluated in first pre market consultation"></div></div>FDA invites additional consultations from cultured meat producers looking to enter the U.S. market. “FDA is ready to work with additional firms,” and <a href="https://www.fda.gov/food/guidance-documents-regulatory-information-topic-food-and-dietary-supplements/foods-program-guidance-under-development" target="_blank">intends to release new guidance</a> on its process for regulating animal cell cultured foods by the end of 2022. Cultured meat and other novel food producers should rejoice: FDA is committed to supporting innovation in the food supply. We are very much looking forward to browsing the cell cultured aisle of the local supermarket and cannot wait to be able to sample the cell cultured products of our clients!

FDA Clears the Path to Lab-Grown Meat

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

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

hosseinzadeh_owen_blog_150x150.png

hosseinzadeh_owen_common_640x280.jpg

hosseinzadeh_owen_heroretina_2700x1160.jpg

hosseinzadeh_owen_mobileretina_750x1040.jpg

hosseinzadeh_owen_social_600x600.jpg

Associate

Owen counsels clients in the life sciences, healthcare, food, and agriculture industries on cross-cutting issues involving regulatory compliance, intellectual property, and litigation.

Owen Grayson Hosseinzadeh

Owen Hosseinzadeh

lifesciences-medical-device-2.jpg

FDA Clears the Path to Lab-Grown Meat

De Novo Classification Final Rule to Take Effect Next Year

lifesciences-medical-device-2

On November 16, 2022, FDA announced the completion of the first ever pre-market consultation process for a human food made from cultured animal cells, UPSIDE Food’s cell-cultured chicken.

On November 8, 2022, FDA issued a draft guidance document on <a href="https://www.fda.gov/media/163018/download" target="_blank">Sameness Evaluations in an ANDA — Active Ingredients</a> (“Draft Guidance”). In the Draft Guidance, FDA indicated that the active ingredient’s chemical form will generally be the entire molecule, but it may also encompass noncovalent derivatives. Importantly, the active ingredient can take a different physical form than the active ingredient in the reference listed drug (RLD), and FDA will not consider this as relevant in determining sameness. FDA also noted that the active ingredient in a drug product “may undergo a change in chemical form during drug product manufacture such that the active ingredient is converted to a different chemical form.” In such cases, FDA considers the converted chemical form to be the active ingredient, and ANDA filers should use the converted form, as present in the final dosage of the RLD, for comparison when demonstrating sameness.Distinguishing Sameness Evaluation in Different Classes of Small Molecule DrugsThe Draft Guidance offers specific discussion on active ingredient sameness in synthetic peptides and complex mixtures. As to synthetic peptides, FDA noted that sameness can “generally be established through physicochemical characterization and biological evaluation,” and while compendial standards may be available for some peptides, FDA still recommends that ANDA applications conduct comparative testing of the generic peptide to the RLD. For complex mixtures, FDA “evaluates all relevant data in the ANDA and other relevant scientific information to determine whether an active ingredient of a complex mixture has been adequately characterized for the purposes of assessing active ingredient.” FDA noted that, while some complex mixtures may have multiple active ingredients, they will not be considered a fixed-drug combination product as they have not been intentionally combined. ANDA filers should characterize constituent components in the generic peptide in reference to the RLD by running multiple batches on both products under similar conditions, and then comparing the two. If the comparison test shows that the complex mixture contains a well-characterized component, “the [filer] should propose ranges for each molecule in common based on the comparative testing,” and provide explanation for why any differences are acceptable. As to other small molecule drugs, FDA encourages ANDA filers to review product-specific guidance documents, which may indicate how FDA will evaluate active ingredient sameness.Active Ingredient Sameness Evaluations and Engaging with FDAIn the Draft Guidance, FDA reiterated its commitment to working with industry through the controlled correspondence process and pre-ANDA meetings to ensure that ANDA filers are utilizing an appropriate method to determine sameness. Interestingly, FDA doubled down on its commitment “to reduce, refine, and replace animal use in testing when feasible,” and FDA encouraged sponsors to consult with FDA as to whether there is an appropriate alternative method to test for equivalency. FDA also committed to updating guidance documents relevant to demonstrating sameness to reflect the appropriate methodology as informed by the evolution of scientific understanding and technology. Finally, <a href="https://www.regulations.gov/docket/FDA-2022-D-0697" target="_blank">FDA is seeking comment</a> on the Draft Guidance, and with the request for comment closing on January 8, 2023, affected members of industry should consider working with counsel to file a comment sooner rather than later. Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this alert.

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

221117-life-science-blog-post.jpg

FDA Clarifies ANDA Active Ingredient Sameness Evaluation in Draft Guidance

221117-life-science-blog-post

On November 8, 2022, FDA issued a draft guidance document on Sameness Evaluations in an ANDA — Active Ingredients (“Draft Guidance”). 

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the Food and Drug Law Institute’s Clinical Trials: Deconstructing Challenges and Providing Practical Insights Conference.  The panel featured a high-ranking attorney from the Department of Justice’s (DOJ) Consumer Protection Branch (CPB) and other regulatory compliance leaders to discuss key trends and issues in clinical trial enforcement that underscored the need to ensure appropriate compliance measures are in place to avoid future investigations.Key takeaways regarding the trajectory of clinical trial fraud investigations and enforcement actions include:<ul><li>Investigation and Prosecution Targets One of the most notable comments from the panel was the confirmation that DOJ is looking not only at the activity of individuals (e.g., clinical trial site owners or executives) but also big corporate actors (e.g., sponsors or CROs), with a specific focus on the submission of false and misleading data to FDA and obstruction of FDA and other regulators. DOJ is also looking at cases where the data at the investigator level may be honest and accurate, but where sponsors may have decided to shape it a certain way or omit information—something that can be exacerbated in a biotech environment, where start-ups may be under pressure to show results for the next round of funding. The DOJ is also highly attuned to bad actors whose activities may subject clinical trial participants to harm, such as a clinical trial intentionally providing experimental treatment to a patient they know does not qualify to participate in the study.</li><li>Charging Mechanisms – Use of the Food Drug and Cosmetic Act (FDCA) Historically, DOJ has used traditional criminal tools like wire fraud and obstruction to prosecute criminal activity in this space. Recently, DOJ has trended to also looking at pursuing cases under the FDCA, including felony or misdemeanor criminal actions, since sponsors are responsible for monitoring investigations, compliance with reporting requirements for clinical trials, and maintaining accurate records. An example is to charge application fraud. However, DOJ has also indicated that even if they choose not to bring a case under the FDCA, such violations can bolster the other criminal charges they may pursue, such as conspiracy under Title 18. It was also noted that DOJ is considering whether it should more frequently exercise its enforcement discretion, both civil and criminal, for a responsible party’s failure to register a clinical trial and submit the results on clinicaltrials.gov. As to other actions, the DOJ noted that it anticipates bringing criminal actions for money laundering and identity theft, as well as civil actions under the False Claims Act.</li><li>The Influence of FDA Inspection Classification on DOJ Actions DOJ gave a clear answer that FDA inspection classification is not determinative of whether DOJ will bring an action. While DOJ noted that FDA inspection classification is informative, they also noted that DOJ’s inspection and investigation tools differ from FDA. DOJ’s tools, such as search warrants, are designed to unearth criminal activity. Indeed, the DOJ further noted that a fraudulent actor may misrepresent their activities to FDA during an inspection, which means that a glowing inspection classification may just be one additional incidence of clinical trial fraud.</li><li>Special Attention to Cybersecurity and Digital Enrollment With the advent of clinical trial process digitalization due to COVID-19, clinical trial sites have intrinsically bound digital operations into their business models. However, the speed of incorporating these digital tools may not be matched with the necessary compliance mechanisms to ensure subject and data integrity. In the clinical trial timeline, there are four key digital concerns that industry must address to ensure compliance.</li><ul><li>Finding the participant: Some patient populations are at a premium, especially if a therapeutic is targeting a rare disease. While using digital technologies can greatly expand the ability to locate appropriate participants, digital misfires happen, and the system should have appropriate confirmation tools to ensure the participant is appropriate for the study.</li><li>Enrolling the participant: Once an appropriate participant is found, they must consent to the study. Electronic informed consent is entirely acceptable, but only if it is properly executed. An example of a potential misstep is if the patient experiences connectivity issues while a healthcare provider is explaining what the study entails. In such a situation, the patient’s consent may not actually be informed, so telemedicine engagements should contain protocols to ensure the participant is able to fully and informedly engage with the healthcare provider.</li><li>Securing the participant’s data: Participant health data may be subject to HIPAA and other privacy and electronic security requirements. Clinical trials should design their digital databanks to comply with appropriate security and privacy protocols and ensure that employees are trained on how to use these systems.</li><li>Reporting health information and outcomes: In the context of larger clinical trials, using inaccurate or misleading algorithms to self-report or synthesize health information may subject the trial to fraud, waste, and abuse liability. This highlights the important need to manage the risks with benefits of using digital technologies in clinical trials.</li></ul></ul><ul><li>What Sponsors and Other Corporate Actors Can Do to Mitigate DOJ Enforcement Risk DOJ places great weight on whether sponsors have implemented and maintained an effective compliance program, which generally includes training, procedures, and auditing mechanisms used by sponsors in this space. Specifically, DOJ considers the sponsor’s oversight and communication flow with CROs, escalation procedures and whether they were followed, what questions were asked, whether documentation or records are accessible to the sponsor, whether there was self-reporting to FDA, and in some cases, whether there was self-reporting to DOJ. These factors underscore the need for sponsors to conduct meaningful due diligence and proactively monitor and audit potential clinical investigators and CROs.</li></ul>MoFo’s FDA + Healthcare Regulatory and Compliance practice works seamlessly with our Investigations + White Collar Defense, Global Ethics + Compliance, Life Sciences Transactions + Licensing, and Privacy + Data Security practice groups to ensure that life sciences companies remain compliant with all federal and state requirements. Please subscribe and follow our Life Sciences Blog, as we continue to update industry on new developments in compliance.Kai Mindick, a Law Clerk in our Austin office, contributed to the writing of this alert.

Prevent a Clinical Trial from Turning Into a Criminal Trial

driscoll_kate_blog_150x150.png

driscoll_kate_common_640x280.jpg

driscoll_kate_heroretina_2700x1160.jpg

driscoll_kate_mobileretina_750x1040.jpg

driscoll_kate_social_600x600.jpg

Katherine (Kate) Driscoll, partner, focuses her practice on white collar defense, investigations and enforcement actions for companies and senior executives.

Kate Driscoll

Katherine (Kate) Driscoll is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice Group. Kate focuses her practice on investigations, enforcement actions, and compliance, representing companies and senior business executives.

kidd_brian_blog_150x150.png

kidd_brian_common_640x280.jpg

kidd_brian_heroretina_2700x1160.jpg

kidd_brian_mobileretina_750x1040.jpg

kidd_brian_social_600x600.jpg

Brian Kidd is a partner in Morrison Foerster’s Investigations + White Collar Defense Practice. 

Brian K. Kidd

Brian K. Kidd is former Chief of the Market Integrity and Major Frauds (MIMF) Unit of the Criminal Division’s Fraud Section at the United States Department of Justice (DOJ) and a partner in Morrison & Foerster’s Investigations + White Collar Defense Practice Group. At DOJ, Brian supervised a team of roughly 40 federal prosecutors and oversaw virtually all major fraud cases, with a special focus on investigating and prosecuting complex securities, commodities, and other major corporate fraud cases.

Brian Kidd

michael_brian_blog_150x150.png

michael_brian_common_640x280.jpg

michael_brian_heroretina_2700x1160.jpg

michael_brian_mobileretina_750x1040.jpg

michael_brian_social_600x600.jpg

Brian R. Michael is a partner in Morrison Foerster’s Investigations + White Collar Defense Group, and the chair of the firm’s Global Ethics + Compliance practice.

Brian R. Michael

Brian Michael

220923-content.jpg

Prevent a Clinical Trial from Turning Into a Criminal Trial

220923-content

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement,” during the Food and Drug Law Institute’s Clinical Trials: Deconstructing Challenges and Providing Practical Insights Conference.

Innovation, agriculture, and technology took center stage at San Diego’s first AgTech Hackathon. The event took place October 21 – 23 in the city of Escondido, a key farming hub in San Diego County looking to attract agtech startups to the region. The event brought together entrepreneurs, farmers, investors, students, and community leaders to collaborate and develop innovative agtech ideas into viable business pitches.MoFo was a proud sponsor of the event, and Partner Matthew Ferry served as a judge in the pitch competition that culminated the weekend. Prior to the competition, Matthew Ferry and scientific analyst Dr. Edith Pierre-Jerome presented on the Top Three IP Issues for AgTech Startups, including:#3. Not understanding the different IP areas applicable to your business.Intellectual property takes many different forms. Classic forms of IP, such as patents, copyrights, trademarks, and trade secrets, are all forms of intellectual property protection that can be used strategically to protect different aspects of a business. Here are the main differences between them:Patents provide exclusive rights to inventions. There are three types of patents within the United States:<ul><li>Utility patents, which protect a new and useful process, machine, manufacture, or composition of matter;</li><li>Design patents, which protect a new, original, and ornamental design of a functional item; and</li><li>Plant patents, which protect the invention or discovery of a new and distinct plant varieties </li></ul>Copyrights protect original works of authorship fixed in a tangible medium of expression, like a book or this blog post.Trademark rights protect words, phrases, or designs that denote a product or service and help consumers associate the product or service with its source.Trade secret rights protect information that derives value from not being generally known and is subject to reasonable efforts to maintain secrecy.Plant Variety Protection (PVP) certificates are a plant-specific form of IP protection that, similar to patents, provide exclusive rights to new sexually reproduced, tuber propagated, and, as of 2020, asexually reproduced plant varieties. Unlike patents, PVP certificates are issued by the USDA Plant Variety Protection Office, offer use exemptions for noncommercial purposes, and cover Essentially Derived Varieties. For more information, see <a href="https://lifesciences.mofo.com/topics/planting-the-seeds-of-change">Planting the Seeds of Change | MoFo Life Sciences</a>.#2. Employees, contractors, and founders failing to assign IP to the company.In the United States, a patentable invention or discovery belongs to the inventor until ownership is assigned to another person or entity. This is true (generally) even if the inventor was an employee or founder of the company.Without owning the IP, the company may not be able to stop others from practicing the invention and may have unclear rights in its own freedom to operate. As a company matures and seeks to attract investment, investors will often look to make sure all the intellectual property meant to be owned by the company is actually owned by the company. This may not be the case if the inventor did not assign their rights to the company in writing.Assignment to the company should happen early on since it is often difficult to track down inventors the more time passes.#1. Publishing inventions before filing for patent protection.Inventors are often their own worst enemy when it comes to obtaining a patent. AgTech startups may want to publish whitepapers, sell prototypes, or gain traction for their market by publishing and presenting their discoveries. But they should beware of doing so without first consulting IP counsel. Once the subject matter is published or publicly used, the inventor may no longer be able to obtain patent protection in many foreign jurisdictions and has a strict one-year deadline to seek a patent within the U.S. Matthew Ferry also shared his thoughts on MoFo’s support of the AgTech industry:“For more than two decades, MoFo’s global Food + Agriculture practice has helped shape the food and agribusiness sector. We pride ourselves on delivering innovative, business-minded solutions to help our clients feed a rapidly growing global population.We have unparalleled technology experience, with a top-tier patent group that has a deep technological understanding of critical areas driving the industry. Our collaborative team offers full life cycle counseling from farm to table to help companies and investors navigate the future of food across the supply chain.With a growing population demanding an increased supply of healthier foods and global climate change altering where and how we can grow it, the innovations being developed by the AgTech community have never been more vital.”

ferry_matt_blog_150x150.png

ferry_matt_common_640x280.jpg

ferry_matt_heroretina_2700x1160.jpg

ferry_matt_mobileretina_750x1040.jpg

ferry_matt_social_600x600.jpg

Matt Ferry is a partner in the San Diego office and a member of the firm’s Technology Transactions Group.
Matt’s practice focuses on strategic transactions involving intellectual property (IP), techno

Matthew Ferry

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

Top Three IP Issues for AgTech Startups