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MoFo Provides Crucial Assistance to African Orphan Crops Consortium

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Morrison Foerster is honored to engage its best-in-class patent practice in a pro bono partnership with the African Orphan Crops Consortium (AOCC) to advance the development of more resilient and more nutritious food crops to support the continent’s population while strengthening its farm economy.

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We are Morrison Foerster — a global firm of exceptional credentials. Our clients include some of the largest financial institutions, investment banks, and Fortune 100, technology, and life sciences companies. Our lawyers are committed to achieving innovative and business-minded results for our clients, while preserving the differences that make us stronger.Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations. Prior results do not guarantee a similar outcome.

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Morrison Foerster is honored to engage its best-in-class patent practice in a pro bono partnership with the African Orphan Crops Consortium (AOCC) to advance the development of more resilient and more nutritious food crops to support the continent’s population while strengthening its farm economy.Read the <a href="https://together.mofo.com/topics/mofo-provides-crucial-assistance-to-african-orphan-crops-consortium" target="_blank">full blog post</a>.

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Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group and Food + Agriculture Group.Life SciencesFor his work across the life sciences sector, Mike was named San Francisco Biotechnology Lawyer of the Year by Best Lawyers in America in 2020 and is recommended for his patent strategy and prosecution practice in LMG Life Sciences. He also led the team that was named 2022 Patent Management and Strategy Firm of the Year at the 2022 LMG Life Sciences Americas Awards.Food + AgricultureRecognized as “one of the world’s foremost plant and agriculture IP lawyers,” Mike manages a wide range of intellectual property issues related to plants and plant products. He and his team advise clients on plant and plant utility patents; licensing agreements for plant IP; litigation in U.S. state and federal court and before the International Trade Commission; and regulatory approvals from the USDA, FDA, and EPA for gene edited and genetically engineered plants.Patent Strategy + ProsecutionMike is a Legal 500 US Hall of Fame lawyer for patent prosecution and is consistently named one of the leading IP lawyers by Managing Intellectual Property, Chambers USA and Chambers Global, and IAM Patent 1000.Mike works closely with many clients to develop and manage their patent portfolios. He helps clients identify, monitor, and assess the infringement risks of third-party patents. He also assists clients in preparing both offensive and defensive patent portfolios, with a particular emphasis on drafting patent applications that will be utilized in licensing and in litigation efforts.IP Due DiligenceFor venture capitalists seeking to invest in early- and mid-stage companies, underwriters involved in IPOs, and companies seeking to acquire or merge with other companies, Mike has managed extensive IP diligence. His work includes assessment of the strengths and weaknesses of patent portfolios, evaluation of freedom to operate issues, and strategic recommendations for maximizing the value of patent portfolios going forward.Mike also works closely with the IP Litigation Group on various litigation matters including patent interferences to determine the first-to-invent and patent re-examination work and actively participates in both mediation and arbitration proceedings on behalf of clients in the life sciences and food and agriculture areas.He is a frequent lecturer and speaker. Among numerous speaking engagements, Mike is the IP instructor at the UC Davis Licensing Academy and founded Morrison Foerster’s annual Harvard Biotechnology Club Fall Patent Law Course.Mike holds a Ph.D. in plant physiology (biochemistry) and an M.S. in agronomy from the University of California, Davis; a B.S. in biology from the University of California, Berkeley; and a J.D. from Golden Gate University School of Law. He was a post-doctoral fellow in plant molecular biology at the Harvard Medical School and the Department of Molecular Biology at Massachusetts General Hospital, where he worked on the Arabidopsis genome project.

Michael Ward

Partner

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.As the lead of our FDA + Healthcare Regulatory and Compliance Group, Brigid practices across the spectrum of FDA-regulated products, including medical devices, drugs, biologics, cell and gene therapies, food, cosmetics, dietary supplements, tobacco, laboratory-developed tests, in vitro diagnostics, radiation-emitting electronic products, combination products, and products that may not fit neatly into any of these categories. Accordingly, she counsels established and start-up companies in life sciences, healthcare, and consumer products on a wide range of FDA pre- and post-market regulatory issues. Brigid also frequently advises innovative product developers on threshold FDA jurisdictional questions and develops strategies for approval and marketing, while identifying and mitigating regulatory risks.In her day-to-day practice, Brigid advises on:<ul><li>product development and FDA’s pre-authorization requirements;</li><li>advertising and promotion of FDA-regulated products;</li><li>clinical trials regulation, including strategic advice for sponsors in receipt of a clinical hold;</li><li>responses to warning letters, Form 483s, import alerts, and FDA enforcement actions;</li><li>informal and formal dispute resolution for high-stakes issues;</li><li>compliance with FDA regulatory requirements such as current good manufacturing practice (GMP), quality system regulation (QSR), food safety preventive controls, adverse event reports, product recalls, radiological health issues, risk evaluation and mitigation strategies (REMS), pharmacy compounding and the new track-and-trace regulations for prescription drugs; and</li><li>technical legal questions involving the Food, Drug and Cosmetic Act (FDCA), the Public Health Service Act (PHSA), Federal Advisory Committee Act (FACA), Freedom of Information Act (FOIA), and the Administrative Procedure Act (APA).</li></ul>Brigid also has experience in the development, regulation, and procurement of medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear (CBRN) threats and pandemic infectious diseases, including animal rule approvals and special incentives for the development of MCMs.Complementing her focus on FDA regulatory law, Brigid has a strong litigation background and has served as FDA counsel in product liability cases, civil litigation, international arbitration, and FDA enforcement proceedings. She particularly enjoys providing clients with advice that integrates technical, legal, and political considerations.Brigid maintains an active pro bono practice focused primarily on reproductive health and especially enjoys working with inventors who aim to improve health outcomes for mothers and infants in the peri- and post-natal period. She has represented several clients before the Social Security Administration in appealing denials of applications for disability benefits. She has also worked on several appeals in criminal cases in the District of Columbia.Brigid is a graduate of the University of Tulsa, where she earned her B.S. in biochemistry before attending law school at Stanford Law School. Prior to law school, Brigid worked as an Environmental Policy Analyst in the Office of the Secretary at the U.S. Department of Transportation. She has also worked as a benchtop scientist in a number of laboratories, including FDA’s National Center for Toxicological Research.<h4>Representative Experience</h4><ul><li>Counseled online marketplaces regarding FDA compliance and enforcement for a variety of products.</li><li>Advised development-stage companies on regulatory considerations and FDA engagement strategies related to development and launch of products based on disruptive technologies.</li><li>Advised consumer technology companies with respect to potential FDA regulation under the medical device provisions of the FDCA;</li><li>Served as FDA regulatory counsel to clients evaluating compliance issues under reporting provisions of Corporate Integrity Agreements and related negotiated resolutions of government investigations.</li><li>Helped a large, publicly traded drug company comply with the FDA’s new track-and-trace pedigree requirements for prescription drugs.</li><li>Led regulatory team on numerous initial public offerings (IPO), stock and asset purchase agreements, acquisitions, mergers, and other transactions for life science company.</li><li>Provided strategic advice, conducting regulatory assessments and negotiating key FDA-related terms in connection with due diligence for transactions and post-acquisition integration activities.</li><li>Developed policy positions related to FDA regulation of laboratory-developed tests (LDTs) for multiple clients in this space.</li><li>Represented manufacturers in matters involving regulatory letters, inquiries, advisory comment proceedings, competitor complaints and citizen petitions focused on their products and policy issues affecting their strategic priorities.</li><li>Advised on issues related to promotion of drugs and medical devices, including communication of pharmacoeconomic/healthcare economic information (HCEI), communications by medical science liaisons (MSLs).</li><li>Provided solutions-oriented advice to development-stage companies confronting FDA regulatory issues for the first time, including good clinical practices (GCP), investigator-initiated research (IIR), pre-approval communications and strategies for obtaining FDA approval.</li><li>Collaboratively advised client on FDA, ethical, and product liability issues associated with early termination of a clinical study involving an implanted medical device.</li></ul>

Brigid Bondoc

Dr. Qiwen Zhong is a patent attorney in the San Diego office of Morrison Foerster, where her practice focuses on strategic patent counseling, global patent portfolio development and management, patent prosecution, and IP due diligence including patentability assessments and freedom-to-operate assessments.Qiwen obtained her Ph.D. in chemistry from the University of Southern California and her J.D. from UCLA School of Law. Building on her chemistry background, Qiwen works closely with pharmaceutical and biotech companies developing small molecule pharmaceuticals, peptide therapeutics, antibody-drug-conjugates, radionuclides, and blood-based therapies, as well as other chemistry-related technologies. Before joining the San Diego office, Qiwen was a legal extern for the UCLA Technology Development Group, Los Angeles. She was also a summer associate of the two-summer patent program in the Palo Alto office of Morrison Foerster.Dr. Qiwen Zhong is registered to practice in California and before the U.S. Patent and Trademark Office. She is fluent in Mandarin and Cantonese.

Qiwen Zhong

Associate

Briana’s practice focuses on patent preparation, prosecution, and counseling in the areas of biotechnology, pharmaceuticals, and artificial intelligence.Prior to joining Morrison Foerster as an associate, Briana was a summer associate and worked as a law clerk where she advised companies and nonprofit organizations on regulatory pathways to conduct research in novel areas and assisted partners in the design and execution of international patent searches to identify prior art and freedom to operate boundaries.Briana received her J.D. from Stanford Law School where she served as the co-president of the BioLaw club, editor of the Stanford Technology Law Review, and a 2022-2023 Stanford Center for Law and Bioscience Student Fellow.Briana holds an M.S. and Ph.D. in genetics, genomic, and systems biology from the University of Chicago, where she conducted studies of gene regulation to explore the mechanistic basis for complex traits and diseases. While at the University of Chicago, she created reproducible pipelines to analyze functional genomic data using multiple programming languages. For her work, she was awarded the Nan Xiao Prize for Computational Reproducibility and a NIH Ruth L. Kirschtein F31 Fellowship.Briana also holds a B.S., magna cum laude, in biology and Spanish from Duke University. As an undergraduate student, she conducted population genetics research to understand the impact of genetic variation on trait variation between and within species.

Briana Mittleman

Dr. Deborah Pohlmann focuses on patent preparation and prosecution, specializing in biology.Prior to joining the firm, Deborah earned her Ph.D. in biology from the Massachusetts Institute of Technology, where she studied the interplay between gene regulation and epigenetics in the model plant species Arabidopsis in Dr. Mary Gehring’s lab. She used CRISPR-based mutagenesis to create deletions in the endogenous chromosomes of Arabidopsis in order to identify DNA regions that regulate transcription of the DNA demethylase ROS1, and characterized flowering time and fertility defects in quadruple demethylase mutant plants.Deborah earned her B.S. in biology from the University of Richmond, where she worked on the Porifera Tree of Life (PorToL) project and used molecular DNA techniques and phylogenetics to evaluate evolutionary relationships between families of Porifera.

Deborah Pohlmann

Patent Agent

Dr. Yujia Sun focuses her work on patent drafting and prosecution and strategic planning of patent portfolios. She also has extensive experience in IP due diligence inquiries, including freedom-to-operate and patentability analyses, and complex target IP evaluation for investors and acquirers, with an emphasis on biotechnology and pharmaceuticals.Dr. Sun has worked with a wide range of clients, including startup biotech companies, large pharmaceutical companies, universities, independent inventors, and venture capitalists. She has worked with clients in a number of areas, including gene therapy, antibody therapeutics, cell therapeutics, immunotherapy, next-generation sequencing, and drug delivery systems.Prior to joining Morrison & Foerster, Dr. Sun worked as a Biotechnology Intern at the Office of Industrial Liaison of New York University, where she helped develop the business plan for a startup to be formed around a pharmacotherapy device invented by NYU faculty. Her role included researching the relevant technology, analyzing the market potential and competitive landscape, and designing strategies for technological improvement and securing regulatory approval requirements.Dr. Sun received her Ph.D. (dissertation pass with distinction) and M.S. in biology from New York University, where she studied transcriptional regulation and pattern formation in early embryos and concentrated on developmental genetics, epigenetics, genomics, next-generation sequencing techniques, molecular biology, and confocal microscopy. She received her B.S. in biological sciences from Tsinghua University in China.Dr. Sun is fluent in English and Mandarin.