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IP Implications of USDA Research Collaborations

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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. 

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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.Read the <a href="https://lifesciences.mofo.com/topics/ip-implications-of-usda-research-collaborations" target="_blank">full blog post</a>.

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Tina is Co-chair of Morrison Foerster’s Government Contracts & Public Procurement practice. She represents a wide variety of government contractors including information technology, defense, biotechnology, and pharmaceutical companies, with a focus on general contract counseling and compliance, particularly concerning intellectual property, and cybersecurity matters and federal grant funding.Tina counsels contractors on compliance with federal, state and local acquisition and ethics regulations and with the evolving myriad of requirements pertaining to data security and cybersecurity. She has been involved with numerous internal investigations and compliance reviews, and with mandatory and voluntary disclosures to agencies, and litigation of False Claims Act matters.Tina routinely advises clients concerning:<ul><li>Prime-subcontractor relationships</li><li>Sources of supply and country of origin requirements</li><li>Price reductions and price reporting issues</li><li>Organizational conflicts of interest</li><li>Safeguarding of intellectual property and other proprietary interests</li><li>Licensing and data rights issues</li><li>Handling of classified materials and controlled unclassified information</li><li>Agency suspension and debarment proceedings</li></ul>She also assists clients with due diligence and other activities related to the acquisition of government contracting concerns, and with the drafting and negotiation of teaming agreements, subcontracts, licensing agreements, and cooperative research and development agreements. She also assists clients applying for federal grants (including SBIR and STTR agreements), and those who seek to obtain other transactional authority agreements, as well as those competing for state and local government work.Tina’s litigation experience includes government contracts claims litigation in federal courts and before boards of contract appeals, bid protests before the Government Accountability Office and the Court of Federal Claims, and complex disputes in federal courts, including civil fraud and False Claims Act litigation and reverse Freedom of Information Act litigation.Prior to joining Morrison Foerster, Tina worked at another large national firm and as a trial attorney in the Office of the General Counsel of the Navy, Navy Litigation Office.<h4>Representative Experience</h4><ul><li>Negotiation of largest CHIPS Act federal funding agreement between multinational semiconductor corporation and U.S. Department of Commerce.</li><li>Negotiated prime contract and major subcontracts related to the Department of Energy’s next generation supercomputer program, including extensive IP rights negotiations and negotiation of associated patent rights waivers.</li><li>Negotiated series of other transaction authority agreements with DARPA and associated subcontracts with more than a dozen research universities on behalf of a firm biotech client, including complex IP rights allocations and material transfer agreements.</li><li>Assist clients with FedRAMP authorization process and with development of license agreements for software products sold to federal, state and local government agencies.</li><li>Cyber incident response counseling to some of the largest companies and organizations impacted by security incidents.</li><li>Advises clients on Bayh-Dole reporting of inventions and IP strategies for contracts and grants.</li><li>Conducts due diligence for major government contract mergers and acquisitions.</li></ul>

Tina D. Reynolds

Partner

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; algae; environmental incentives such as carbon credits; crop science; gene editing; genetics; GM/GE plants; molecular biology; plant breeders’ rights/plant variety protection; plant breeding; plant IP; and soil technologies.Prior to joining the firm as an associate, Dr. Freeman Rosenzweig was a summer associate, a law clerk, and a scientific analyst intern at Morrison & Foerster, where she drafted office action responses for foreign and domestic patent applications, amended claims, drafted domestic utility and plant patent applications, and analyzed freedom to operate agreements.Liz earned her J.D. from the University of California, Berkeley, School of Law. At Berkeley Law, Liz was an associate editor of the Berkeley Technology Law Journal, in which she published “<a href="https://btlj.org/2022/01/volume-35-issue-4/" target="_blank">A Framework for Patent Exhaustion of Self-Replicating Technologies</a>”. She was also vice president of Faculty Relations for the Patent Law Society; she also earned a Law & Technology Certificate from the Berkeley Center for Law & Technology. Prior to law school, she received her Ph.D. in plant cell and molecular biology from Stanford University, where her doctoral research focused on high-efficiency carbon fixation in green algae. Her doctoral work was published in and featured on the cover of Cell. At Stanford, she designed and conducted experiments in algal cell biology using genetic engineering, recombinant protein design, fluorescent biosensors, quantitative confocal microscopy, and computational image analysis. Liz obtained her A.B. in biology magna cum laude from Washington University in St. Louis, with a focus in biochemistry and a minor in Modern Hebrew.

Liz Freeman Rosenzweig

Associate

For over a decade, Bu Yin has been working with innovative companies, institutions, and investors in the biotech, pharma, medical device, and agriculture sectors. While patent drafting and prosecution are the bread and butter of his practice, Bu also has extensive experience in providing support for transactional matters, litigation, and patent office proceedings.Bu strives to add value to clients’ businesses by gaining deep understanding of the technologies and providing tailored IP strategies to support the business objectives. Drawing on his scientific training and patent expertise, Bu has become a go-to person for interdisciplinary technologies in the life sciences.Biopharmaceuticals: Bu’s research experience focused on molecular biology and immunology and his patent experience spans a wide spectrum of modalities, including antibodies and other protein therapeutics, viral and non-viral gene therapies, genome editing, cell therapies (e.g., stem cells and CAR-T cells), vaccines, modified nucleic acids (e.g., RNA-based therapeutics), antibiotics, and small molecule drugs, as well as drug formulations and drug delivery systems.Representative matters include:<ul><li>Portfolio management and company side IP due diligence relating to the entire pipeline of a clinical-stage company developing gene therapies for oncology, dermatology, and pulmonology indications;</li><li>IPO due diligence, cross-border R&D collaboration, and patent prosecution for a multinational biopharmaceutical company developing immuno-oncology and vaccine products;</li><li>Litigation support for a case involving a groundbreaking antibody platform technology;</li><li>Patentability analysis and patent prosecution for a biotech company relating to its therapeutic antibodies and antibody drug conjugates (ADCs);</li><li>IP due diligence for various investors in matters involving brand biologics, biosimilar products, mRNA/self-replicating RNA/self-amplifying RNA technologies, CRIPSR/Cas, antibiotics screening, and therapeutics for kidney and eye diseases; and</li><li>Patent prosecution for major global biopharma companies relating to kinase inhibitors, checkpoint inhibitors, cytokines, small peptide therapeutics, TCR-like antibodies, diagnostic and prognostic biomarkers, glyco-engineered therapeutics, personalized medicine, and various combination therapies.</li></ul>Advanced Omics Technologies: Bu has developed extensive patent experience in DNA, RNA, and protein detection and analysis. He is well versed in various immunological assays, PCR assays, next-generation sequencing chemistries, sample preparation, and multi-omics data collection and analysis, particularly those useful for high-throughput, single-cell, spatial, and/or in situ analysis of biomolecules.Representative matters include:<ul><li>Application drafting and patent clearance relating product launch for a company providing powerful tools for life sciences research;</li><li>Patent office proceedings and transactional matters for a commercial-stage precision medicine company developing early cancer detection products;</li><li>Development of patent portfolio for a company developing single-molecule nucleic acid sequencing-based diagnostics, including pandemic scale, point-of-care diagnostics for infectious diseases;</li><li>Patent procurement and counseling for a VC-backed company developing high-throughput, multiplex protein sequencing solutions; and</li><li>Investor/buyer-side IP due diligence and patent prosecution for various clients relating to lateral flow tests (e.g., at-home tests for pregnancy, HIV, or COVID-19), devices, and consumables; rapid PCR tests; and solid phase DNA sequencing devices.</li></ul>Agriculture and food: Bu also has patent experience in the AgTech space. Representative matters include:<ul><li>Global patent portfolio management and collaboration for a leading developer of engineered insects for disease and agriculture pest control;</li><li>Investor/buyer-side IP due diligence for various clients relating to microbiome-inspired feed supplements for livestock; microbial fertilizers; precision fermentation; edible coating for fruits and vegetables; alternative, nature-equivalent proteins; biocatalysts; synthetic pheromones for insect control; and engineered organisms such as insects and plants.</li></ul>Medical device: Bu actively works with medical device companies to develop their IP portfolios, attract capital, and secure market advantage. Representative matters include:<ul><li>All aspects of patent counseling for a company developing soft robotic devices and endoscopic products;</li><li>All aspects of patent counseling for a company in connection with ophthalmic surgical devices, drug formulations, and companion diagnostics; and</li><li>IP due diligence for a global investment company in matters involving dental devices, interventional pulmonology, and vascular medical devices.</li></ul>Bu earned his J.D. cum laude and a certificate in the Business and Corporate Law concentration while working full time as a patent agent. He was a member of the San Diego International Law Journal and received multiple CALI Awards recognizing highest grades in classes. Bu was a Presidential Postdoctoral Fellow at Novartis, and conducted his Ph.D. research at the Children’s Hospital of Philadelphia and the Wistar Institute. His research focused on genetics and epigenetics of DNA damage and repair during lymphocyte development, mechanisms of antibody production and cellular immunity, and genomic instability. Bu was also trained in advanced biotechnology and bioinformatics at Uppsala University, Sweden, and completed research in neurobiology, peptide biochemistry, and organic synthesis of viral inhibitors at Tsinghua University, China.