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

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On December 17, 2024, Congress presented a short-term funding bill that, if passed, would prevent a partial government shut down...

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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On December 17, 2024, Congress presented a short-term funding bill that, if passed, would prevent a partial government shut down and fund the government through March 14, 2025.[1] On top of additional spending for disaster relief, the draft funding bill includes a more than 500-page health care package with a short section that may raise the eyebrows of everyone working at life sciences and pharmaceutical companies. Read the full <a href="https://lifesciences.mofo.com/topics/stop-gap-spending-bill-provision-takes-aim-at-biologics-patent-litigation" target="_blank">blog post</a>.

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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

Associate

Lisa N. Silverman focuses on patent portfolio management and strategic patent counseling in the areas of chemistry and life sciences. She has extensive experience in securing U.S. and foreign patent protection for pharmaceutical products and a deep understanding of patent lifecycle management and strategies for maximizing patent term. In addition to pharmaceuticals, Dr. Silverman also works with clients in the areas of clean technology, bioassays, and medical devices.Dr. Silverman routinely represents clients in both investor- and target-side due diligence, including patentability and freedom-to-operate assessments. She has a keen interest in the intersection of patent and regulatory considerations for pharmaceutical products and medical devices, and she has prepared numerous applications for patent term extension.Dr. Silverman has represented companies of all sizes, from start-ups to multi-national corporations, and provides advice tailored to each client’s unique business needs. She has worked with large companies to ensure robust patent protection for marketed drug products. She has worked closely with several mid-size companies to expand patent protection and mitigate potential infringement risks as lead drug candidates have moved through clinical development toward commercialization. She has also advised small companies on securing early foundational patents.Prior to entering the legal field, Dr. Silverman obtained her Ph.D. in chemistry from Stanford University, where she was the recipient of a National Science Foundation Graduate Research Fellowship. Her doctoral research in the laboratory of Professor Steven G. Boxer focused on spectroscopic investigation of charge transfer reactions in organic, organometallic, and biological molecules. Dr. Silverman received her B.A. summa cum laude, in chemistry and political science from Barnard College, where she performed synthetic organic chemistry research in the laboratory of Professor Christian M. Rojas. She also studied alpha-helical folding of small peptides in the laboratory of Professor Ronald Breslow at Columbia University.Dr. Silverman received her J.D. from Stanford Law School. She was a member of the Organizations and Transactions Group of the Stanford Law School Mills Legal Clinic, where she provided governance advice and drafted contracts and management materials for Northern California non-profit organizations.

Lisa Silverman

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 a member 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

Life Sciences + Healthcare