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FDA and Patent Strategies for Life Sciences Innovators

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Life sciences innovators at all stages seek patent protection to limit market competition and, in some cases, attract further investment. Careful IP planning is especially important in the life sciences, with many companies relying on a handful of patents

Life sciences innovators at all stages seek patent protection to limit market competition and, in some cases, attract further investment. Careful IP planning is especially important in the life sciences, with many companies relying on a handful of patents to protect their high-value products.It is essential that companies pay close attention to the interrelationship between patent and US Food and Drug Administration (FDA) regulatory considerations to protect their most valuable assets for the long term.Morrison & Forester is a proud sponsor of LSPN Connect. Join attorneys Brigid Bondoc and Lisa Silverman on Thursday, December 2, at 12pm EST for a LSPN Connect session, “FDA and Patent Strategies for Life Sciences Innovators”.This webinar will explore: <ul><li>Strategies for obtaining strong patent protection for small molecule and biologics drugs</li><li>Maximizing patent term through Patent Term Adjustment (PTA) and Patent Term Extension (PTE)</li><li>FDA regulatory exclusivities</li><li>Orange Book vs Purple Book patent listings</li><li>Due diligence considerations</li></ul>If you’re not already a member of LSPN Connect, you can register for a <a target="_blank" href="https://www.lspnconnect.com/page/1552737/become-a-member?utm_source=Speaker&utm_medium=Email&utm_campaign=Membership+Drive">Taster Ticket</a>, which gives you complimentary access to 3 sessions.<hr>

FDA and Patent Strategies for Life Sciences Innovators

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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

FDA + Healthcare Regulatory and Compliance

FDA and Patent Strategies for Life Sciences Innovators - 575804101

FDA and Patent Strategies for Life Sciences Innovators

02 Dec 2021 3:00 PM - 4:00 PM EST