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Advanced Topics in Patent Law

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Morrison & Foerster and Nucleate invite you to attend our Advanced Topics in Patent Law Course, featuring a series of lectures...

Morrison & Foerster and Nucleate invite you to attend our Advanced Topics in Patent Law Course, featuring a series of lectures designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds. This ten-week workshop will allow attendees to expand their knowledge and learn more about:<ul><li>Intellectual Property law, including patent prosecution, litigation, trademarks, licensing, and commercial transactions</li><li>Business law, including raising funds, and company exit strategies</li><li>Regulatory law, including the FDA, privacy, and data security</li></ul>Each session will explore more advanced topics in patent and life sciences law, such as US/EU patent drafting, small molecules, medical devices, biologics, FDA strategies, trade secrets, and licensing. Attendees will gain the hands-on knowledge scientists, engineers, entrepreneurs, and investors need to manage the legal aspects for launching and growing a startup including how to avoid common mistakes that can have serious consequences down the road.MoFo’s seasoned patent, corporate, privacy, licensing, and trademarks lawyers as well as IP litigators will lead each class with a real-world experienced-based approach. All sessions are moderated by Michael R. Ward, Ph.D., global head of the firm’s Life Sciences Practice Group, head of the firm’s Patent Practice Group, co-chair of the firm’s Intellectual Property Practice Group and co-chair of our global Food + Agriculture practice.<h5>Session 1 – Developing an IP Strategy</h5>Speaker: Michael Ward January 12, 2022<h5>Session 2 – Small Molecule Patent Drafting and IP Strategy</h5>Speaker: Anita Choi January 19, 2022<h5>Session 3 – Medical Device Patent Drafting and IP Strategy</h5>Speaker: Christopher Gloria January 26, 2022<h5>Session 4 – Patent Strategies for Personalized Medicine and Diagnostics</h5>Speakers: Rachel Rice, Liz Newman February 2, 2022<h5>Session 5 – Biologics Patent Drafting and IP Strategy</h5>Speaker: Meghan Poon February 9, 2022<h5>Session 6 – Patent and FDA Strategies for new drugs</h5>Speaker: Brigid Bondoc, Lisa Silverman February 16, 2022<h5>Session 7 – Life Science AI and Machine Learning Patent Drafting and IP Strategy (Case Studies)</h5>Speakers: Anna Yuan, Jean Nguyen February 23, 2022<h5>Session 8 – Trade Secret Strategies for Life Sciences</h5>Speaker: Mark Whitaker March 2, 2022<h5>Session 9 – Patent Drafting for the US and Europe</h5>Speakers: Nathan Vogler and Anna Leathley (Carpmaels & Ransford) March 9, 2022<h5>Session 10 – Advanced Licensing Topics</h5>Speaker: Matt Karlyn March 16, 2022<hr>

Hosted by Nucleate and Morrison & Foerster LLP

Advanced Topics in Patent Law

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Anita Choi has decades of experience providing strategic advice to companies and investors in the <a href="/capabilities/life-sciences-healthcare" target="_self" dir="ltr">Life Sciences</a> and <a href="/capabilities/food-agriculture" target="_self">Food + Agriculture</a> industries. She has helped start-up companies build IP portfolios around their core technologies, and counseled them on issues related to patents versus trade secrets. She has worked with larger, more established companies to manage global patent portfolios in a way that integrates IP with their business models. Combining her legal and business expertise enables her to navigate complex challenges that require complex solutions hence why she is so often called upon by clients to help with assessing, building and strengthening patent portfolios.  She has also counseled investors in IP due diligence, identifying critical issues that may affect valuation and risk assessment in deals.Anita is part of the <a href="/life-sciences-healthcare-leadership" target="_self">Life Sciences + Healthcare Leadership Team</a>, as well as the Food + Agriculture Leadership Team within the firm. She co-leads the firm’s Chemistry Subgroup within the patent practice, which covers both the Pharmaceuticals and Materials sector within the chemistry space. She also co-leads the firm’s Food + Agriculture patent practice. Anita’s clients praise her ability to quickly gain a deep understanding of their technology and business, which allows her to think critically, creatively and practically in patent portfolio management.Anita is recognized as a key lawyer by The Legal 500 US for patent prosecution. She received her J.D. from the University of Pennsylvania Law School where she graduated magna cum laude with a degree in Chemistry and was named to the Order of the Coif. During law school, Anita also completed her M.B.A. at the Wharton School of Business.Anita is co-editor of our <a href="https://lifesciences.mofo.com/" target="_blank" dir="ltr">MoFo Life Sciences Blog</a>.Life SciencesAnita gained a solid technical background across disciplines during her time studying at the California Institute of Technology (CalTech), where she received her Bachelor of Science with honors. She spent several years working at Pfizer, developing small molecule compounds for use in oncology therapies. She has performed research at CalTech involving unnatural amino acids, and at MIT involving fluorescent zinc sensors, both for use in developing neuroscience applications.Anita has counseled clients in a wide variety of life science technologies, including small-molecule pharmaceuticals, cannabinoids, nutraceuticals, pharmaceutical and cosmetic uses, pharmaceutical formulations, medical devices, diagnostics, and digital health.Food and AgTechAnita has advised businesses in developing IP strategies for soil and crop technologies, sustainable farming, alternative protein sources, fermentation technologies, extraction technologies, new categories of food and beverage products, and food packaging.The breadth of technologies that Anita works with also enables her to provide IP advice at the intersection of multiple technical disciplines. For example, Anita’s practice is also well positioned at the convergence of data analytics in the Life Sciences and Agriculture industries.ChemistryAnita also has technical expertise in chemistry outside of Life Sciences, such as in the Materials space, including Cleantech. She has developed IP strategies for biobased materials, polymer chemistry, composite materials, catalyst-based technologies, industrial processing, batteries, and carbon capture technologies.IP Due DiligenceAnita is skillful with investor-side and company-side patent due diligence. She supports many of the firm’s corporate deals, advising on ownership and patent portfolio risks and conducting patentability and freedom-to-operate assessments. She also supports her own clients undergoing IP due diligence by investors.IP Litigation SupportAnita also works closely with the IP Litigation Group to formulate strategies for infringement contentions, validity/invalidity contentions, and claim construction positions. She actively supports the patent litigators in pre-litigation diligence matters to evaluate the strength of patents and patent portfolios.Pro BonoAnita has an active pro bono practice and has been awarded the State Bar of California's Wiley W. Manuel Award for Pro Bono Legal Services for many consecutive years. She regularly represents families seeking legal guardianship. She also assists numerous non-profit organizations in developing and securing patent protection for their core technologies.

Anita Choi

Partner

Christopher Gloria is a partner in the firm’s Patent Group. Mr. Gloria’s practice concentrates on domestic and international patent prosecution, IP due diligence, and IP litigation support including patent infringement and validity determinations.Mr. Gloria has drafted and prosecuted patents in numerous technology areas including medical devices, user interfaces, autonomous devices, image analysis, machine learning, and consumer products. Before attending law school, Mr. Gloria worked as an engineer in the semiconductor and aerospace industries.Mr. Gloria received his J.D. with highest honors from The George Washington University Law School where he was a member of The George Washington Law Review, a George Washington Scholar, and a Presidential Merit Scholarship recipient. He received his M.S. and B.S. in mechanical engineering from The University of Texas. He was previously a summer associate at the firm.Mr. Gloria is registered to practice before the Patent and Trademark Office and is licensed to practice law in the Commonwealth of Virginia.

Christopher Gloria

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.

Meghan Poon

A former lead engineer at the NASA Jet Propulsion Laboratory, Dr. Nguyen focuses her practice on domestic and international patent prosecution. She is a founder and co-leader of the firm’s Life Sciences Data Analytics patent group. She applies her experience also from her doctoral studies and her work as a former research scholar to provide portfolio management and counseling, IP due diligence, and freedom-to-operate analyses. Dr. Nguyen also has experience drafting briefs and inter partes reviews (IPRs), analyzing prior art and patent infringement, working with experts, and handling disputes before the U.S. International Trade Commission (ITC) and the federal courts. Her clients include large domestic and international companies, early-stage startups, and universities.Dr. Nguyen’s knowledge spans a wide range of technology areas, including electronic devices, medical devices and health systems, semiconductor materials and fabrication, computer/device hardware, memory, optoelectronics, optics, nanotechnology, microelectromechanical systems (MEMs), electronic packaging, augmented/virtual reality systems, autonomous vehicles, smart glass, mechanical assemblies, and consumer products. Her experience also encompasses telecommunications and networks, integrated circuits and digital designs, quantum computing, computer software, and digital cameras.Prior to joining Morrison & Foerster, Dr. Nguyen was a lead engineer at the NASA Jet Propulsion Laboratory and a hardware engineer at Hewlett-Packard. She also worked as a research scholar at the Center for Quantum Devices, Georgia Tech Computer Aid Design Lab, and Berkeley Wireless Research Center, where her research involved collaborating with several companies and laboratories such as Raytheon, Cree, IBM, Intel, BAE Systems, Lockheed Martin, Sandia National Labs, U.S. Army Night Vision Labs, Naval Research Lab, Aerospace Corporation, Argonne National Lab, Lawrence Livermore National Lab, Los Alamos National Lab, L3 Communications, Boeing, General Electric, FLIR, Teledyne, and Rockwell Automation.Dr. Nguyen received her J.D. from Loyola Law School. She also received her Ph.D. in electrical engineering from Northwestern University, where she focused her studies on semiconductor materials and optoelectronic devices. She received her M.S. in computer science from the Georgia Institute of Technology, where she focused her studies on computer-aided design and quantum computing. Jean also received her B.S. degree in computer engineering from the University of Wisconsin at Madison with emphasis on integrated circuits and digital designs. She has authored over 40 technical publications, 50 conference proceedings, and three book chapters. She also holds three patents.Dr. Nguyen has served on several committees with the Los Angeles Intellectual Property Law Association (LAIPLA). She is registered to practice in California and before the United States Patent and Trademark Office.

Jean Nguyen

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

Nathan Vogler is Of Counsel in the firm’s Patent Group and heads the patent group’s Materials Science and Energy Storage practice. His practice concentrates on domestic and international patent prosecution, IP due diligence, IP counseling, IP portfolio management, and IP litigation support including patent infringement and validity determinations. Nathan has handled matters in all stages of patent prosecution, including new application drafting, office action responses, patent appeals, and continuation and divisional filings. He has drafted and prosecuted patents in various technology areas, including polymer chemistry, composite materials, industrial processing, nanotechnology, catalysts, batteries, magnets, consumer electronics, and software. In addition, Nathan has experience handling reexaminations, reissue applications, and supplemental examinations before the United States Patent and Trademark Office.In addition to his patent prosecution experience, Nathan also has considerable experience in adversarial proceedings before the USPTO including inter partes review proceedings instituted by the America Invents Act. He has experience representing both Petitioners and Patent Owners, and has represented clients in all stages of the proceedings, such as drafting petitions, patent owner responses, expert depositions, and oral hearings before the PTAB.Representative completed post-grant matters include the following:<ul><li>IPR2021-00210, -00211, -00213: Successfully defended patent owner Malvern against three inter partes reviews, resulting in petition denials.</li><li>IPR2017-01312: Successfully defended patent owner HML. The USPTO found all claims patentable in a final written decision.</li><li>IPR2014-01266, -01313: Defended patent owner HML against two inter partes reviews by different parties, resulting in claim survival or petition denial.</li></ul>Nathan received his J.D. with high honors from The George Washington University Law School, where he was elected to the Order of the Coif and was a member of the George Washington Law Review. He received his B.S. in chemical engineering, with a minor in chemistry, summa cum laude from Purdue University. While in law school, Mr. Vogler was a summer associate at Morrison Foerster.Nathan is admitted to practice in Massachusetts, Virginia and District of Columbia and is registered to practice before the USPTO.

Nathan Vogler

Of Counsel

Michael (Mike) Ward is co-chair of the firm's Life Sciences + Healthcare Group, Patent Group, Intellectual Property Group, and Food + Agriculture Group.As co-chair of the Patent Group, Mike manages a team that includes 80+ Ph.D.s and 100+ attorneys and others with advanced scientific degrees in life sciences and related engineering disciplines. From small molecules and antibodies to gene editing, artificial intelligence, and machine learning, MoFo has deep experience protecting some of the most important innovations in the life sciences and food and agriculture sectors.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

Anna Yuan’s practice focuses on patent prosecution, IP due diligence, post-grant proceedings, and IP litigation support. She has been recognized as one of the “Ones to Watch” in America by Best Lawyer and a Rising Star in Intellectual Property by Americas Women in Business Law. Anna is the co-founder and co-chair of the firm’s Life Sciences + AI patent practice. She leverages her experience in software development and product design gained as a product manager at Microsoft to build valuable patent portfolios covering highly complex technologies to maximize their commercial value. Anna’s practice spans a wide array of technologies, including artificial intelligence, autonomous driving, blockchain, robotics, electronic devices, data analytics, virtual reality, wireless communications, network security, medical devices, diagnostics, health care, and genomics. She has developed and managed clients’ core portfolios in the United States, China, Canada, Europe, Japan, Korea, Mexico, and Australia. Anna’s clients include emerging companies, multinational corporations, and universities.Anna received her J.D. from Harvard Law School. During law school, she served as an executive editor of the Harvard International Law Journal and co-founded the Harvard China Law Association. She was also active in clinical and pro bono programs such as the Cyberlaw Clinic based at the Harvard Berkman Center for Internet and Society, and the Harvard Mediation Program.She received her B.S. summa cum laude in computer engineering from Louisiana State University, with minors in computer science and mathematics. Prior to attending law school, Anna worked as a program manager at Microsoft in the Windows Division. At Microsoft, she led projects relating to software user interface design, software reliability, and software privacy compliance. She has also worked as a facilities engineer at Chevron and as a software developer at Halliburton.She is admitted to practice in California and is registered to practice before the United States Patent and Trademark Office. Anna is a fluent Chinese speaker and regularly counsels Chinese clients in Silicon Valley and abroad.

Anna Yuan

Mark Whitaker is co-chair of the firm’s Intellectual Property Litigation Practice and has more than 30 years of experience crafting legal strategies in high-stakes patent and trade secret litigation.Mark sees the whole board for each of his clients, and works closely with them to define a successful litigation outcome and determine the best path to achieve that goal. He has extensive experience navigating the rules and procedures in the nation’s top patent litigation venues, including U.S. district courts, the International Trade Commission, and the Court of Federal Claims.Mark regularly acts as lead counsel in matters involving technologies such as semiconductors, photo/optical technologies, chemicals, and database analytics. His clients do business in a broad range of industries including pharmaceuticals, medical devices, consumer products, and telecommunications. He often leads a team of MoFo lawyers representing several defendants in parallel multipatent litigations.A past president of the American Intellectual Property Law Association, Mark was elected to their prestigious Fellows membership in 2019. He is a frequent speaker at the American Bar Association, the Practising Law Institute, the Minority Corporate Counsel Association, and numerous CLE events all over the country. He is also the current co-chair of MoFo’s Diversity Strategy Committee, building on decades of experience leading law firm diversity and inclusion efforts. Additionally, Mark currently serves on Law360’s Intellectual Property Editorial Advisory Board, having been selected twice since 2021.Mark is a veteran of the U.S. Navy, having served first as a surface warfare officer and later as a member of the Navy Judge Advocate General’s Corps. Following his military service, he began his private-practice legal career as a commercial litigator before concentrating on IP and technology litigation.

Mark L. Whitaker

Matt Karlyn has 25 years of experience in working with companies in the healthcare, pharmaceutical, medical device, and technology industries on a wide range of commercial life sciences, licensing, and technology transactions. His clients range from Fortune 100 companies to start-ups, and he regularly advises companies on matters involving IP commercialization, complex collaboration transactions, licensing initiatives, subscription-based economics, and business transactions related to the procurement, development, commercialization, and use of technology and life sciences products. He has also worked with a number of clients on corporate transactions including mergers and acquisitions, as well as private equity and venture capital financing.Matt is ranked Band 1 by Chambers USA for Intellectual Property: Licensing in Massachusetts. Clients in Chambers describe Matt as: “accessible and engaged, and he is really focused on getting the right answer for us."<h4>Life Sciences</h4>Life sciences clients, including pharmaceutical, medical device, and healthcare companies, rely on Matt for his breadth of knowledge in licensing, collaboration, and commercialization strategies across a wide range of transactions designed to strengthen operations and maximize value. Matt’s clients come from sectors across the global economy and include emerging companies, privately held companies, and many of the world’s biggest brands.Matt has broad experience with commercial transactions and agreements in the life sciences space, including:<ul><li>Intellectual property and technology licenses</li><li>Collaboration and development transactions</li><li>Commercialization agreements</li><li>Supply and manufacturing transactions</li></ul><h4>Technology</h4>Matt regularly advises on the use of technology in business, pricing strategies, and market terms across a wide variety of technology transactions that benefit clients both large and small. He has extensive experience negotiating a wide range of transactions, including:<ul><li>Enterprise resource planning and customer relationship management licensing and implementation transactions</li><li>Cloud-based transactions including software-as-a-services, platform-as-a-service, and infrastructure-as-a-service.</li><li>Software licensing</li><li>Supply chain and procurement deals</li></ul>Additionally, Matt has worked on many of the largest outsourcing transactions in the United States, representing numerous Fortune 100 companies on information technology, business process, finance and accounting, facilities services, and other outsourcing transactions.Matt is a frequent author and speaker on topics pertaining to drafting and negotiating commercial technology, outsourcing, and licensing transactions. He has published over 25 articles (including chapters in two books), given over 175 presentations on licensing, technology, outsourcing, and data security, and is the co-author of A Guide to IT Contracting: Checklists, Tools, and Techniques.Matt is currently co-chair of the Legal and Regulatory policy group at the Massachusetts Biotechnology Council. He served as chair of the New England Chapter of the International Association of Outsourcing Professionals, and served for five years on the board of directors of Julie’s Family Learning Program, a wellness program for mothers and children in South Boston.

Matt Karlyn

Dr. Elizabeth (Liz) Newman focuses her work on patent drafting and assisting prosecution. She also has experience in IP due diligence inquiries, including freedom-to-operate analyses, with an emphasis on biotechnology and pharmaceuticals.Liz has worked with a wide range of clients, including startup biotech companies, large pharmaceutical companies, and universities. She has worked with clients in a number of areas, primarily in cancer immunotherapy.Liz received her Ph.D., dissertation awarded with honors, in microbiology and immunology from New York Medical College, where she studied antibody responses to influenza and concentrated on viral genomics, vaccine design, high throughput immunological assays including epitope mapping, molecular biology, and confocal microscopy.She received her B.S. in molecular and cellular biology from Mills College in Oakland, California.

Liz Newman

Patent Agent

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>

Advanced Topics in Patent Law

02 Mar 2022 - 16 Mar 2022

Session 1 – Developing an IP Strategy

Session 2 – Small Molecule Patent Drafting and IP Strategy

Session 3 – Medical Device Patent Drafting and IP Strategy

Session 4 – Patent Strategies for Personalized Medicine and Diagnostics

Session 5 – Biologics Patent Drafting and IP Strategy

Session 6 – Patent and FDA Strategies for new drugs

Session 7 – Life Science AI and Machine Learning Patent Drafting and IP Strategy (Case Studies)

Session 8 – Trade Secret Strategies for Life Sciences

Session 9 – Patent Drafting for the US and Europe

Session 10 – Advanced Licensing Topics