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Fall 2021 Patent Law Virtual Course

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Now in its 3rd year, the 2021 Morrison & Foerster Patent Law Course is designed for students and post-docs with life sciences backgrounds interested in learning more about intellectual property (IP) law. MoFo’s Patent Law Course features a combination of lectures and interactive workshops, introducing students to IP law, with an emphasis on key life sciences patent issues, FDA regulatory compliance, and patent licensing. Each session will teach important elements of life science law through discussions of court cases and practical examples. Students will be introduced to the teaching style followed by U.S. law schools and the course is designed to familiarize students with life in a patent law firm.

Now in its 3rd year, the 2021 Morrison & Foerster Patent Law Course is designed for students and post-docs with life sciences backgrounds interested in learning more about intellectual property (IP) law. MoFo’s Patent Law Course features a combination of lectures and interactive workshops, introducing students to IP law, with an emphasis on key life sciences patent issues, FDA regulatory compliance, and patent licensing. Each session will teach important elements of life science law through discussions of court cases and practical examples. Students will be introduced to the teaching style followed by U.S. law schools and the course is designed to familiarize students with life in a patent law firm.<h4>Topics of Discussion:</h4><h5>Session 1 – IP 101, Michael R. Ward and Matthew A. Chivvis</h5><ul><li>Introduction to Intellectual Property Law: Patentability, FTO, Inventorship</li><li>The IP saga of a professor who tried to take his invention without permission</li></ul><h5>Session 2 – Patent Drafting, Nathan Vogler</h5><ul><li>Parts of a Patent</li><li>Taking a Disclosure</li><li>Claim Drafting Exercise</li></ul><h5>Session 3 – Special Patent Topics, Janet Xiao and Anna Yuan</h5><ul><li>Antibodies/CAR-T</li><li>Gene and Cell Therapies</li><li>Biosimilars and Generics</li><li>Life Sciences Data Analytics: AI/Software/Data Science</li></ul><h5>Session 4 –The CRISPR Interference/FDA, Yan Qi, Bethany Hills, and Brigid Bondoc</h5><ul><li>The CRISPR Patent Interference</li><li>FDA: The Drug and Software Approval Process</li></ul><h5 dir="ltr">Session 5 – Formation and Licensing Issues in Life Sciences, Matt Karlyn and Jim Krenn</h5><ul><li>Life Sciences Startups — The Top 10 Things to Know About When Forming a Life Sciences Startup</li><li>Patent Licenses Including a Discussion of University Technology Transfer</li></ul><h5>Session 6 – Careers in Patent Law, Panel Discussion</h5><ul><li>Panelists Include: Jillian Pesin-Fulop, Thomas Dawson, Anushree Gulvady-Hayes, Thomas Keane</li><li>Moderated by: Michael R. Ward</li></ul>Meeting Times 4:00 p.m. – 6:15 p.m.Meeting Dates Wednesday, September 22 Wednesday, September 29 Wednesday, October 6 Wednesday, October 13 Wednesday, October 20 Wednesday, October 27If you would like to attend, please <a target="_blank" href="mailto:BLester@mofo.com">contact us</a> for more information.<hr>

Hosted by GSAS Harvard Biotech Club and Morrison & Foerster LLP

Fall 2021 Patent Law Virtual Course

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Matthew protects his clients’ intellectual property and defends his clients wrongly accused of infringement. His hearing and trial experience is extensive. Whether exploring complex technical issues regarding a biologic drug, or digging into the finer points of patent law, he excels at keeping his opponents on their toes. Intellectual Asset Management 1000 remarked that Matthew is “a skilled technical lawyer and brief writer who can handle large and nuanced cases.” He has litigated patent matters in many of the top patent venues throughout the United States, including the District Courts of California, Texas, Delaware, and New Jersey, the Federal Circuit, and the International Trade Commission.Life sciences clients often rely on Matthew’s extensive technical experience and his ability to grasp complex and cutting-edge issues quickly. His work in this area includes proceedings involving monoclonal antibodies, antibody-drug conjugates, small molecule inhibitors, vaccines, nutritional supplements, bioimplants, drug-eluting stents, blood glucose monitoring devices, plant genetics, and animal husbandry. He knows the ins and outs of the “patent dance” in Biologics Price Competition and Innovation Act (BPCIA) proceedings, and has advised clients on successful strategies for engaging in multi-phased BPCIA and Hatch-Waxman Act matters.Matthew is a registered patent attorney, and his considerable experience includes practicing before the United States Patent and Trademark Office, especially in inter partes and post-grant review proceedings. He also regularly advises clients on plant and agriculture intellectual property matters, including strategic use of plant patents, plant-variety protection certificates, and trademark rights. In addition to life sciences matters, Matthew has litigated cases involving internet firewalls, network security, virtualization, smartphone, interactive television, website, and display technologies.Matthew graduated from law school magna cum laude and was presented with the Academic Excellence Award for his graduating class. He clerked for Chief Judge James Ware (ret.) of the Northern District of California from 2007 to 2008. Before law school, Matthew received a Bachelor of Science in molecular biology.Having grown up in Alaska, Matthew has great appreciation for the outdoors. In his free time, he enjoys skiing, hiking, and trail running.

Matthew A. Chivvis

Partner

Jim Krenn is a corporate partner and co-chair of the firm’s Emerging Companies + Venture Capital Group. Jim has extensive experience representing private and public companies and investors in significant business transactions from formation through liquidity. His practice focuses on mergers and acquisitions, venture capital financings, and emerging company counseling. His clients span a broad range of industries, with a concentration in life science and technology companies.Jim advises clients on private and public acquisitions on both the buy-side and sell-side across numerous transaction structures, including equity purchases, asset purchases, mergers, acquisitions, divestitures, cross-border transactions, and auctions. He has represented buyers and sellers in acquisitions and divestitures ranging from the low millions to over $1 billion.Jim counsels emerging and established life sciences and technology companies in equity financings and general corporate matters, and angel, corporate, and venture capital investors in investments in such companies. He has represented clients in hundreds of venture capital financings ranging from seed rounds to $100 million-plus later-stage rounds.In addition, Jim represents public companies in public offerings, other capital markets transactions, and SEC reporting and compliance matters, and advises boards of directors on corporate governance issues.Jim is member of the firm’s Life Sciences + Healthcare Group leadership team and Artificial Intelligence steering committee and serves on the Board of Directors of the San Diego Entrepreneurs Exchange.<h4 dir="ltr">Mergers and Acquisitions</h4><ul dir="ltr"><li dir="ltr">ACEA Biosciences, a medical instruments company, in its sale to Agilent Technologies (NYSE: A) for $250 million.</li><li>Adicet Bio (Nasdaq: ACET), a biopharmaceutical company, in its merger with a wholly owned subsidiary of resTORbio (Nasdaq: TORC) to create a combined publicly traded biotechnology company.</li><li>Alaska Energy & Resources Company, a parent company of a regulated electric utility in Alaska, in its $170 million sale to Avista (NYSE: AVA).</li><li>Astute Medical, a medical diagnostic company, in its $90 million sale to bioMérieux (EPA: BIM).</li><li>B. Riley Financial (Nasdaq: RILY), a diversified financial services company, in its $53 million private placement and merger with investment banking firm B. Riley & Co.</li><li>Biotix, a private equity-backed developer and manufacturer of laboratory consumables and liquid handling solutions, in its sale to Mettler-Toledo (NYSE: MTD).</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple acquisitions.</li><li>Clean Energy Fuels (Nasdaq: CLNE), a provider of natural gas as an alternative fuel for vehicle fleets, in its sale for up to $180 million of components of its renewable natural gas business to BP (NYSE: BP).</li><li>Cogent (Nasdaq: COGT), a biometric identification solutions provider, in its $943 million sale to 3M (NYSE: MMM).</li><li>Deere & Company (NYSE: DE), an agricultural, construction, and forestry machinery corporation, in its planned acquisition of the precision planting unit of Monsanto (NYSE: MON).</li><li>Dosatron International, a distributor of water-powered dosing pumps and systems, in connection with its sale to Ingersoll Rand (NYSE:IR).</li><li>Gillco, a leading specialty ingredient provider, in its sale to Azelis (BR: AZE).</li><li>Mentor (NYSE: MNT), a leading supplier of medical products for the global aesthetic market, in its $1.12 billion sale to Johnson & Johnson (NYSE: JNJ).</li><li>Mitchell International, a developer of smart technology solutions, in its acquisition of Cogent Works.</li><li>MyChem, a provider of ultra-pure nucleotides, in connection with its sale to Maravai (NASDAQ: MRVI) for $240 million at closing with potential additional consideration.</li><li>Protomer Technologies, a biotechnology company, in its sale to Eli Lilly and Company (NYSE: LLY) with a potential value of over $1 billion with successful achievement of future development and commercial milestones.</li><li>Rakuten Medical, a biotechnology and medical device company, in its acquisition of Medlight SA and its acquisition of key assets and manufacturing technology from Li-Cor Biosciences.</li><li>Safebuilt Insurance Services, a managing general agent and insurance technology company, in its sale to Integrated Specialty Coverages.</li><li>Sequlite Genomics, a DNA sequencing firm, in connection with its sale to Fapon Biotech, a diagnostic technology company.</li><li>Tendo, a digital health software company, in its acquisition of MDsave, a healthcare marketplace company.</li><li>Wavestream, a provider of high-power solid-state amplifiers, in its $137 million sale to Spacenet, a subsidiary of Gilat Satellite Networks (Nasdaq: GILT).</li></ul><h4 dir="ltr">﻿Venture Financings</h4><ul><li dir="ltr">9amHealth, a provider of virtual diabetes care, in its $4 million Series Seed financing and $16 million Series A financing.</li><li>ACEA Biosciences, a developer of cell analysis instrumentation technologies, in its $30 million Series E Preferred Stock financing.</li><li>Adicet Bio, a biopharmaceutical company, in its Series A financing of up to $51 million, and $80 million Series B financing.</li><li>Astute Medical, a medical diagnostic company focused on high-risk medical conditions and diseases, in over $200 million of equity and debt financings.</li><li>Bidra as an investor in multiple equity financings.</li><li>Biolumic, an agtech company, in its $13.5 million Series B financing.</li><li>California Cryobank, a private equity-backed leader in reproductive tissue donor services and stem cell banking, in multiple equity and debt financings.</li><li>Carlsmed, a medical device and artificial intelligence company, in its $10 million Series A financing, $30 million Series B financing and $52.5 million Series C financing.</li><li>Crinetics as a strategic investor in Radionetics Oncology’s $52.5 million Series A financing.</li><li>Forward Ventures as an investor in multiple equity financings, convertible debt financings, and M&A transactions.</li><li>Foxen, a provider of financial technology solutions for the real estate industry, in its $44 million Series A financing.</li><li>Greenoaks Capital Partners and its affiliates as investors in multiple equity financings, debt financings, and secondary transactions.</li><li>GroupSolver, an artificial intelligence market research platform, in multiple preferred stock financings.</li><li>Hume.ai, an artificial intelligence company, in multiple preferred stock financings.</li><li>Oak Investment Partners as an investor in multiple preferred stock financings.</li><li>OrbiMed as an investor in multiple equity financings, debt financings, and M&A transactions.</li><li>Petuum, an artificial intelligence and machine learning software infrastructure provider, in its $93 million Series B financing.</li><li>Pi Health, an AI-enabled health technology and clinical research company, in its spin-out from BeiGene, Ltd. and $35 million Series A financing.</li><li>RA Capital as an investor in multiple equity financings.</li><li>Rakuten Medical, a biotechnology and medical device company, in over $730 million of debt and equity financings.</li><li>Softbank affiliates as investors in multiple equity financings.</li><li>Solarflare Communications, a software and hardware company, in over $200 million of equity and debt financings.</li><li>VoloAgri, an agriculture technology company focused on seed genetics, in over $150 million of equity financings.</li><li>Western Digital Capital as an investor in multiple preferred stock financings.</li></ul>

Jim Krenn

Co-Chair of Emerging Companies + Venture Capital Practice

Jillian brings over a decade of experience in patent prosecution and strategy to her practice. Her practice focuses on patent preparation and prosecution, patent portfolio management, and patent due diligence for life sciences and biotech companies in a wide array of fields, including biologics, pharmaceuticals, cell therapy, cancer therapeutics, personalized medicine, neurodegenerative disease, biofuels, and agricultural biotechnology. She has experience developing and managing U.S. and worldwide patent portfolios, developing global patent strategies, performing due diligence analyses, filing Patent Term Extension applications, and providing strategic advice to align patent strategy with business goals. Jillian also assists clients in technology transaction matters, including licenses and collaborations for development and commercialization.Dr. Pesin-Fulop received her J.D. from the University of California, Berkeley, School of Law, where she received the Law and Technology Certificate and earned the Jurisprudence Award in copyright law. Before attending law school, Dr. Pesin-Fulop was a scientific analyst and patent agent with the firm.Dr. Pesin-Fulop received her Ph.D. in biology from the Massachusetts Institute of Technology, where she was a recipient of a National Science Foundation Graduate Research Fellowship. She graduated magna cum laude from Williams College with a B.A. in biology and Russian and was elected to Phi Beta Kappa.

Jillian Pesin-Fulop

Of Counsel

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

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

Janet focuses her practice on worldwide patent procurement, patent portfolio management, and strategic planning for life sciences companies. Janet’s clients range from large multinational biopharmaceutical companies, such as Celgene and Genentech, to emerging startup companies around the world. She advises her clients on patent matters relating to various technologies, including antibody therapeutics, cell therapeutics, nanomedicine, gene therapy, drug delivery systems, diagnostics, and nutraceuticals.Recognized by Chambers as being highly sought after for patent prosecution and strategy mandates by innovators from around the world, Janet develops and strengthens her clients’ complex patent portfolios to maximize their commercial value. She is instrumental in developing strategies for multibillion-dollar patent portfolios for pharmaceutical clients. As impressed clients noted to Chambers, “Janet’s work is thorough, polished and always of the highest caliber. She is well equipped to advise international clients on patent prosecution and strategy in the biotech industry, drawing on substantial technical knowledge.”Janet works extensively in performing IP due diligence reviews in the contexts of VC investments, technology transactions, mergers and acquisitions, and marketing and manufacturing clearance for biopharmaceutical products. She helps some of the world’s most-sophisticated biopharmaceutical companies and investors assess potential risks and devise preemptive risk-management strategies for their product development and investments. She has led hundreds of IP due diligence projects, and is noted for her in-depth knowledge of patent landscapes in the fields of cancer immunotherapy, gene editing, next-generation sequencing, liquid biopsy, antibody manufacturing, and medical devices. Janet works regularly with patent litigators in the event of legal challenges by third-party competitors or vice versa, and she is frequently called upon to represent clients in litigation and post-grant proceedings.Janet is the Head of firm’s China Life Sciences Group and served as co-chair of the global Life Sciences Group from 2016 to 2019. She is among the very few IP attorneys in the world who are both equipped with solid skills in global strategic IP management and knowledgeable about IP issues unique to China and Chinese clients, and she has been the go-to counsel for IP issues in U.S./China cross-border transactions and operations in China. Chambers Global praises her as an outstanding IP lawyer “who is renowned for her work on IP issues concerning complex cross-border transactions, where she regularly advises Chinese clients.” In a recent edition of Chambers Global, a client says, “Janet . . . is very experienced in advising life sciences clients doing business in China and the US . . . She is highly responsive and always gives practical advice. Her IP expertise adds tremendous value to our business.”Since 2005, Janet has been actively involved in the leadership team of the Chinese-American Biopharmaceutical Society (CABS), a nonprofit organization dedicated to bridging the life sciences communities in the U.S. and China, including serving as president for the 2011–2012 term. She is also a member of BayHelix, a nonprofit organization of Chinese heritage leaders in the global life sciences and healthcare fields.

肖荐（Janet Xiao）博士的业务侧重于为生命科学公司处理在全球范围内的专利采购、专利组合管理和战略策划事宜。肖博士服务的客户范围广泛，包括大型跨国生物制药公司，例如赛尔基因公司（Celgene）和基因泰克公司（Genentech），也包括全球范围的新兴创业公司。她经常就与各种技术有关的专利事宜向客户提供法律意见，其中涉及的技术包括抗体疗法、细胞疗法、纳米医学、基因疗法、给药系统、诊断和和营养学等。来自全球的创新者纷纷向肖博士寻求专利申请和专利战略的法律咨询，这一点也得到了《钱伯斯指南》的认可。她帮助客户开发和加强其复杂的专利组合，从而为客户实现最大的商业价值。在为制药行业的客户制定数十亿美元专利组合的战略方面，肖博士发挥着重要的作用。《钱伯斯指南》曾引用客户评价称，“肖博士是我曾合作过的律师当中知识最渊博、效率最高的一位律师。她能很好地将专利组合的历史信息用于全球专利申请问题上。”肖博士针对风险投资、技术交易、并购和生物医药产品的市场推广与生产许可事宜开展广泛的知识产权尽职调查审查工作。她协助世界上一些最成功的生物制药公司和投资者，为其产品开发和投资评估潜在风险，并制定先发制人的风险管理策略。她曾牵头处理过数百个知识产权尽职调查项目，并凭借自己对癌症免疫治疗、基因编辑、新一代测序、液体活检、抗体制造和医疗设备领域的专利方面的深厚知识而闻名。肖博士时常与专利诉讼律师合作，处理由第三方竞争者提出的法律质疑，或对第三方竞争者提出的法律质疑，她还经常受聘代表客户处理专利诉讼和授予后程序。肖博士是美富中国生命科学业务组主管，她曾在2016至2019期间担任美富全球生命科学业务组的联席主管。肖博士是全球为数不多的既拥有很强的全球战略性知识产权管理技能，同时又对中国和中国客户独特的知识产权问题具有深刻理解的知识产权律师之一，她一直是处理中美跨境交易和在中国境内经营中所涉知识产权问题的首选律师。《钱伯斯全球指南》称赞她是一位优秀的知识产权律师，“她因处理与复杂跨境交易有关的知识产权问题工作而知名，经常代表中国客户处理这方面的事宜” 。在近期一版《钱伯斯全球指南》中，某客户评价称，“肖博士在为于中国和美国开展业务的生命科学客户提供法律意见方面，有非常丰富的经验。她非常负责而且总是提供切实可行的法律意见。她在知识产权方面的专业意见为我们的业务增添了巨大价值。”自2005年以来，肖博士一直积极参与北美华人生物医药协会（CABS）的领导工作。该协会是一家非营利组织，致力于成为连接中美两国生命科学领域的纽带。肖博士在2011至2012年间担任该协会主席。她还是百华协会（BayHelix）的成员。百华协会是一家非营利组织，由全球生命科技和医疗保健产业领域的华人精英组成。

Janet Xiao

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

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

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

Dr. Anushree Gulvady-Hayes focuses her work on patent drafting and prosecution with an emphasis on immunotherapy, genetics, genomics, and microbiology.Prior to joining the firm, Anushree was a postdoctoral fellow at the Dana-Farber Cancer Institute, a principal affiliate of Harvard Medical University, where she conducted research for multiple immuno-oncology projects to identify novel metastatic signatures of breast cancer using cutting-edge transcriptomics, gene expression, CRISPR/Cas9 screens, immune profiling, and preclinical mouse models of breast cancer. She also collaborated on tumor evolution projects using targeted therapeutic strategies and high-complexity DNA barcoding techniques, resulting in a peer-reviewed publication. While she was a postdoctoral fellow, Anushree was also a business development fellow at the Office of Technology Development at Harvard University where she evaluated intellectual property landscapes, including prior art searches, patentability analysis, commercialization potential, and market research while developing successful commercialization strategies for cutting-edge Harvard technologies. She also drafted evolutionary maps of divisional/continuation patents for the patent team at the Wyss Institute at Harvard, and analyzed funding applications and drafted high-level progress reports for technologies, including therapeutics, immuno-modulatory drugs, anti-angiogenics, and antimicrobial peptide inhibitors for the Blavatnik Biomedical Accelerator at Harvard.Anushree earned her Ph.D., with distinction, in anatomy and cell biology at the SUNY Upstate Medical University in Syracuse, New York. Her doctoral research focused on identifying novel signaling pathways required for cancer migration using advanced microscopy techniques that resulted in presentations at multiple scientific conferences.  Anushree received her M.S. and B.S. in microbiology from the University of Mumbai, India.

Anushree Gulvady-Hayes

Patent Agent

With a research background in medicinal chemistry, Dr. Thomas Dawson focuses on patent prosecution and IP due diligence for clients in the pharmaceutical and chemical industries.Before joining the firm, Thomas held postdoctoral appointments at the University of Massachusetts Amherst and Yale University, where he created molecular libraries designed to modulate cellular targets involved in cancer and hyperproliferative diseases. As a graduate student at the University of Virginia, he developed subtype-selective inhibitors of the sphingosine kinases, and was an ARCS Scholar.Thomas earned a B.S. in chemistry from the University of Wyoming in 2011. He hails from Lander, WY.

Thomas Dawson

Dr. Thomas Keane focuses his practice on patent drafting and prosecution, freedom-to-operate analyses, and IP due diligence, with an emphasis on chemistry and pharmaceuticals.Thomas earned his Ph.D. in chemistry from Harvard University, where he was a National Science Foundation graduate research fellow. During his doctoral research, he studied metal oxide water oxidation catalysts for use in clean energy storage systems. He also worked on the development of catalysts for the partial and total electrochemical oxidation of organic substrates for use in synthetic and fuel cell applications, respectively.Thomas earned his B.S. in chemistry, summa cum laude, from the University of Delaware. His undergraduate research focused on the development of heterogeneous catalysts for the conversion of carbon dioxide to fuel precursors.Thomas is registered to practice before the U.S. Patent and Trademark Office.

Fall 2021 Patent Law Virtual Course

22 Sep 2021 - 27 Oct 2021

Topics of Discussion:

Session 1 – IP 101, Michael R. Ward and Matthew A. Chivvis

Session 2 – Patent Drafting, Nathan Vogler

Session 3 – Special Patent Topics, Janet Xiao and Anna Yuan

Session 4 –The CRISPR Interference/FDA, Yan Qi, Bethany Hills, and Brigid Bondoc

Session 5 – Formation and Licensing Issues in Life Sciences, Matt Karlyn and Jim Krenn

Session 6 – Careers in Patent Law, Panel Discussion