As there continues to be an increase in biologic and biosimilar product applications and approvals, new lawsuits and judicial decisions area also on the rise. This webinar will provide updates and trends in biologic and biosimilar litigation, including lawsuits by biosimilar applicants against biologic sponsors, lawsuits between biologic sponsors, and lawsuits between biosimilar manufacturers. Speakers will also discuss recent case law related to patent term exclusivity, United States Patent and Trademark Office (USPTO) proceedings, and important recent and pending Courts of Appeal decisions.
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Chad A. Landmon, Partner, Axinn, Veltrop & Harkrider LLP Christopher M. Mikson, Partner, DLA Piper LLP (US) Teresa (Terry) Stanek Rea, Partner, Crowell & Moring LLP Moderated byNeil Di Spirito, Partner, Epstein Becker & Green, PC
CHAD A. LANDMON is a partner at Axinn, Veltrop & Harkrider LLP, where he chairs the IP and FDA Practice Groups. Over his 20+ years of experience, Chad has maintained a particular focus on FDA litigation and patent trial work, having served as a first chair trial lawyer on multiple cases and having litigated over 50 cases in numerous federal district and appellate courts in the last 10 years alone, many of which have involved products with billions of dollars in annual sales. In addition to his patent litigation practice, his FDA work involves client counseling and petitioning FDA relating to pharmaceuticals, biologics, medical devices, and regenerative medicine products. During the course of his career, Chad has worked on eight of the top ten generic drugs ranked by cost savings and nearly half of the top 100 generic drugs by sales volume. Chad’s practice also includes matters involving the intersection of the antitrust, FDA, and patent laws, such as issues arising from the settlement of patent and FDA exclusivity disputes.
CHRISTOPHER M. MIKSON is a partner at DLA Piper in Washington, DC and Philadelphia, PA where he is a member of the Litigation and Regulatory practice group. With his unique combination of training and experience as a medical doctor, registered patent attorney, and seasoned litigator, Chris focuses his practice on advising and representing clients in FDA regulatory matters and complex litigation and transactional matters involving healthcare and the life sciences. He has extensive experience in the regulation of drugs, biologics, human cell and tissue products (HCT/Ps), and medical devices by FDA and other federal and state agencies. Chris has counseled and represented clients in regulatory matters across all stages of the product life cycle from research and development to nonclinical testing, clinical trials, premarket clearance and approval, manufacturing and distribution compliance, and post market surveillance and reporting. He has handled a broad range of agency proceedings such as Orange Book listing disputes, comments during rulemaking, citizen petitions, establishment inspections, responses to agency letters, and enforcement actions, as well as litigation against FDA under the Administrative Procedure Act. Chris has taught patent and FDA law at the University of Pennsylvania, and has spoken and written extensively on regulatory and intellectual property issues. LMG Life Sciences has recognized him as a “Life Sciences Star” since 2018.
TERESA (TERRY) STANEK REA joined Crowell & Moring LLP, in their Washington, DC office and is a partner and co-vice chair of the Intellectual Property Group. She served as Acting Under Secretary of Commerce for Intellectual Property, and Acting Director of the US Patent and Trademark Office (USPTO). Ms. Stanek Rea focuses on intellectual property and dispute resolution related to pharmaceutical, biotechnology, and other life science issues. She is a licensed pharmacist. Ms. Stanek Rea is the former president of the American Intellectual Property Law Association (AIPLA) and a past president of the National Inventors Hall of Fame. She is a member of The Sedona Conference. Managing IP identified her as one of the Top 50 Most Influential People in Intellectual Property (2013). IAM Strategy 300 selected her as one of The World’s Leading IP Strategists (2015). She was also named one of Law360’s Top 25 Icons of IP (2016). She received the Patent and Trademark Office Society’s 2017 Pasquale J. Federico Memorial Award. Ms. Stanek Rea obtained her Juris Doctor degree from Wayne State University and her Bachelor of Science degree from the University of Michigan.
NEIL P. DI SPIRITO is a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, and the St. Petersburg offices of Epstein Becker Green. He has more than two decades of experience helping pharmaceutical, medical device, biologic, and life sciences clients comply with U.S. and international drug, biologic, and medical product regulation. Mr. Di Spirito has successfully litigated against the FDA, defending clients on alleged cGMP violations and approval issues. He also has substantial experience negotiating with the FDA’s Office of Chief Counsel and with the Regulatory, Compliance, and Review departments within the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health on matters of policy and product approvals. Before joining Epstein Becker Green, Mr. Di Spirito was a member of the Business and Finance Department, and the Life Sciences and Technology and Health Care Groups, at a national law firm, where he also established and led the firm’s FDA practice. Prior to becoming an attorney, Mr. Di Spirito worked as an executive for major pharmaceutical manufacturers in marketing, manufacturing, advertising, FDA regulatory and compliance, new drug approval, and worldwide business development. He also negotiated with regulatory authorities to launch products and manage them throughout the product life cycle. Mr. Di Spirito teaches pharmaceutical, biologic, and medical device law at the Food and Drug Law Institute (FDLI) and to FDA’s newly hired attorneys, reviewers, and compliance officers. He also serves as co-chair of FDLI’s 2018 Annual Conference Planning Committee and as chair of the Regulatory Committee of the Florida Medical Device Manufacturers Consortium. In addition, Mr. Di Spirito was named to the Florida Rising Stars list (2013-2018) in the area of Food and Drugs.