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10/26: CONCURRENT SESSION: Prescription Drug Importation, Legal Limits and Remedies
October 26, 2020 9:00 AM to 10:30 AM
90 CLE Minutes
CONCURRENT SESSION: Prescription Drug Importation, Legal Limits and Remedies
Alison Kessler, LifeSci Consulting, LLC
Sara Koblitz, Hyman Phelps & McNamara, Washington, DC,
Monisha Deka, US International Trade Commission, Washington, DC
Jennifer Dienes, US International Trade Commission, Washington, DC
Craig Svoboda, Alvotech USA Inc., Arlington, VA
A joint program of the Food & Drug, IP Transactions, ITC, and Biotechnology Committees
US International Trade Commission | Investigative AttorneyJennifer Dienes has been an Investigative Attorney at the US International Trade Commission (ITC) in Washington DC for 1 year. Investigative attorneys advocate on behalf of the public interest in intellectual property investigations initiated under 19 U.S.C. 1337, commonly referred to as Section 337 litigations.
US International Trade Commission | Investigative AttorneyMonisha Deka (Mo) has been an Investigative Attorney at the US International Trade Commission (ITC) in Washington DC for almost 8 years. Investigative attorneys advocate on behalf of the public interest in intellectual property investigations initiated under 19 U.S.C. 1337, commonly referred to as Section 337 litigations.
Alvotech | Global Head Intellectual PropertyCraig Svoboda has extensive experience with patents and intellectual property in the pharmaceutical industry. He has served as in-house counsel for innovator small molecule and biologics and most recently with the biosimilar company Alvotech. Craig’s skills includes patent drafting, prosecution and portfolio management; client advising including patentability, freedom to operate, non-infringement and validity opinions; licensing including IP diligence, contract drafting and negotiations. Craig’s former and current roles include strategic counseling and creative applications of providing legal advice to efficiently and effectively influence fast moving product development.
LifeSci ConsultingAlison Kessler is Principal Member and Founder of LifeSci Consulting LLC, where she guides Life Sciences companies through decision-making processes on matters ranging from strategy, intellectual property, and business development. With over 20 years’ experience, Alison has served as General Counsel at Cosette Pharmaceuticals; Vice President, Global Head of Intellectual Property at ConvaTec; Global Head of Patents at Novartis Consumer Health; and US Head of IP, Business Development & Licensing at Sandoz. Alison began her legal career at Goodwin Procter LLP focusing on IP matters in both the corporate and litigation groups.
Koblitz, Sara W.
Hyman, Phelps & McNamara | AssociateSara W. Koblitz advises FDA-regulated clients on a range of issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, and the Orange Book. She helps drug and device manufacturers in various stages of product development and guides clients through the applicable regulatory requirements with respect to applications and submissions, device classification, potential exclusivities, promotional issues, and post-marketing requirements.