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What Constitutes Adequate Written Federal Circuit Bar Journal The National Quarterly Review of the United States Court of Appeals for the Federal Circuit Volume 29, Number 3 Published by Federal Circuit Bar Association® Federal Circuit Bar Journal Volume 29, Number 3 FACULTY EDITORIAL COMMITTEE Steven L. Schooner Joshua I. Schwartz John M. Whealan Professor Professor Associate Dean, Intellectual Property The George Washington University Law School The George Washington University Law School The George Washington University Law School Federal Circuit Bar Journal Washington, DC Washington, DC Washington, DC Student Editorial Board The George Washington University Law School 2019–2020 ASSOCIATION JOURNAL ADVISORY COMMITTEE Sharon Israel James E. Brookshire James F. McKeown Chair, Federal Circuit Bar Journal Executive Director Crowell & Moring LLP Committee Federal Circuit Bar Association® Washington, DC Editor-in-Chief Shook, Hardy & Bacon LLP Washington, DC Jonathan Trinh Houston, TX Charles F. Schill Executive Editors Washington, DC Alexis Ferruccio Natalie Goldberg FOUNDER Senior Articles Editor Managing Editor Senior Notes Editor Gerald H. Bjorge Jennifer Narvaez Kisa Motiwala Andrew Current Washington, DC Articles Editors Notes Editors Submissions Editor John Antishin Kyle Barry Jiaxin (Gillian) Fan Rebecca Connolly Arrash Fattahi FEDERAL CIRCUIT BAR ASSOCIATION® OFFICERS Carol Conroy Irene Jung Case Briefs Editor Elizabeth Vincento Griffin Simpson Jamie Underwood Sonal Mehta President President-Elect Latham & Watkins LLP WilmerHale Washington, DC Palo Alto, California Senior Staff Members Maximillian Blinder-Acenal Jamie Hay Jordan Nimitz Laura Masurovsky Joseph M. Reisman Robert K. Huffman Andrew Brown Danica Hong Rebecca Olson Treasurer Secretary Immediate Past President Stephen Cundra Justin Kim Pauline Weissman Finnegan, Henderson, Farabow, Knobbe Martens Olsen & Bear LLP Akin Gump Strauss Hauer & Feld LLP Michael Essiaw Neal Mehrotra Wenxi (Jasmine) Zhu Garrett & Dunner LLP Irvine, California Washington, DC Gabrielle Fortunato Rebecca Miller Washington, DC EX OFFICIO Junior Staff Members Peter R. Marksteiner Lauren Astone James Heaney Rushil Mehta Chief Executive of the U.S. Court of Appeals Brooke Carroll Mariah Henry Samuel Moore for the Federal Circuit Elizabeth (Corrie) Chase Nicholas Hopkins Alondra Nin Rivera Washington, DC Tiange (Tim) Chen Megan Hughes Jillian Pascua Meredith Condren Susanna Israelsson Matthew Robinson Erin Drolet Jordan Jean Nicole Salisbury Jasmine Elmasry Courtney Jones Richard Samboy BOARD OF DIRECTORS Rebecca (Chase) Frederick Laura Kaiser Ravi Shah Joshua Gilmer Madison Kewin Markus Speidel William Burgess, Esquire John Dragseth, Esquire Scott Kieff, Esquire Cori Grunenwald Jonathan Kim Lena Streisand Kirkland & Ellis LLP Kieff Strategies LLC Fish & Richardson P.C. Victoria Hanafin Saroja Koneru Hannah Taylor Jestelle Hanrahan Adison Marshall David Templeton Tim Brightbill, Esquire Ann Fort, Esquire David Killough, Esquire Ian Hargreaves Rebecca Martin Alexa Zogopoulos Wiley Rein Eversheds Sutherland (US) Microsoft Corporation Jim Calkins, Esquire Erin Gibson, Esquire Sandra Kuzmich, Esquire Haug Partners LLP Qualcomm Incorporated DLA Piper LLP Charlene Morrow, Esquire Nicholas Cannella, Esquire Sarah Harris, Esquire Fenwick & West LLP Tina Chappell, Esquire United States Patent & Tradenark Office Amalie Weber, Esquire Peter Cicala, Esquire Emily Johnson, Esquire Snowflake Computing Celgene Corporation Amgen Inc. Jennifer Wu, Esquire Robert DeBerardine, Esquire Patrick Keane, Esquire Paul, Weiss, Rifkind Wharton Johnson & Johnson Buchanan Ingersoll & Rooney PC & Garrison LLP ii iii AS A SERVICE TO ITS MEMBERS, the Federal Circuit Bar Association® publishes the FEDERAL CIRCUIT BAR ASSOCIATION® Federal Circuit Bar Journal (ISSN 1055-8195), a national quarterly law journal concerning The United States Court of Appeals for the Federal Circuit is supported by the Federal Cir- issues and cases within or related to the jurisdiction of the U.S. Court of Appeals for the cuit Bar Association® which is a national organization for the bar of the court. Leadership Federal Circuit. of the association comes from all areas of the country and represents all areas of the court’s jurisdiction. The association was organized to unite the different groups who practice within THE FEDERAL CIRCUIT BAR JOURNAL WELCOMES submission of original articles, the court’s jurisdiction. 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No compensation is paid for materials published. Correspondence, an organization that will meet your special needs and the needs of the court. Membership manuscripts, and books for review should be sent to [email protected]. provides an opportunity for active participation in addressing issues and legal developments of the court. A valuable membership benefit is participation in the work of the association’s DUES-PAYING MEMBERS OF THE ASSOCIATION enjoy complimentary access to committees, bringing together, from all areas of the country, members specializing in the The Journal. Members also have unlimited access to present and past publications from our areas of the court’s jurisdiction. Through participation in committees, association members website fedcirbar.org. In addition, hard copies of the Journal may be obtained by individuals meet and benefit from the experience of others having a common practice or interest, as or libraries at $100/year for four issues. Membership inquiries should be directed to Vernon well as the understanding and ability of the organized bar to respond to common issues and Love at [email protected] or 202-391-0622 and subscription inquiries should be directed concerns facing the court and its bar. To join the Association, please visit https://myfcba. to Roseanna Quinlan at [email protected] or 240-317-5648. fedcirbar.org/NC__Login?startURL=%2F. Back issues, in both hardcopy and microfiche, can be purchased from: FEDERAL CIRCUIT BAR ASSOCIATION® COMMITTEES William S. Hein & Co., Inc. Each member is assured of appointment to at least one of the committees of his or her choice. Periodicals Department To view the current standing committees, please visit http://fedcirbar.org/Committees. 1285 Main Street Buffalo, NY 14209-1987 (800) 828-7571 CATEGORIES OF MEMBERSHIP (716) 883-8100 (fax) Annual Dues are set depending on the category of membership. [email protected] (e-mail) Regular and Associate Membership $300.00 MATERIAL CONTAINED HEREIN shall not be construed as actions or positions of the A regular member is a member in good standing of the Federal Circuit Bar. An associate Federal Circuit Bar Association®. member is a member in good standing of the bar of the highest court of a state. Young Lawyer / Small Firm $150.00 Copyright 2020 Federal Circuit Bar Association®. The Federal Circuit Bar Journal is pub- A young lawyer is a practicing attorney under thirty-five years old. A member is considered lished quarterly by the Federal Circuit Bar Association®, 1620 I Street, N.W., Suite 801, part of a small firm if they employ less than 25 attorneys. Washington, D.C. 20006. Third-class postage paid at Washington, D.C. POSTMASTER: Send address changes to the Federal Circuit Bar Journal, 1620 I Street, N.W., Suite 801, Government Membership / Educator Membership $75.00 Washington, D.C. 20006. A government member is a regular or associate member who is employed by a local, state, or federal government agency. An educator member is a faculty member of an accredited law school. Retired Membership $75.00 A retired member currently earns less than fifty percent of their income from the practice of law. Student and Federal Circuit Law Clerk Membership $0.00 A student member is enrolled in an accredited law school. A Federal Circuit Law Clerk member is currently a law clerk of the Court. iv v Federal 343 When is Enough Enough? What Constitutes Circuit Adequate Written Description of a Genus KATIE ALBANESE Bar Introduction Journal I. Background II. Case Studies CONTENTS III. Solutions Conclusion 363 Prescribing Relief for Injured Reference Product Sponsors Under the BPCIA JONATHAN TRINH Introduction I. The Statutory Framework of the Biologics Price and Competition Act II. The Exclusive Remedy is Inadequate for Injured Reference Product Sponsors III. The Proposed Amendment to the BPCIA Conclusion 387 The Bayh-Dole Act: Is it the Proper Treatment for the Big Pharma Price-Gouging Epidemic? NATALIE GOLDBERG Introduction I. Cost of Prescription Drugs and Lack of Affordability II. Proposing the Bayh-Dole Act as a Means to Address the High Cost of Prescription Drugs III. Consequences if the Government Chooses to Use
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