Sign-In
Cart
Biosimilars Litigation and Client Counseling
Paperback
Currently unavailable to order
Please enter your email and a message will be sent to you when this product becomes available on our website.
ISBN13: 9781639054657
Publisher: American Bar Association
Published: Dec 10 2024
Pages: 414
Weight: 1.59
Height: 0.90 Width: 6.90 Depth: 9.90
Language: English
Biosimilars Litigation and Client Counseling is a guide to the field of biologic products and biosimilars, as well as the laws governing them - most notably the Biologics Price Competition and Innovation Act. This guide is instructive to patent attorneys practicing in this field, judges that are assigned cases involving these products and related patents, and managers of pharmaceutical companies that design biologic or biosimilar products or are considering entering this market. It describes the statutory and regulatory framework for applying for and receiving a biologic and biosimilar application, and it provides an in-depth analysis of the legal processes and challenges that come with it.
Legal counsel will find practice strategies and tips from the country's top litigators that provide valuable insight into this developing area of law. This includes guidance on what the biosimilar application process looks like, how to navigate certain questions and pitfalls that are likely to arise during the litigation process, and how to best serve a client that is involved with biologics.
Judges will appreciate this book as a quick reference to the Biologics Price Competition and Innovation Act which will likely be governing the lawsuit related to biologics that is before them. This includes a walkthrough of typical litigation and summary of the relevant statutes and regulations that will be involved. Judges will also have a guide to the common disputes that arise in these cases and an understanding of how they have been decided.
Managers or other decision-making members of a pharmaceutical company will also enjoy this book as a reference when strategizing a patent portfolio or what to consider when designing a biosimilar product, as well as benefiting from the deeper understanding of the legal process that this book provides.
Also from
Dorsney, Kenneth Laurence
Also in
General Law
Before All Is Said and Done: Practical Advice on Living and Dying Well
Watson, Suzanne
Miles, Pat
Hardcover
With Liberty and Justice for Some: How the Law Is Used to Destroy Equality and Protect the Powerful
Greenwald, Glenn
Hardcover
Boy with a Knife: A Story of Murder, Remorse, and a Prisoner's Fight for Justice
Trounstine, Jean
Paperback
The U.S. Constitution: A Comprehensive and Annotated Guide for the Modern Reader
Murray, Melissa
Hardcover
Department of Fate: The Promise, the Power, and the Collapse of America's Most Consequential Institution
Maddow, Rachel
Hardcover
So Ordered: An Originalist's View of the Constitution, the Court, and Our Country
Alito, Samuel A., Jr.
Hardcover
Last Branch Standing: A Potentially Surprising, Occasionally Witty Journey Inside Today's Supreme Court
Isgur, Sarah
Hardcover
Unreasonable Women: Three Stories of Violence, Imprisonment, and Extraordinary Survival
Van Der Leun, Justine
Hardcover
Discovering the Club: Piecing Together the Puzzling Network of Parental Pimping, Ritualistic Abuse, and Sex Trafficking
Clack, Cynthia L.
Paperback
Supremacy: How Rule by the Court Replaced Government by the People
Renan, Daphna
Bowie, Nikolas
Hardcover
North Carolina Notary Public Manual, 2016
Secretary of State, Nc Department
North Carolina Department of the
Secretary of State
Hardcover
Federal Rules of Civil Procedure; 2026 Edition: With Statutory Supplement
Michigan Legal Publishing Ltd
Paperback
Nolo's Guide to Social Security Disability: Getting & Keeping Your Benefits
Morton III, David A.
Paperback
Social Security, Medicare & Government Pensions: Get the Most Out of Your Retirement and Medical Benefits
Matthews, Joseph
Paperback
The Price of Mercy: Unfair Trials, a Violent System, and a Public Defender's Search for Justice in America
Galvin Almanza, Emily
Hardcover
Our Minds Were Always Free: A History of How Black Brilliance Was Exploited--And the Fight to Retake Control
Davis, Lisa E.
Hardcover
Searching for Jane Crow: Black Women and Mass Incarceration in America from the Auction Block to the Cell Block
Leflouria, Talitha L.
Hardcover
The Water Remembers: My Indigenous Family's Fight to Save a River and a Way of Life
Cordalis, Amy Bowers
Hardcover
Five Bullets: The Story of Bernie Goetz, New York's Explosive '80s, and the Subway Vigilante Trial That Divided the Nation
Williams, Elliot
Hardcover
Medical Terminology Made Simple: Easily Learn, Memorize, and Pronounce Medical Terms
Temple, John, MD
Paperback
One in Five: Why Child Sexual Abuse Is Our Biggest Public Health Crisis--And What We Can Do to Stop It
Malone, Luke
Letourneau, Elizabeth J.
Hardcover
Robert's Rules of Order Newly Revised in Brief, 3rd Edition
Honemann, Daniel H.
Balch, Thomas J.
Robert, Henry M., III
Paperback
The Criminal Law Handbook: Know Your Rights, Survive the System
Berman, Sara J.
Bergman, Paul
Paperback
Your Data Will Be Used Against You: Policing in the Age of Self-Surveillance
Ferguson, Andrew Guthrie
Hardcover
Captain's Dinner: A Shipwreck, an Act of Cannibalism, and a Murder Trial That Changed Legal History
Cohen, Adam
Hardcover
Revenge for the Sixties: Sam Alito and the Triumph of the Conservative Legal Movement
Canellos, Peter S.
Hardcover
Getting Permission: Using & Licensing Copyright-Protected Materials Online & Off
Stim, Richard
Paperback
J.K. Lasser's Small Business Taxes 2027: Your Complete Guide to a Better Bottom Line
Weltman, Barbara
Paperback
The Public Domain: Find and Use Free Content for Your Website, Book, App, Music, Video, Art, and More
Secor, Glen
Paperback
Oops...That's Illegal!: A Handbook for the Wildly Curious (and the Accidental Outlaw)
Mandell, Mike
Hardcover
When Companies Run the Courts: How Forced Arbitration Became America's Secret Justice System
Ballou, Brendan
Hardcover
The Pain Brokers: How Con Men, Call Centers, and Rogue Doctors Fuel America's Lawsuit Factory
Chamblee Burch, Elizabeth
Hardcover
Pink Crime: Fighting Against the Criminalization of Motherhood, Pregnancy, and Queer Identity
Beety, Valena
Hardcover
The Trustee's Legal Companion: A Step-By-Step Guide to Administering a Living Trust
Zolla, Carol Elias
Buckley, Shaila
Hanks, Liza
Paperback
Living Trusts for Everyone: Why a Will Is Not the Way to Avoid Probate, Protect Heirs, and Settle Estates (Second Edition)
Sharp, Ronald Farrington
Paperback
Lawless: How the Supreme Court Runs on Conservative Grievance, Fringe Theories, and Bad Vibes
Litman, Leah
Paperback
The Constitution Cannot Save Us: Why We Can No Longer Rely on Our Founding Document
Seidman, Louis Michael
Hardcover
The U.S. Constitution and Other Writings (Deluxe Leatherbound Edition)
Editors of Canterbury Classics
Hardcover
Federal Rules of Evidence; 2026 Edition (Casebook Supplement): With Advisory Committee notes, Rule 502 explanatory note, internal cross-references, qu
Michigan Legal Publishing Ltd
Paperback
No Loose Ends: The Smart & Slightly Morbid Guide to Estate Planning & End-Of-Life Tasks
Zuckerman, Adam
Hardcover
The Constitution of the United States of America: The Declaration of Independence, The Bill of Rights
Founding Fathers
Paperback
Federal Rules of Evidence; 2026 Edition: With Internal Cross-References
Michigan Legal Publishing Ltd
Paperback
Why We Can't Have Nice Things: How Legal Reformers Accidentally Broke America
Bagley, Nicholas
Hardcover
Dig Me a Grave: The Inside Story of the Serial Killer Who Seduced the South
Assael, Shaun
Harpootlian, Richard A.
Hardcover
Is the Government Legally Killing Us?: Is the Evidence Obvious? How Fear of Death and the Illusion of Freedom Turn Us Into Accomplices to Evil
(Scott Schara), Grace's Dad
Paperback
Represent Yourself in Court: Prepare & Try a Winning Civil Case
Bergman, Paul
Berman, Sara J.
Paperback
The Cases That Haunt Us: From Jack the Ripper to JonBenet Ramsey, the Fbi's Legendary Mindhunter Sheds Light on the Mysteries That Won't Go Away
Olshaker, Mark
Douglas, John
Paperback
Redemption: Faith, Justice, and Sisterhood on Death Row (Large Print Edition)
Wright, Lawrence
Paperback
Bone Valley: A True Story of Injustice and Redemption in the Heart of Florida
King, Gilbert
Hardcover
Little Book of Restorative Justice & Community: Reclaiming Connection and Responsibility for Our Neighbors
Morneau, Caitlin
Wilson, Sheryl
Paperback
Stitching Freedom: A True Story of Injustice, Defiance, and Hope in Angola Prison
Tyler, Gary
Hardcover
Until the Last Yoke Is Broken: The Constitutional Vision of Frederick Douglass
Rebeiro, Bradley N.
Hardcover
Iras, 401(k)S & Other Retirement Plans: Strategies for Taking Your Money Out
Shea, Tracy
Slesnick, Twila
Paperback
Understanding Living Trusts(R): How You Can Avoid Probate, Keep Control, Save Taxes, and Enjoy Peace of Mind
Schumacher, Vickie
Paperback
Terrible Stuff Damaging Everybody: The True Story of Lies and Libel in Dominion V. Fox
Rosenberg, Ian
Hardcover
The Presidential Pardon: The Short Clause with a Long, Troubled History
Prakash, Saikrishna Bangalore
Hardcover
55 Successful Harvard Law School Application Essays, 2nd Edition: With Analysis by the Staff of the Harvard Crimson
Staff of the Harvard Crimson
Paperback
The Federalist: A Commentary on the Constitution of the United States
Jay, John
Hamilton, Alexander
Madison, James
Paperback
Confronting Zionism: Decolonizing Palestine and Building the World Anew
Erakat, Noura
Reynolds, John
Paperback
Fireproof: A Five-Step Model to Take Your Law Firm from Unpredictable to Wildly Profitable
Morse, Mike
Nachazel, John
Hardcover
The Only Living Trusts Estate Planning Guide: Protect Your Assets, Avoid Probate, Slash Taxes and Secure Your Heirs' Future.
Sterling, Thayer
Paperback
Every Californian's Guide to Estate Planning: Wills, Trust & Everything Else
Hanks, Liza W.
Paperback
Hitler's American Model: The United States and the Making of Nazi Race Law
Whitman, James Q.
Paperback
Beyond the Body Farm: A Legendary Bone Detective Explores Murders, Mysteries, and the Revolution in Forensic Science
Bass, Bill
Jefferson, Jon
Paperback
Lawless: How the Supreme Court Runs on Conservative Grievance, Fringe Theories, and Bad Vibes
Litman, Leah
Hardcover
Special Needs Trusts: Protect Your Child's Financial Future
Urbatsch, Kevin
Farinas Jones, Jessica
Paperback
Contempt of Court: The Turn-Of-The-Century Lynching That Launched a Hundred Years of Federalism
Curriden, Mark
Phillips, Leroy
Paperback