Print
Professionals
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Name
Advanced Search…
Government Experience…
Practices & Industries
Litigation & Trial
Regulatory & Policy
Transactions & Corporate
Investigations
Digital Transformation
Coronavirus Resource Center
Industries
C&M International
View All Practices & Industries
Locations
Brussels
Doha
London
Los Angeles
New York
Orange County
San Francisco
Shanghai
Washington, D.C.
C&M International
Singapore
Washington, D.C.
News & Events
Events
Firm News & Announcements
Client Alerts & Newsletters
Media Mentions
Publications
Social Media & Blogs
Speeches & Presentations
Podcasts
Creating Tomorrow Series
Coronavirus Resource Center
Biden First 100 Days
Litigation Forecast 2021
About
Overview
Leadership
History
Awards
Innovation in Service
Diversity & Inclusion
Pro Bono
Careers
Lawyers
Law Students
Professionals
Professionals
A
B
C
D
E
F
G
H
I
J
K
L
M
N
O
P
Q
R
S
T
U
V
W
X
Y
Z
Name
Location
All Locations
Brussels
Doha
London
Los Angeles
New York
Orange County
San Francisco
Shanghai
Singapore
Washington, D.C.
Practice
All Practices
Litigation & Trial
Regulatory & Policy
Transactions & Corporate
Administrative Law & Regulatory
Advertising & Media
Antitrust & Competition
Appellate
Arbitration
Aviation
Bankruptcy & Creditors' Rights
Blockchain / Distributed Ledger Technology (DLT)
Broker-Dealer
Business Aviation
C&M International
Class Actions
Commercial Contracts & Outsourcing
Commercial Finance & Lending
Commercial Litigation
Commercial Real Estate
Coronavirus (COVID-19) Response Team
Corporate
Corporate Counseling, Governance & Compliance
Corporate Finance & Securities
Digital Health/MedTech
Digital Transformation
E-Discovery & Information Management
Education
Emerging Companies & Venture Capital
Energy
Environment & Natural Resources
Environmental, Social, and Governance
ERISA & Employee Benefits
European (EU) Regulatory
Executive Practice
False Claims Act
Financial Institutions
Financial Services
Foreign Corrupt Practices Act
Government Affairs
Government Contracts
Government Contracts Transactions
Health Care
Hedge Funds / Investment Funds
Infrastructure
Insurance/Reinsurance
Intellectual Property
Intellectual Property Litigation
International Dispute Resolution
International Trade
Investigations
Investigations: Government & Internal
IP Strategy, Prosecution, and Portfolio Management
Israel Practice
Joint Ventures & Strategic Alliances
Labor & Employment
Latin America Practice
Legal Ethics & Malpractice
Mass Tort, Product, and Consumer Litigation
Mergers & Acquisitions
Middle East and North Africa (MENA) Practice
National Coordinating Counsel & Complex Litigation
National Security
Nonprofit & Tax-Exempt Organizations
Pharmaceuticals & Life Sciences
Plaintiff's Recovery
Privacy & Cybersecurity
Private Equity
Product Risk Management
Public-Private Partnerships
Restructuring & Creditors' Rights
SEC Enforcement
State Attorneys General Practice
Tax
Trade Secrets
Transportation
Trial
Whistleblower
White Collar & Regulatory Enforcement
Industry
All Industries
3D Printing
Aerospace & Defense
Agriculture
Artificial Intelligence and Robotics
Automotive & Trucking
Autonomous Vehicles
Aviation
Chemicals
Education
Financial Services
Food & Beverage
Government Contracts
Health Care
Hospitality & Leisure
Insurance/Reinsurance
Mining
Pharmaceuticals & Life Sciences
Retail & Consumer Products
Technology, Media & Telecommunications
Trade Associations
Transportation
Advanced Search…
Government Experience…
Practices & Industries
Litigation & Trial
Regulatory & Policy
Transactions & Corporate
Investigations
Digital Transformation
Coronavirus Resource Center
Industries
C&M International
View All Practices & Industries
Search By Name
Locations
Brussels
Doha
London
Los Angeles
New York
Orange County
San Francisco
Shanghai
Washington, D.C.
C&M International
Singapore
Washington, D.C.
News & Events
Events
Firm News & Announcements
Client Alerts & Newsletters
Media Mentions
Publications
Social Media & Blogs
Speeches & Presentations
Podcasts
Creating Tomorrow Series
Coronavirus Resource Center
Biden First 100 Days
Litigation Forecast 2021
About
Overview
Leadership
History
Awards
Innovation in Service
Diversity & Inclusion
Pro Bono
Careers
Lawyers
Law Students
Professionals
Pharmaceuticals & Life Sciences
Professionals
Contacts
Representative Engagements
News & Events
Related Services
Antitrust Investigations
C&M International
Environmental & Safety Investigations
Pharmaceutical & Biologics Litigation
Practices
›
Pharmaceuticals & Life Sciences
›
Representative Engagements
Pharmaceuticals & Life Sciences
CONTACTS
+
–
Left
Keith J. Harrison
Partner
Washington, D.C.
+1 202.624.2560
Right
Representative Engagements
Patent license litigation
. Represented a plaintiff licensor of drug development technology in a breach of patent license action in the
Southern District of New York. Prevented assertion of patent invalidity and patent misuse defenses on grounds of licensee estoppel.
Icahn School of Medicine at Mount Sinai v. Neurocrine Biosciences, Inc.
Patent infringement litigation.
Represented the University of California in three related patent infringement actions asserting UCSF patents covering methods of treating atrial fibrillation in the Northern District of California.
Regents of the University of California v. St. Jude Medical, Boston Scientific Corp. and Atricure, Inc.
$34 million jury award for soft-tissue graft technology.
Represented plaintiff LifeNet in patent-infringement action involving soft-tissue grafts in the Eastern District of Virginia. Jury awarded LifeNet over $34 million; decision affirmed on appeal.
LifeNet Health v. Life Cell Corp.
Trade secrets litigation win.
Successfully represented a generic pharmaceutical company in a breach of contract and misappropriation of trade secrets claim in the District of Delaware.
Lonza Sales AG v. Progenics Pharmaceuticals, Inc.
Patent Trial and Appeal Board
victory for anti-cancer drugs.
Represented petitioner Apotex in
inter partes review
before the PTAB related to anti-cancer drugs, securing victory for Apotex.
Appellate victory for multiple sclerosis drug.
Represented petitioner Apotex in
inter partes review
before the PTAB related to a multiple sclerosis drug, securing victory for Apotex at the PTAB and in the resulting appeal at the Federal Circuit.
Apotex, Inc., et al. v. Novartis AG, et al.
Coumadin®
antitrust and consumer fraud cases
. Represented a pharmaceutical manufacturer in Federal Trade Commission (FTC) proceedings and as national coordinating trial and appellate counsel in a series of antitrust and consumer fraud class actions directed at alleged misrepresentations regarding a pharmaceutical product and its generic competition.
Brand name prescription drug antitrust litigation
. Defended a major pharmaceutical company against a nationwide class of retail pharmacies and thousands of individual opt-out pharmacies alleging antitrust claims in federal court. We also represented the company in numerous parallel state court class actions brought by retail pharmacies and consumers alleging state law antitrust and consumer fraud violations.
Acquittal of criminal charges.
Obtained acquittal of the vice president for quality assurance of a major pharmaceutical company, accused of conspiracy, obstruction and other charges, in federal court in Maryland after the company itself had pleaded guilty and paid a $10 million fine for the same.
Grand jury investigations.
Represented of the leading blood bank in the New York metropolitan area, and one of the largest in the country, in two grand jury investigations of alleged falsification of viral testing. Despite the conviction of two lab supervisors, no criminal changes were brought against our client.
New Drug Application (NDA) approval process assistance.
Blocked the Food and Drug Administration (FDA) from giving a competitor's product an unfair advantage in the NDA approval process. On behalf of a drug manufacturer, we petitioned the agency to treat similar products similarly, and successfully sued in federal court when FDA failed to do so.
Product seizures.
Represented an over-the-counter (OTC) drug manufacturer in federal court and in negotiations with FDA to resolve the agency's seizure of a large quantity of product at a distributor's warehouse. The settlement permitted the company to continue distributing the product.
Investigator disqualification hearings.
Defended a clinical investigator in the first disqualification hearing held in years, the result of FDA's increasingly aggressive enforcement activities aimed at clinical investigators and their institutions.
Trade matters.
Defended the boycott and restraint of trade charges against a health plan for maintenance of a limited pharmacy network.
Antitrust litigation.
Served successfully as defense counsel in antitrust litigation in Alabama arising out of the pricing system that pharmaceutical manufacturers have implemented that differentiates between "retail" pharmacies and managed care payers/providers of prescription drug products.
Junk science cases.
Prepared successful Amici briefs
in Daubert v. Merrell Dow
Pharmaceuticals, Inc., and
Carmichael v. Kumho Tire Co.
, two Supreme Court junk science cases.