Karen A. Gibbs is a partner at Crowell & Moring. Karen focuses her practice on strategic counseling and litigation in the areas of product distribution, antitrust, unfair competition, intellectual property, license, general commercial, regulatory compliance, sales and marketing ethics, and non-compete and employment matters.

Karen specializes in representing medical device, pharmaceutical, biotechnology and other life science companies. She also has successfully represented companies in the airline, computer hardware and software, currency exchange, food and beverage, office products, sports equipment and telecommunications industries.

In addition to having broad strategic counseling and litigation experience, Karen has experience dealing with the U.S. Department of Justice, the U.S. Department of Health and Human Services Office of Inspector General, the Federal Bureau of Investigation, the Federal Trade Commission, State Attorneys General, and certain congressional committees and their counsel on behalf of her clients.

Before joining Crowell & Moring, Karen was the principal and lead in-house counsel at Applied Medical, a global medical device company, where she was responsible for the company's legal affairs and transactions, and counseled all of the company's divisions and global subsidiaries. Karen's in-house experience provides her with insight into the challenges in-house business and legal teams face in an increasingly globally-competitive and regulated environment.

While in-house, Karen drafted, reviewed, negotiated and otherwise managed a broad variety of agreements, including distribution, group purchasing organization, integrated health delivery systems, HIPAA, confidentiality, license, research and development, joint venture, consulting, private label, OEM, real estate, service and procurement agreements. She also engaged in all aspects of litigation and trial preparation, including litigation strategy and management, pre-litigation investigations and analyses, jury research, mediation, arbitration, and the preparation of pleadings, discovery responses, briefs, fact and expert witnesses, complex damages cases and settlement agreements.

Karen's representative cases include:

• Allergan, Inc. v. Santen,Inc . Represented Allergan in patent and licensing dispute with a Japanese competitor concerning a prescription anti-infective ophthalmic solution.
• Applied Medical Resources Corp. v. United States Surgical Corp. Represented Applied Medical in two successive patent cases against competitor U.S. Surgical (now Covidien), obtaining in the first case damages, enhanced damages, fees, costs and interest exceeding $65 million.
• Applied Medical Resources Corp. v. Johnson & Johnson et al. Represented Applied Medical in antitrust bundling case against certain Johnson & Johnson subsidiaries and Novation, the nation's largest group purchasing organization.
• Applied Medical Resources Corp. v. Ethicon Endo-Surgery, Inc. Represented Applied Medical in complex patent case involving multiple patents and product lines, settling favorably for Applied Medical.
• Bauman v. Applied Medical Resources Corp. etal . Represented Applied Medical in defense of discrimination and wage and hour claims by a former employee, securing full dismissal after mediation with former employee taking no damages.
• Biogen, Inc. v. Amgen Inc. Defended Amgen in patent case brought by Biogen against Amgen's Neupogen® drug and involving recombinant DNA technologies. After summary judgment of non-infringement was granted in Amgen's favor, Biogen conceded.
• Electronics for Imaging, Inc. and MIT v. Abacus et al. Represented EFI and MIT in patent case concerning photo image editing. Responsible for complex discovery effort involving over 200 defendants, damages case and multiple settlements.
• Hutchinson Technology v. Magnecomp Int'l et al. and Magnecomp Co. v. Hutchinson Technology. Represented Magnecomp in cases involving antitrust claims and multiple patents relating to computer disk drive suspension assemblies, securing favorable settlement for Magnecomp.
• Interpore Cross Int'l v. Biomet Inc. Defended Interpore Cross International against claims of trade secret misappropriation concerning spinal implant technology. Case settled favorably for Interpore.
• Katz v. Verizon Communications and Verizon California v.Katz . Represented Verizon entities in defense of patent claims for interactive voice communication systems.
• Ortho Pharmaceutical Corp. v. Amgen Inc. Represented Amgen in license-related arbitrations adverse to a Johnson & Johnson pharmaceutical subsidiary concerning Amgen's Epogen® and Aranesp® drugs. Secured exclusive, worldwide marketing rights to a new $2 billion erythropoietic stimulating factor for Amgen.
• Schwartz v. Visa andMasterCard . Represented third-party Travelex Currency Services in class action related to foreign currency exchange practices.
• Sun Microsystems, Inc. v. Microsoft Corp. Represented Sun Microsystems in antitrust, unfair competition, license, copyright and trademark disputes with Microsoft. Secured injunctions against Microsoft for trademark infringement, copyright infringement, and unfair competition arising out of Microsoft's distribution of Windows98 and other products that incorporate unauthorized implementations of Sun's JAVA® technology.

Karen received her B.A. with a double major in Law & Society (Political Science) and Psychology from the University of California at Santa Barbara, with Distinction, Phi Beta Kappa and High Honors. She received her J.D. from the University of California, Hastings College of the Law. During law school, Karen was Editor-in-Chief of the Hastings Communications and Entertainment Law Journal and was a member of the Hastings Moot Court Board. She also was a judicial extern to the Honorable Joseph T. Sneed III of the United States Court of Appeals for the Ninth Circuit.

Education
University of California at Santa Barbara, B.A., 1991
University of California, Hastings College of the Law, J.D., 1995

Affiliations
Admitted to practice: California and multiple federal courts, including the U.S. Federal Circuit Court of Appeals

Professional Affiliations

• Advisory Board of BNA's Medical Devices Law & Industry Report
• American Bar Association, Antitrust and Intellectual Property Sections
• American Health Lawyers Association, Life Sciences Practice Group
• American Intellectual Property Law Association
• Intellectual Property Owners Association, Antitrust and Competition Law Committee
• Federal Bar Association
• State Bar of California, Antitrust & Unfair Competition Section

Publications
"Antitrust Counseling on Bundling in High-Technology Industries," The Antitrust Counselor (September 2008). Co-Authors: Karen A. Gibbs and Thy B. Bui.

"Generics: Hot Issues as Hatch-Waxman Approaches Its 25th Year," AHLA Life Sciences (September 2008). Author: Karen A. Gibbs.

"Massachusetts Law Imposes Limitations and Monitoring Requirements on Medical Device and Pharmaceutical Company Interactions with Health Care Practitioners and Facilities," Crowell & Moring Health Law 'In The News' Update (August 26, 2008). Author: Karen A. Gibbs.

"PhRMA Updates Marketing Code for Interacting with Healthcare Professionals; California Law Mandates Updates to Comprehensive Compliance Programs of Covered Pharmaceutical and Medical Device Companies," Crowell & Moring Health Law 'In The News' Update (July 15, 2008). Author: Karen A. Gibbs.

"FTC's Bureau of Competition Issues Report and Statement Emphasizing Continued Scrutiny of Pharmaceutical Agreements," Crowell & Moring Antitrust Client Alert (May 27, 2008). Author: Karen A. Gibbs.

"Observations On Brand Name-Generic Sham Litigation Disputes and Settlements," AIPLA Antitrust News (May 2008). Co-Authors: Robert A. Lipstein, Karen A. Gibbs and Valerie Hinko O'Such.

"The Implications of Twombly and PeaceHealth," Competition Law360 (April 25, 2008). Co-Authors: Karen A. Gibbs and David E. Crowe.

"Anti-Kickback Enforcement and Legislation Developments: What Drug, Medical Device and Biologics Companies Must Know," BNA's Pharmaceutical Law & Industry, Vol. 6, No. 10 and BNA’s Medical Devices Law & Industry, Vol. 2, No. 5 (March 2008). Author: Karen A. Gibbs

"U.S. Supreme Court Limits Lawsuits Against Medical Device Manufacturers – Products Approved Under FDA's PMA Process Exempt From State Tort Law Claims," Crowell & Moring Life Sciences Client Alert (February 21, 2008). Author: Karen A. Gibbs.

Speeches & Presentations
"Strategic Management of Distribution and Competitive Challenges," Medical Device Manufacturers Association's 2008 Medical Technology Executive Forum (October 15, 2008). Presenter: Karen A. Gibbs.

"Expanding Export Markets for Medical Devices: International Distribution – Challenges and Solutions," U.S. Commercial Service, U.S. Department of Commerce Conference Hosted by Allergan (April 2008). Co-Presenters: Karen A. Gibbs and Amanda J. Paracuellos.

"Global Distribution of Medical Devices: Strategies for Contracts and Effective Dispute Avoidance and Management," AdvaMed Emerging Growth Company Conference (March 11, 2008). Presenter: Karen A. Gibbs.

"Health Care Marketing and Sales Practices, Protection of Intellectual Property Rights, Conflicts of Interest, Attorney-Client Privilege," more than 30 presentations to various engineer, sales, marketing and management groups (2003 to 2007). Presenter: Karen A. Gibbs.

"Protecting and Managing Intellectual Property," Executive Speaker Series, University of California, Irvine, Paul Merage School of Business (2001). Presenter: Karen A. Gibbs.