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JAMES J. KOZUCH PARTNER TELEPHONE: 215-567-2010. EXTENSION 133 FAX: 215-751-1142
jjkozuch@crbcp.com
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Mr. Kozuch has been lead counsel in jury trials, bench trials, and hearings in cases involving patent infringement and other intellectual property matters. He has extensive experience in litigation, including pharmaceutical patent litigation involving Abbreviated New Drug Applications (ANDAs) under the Hatch-Waxman Act.
Prior to practicing law, Mr. Kozuch worked in strategic planning, financial analysis, and engineering for several Fortune 500 companies, including a major chemical company. With his experience and education in business (MBA) and engineering, Mr. Kozuch works well with management and in-house counsel on litigation strategies, as well as with expert witnesses who testify on commercial success and other secondary considerations of non-obviousness in patent infringement cases.
Mr. Kozuch has represented generic manufacturers in a number of patent infringement cases involving ANDAs which included Paragraph IV certifications to patents for brand-name drugs listed in the Orange Book.
Unigene Labs, Inc. v. Apotex, Inc. (S.D.N.Y. 2006) represent generic defendant concerning nasal osteoporosis pharmaceutical drug, Fortical® (calcitonin)
In re '318 Patent Litigation, 578 F.Supp.2d 711 (D. Del. 2008), aff'd, 583 F.3d 1317 (Fed. Cir. 2009). represented generic manufacturer in ANDA litigation involving the Alzheimer's drug Razadyne®/Reminyl® (galanthamine)
Biovail Laboratories, Inc. v. TorPharm, Inc. (E.D. Pa. 2004) represented generic manufacturer regarding blood pressure medication Tiazac® (diltiazem hydrochloride)
Sanofi-Aventis, Sanofi-Synthelabo Inc., and Bristol-Myers Squibb Sanofi Pharmaceuticals Holding Partnership v. Apotex, Inc. (S.D.N.Y. 2003) represented generic in ANDA litigation on anti-platelet medication Plavix® (clopidogrel bisulphate)
Biovail Laboratories, Inc. v. TorPharm, Inc. (N.D. Ill. 2003) represented generic manufacturer in suit involving calcium channel blocker medication for hypertension, Cardizem CD® (diltiazem hydrochloride)
Novartis Pharma. v. Apotex, Inc. (S.D.N.Y. 2002) represent generic in ANDA litigation concerning nasal osteoporosis pharmaceutical Miacalcin® (calcitonin)
Pennsylvania
United States Court of Appeals for the Federal Circuit
United States Court of Appeals for the Third Circuit
United States District Court for the Eastern District of Pennsylvania
United States District Court for the Middle District of Pennsylvania
United States District Court for the Western District of Michigan
United States District Court for the District of Arizona
United States Patent and Trademark Office
“Commercial Success” in Pharmaceutical Patent Litigation, and Cross-Examination of the Patent Owner’s Economist, Originally published in the April 2009 issue of Intellectual Property Today [www.iptoday.com]
How to Minimize Risk of Losing Patent Rights, Originally published in the March 2006 issue of Small Times magazine[www.smalltimes.com]
Speeches:
Protecting And Enforcing Intellectual Property Rights In A Global Marketplace, Annual Meeting of the American Society of Mechanical Engineers (ASME), 2009
Mock Expert Examination in Patent Infringement Case, 3rd Annual Intellectual Property Law Institute, Pennsylvania Bar Institute, 2009
Proving the Elements of Inequitable Conduct – Materiality and an Intent to Deceive, Paragraph IV on Trial Conference, November 2008
Cross-Examination of the Patent Owner's Economist on "Commercial Success" in Pharmaceutical Patent Litigation, Paragraph IV on Trial Conference, November 2008
Introduction to Patents, Pennsylvania Bar Institute, 2008
Strategies for Addressing Key Issues in Patent Claim Construction, Law Seminars International, 2007
Intellectual Property Basics: Protection of Competitive Assets, Engineering Enterprises Seminar, Cornell University, 2006
Martindale-Hubbell AV Rated
Trial Advocacy Award for Achievement in the Field of Trial Advocacy, The Barristers Society, Temple University School of Law
Pennsylvania SuperLawyer by Philadelphia Magazine, 2004-2008
Temple University School of Law: J.D.
Lehigh University: M.B.A.
Cornell University: B.S. Engineering
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JAMES J. KOZUCH partner
INDUSTRIES SERVED
Alternative Energy
Automotive
Chemicals and Industrial Gases
Defense
Energy
Engineering, Architecture & Construction
Food Processing
Metallurgy and Materials
Materials Handling
Medical Devices
Pharmaceuticals
Sporting Goods
Tools
ADMITTED TO PRACTICE
Pennsylvania
U.S. Court of Appeals Federal Circuit
U.S. Court of Appeals Third Circuit
U.S. District Court Eastern District of Pennsylvania
U.S. District Court Middle District of Pennsylvania
U.S. District Court Western District of Michigan
U.S. District Court District of Arizona
U.S. Patent and Trademark Office
AWARDS & RECOGNITION
Named Pennsylvania SuperLawyer by Philadelphia Magazine, 2006 - 2008
Trial Advocacy Award for Achievement in the Field of Trial Advocacy, The Barristers Society,
Temple University School of Law
Martindale Hubbell AV rated
EDUCATIONAL BACKGROUND
Cornell University: B.S. Engineering
Lehigh University: M.B.A.
Temple University School of Law: J.D.
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