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Practices
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Michael R.
Dzwonczyk
Partner
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Mr. Dzwonczyk has 20 years experience successfully representing multinational companies as lead counsel in trials and appeals of patent cases and Section 337 cases at the International Trade Commission. His experience has encompassed technical areas that include recombinantly produced hormones, pharmaceuticals, protein synthesis and expression products, fibers, films, polymers, plastics and medical devices Mr. Dzwonczyk also counsels clients on intellectual property issues, including validity and infringement of intellectual property rights, licensing and contract matters and Hatch-Waxman issues.
He has lectured on numerous topics including strategies for opinion drafting, pharmaceutical litigation strategies, experimental and exempt uses after Merck, and Patent Law Reform. He is former Chair of FCBA's amicus committee and currently serves on its Board of Directors, as well as -Chair of the AIPLA Chemical Practice Committee. Prior to working as a patent attorney, Mr. Dzwonczyk worked at FMC Corporation agricultural chemicals research facility on the synthesis, isolation and characterization of novel plant growth regulators, herbicides and insecticides.
Mr. Dzwonczyk is an adjunct professor of law at George Washington University's National Law Center, where he co-teaches International and Comparative Patent Law. He has been quoted by The Washington Post, The Legal Times, The Corporate Legal Times, Bloomberg News Service, The IP Law Bulletin, and others.
Mr. Dzwonczyk is a member of the Firm’s Management Committee.
Bars
District of Columbia, Pennsylvania
U.S. Court of Appeals - Federal Circuit
Supreme Court of the United States
U.S. Patent and Trademark Office
Education
Dickinson School of Law (J.D. 1990)
Temple University (B.S. Chemistry, 1984)
Representative Cases
In re: Alfuzosin Hydrochloride Patent Litigation, MDL No. 08-md-1941 (GMS) - trial counsel for Wockhardt defendants in ANDA litigation involving the use of the drug alfuzosin hydrochloride, used in the treatment of dysuria and benign hypertrophy of the prostrate
Forest Labs. vs. Wockhardt et al, Civil Action No. 08-021 (D. Del) - trial counsel for Wockhardt defendants in ANDA litigation involving use of memantine hydrochloride in the treatment of Alzheimer’s disease.
Mars vs. Natraceutical, S.A., Civil Action No. 02:07-CV-01574 (D. NJ) - trial counsel for Natraceutical in multi-patent case relating to polyphenol-enriched chocolate products, cocoa powders and extracts. Defeated Mars’ request for preliminary injunction.
In re Certain Buffer Systems And Components Thereof Used In Container Processing Lines, - 337-TA-609, trial counsel for complainant Sidel, Inc. in patent infringement-based investigation relating to conveyor tables used in manufacturing lines. Settled favorably (May, 2008)
Ortho-McNeil Pharm., Inc., et. al. v. Mylan Labs., Inc. et al., 348 F. Supp. 2d 713 (N.D.W.V. 2004), aff'd 161 Fed. Appx. 944 (Fed. Cir. 2005) - -- counsel for Plaintiff-patentee Daiichi in Hatch-Waxman based challenge to Daiichi's levofloxacin patent. Judgment for Daiichi after 8-week bench trial (348 F.Supp.2d 713, N.D. W.VA 2004). Affirmed by Federal Circuit (December 2005).
Associations
Federal Circuit Bar Association -- Board of Directors AIPLA -- Chemical Practice Committee, Chair University of Akron School of Law -- IP Advisory Council
Publications and Teaching
Implementing a "Predictable" Obviousness Standard Post-KSR
Strategies for Effective Opinion Drafting
Recent Decisions Impacting Patent Litigation
Looking at Federal Circuit Developments 2005: The Year in Review, 6 J. High Tech L. 113 (2006)
Dzwonczyk, M. and Hissong, D., EST Patents After Fisher, The Patent Lawyer, Vol. 2, Issue 3, 18 (2005)
Dzwonczyk, M. et. al. "The Shaky Foundations of the Written Description Requirement", World IP Contacts handbook, 2005, Managing Intellectual Property, ed. (2005)
Speeches
“ National Approaches to the Compulsory Licensing of Drugs Under TRIPS,” 2010 LES International Conference The Role And Impact Of Emerging Economies, Sandton, Johannesburg, South Africa April 12, 2010
“Considerations in Developing an ANDA Strategy,” 2010 Korea Drug Research Association Spring Seminar, Seoul, Korea, April 16, 2010
“Implementing a “Predictable” Obviousness Standard Post-KSR”, IPIC 83rd Annual Meeting, St. John’s, Newfoundland, Canada, September 25, 2009
“Litigating Effectively at the ITC,” UBIC Tokyo Conference 2009, Belle Salle Yaesu Conference Center, Tokyo, Japan September 18, 2009
“NDA and ANDA Products: The Use of Solid Forms as a Rational Design Strategy, IIPRD International Symposium on Strategies for Managing a Pharma/Biotech/Chemical Patent Portfolio,” Hotel Le Royal Meridien, Mumbai, INDIA, September 2-4, 2009
“Authorized Generics and the Battle Over Generic Market Exclusivity,” IIPRD International Symposium on Strategies for Managing a Pharma/Biotech/Chemical Patent Portfolio, Hotel Le Royal Meridien, Mumbai, INDIA, September 2-4, 2009
“Compulsory Patent Licensing in the U.S. and Japan,’” Invited Lecture, 2009 LESI Conference, Licensing in Emerging Economies, Manila, Phillipines, June 8, 2009
“The Impact Of President Obama’s Healthcare Plan On Pharmaceutical Companies In The U.S.,” Invited Lecture, Korean Drug Research Association, Seoul, Korea, April 1, 2009
“IP Risk Management, IP Insurance, IP Litigation & Dispute Resolution,” Conference, Empowering Business Entities Through IPR, Kolkata, West Bengal, India, January 8-10, 2009
“The Unique Aspects of Litigating ANDA and Pharmaceutical Cases,” Invited Lecture, UBIC Conference, Trends in U.S. Litigation and How Japanese Companies Attack Them, Tokyo, Japan, September 19, 2008
“Lessons From KSR And Post-KSR Pharma Cases; Overview of ANDA litigation and the strategic use of ANDA's Infringement and Remedies under 271(e)(2) and 271(e)(4); Action for patent certainty under §355(j)(5)(c) and broadened declaratory judgment jurisdiction after Medimmune; Actions to delist pharmaceutical patents from the FDA Orange Book,” Symposium, Leveraging Patent Exclusivities, Resolving Principal Patent Issues Related to Pharma, Biotech & Chemicals, Noida, India, Aug. 21-23, 2008
“Prelitigation Chess in a post-Medimmune World,” Symposium, Tenth Annual Richard C. Sughrue Symposium on Intellectual Property Law and Policy, The University of Akron School of Law, Akron, Ohio, March 10, 2008
"Discovery After Seagate Under the New Rules," Mock Deposition and Trial Presentation, AIPPI Japan Fall Meeting, Tokyo, Japan, November 7, 2007
“Patent Drafting Dilemmas after KSR Using the Problem Solution Approach,” TACPI Tokyo Conference Panel Presentation, Tokyo, Japan, Nov. 6, 2007
“Early Access Agreements In Pharma: Authorized Generics and the Battle Over Generic Market Exclusivity,” LES Annual Meeting 2007, Vancouver, BC, Canada, October 16, 2007
“The Unobvious Implications of MedImmune for Licensors, Licensees and Litigants,” APLF Annual Meeting, The Benjamin N. Cardozo School of Law, New York, N.Y., September 26, 2007
“Leveraging Pharmaceutical Patent Exclusivities,” Symposium on Global Perspective on Pharma and Biotech Patents, Ummed, Ahmedabad, India, April 19, 2007.
“IP Risk Avoidance and What to do if You Get Sued,” Invited Lecture, Third Global Conference on API Outsourcing & Compliance, Zhejiang, Hangzhou, China, April 12-13, 2007.
“Discovery in US Litigation: Compulsion and Compliance,” Invited Lecture, The PanEuropean Intellectual Property Summit, Brussels, Belgium, December 7, 2006; also presented at Patentanwaltskammer Conference, Europaisches Patentamt, Munich, Germany, March 27, 2007.
“Pharmaceuticals and Patent-Eligible Subject Matter After LabCorp,” Invited Lecture, Institute of Intellectual Property and Social Justice at Howard University School of Law, Fourth Annual Intellectual Property Seminar, Washington, D.C., March 1-2, 2007
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