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Michael R.
Dzwonczyk
Partner
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Mr. Dzwonczyk has over 18 years experience successfully representing multinational companies in patent litigation, including 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. His interference practice has included topics in chemistry and biotechnology including hormone and gene therapeutics, as well as anticholesterics. 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 Vice-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. He contributes regularly to APLF newsletter Issues and has authored amicus curiae briefs to the Federal Circuit in, e.g., Aukerman v. Chaides, CPC International v. ADM, Phillips v. AWH, and to the United States Supreme Court in Merck v. Integra.
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
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).
In re Certain Breath Test Systems For The Detection Of Gastrointestinal Disorders And Components Thereof, ITC Inv. 337-TA-495 (2003) - - trial counsel for complainant in Section 337 Investigation directed to instruments and methods for testing for h. pylori. Settled favorably (2003)
Interlates Limited et al v. Kemira Chemicals Inc. and J.M. Huber Corp., No. 3:04-cv-05834-RJB (W.D. Wa. 2004) - - lead trial counsel for J.M. Huber Corp. in patent infringement case relating to paper manufacturing. Settled favorably (June, 2005)
AHP Corp., Woco Investments Ltd., Pre Jay Holdings Ltd. v. Novo Nordisk Pharmaceuticals, Inc. (D.N.J. 1999)
Applied Medical Resources, Inc. v. U.S. Surgical Co., No SACV 99-625-AHS (EEx) (C.D. Ca. 1999)
In re Certain Recombinantly Produced Hormones, ITC INv. No. 337-TA-358 (1994)
Associations
Federal Circuit Bar Association -- Board of Directors
AIPLA -- Chemical Practice Committee, Vice 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
“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
“The IP Manager’s Role in U.S. Litigation,” Conference, The George Washington University School of Law PRIP IP Program, Washington, D.C., July 10, 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
“The Impact of Recent Decisions on Chemical Patent Practice,” AIPLA Annual Meeting, Chemical Practice Committee, Speaker Presentation, Washington, D.C., October 19, 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
“Discovery in U.S. Litigation: Compulsion and Compliance,” Conference, The George Washington University School of Law PRIP IP Program, Washington, D.C., July 10, 2007
“Recent Decisions Impacting Patent Litigation,” AIPLA 2007 Advanced Patent Litigation Seminar, Washington, D.C., June 9, 2007.
“KSR Int Co. v. Teleflex Inc. , - Practically Speaking What This Means To You,” presentation at APLF webcast Roundtable Panel Discussion, May 11, 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
“Looking at Patent Law Developments 2006: The Year in Review,” AIPLA web seminar, “Patent, Trademarks and Copyright: Hot Topics in 2006,” January 12, 2007
“Medical Treatment Method Patents in the U.S. and Europe,” Invited Lecture, Kyoto University Industry-Academia Collaboration Seminar - Medicine Related Patents and Universities, Kyoto University School of Medicine, Kyoto, Japan, Nov. 9, 2006
“Pretrial Practice and Procedure,” U.S. IP Patent Litigation Seminar and Mock Trial Presentation, Hainan, China, November 6-7, 2006.
“Patent Reform and the New Proposed Rule Changes: Protecting Innovation in a Changing Environment”, Panel Chair, Moderator, Symposium, CALBIO 2006, San Diego, CA, May 18, 2006
“Section 337 vs. District Court Distinctions and Implications for Intellectual Property Litigation Strategy,” Eighth Annual Sughrue Symposium on Intellectual Property Law & Policy, The University of Akron School of Law, March 13, 2006
”Insights into IP Infringement - A Law Firm Perspective,” Conference lecture, IPR Summit 2006: International Conf. on IPR, Bangalore, India, January 31, 2006
”Experimental and Exempt Uses of Pharmaceutical Inventions After Merck,” Conference lecture, IPR Summit 2006: International Conf. on IPR, Delhi, India, January 25, 2006
”Federal Circuit Developments 2005,” Biotechnology Symposium, Safe Harbor/Experimental Use, Inherency, Obviousness and Utility, Suffolk University School of Law, Boston, MA, November 18, 2005
”The Extraterritorial reach of §271(f),” Rochester Intellectual Property Lawyers Association (RIPLA) Annual Meeting, Rochester, N.Y., November 9, 2005
”Claim Construction After Phillips,” Seventh Annual Sughrue Symposium on Intellectual Property Law & Policy, The University of Akron School of Law, Akron, OH, March 7, 2005 (panel discussion)
”Strategies for Drafting Opinions of Counsel: What Will Knorr-Bremse Change?,” AIPLA Advanced Biotechnology & Chemical Patent Practice and Advanced Computer and Electronic Seminars, Seattle, WA, St. Louis, MO, Wilmington, DE, June, 2004
”Should the Hatch-Waxman Act apply to generic biologics?,” AIPLA 2003 Mid-Winter meeting, January 24, 2003, (Biotechnology Committee panel presentation)
”The Need for the Statutory Creation of an Experimental Use Exception: Harmonizing Roche, Embrex and Madey,” Invited Lecture, BADC IP section, Washington, D.C., Dec. 9, 2002
”Strategies for Effective Opinion Drafting,” AIPLA 2002 Advanced Biotechnology, Chemical Patent Practice Seminars, May 2002