Michael R. Dzwonczyk Partner

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.


District of Columbia, Pennsylvania
U.S. Court of Appeals - Federal Circuit
Supreme Court of the United States
U.S. Patent and Trademark Office

Dickinson School of Law (J.D.  1990)
Temple University (B.S. Chemistry, 1984)

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

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)

"Amicus Curiae Practice Before the Federal Circuit," Innovation and Commerce-Global Legal Considerations: Joint U.S.-Japan Judicial Coference, Tokyo, Japan, October 25-28, 2011

"The Changing Global Standards of Description, Disclosure, and Sufficiency," Joint Chemical Practice/IP Practice in Europe Committee Meeting, AIPLA 2011 Annual Meeting, Washington, D.C., October 21, 2011

“The Exergen Pleading Requirements for Inequitable Conduct,” IIPRD International Symposium On Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios, Mumbai, India, October 11, 2011

“ANDA Case Law Review of Recent Strategies, Tips and Tactics,” IIPRD International Symposium On Strategies for Managing Pharmaceutical, Biotechnology & Chemical Patent Portfolios, Mumbai, India, October 10, 2011

“Patents and the Written Description Requirement: Lessons Learned Since Ariad v. Lilly,” Strafford Web Seminars, Atlanta Ga., September 8, 2011

"Licensing IP and Its Role in Commercializing Technology: Structuring Key Pharma/Biotech Licensing Provisions in a Post-Recession US," 2011 InterBiz BioPartnering & Investment Forum, Jeju, Korea, July 8, 2011

"Generic Approaches to Solid Form Pharmaceuticals," IWPCPS® 13--Thirteenth International Conference on Physical Characterization of Pharmaceutical Solids, Indianapolis, Indiana, USA, June 20, 2011

"Compulsory Patent Licensing in the U.S.: Shhhhh! Don't Tell Anyone," 2011 LES International Conference, Licensing in the 21st Century - Better, Faster, Smarter, London, England, June 6, 2011

"An Overview and Current Trends in U.S. Biosimilars," iTAG Intellectual Property Rights Conference, Global IP Convention 2011 Bangalore, India, April 29, 2011

“Litigating Infringement of Different Pharmaceutical Claims," Korea Drug Research Assocation, Seoul, Korea, April 26, 2011

"Development Strategies Based on Early Stage Navigation of the Patent Landscape" Korea Drug Research Assocation, Seoul, Korea, April 26, 2011 

ANDA Case Law Update," IIPRD International Symposium On Effective Strategies For Managing Pharma & Biotech Patent Portfolio, Mumbai, India, September 15-16, 2010; New Delhi. India, September 17-18, 2010

"Navigating the U.S. Biosimilar Pathway," Panel Speaker, ABA-IP Teleconference and Live Audio Webcast, June 29, 2010

"Ariad Pharmaceuticals v. Eli Lilly: Examining the Written Requirement for Patentability," Panel Speaker, ABA-IP Teleconference and Live Audio Webcast, April 21, 2010

"NeuBlocTM: Strategies for the Development of Noninfringing Alternatives," IWPCPS® 12 Twelfth International Workshop on Physical Characterization of Pharmaceutical Solids, June 21-24, 2010, Lille, France

"Exploring The Use of Alternative Forms as a Rational Design Strategy," 2010 Korean Drug Research Association Spring Conference, April 16, 2010

"The Advent of Biosimilars in the U.S. Where Are We Now? Where Are We Likely Headed?" (panel presentation), 26th Annual ABA Intellectual Property Law Conference, Arlington, Virginia, April 7, 2010

"Bilski Applied, Bilski Denied," Twelfth Annual Richard C. Sughrue Symposium on Intellectual Property Law and Policy, Univ. Akron School of Law, Akron, Ohio, March 9, 2010

“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