John L. Marquardt is a registered patent attorney based in Washington, DC. He focuses his practice on biotechnology and pharmaceutical patents and associated litigation. He has extensive experience in biochemistry and molecular pharmacology, including experience working with multiple blockbuster drugs. Dr. Marquardt frequently speaks on developments in biosimilar law.
Dr. Marquardt has in-depth experience in litigation, due-diligence and patent prosecution. He has performed and managed complex and extensive electronic discovery. Dr. Marquardt also conducts pre-suit investigations and provides opinions on freedom to operate, patent validity and infringement.
Dr. Marquardt draws on over fourteen years of experience in scientific research at MIT, Harvard University, and the NIH. His laboratory experience includes work in genetic and protein engineering, macromolecular structure determination using nuclear magnetic resonance (NMR) spectroscopy and x-Ray crystallography, and modern drug-design.
Dr. Marquardt works on subject matter including traditional small-molecule drugs, gene therapies, protein therapeutics, monoclonal antibody therapies, diagnostic methods, and devices. He has extensive experience in biochemistry and molecular pharmacology including methods in molecular and cellular biology, immunology, microbiology, biochemistry, genomics, computational biology, small molecule pharmaceuticals, and biopharmaceuticals. Dr. Marquardt is a frequent commentator, speaker and author on patent law and is involved in both the Biotechnology Committee and Chemical Practice Group of the American Intellectual Property Law Association (AIPLA). He has lectured on strategic considerations under the Biologics Price Competition and Innovation Act (BPCIA). He serves on the Editorial Board for mAbs - an international peer-reviewed journal focused exclusively on monoclonal antibodies.
Dr. Marquardt served as an intern to the Honorable Randall R. Rader, in the U.S. Court of Appeals for the Federal Circuit.
Representative Matters - Patent Litigation
Monsanto v. Syngenta (D. Del.) - Defended against claims of infringement relating to two United States Patents involving technology for creation of herbicide resistant plants. Second chaired depositions of fact and expert witnesses relating to calculation of damages.
Telcordia v. Cisco, Lucent and Alcatel (D. Del.) - Asserted three patents relating to telecommunications protocols against defendants. Managed extensive offensive and defensive electronic discovery.
Wyeth Effexor XR® Litigations - Asserted three patents in ANDA litigations relating to Effexor XR® against 14 defendants. Supervised three junior attorneys and three consultants in extensive offensive and defensive electronic discovery in litigation asserting three patents against defendants. Second chaired depositions of expert witnesses.See more.
Prosecuted patent applications relating to novel pharmaceutical compositions and formulations. The compositions included novel families of small molecule therapeutics; protein based therapeutics, including monoclonal and therapeutic antibodies; and nucleotide based therapeutics, including RNAi, microRNA, antisense and nucleotide analogues.
Prosecuted applications relating to electrochemiluminescent diagnostic devices and reagents. The electrochemiluminescent assays included enzyme linked immunoassays.
Managed three junior attorneys over the course of four years in prosecution applications relating to diagnostic devices and reagents employing Raman spectroscopic detection. These included enzyme conjugated immunoassays and labeled antibody assays employing novel chemistry and methods for detection.
Participated in Examiner interviews with the USPTO. Prepared materials for reexamination and patent opposition proceedings. Obtained patent term extensions and supplementary protection certificates extending patent term.
Performed extensive pre-litigation review of English and Japanese language documents, totaling more than 500,000 pages, relating to a drug with sales in excess of $2 billion per year in preparation for ANDA challenge.See less.
Selected Legal and Scientific Publications
Marquardt, J.L. and Auten, S.R., "Strategic considerations under the Biologics Price Competition and Innovation Act" Expert Opinion in Therapeutic Proteins, 23(8):915-8 (2013).
Marquardt J., Begent R.H., Chester K., Huston J.S., Bradbury A., Scott J.K., Thorpe P.E., Veldman T., Reichert J.M., and Weiner, L.M., "IBC's 23rd Antibody Engineering and 10th Antibody Therapeutics Conferences and the Annual Meeting of The Antibody Society: December 2-6, 2012, San Diego, CA." mAbs, 4(6):648-52 (2012).
Biotechnology Innovation Report 2005 (A. Michelsohn editor, J. Marquardt and S. Lewis assistant editors) BIO-2005 (Finnegan Henderson publication, Philadelphia 2005).See more.
Ottiger M., Delaglio, F., Marquardt, J.L., Tjandra, N., and Bax, A., "Measurement of Dipolar Couplings for Methylene and Methyl Sites in Weakly Oriented Macromolecules and their Use in Structure Determination," Journal of Biomolecular NMR, Vol. 134, 1998.
Cornilescu G., Marquardt, J.L., Ottiger, M., and Bax, A., "Validation of Protein Structure from Anisotropic Carbonyl Chemical Shifts in a Dilute Liquid Crystalline Phase," Journal of the American Chemical Society, Vol. 120, No. 27, 1998, pp. 6836-6837.
Wang, Y-X., Marquardt, J.L., Wingfield, P., Lee-Huang, S., Torchia, D. and Bax, A., "Simultaneous Measurement of 1H-15N, 1H-13C and 15N-13C Dipolar Couplings in a Perdeuterated 30kDa Protein Dissolved in a Dilute Liquid Crystalline Phase," Journal of the American Chemical Society, Vol. 120, No. 29, 1998, pp. 7385-7386.
Vuister, G.W., Kim, S-J, Orosz, A., Marquardt, J.L., Wu, C., and Bax, A., "Solution Structure of the DNA-Binding Domain of Drosophila Heat Shock Transcription Factor," Nature Structural Biology, Vol. 1, No. 9, 1994, pp.605-614.
Marquardt, J.L., Brown, E.D., Lane, W.S., Haley, T.D., Ichikawa, Y., Wong, C-H, and Walsh, C.T., "Kinetics, Stoichiometry and Identification of the Active Site Thiol for Phosphomycin Inactivation of UDP-GlcNAc Enolpyruvate Transferase," Biochemistry, Vol. 33, 1994, pp. 10646-51.
Brown, E.D., Marquardt, J.L., Lee, J.P., Walsh, C.T., and Anderson, K.S., "Detection and Characterization of a Phospholactyl-enzyme Adduct in the Reaction Catalyzed by UDP-NAcetylGlucosamine Enolpyruvoyl Transferase, MurZ," Biochemistry, Vol. 33, 1994, pp. 10638-45.
Marquardt, J.L., Brown, E.D., Walsh, C.T., and Anderson, K.S., "Isolation and Structural Elucidation of a Tetrahedral Intermediate in the UDP-N-acetylglucosamine Enolpyruvoyl Transferase Enzymatic Pathway," Journal of the American Chemical Society, Vol. 115, 1993, pp. 10398-9.
Benson, T.E., Marquardt, J.L., Marquardt, A.C., Etzkorn, F.A., and Walsh, C.T., "Overexpression, Purification and Mechanistic Study of UDP-NAcetylenolpyruvylglucosamine Reductase," Biochemistry, Vol. 32, 1993, pp. 2024-2030.
Marquardt, J.L., Siegele, D.A., Kolter, R., and Walsh, C.T., "Cloning and Sequencing of the E.coli murZ Gene and Purification of its Product, a UDP-N-Acetylglucosamine Enolpyruvyl Transferase," Journal of Bacteriology, Vol. 174, No. 17, 1992, pp. 5748-5752.See less.
Selected Public Speaking Engagements
Invited Speaker, "Generic Monoclonal Antibody Therapies - Will We Ever Have Them in the United States?" Rhineland Biopatent Forum (Michalski Hüttermann & Partner), Düsseldorf, Germany, May 23, 2014.
Invited Speaker, "Recent Changes in Intellectual Property Law - Will Your Therapeutic Antibody Patents Survive?" PEP Talk, Palm Springs, CA, January 15, 2014.
Chaired Session, "Biosimilars: Strategic Considerations for Regulatory Approval and Patents under the BPCIA" BIO, Chicago, IL, April 23, 2013.
Led Workshop, "Avoiding Intellectual Property Problems in Researdch Collaborations Using Information Technology" Bio IT World, Boston, MA, April 9, 2013.
Chaired Session, "Biosimilars - How Do You Approach It Competitively?", Phacilitate Protein Therapeutics, Washington, DC, January 28, 2013.
Chaired Session, "Biosimilar or Biobetter? What Do Innovators and Competitors Need to Know to Make the Call?", Phacilitate Protein Therapeutics, Washington, DC, January 30, 2012.See less.