Insights

Additional insights

Speaking Engagements

Publications

  • “Principles for Patent Legislation Needed to Restore the Balance Intended by the Modern Patent Act,” Albany Law Journal of Science and Technology (May 2023)
  • "Biosimilars: Comparison Chart Between Canada, U.S., and Europe," JD Supra (December 2, 2019)
  • “A District Court Split on Hatch-Waxman Venue Determinations,” Law360 (August 2019)
  • “Who can be a Defendant in Biosimilar Patent Litigation?,” Law360 (April 2019)
  • “Litigation-Related Issues under the Biologics Price Competition and Innovation Act,” AAPS Advances in the Pharmaceutical Sciences Series, Vol 34. (January 2019)
  • “Canada’s New Linkage Litigation Scheme: A Comparison to Hatch-Waxman,” Smart & Biggar (January 2019), updated July 2022
  • "Litigation-Related Issues Under the Biologics Price Competition and Innovation Act (BPCIA)," Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (2018)
  • “What the Court Got Wrong About Hatch-Waxman in Alcon” Law360 (February 2016)
  • “Fed. Cir. Limits Safe Harbor for Post-Approval Conduct,” Law360 (November 2015)
  • “Safe Harbor Protects Supplier of Active Ingredient for ANDA,” Law360 (September 2015)
  • “Process Patents Are Vital in Biotech — Why Not Extend Them?” Law360 (August 2015)
  • “Hatch-Waxman Action: Who Do You (Can You) Sue?,” Pharmaceutical Compliance Monitor (June 2015)
  • “Commil v. Cisco – Who Really Won?” IP Law360 (June 2015)
  • “Personal Jurisdiction in Hatch-Waxman Actions in view of Daimler,” Pharmaceutical Compliance Monitor (June 2015)
  • “The Trouble with Commil is DSU,” Law360 (January 2015)
  • “Inter Partes Review by Hatch-Waxman Competitors Will Likely Increase Because of the Effect of IPR Decisions on the 30-Month Stay,” BioTechnology Rept. Vol 33, No. 6:249-51 (December 2014)
  • “Is Stockpiling Protected By Hatch-Waxman Safe Harbor?,” Law360 (November 2014)
  • “Drug Labels Can Provide Specific Intent for Inducement,” IP Law 360 (October 2014)
  • “A Common Sense Discussion of Patenting Medical Diagnostics,” Genetic Engineering & Biotechnology News (April 15, 2014).
  • “In Vivo Conversion as Inducement to Infringe,” Pharmaceutical Compliance Monitor (February 2014)
  • “Hatch-Waxman Safe Harbor Expansion continues,” Fish Litigation Blog (February 2014)
  • “Research Tools and the Hatch-Waxman Safe Harbor,” 22 Biotechnology Law Report 1 (November 2014)
  • “License to Infringe on Research Tool Patents,” 33 Genetic Engineering & Biotechnology News 10 (October 2013)
  • "Ariad Decision Underlines Importance of Fully Describing Patented Biotech Inventions," Industrial Biotechnology (June 2009)
  • “Strategies to Strengthen Your Patent,” Fish & Richardson (February 2009)
  • “The Patentability of Drug Enantiomers,” 190 N.J.L.J. 51 (October 2007)
  • “Scope of the Safe Harbor Exemption of the Hatch-Waxman Act After Merck v. Integra Lifesciences,” 15 Fordham Intellectual Prop. L.J. (2005)
  • “Overview of Patent Litigation,” 11(1) IP Litigator 1 (2005)
  • “‘CREATE’ Act of 2004 Extends ‘Safe Harbor’ Aspects of Patent Laws,” Y.L.J. 4 (February 2005)
  • “The Right to a Jury Trial in Actions for Patent Infringement and Suits for Declaratory Judgment,” 13 Fordham Intellectual Prop. L.J. 205 (2002); Reprinted as Chapter 21, “Survey of Developments of Intellectual Property and Technology Law,” WebCredenza, Inc. (2004)
  • “New Horizons in Patent Litigation: Discovering Electronic Information,” Y.L.J. S4 (October 2004)
  • “Recent Federal Circuit Decisions of Significance to Biotech/Pharmaceutical Practitioners,” Biotechnology & Pharmaceutical Law 2004, Practising Law Institute (October 2004)
  • "Overview Of Patent Litigation," Practising Law Institute (July 2004)
  • “Electronic Discovery: Where We Are and Where We are Headed,” 16 Int’l Prop. & Tech. L.J. 16 (March 2004).
  • “Recent Developments Regarding The Hatch-Waxman Act,” Y.L.J. S2 (January 2004)
  • “Can the Seventh Amendment Ever Require That the Defense of Inequitable Conduct be Presented to a Jury?,” 9 (7) IP Litigator 1 (2003)
  • “The Period of Liability for Patent Infringement,” 10(7) IP Today 36 (2003)
  • Contributor: “Patent Disputes: Litigation Forms and Analysis,” Battersby & Grimes, Aspen Pub. (2003)
  • “Trademark & Copyright Disputes: Litigation Forms and Analysis,” Battersby & Grimes, Aspen Pub. (2003)
  • “Disqualification of Opinion Counsel as Trial Counsel When an Advice of Counsel Defense is Asserted,” 9(2) IP Litigator 11 (2003)
  • “Integra Life Sciences I Ltd. v. Merck KGaA: Exemptions For Research Tool Patents,” 9(3) IP Strategist 6 (2002)
  • “Court is Taking a Dim View of Best-Mode Defense,” 25(12) Nat’l L.J., Sec. C. (November 2002)
  • “The Safe Harbor Provision of the Hatch-Waxman Act: Present Scope, New Possibilities, and International Considerations,” 57 Food Drug L.J. 161 (2002)
  • “The Right to a Jury Trial Under the Waxman-Hatch Act — The Question Revisited and Resolved,” 57 Food Drug L. J. 1 (2002)
  • “The Identification and Selection of Expert Witnesses,” 6(3) IP Litigator 1 (2000)
  • “Adequate Notice: The Key to Obtaining Pre-Suit Damages in Patent Infringement Actions,” 6(2) Met. Corp. Counsel 20 (1998)
  • “Arbitration of Patent Infringement Disputes,” 6(3) Metropolitan Corp. Counsel 13 (1998)
  • “Avoiding Patent Infringement During the Drug Approval Process,” N.Y.L.J. S4 (March 1998)
  • “The Application of the Patent Laws to the Drug Approval Process,” 52 Food Drug L.J. 345 (1997)
  • “The Right to a Jury Trial in Actions Under the Hatch-Waxman Act,” 52 Food Drug L.J. 259 (1997)
  • “Developing Pharmaceutical Products Without Fear of Patent Infringement,” 5(6) Met. Corp. Counsel (1997)
  • “Are Clinical Trials Conducted to Obtain FDA Approval Fatal to Patent Validity?” 5(4) Met. Corp. Counsel (1997)
  • “The Utilization of U.S. Patents to Prevent the Importation and Sale of Gray Goods,” 83 Trademark Rptr. 481 (1993)
  • “The Exercise of Patent Rights Through Multiple Exclusive Field-of-Use Licensing,” 4 Rutgers Comp. & Tech. L.J. 383 (1985)
  • “History and Present Status of Gray Goods,” 75 Trademark Rptr. 433 (1985)