Conference Presentation List

Bruce A. Pokras


January 2004, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “FDA’s New Orange Book Rules: Old Claims Under the New Rules”

October 2004, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “FDA’s New Orange Book Rules: Old and New Claims Under the New Rules”

December 2004, Food and Drug Law Institute, Two Decades of Hatch-Waxman conference: “Applying the New Orange Book Rules”

April 2005, C5,  Advanced Legal and Practical Guide to Maximizing Pharmaceutical Patent Life Cycles conference (London): “Life Cycle Maximization Opportunities: A US Perspective” (including Orange Book aspects)

May 2005, American Conference Institute, In-House Counsel Forum on Pharmaceutical Antitrust conference joint presentation: “Maximizing Life Cycles/Minimizing Antitrust Risks”

October 2005, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “Orange Book Listing Strategies: Dowsing for Device Patents”

December 2005, MarcusEvans Conferences, Forum on Preventing and Defending Pharmaceutical And Biotech Patent Litigation conference: “Orange Book Listings: The Latest Challenges”

May 2006, Seton Hall School of Law and NJIPLA, Drug Approval for Patent Practitioners seminar: “Patent Linkage and Exclusivity”

September 2006, World Research Group, Life Sciences Intellectual Property Summit conference: “Pharmaceutical Life Management Strategies: Understanding Legal Issues”

October 2006, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “Applying the Orange Book Rules”
November 2006, Food and Drug Law Institute, Hatch-Waxman: At the Intersection of FDA and Patent Law conference: “Applying the Orange Book Rules”

May 2007, American Conference Institute, In-House Counsel Forum on Pharmaceutical Antitrust conference: “Antitrust Risks of Lifecycle Management”

October 2007, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “Applying the Orange Book Rules” (including patents covering aspects of labeling)

May 2008, American Conference Institute, In-House Counsel Forum on Pharmaceutical Antitrust conference: “Pharma Industry Issues in the DOJ/FTC Report on Antitrust Enforcement and Intellectual Property Rights”

October 2008, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “Mining the Orange Book and Patent Delisting: Effect on 180-day Generic Exclusivity”

January 2009, American Conference Institute, Pharma/Biotech IP Due Diligence conference: “Due Diligence and the Orange Book”

March 2009, MarcusEvans Conferences, IP Law Summit conference: “Hatch-Waxman Act: Lessons and Relevance for Today”
October 2009, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference: “Applying the Orange Book Rules” (including “old antibiotics” under the QI Act)

October 2009, Center for Business Intelligence, Pharmaceutical Congress on Paragraph IV Disputes and Settlements conference: “Leveraging FDA Law for Paragraph IV Patent Strategies”

January 2010, American Conference Institute, Pharma/Biotech IP Due Diligence conference: “Due Diligence and the Orange Book”
April 2010, World Research Group, Corporate IP Counsel Summit conference: “Maximizing Patent Life Cycles: Lessons Learned from the Pharma Industry”

October 2010, Center for Business Intelligence, Pharmaceutical Congress on Paragraph IV Disputes and Settlements conference: “Challenges of Patent Extensions, Patent Listings and Delistings in Paragraph IV Litigations”

November 2010, World Research Group, TechNet Intellectual Property Forum conference panelist: “Dissecting the Top Court Decisions of 2010 to Improve Portfolio Management”

May 2011, American Conference Institute, In-House Counsel Forum on Pharmaceutical Antitrust conference: “Antitrust Risks of Lifecycle Management” (including Caraco use code issue)

October 2011, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference joint presentation: “Carve-Outs, Skinny Labeling and Use Codes: Understanding Their Role in Orange Book Listing Strategies and Life Cycle Management”

July 2012, Q1 Productions, Regulatory Clearance and Commercialization of Generic Drugs and Biosimilars conference:  1) “Review of Hatch-Waxman and the Ongoing Impact on the Generic Industry,” and 2) “Orange Book Use Codes”

October 2012, American Conference Institute, Maximizing Pharmaceutical Patent Life Cycles conference joint presentation: “Understanding How Caraco Has Redefined the Relationship Between Pharmaceutical Patents, Labels and Use Codes”

October 2012, Center for Business Intelligence, Life Sciences Congress on Paragraph IV Disputes conference: “History and Review of the Supreme Court’s Decision on Patent Use Codes”

September 2013, Momentum, International Congress on Paragraph IV Litigation conference: “Interesting Use Codes in the Orange Book”
January 2014, Momentum, IP Counsel Exchange for Biosimilar Applicants and Innovator Biologic Sponsors conference: “Surviving Orange Book Withdrawal!”

June 2014, ExL Pharma, Due Diligence Summit for Life Sciences conference: “Assessing the Patent State of the Product”

October 2014, Momentum, International Congress on Paragraph IV Litigation Strategy conference joint interactive session: “PTEs, Combination Products and ‘Product Hopping’: Life Cycle Management Insights for Brand Name Drug Manufacturers”

January 2015, American Conference Institute, Advanced Forum on Life Sciences Patents conference joint presentation: “Lessons Learned From the First IPRs and PGRs:  Best Practices for Offensive and Defensive Use of AIA Procedures in the Life Sciences Space”

February 2015, World Congress, Summit on Biosimilars Market Access conference: “What, no Orange Book?!”

February 2016, American Conference Institute, Advanced Summit on Life Sciences Patents conference joint presentation: “Method Claims: Understanding the Impact of Akamai on Direct and Divided Infringement”

May 2016, ExL Pharma, Due Diligence Summit for Life Sciences conference: ”Road Map for an Efficient and Comprehensive IP Due Diligence Investigation”

February 2017, American Conference Institute, Advanced Summit on Life Sciences Patents conference joint presentation: “Diving into Divided Infringement: Method Claims post-Akamai”

November 2017, Center for Business Intelligence, Due Diligence for Life Sciences M&A, Partnerships and Divestitures conference: “Effectively Managing Intellectual Property Due Diligence – Spotting IP Deal Killers”

February 2018, American Conference Institute, Advanced Summit on Life Sciences Patents conference: “Leveraging Your Life Sciences Assets: Best Practices for Licensing and IP Due Diligence”

Other Presentations of Note


Made a Hatch-Waxman presentation for eleven straight years to a class at Fordham Law being taught by Jolene Appleman who previously worked with Bruce at Pfizer.

Made a Hatch-Waxman presentation via WebEx to a government and industry group in Taiwan that included the head of the Taiwan Patent Office and high ranking officials from the Taiwan FDA.  The Taiwan FDA officicals were happy to learn that the US FDA did not pass judgment on the eligibllity of patents to be listed in the Orange Book. The final Taiwan patent linkage law followed the US FDA example by allowing interested parties the opportunity to question the listing of a patent on the Taiwan version of the Orange Book.