Lerner David Partners Presenting at Upcoming ACI's Hatch Waxman Series: Paragraph IV Disputes Conference

ACI's Hatch Waxman Series: Paragraph IV Disputes
April 23-25, 2018 | New York, NY

Lerner David is pleased to announce that two of its Hatch-Waxman attorneys will be presenting at an upcoming conference on Paragraph IV Disputes. This national conference has been taking place for nearly a decade and brings together the “who’s who” of Hatch-Waxman litigators, industry decision makers and stakeholders, as well as Judges –now from two different forums – and key government representatives.

The two presentations being made by Lerner David partners are:

The Cost and Worth of a Patent: The Economics of a Paragraph IV Challenge
April 23 | 1:00 pm

Partner Kelly Y. Hwang will join a panel of in-house and outside counsel to address the following points of discussion:

  • Conducting IP and economic due diligence assessments for brand name and generic manufacturers relative to such matters as NCE exclusivity, patent positions, screenings and alleged product hopping


    • 1. Factoring-in R&D considerations and market trends
    • 2. Analyzing available exclusivities, both regulatory and patent
  • Assessing key litigation considerations and related costs for pharmaceutical patent challenges
  • Considering the likelihood of victory at the District Court level and the PTAB on patent type and review of recent decisions
  • Mastering the art of budgeting, forecasting, and aligning litigation costs to business goals
  • Exploring cost saving options in litigation, including alternate billing, contingency clauses and outside funding
  • Examining value of licensing deals and structures
  • Calculating the costs and analyzing the benefits of settlement

Antitrust and Economic Considerations for Settlements: May it Please the Court and the FTC
April 23 | 2:45 pm

In this session, Partner, Brian R. Tomkins will engage in a panel discussion to address the antitrust and economic implications of settlement including:

  • Exploring industry challenges in light of recent court decisions and the Commission’s stance with respect to designing settlement agreements
  • Satisfying the “Rule of Reason” test • Drafting and structuring an agreement in accord with new jurisprudence and pending actions
  • Incorporating elements that emphasize the procompetitive nature of the agreement
  • Assessing the role of "no-AG" commitments as to authorized generics and licensing in view of recent FTC guidance
  • Understanding how concepts such as valuation, pricing, government contracting and managed markets, royalties and lost profits apply to these agreements

For more information on the ACI conference or to register your attendance, please click here.