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