Steffen Johnson Speaks at ACI’s 2nd West Coast Paragraph IV Disputes Conference

Winston & Strawn partner Steffen Johnson spoke at ACI's 2nd West Coast Edition Paragraph IV Disputes: Expert Insights on Hatch-Waxman Litigation Strategies for Brand Names and Generics Conference held on December 6-7, 2011 in San Francisco.

Mr. Johnson participated in a December 7 panel, "Carve Outs and Inducement Controversies: Examining the Intersection Between a Drug's Patent and Its Label," which addressed:

• Comprehending the newfound significance of inducement actions post the Supreme Court's decision in Global Tech v. SEB
• AstraZeneca LP v. Apotex, Inc.: the role of Section 8 carve-outs and the inducement controversy
• Caraco Pharmaceutical v. Novo Nordisk A/S
• Skinny labeling challenges: is there a way around patents? 

Joining Mr. Johnson were Meg Snowden from Impax Laboratories, Inc.; Jeffry Nicols from Brinks Hoefer Gilson & Lione; and Mark Perry from Gibson Dunn & Crutcher.

Leading counsel from branded and generic drug makers, experienced jurists, and the Federal Trade Commission reviewed the latest legal challenges affecting Hatch-Waxman disputes, including: 

• Pinpointing patents which may be vulnerable to a Paragraph IV challenge
• Demystifying an ANDA applicant’s Orange Book strategy and dissecting a challenger’s obligations under Paragraph IV
• Understanding the FTC’s current position on pay-for-delay settlements and anticipating any antitrust concerns stemming from agreements between brand names and generics
• Mastering the intricacies of litigation with multiple ANDA filers
• Weighing the benefits and risks of an at-risk launch and minimizing downstream risk
• Identifying the legal and ethical impact that Therasense will have on the affirmative defense of inequitable conduct
• Exploring the ramifications of increased generic versus generic litigation in the quest for the prize of 180-day exclusivity
• Navigating the evolving case law surrounding double patenting obviousness and formulating litigation strategies based on the prior art analysis
• Scrutinizing labeling controversies and determining whether a use code expansion is reasonable