Speaking Engagement
Steffen Johnson Speaks at ACI’s 2nd West Coast Paragraph IV Disputes Conference
Speaking Engagement
Steffen Johnson Speaks at ACI’s 2nd West Coast Paragraph IV Disputes Conference
December 7, 2011
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:
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Pinpointing patents which may be vulnerable to a Paragraph IV challenge
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Demystifying an ANDA applicant’s Orange Book strategy and dissecting a challenger’s obligations under Paragraph IV
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Understanding the FTC’s current position on pay-for-delay settlements and anticipating any antitrust concerns stemming from agreements between brand names and generics
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Mastering the intricacies of litigation with multiple ANDA filers
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Weighing the benefits and risks of an at-risk launch and minimizing downstream risk
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Identifying the legal and ethical impact that Therasense will have on the affirmative defense of inequitable conduct
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Exploring the ramifications of increased generic versus generic litigation in the quest for the prize of 180-day exclusivity
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Navigating the evolving case law surrounding double patenting obviousness and formulating litigation strategies based on the prior art analysis
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Scrutinizing labeling controversies and determining whether a use code expansion is reasonable