A generic drug applicant can change a product’s label by deleting approved indications to avoid patent infringement. This has typically been called a “Skinny Label.” But what happens when a generic and 505(b)(2) applicant adds language, making the label ‘chubbier,’ to avoid patent infringement?

Join us for a practical, fast-paced discussion on one of the most dynamic fault lines in pharmaceutical litigation and FDA regulation: how “chubby labels”, full or expanded indications and comprehensive labeling, intersect with patent infringement theories. This session will unpack the current legal landscape and regulatory framework, highlight recent case developments, and offer concrete strategies for mitigating risk from label drafting through launch and lifecycle management.

This webinar is tailored for branded pharmaceutical in-house counsel, regulatory affairs professionals, litigation teams, and product strategists navigating the complex interplay between Orange Book listings, use codes, label expansions and overlapping indications, and theories of induced and contributory infringement. Whether you are preparing a pre-launch strategy or defending post-launch conduct, the program will provide actionable guidance grounded in real-world scenarios.

Topics will include:

• Understanding label changes under the Hatch-Waxman Act, “chubby labels,” full labels, and expanded indications.
• The evolving contours of induced infringement claims based on labeling, promotional materials, and market conduct.
• Implications of recent decisions for brand protection, product labeling, and the risks of label expansion and indication overlap.
• Best practices for cross-functional coordination among regulatory, IP, and commercial teams to reduce litigation exposure and strengthen positions.
• Practical tips for evidence development, labeling documentation, and communications that withstand scrutiny.

CLE credit for this course is available in New York and California. This program is offering 1.0 Areas of Professional Practice Credit(s) in NY, and 1.0 General Credit(s) in CA. The program is appropriate for both newly admitted attorneys and experienced attorneys. Please contact us for details.