2012 All Hands Meeting
December 6th Main Session
Life Sciences Track Agenda
Life Sciences IP Update
William Gaede & Bhanu Sadasivan
McDermott Will & Emery
This year-in-review segment will discuss: The narrowing scope of patent-eligible subject matter; How commercial manufacturing method patents may be exempt from infringement under Section 271; Indirect infringement, even where no one directly infringes; Liability for selling a method in the United States even if performance of the method is off shore; Settlements and Hatch-Waxman suits (the FTC Is watching).
FDA Update: Drugs, Biologics, Medical Devices
Elaine Tseng & Michael Petty
King & Spalding LLP
Recent months have brought substantial changes in law and regulation affecting life sciences companies. This session will identify and discuss practical implications for pharmaceutical, biotechnology, and medical device companies of key provisions of new laws, including the Food and Drug Administration Safety and Innovation Act, and current trends in regulation and enforcement, including in the areas of cGMP and quality systems. We will also draw on our experience working with various types of companies, as well as our recent experience in-house, to provide tips to aid in-house counsel in communicating and working collaboratively with internal business clients.
FDA and Off-Label Extensions
Inbound Development and Licensing issues for Medical Device and Biotechnology Companies
E.A. Lisa Kenkel & Jake Handy
Fenwick & West LLP
Successful development and in-licensing relationships are critical to building value in a medical device or biotechnology company. Understanding and avoiding common pitfalls is key to an effective strategy for development and in-license agreements. A discussion of practical tips to securing solid, lasting rights which can be exploited by the company, its collaboration partners and acquirers.
Congratulations, You Have Marketing Approval! Now What? How to Manage Risk and Extract Value Through Your Commercial Agreements
Commercial distribution and sale of drugs, diagnostics and medical devices presents a special set of challenges that are different from those that arise during product development. This presentation will explore the range of agreements that govern the commercialization phase in the life sciences industry, including agreements for co-promotion, supply, distribution (domestic and ex-U.S.), services (e.g., billing) and pharmacovigilance. We will focus on key take-aways and best practices to help you manage the complex and often overlooked issues that arise from the distribution and sale of your drug, diagnostic and medical device products around the world, with an emphasis on real-world examples.
Understanding Privacy and FTC Enforcement in the Life Sciences Sector
Foley & Lardner LLP
A discussion of privacy, FTC enforcement issues, behavioral advertising, cyber-security, and many other topics related to information, and its emerging role in today's economy.
FCPA Update 2012 for Life Science Companies
Mayer Brown LLP
This presentation will discuss: Key elements of FCPA; Enforcement of FCPA in the healthcare industry; How to avoid or minimize liability; Impact of Dodd-Frank; The future of FCPA.
Please Note: Program details are subject to change without notice