Orange Book Blog

CBI "Paragraph IV Disputes" Conference, Philadelphia, October 15-16

On October 15-16 in Philadelphia, the Center for Business Intelligence will hold a conference entitled "Pharmaceutical Congress on Paragraph IV Disputes:  Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies."

CBI provides its top five reasons to attend:

• To hear the FTC's stance on antitrust and acceptable settlement strategies
• To learn to optimize cost savings in e-discovery
• To assess ANDA litigation after KSR
• To understand the "earlier of" - "later of" maze in forfeiture provisions
• To conduct an in-depth analysis of recent paragraph IV developments and their implications on industry

The conference will begin with a workshop, "Assess Litigation Strategies to Proactively Plan for Paragraph IV Disputes," on October 15 from 8:30 am to noon.

The main agenda then includes numerous talks that look interesting:

• "Strategies to Optimize Patent Lifecycle from Drafting to Maturity"
• "Preparing for Paragraph IV Challenges -- Generic Pre-suit Strategies"
• "Best Practices in E-Discovery -- Overcoming Obstacles, Controlling Costs and Maximizing Benefits"
• "The KSR Decision and ANDA Litigation"
• "Implications of Recent Developments and Trends in Litigating Paragraph IV Disputes" (I'll be speaking on this topic as one of the panelists)
• "Citizen Petitions and Their Impact on Generic Entry"
• "Interpreting Forfeiture Provisions -- An Analysis of Recent Cases to Increase Preparedness and Improve Product Strategy"
• "The FTC, Antitrust Law and Settling Paragraph IV Litigation," presented by Markus Meier, Assistant Director, FTC

For more information or to register, please visit the conference website.

Orange Book Blog readers can save $400 by using registration code SAQ782.

ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 15-16

American Conference Institute is holding its ninth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 15-16 in New York.  According to ACI, this "definitive Hatch-Waxman event provides the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a foundation for their life cycle strategies."

The agenda includes many topics covered on Orange Book Blog.  Selected talks include:

• "Constructing, Adjusting, and Executing a Pharmaceutical Patent Life Cycle Management Plan"
• "View from the FTC," presented by Saralisa Brau, Health Care Services and Products Division, FTC
• "Navigating the Complexity of Structuring Patent Settlement Options Between Brand Name and Generic Pharmaceutical Companies"
• "Eye on the Bench:  Identifying Judicial Trends in Pharmaceutical Patent Cases"
• "Mastering the Intricacies of the 180-Day Generic Market Exclusivity"
• "Plotting a Course Into Safe Harbor for Branded Pharma"
• "View from the FDA," presented by Elizabeth Dickinson, Office of Chief Counsel, FDA
• "Slicing Through the Complex Spectrum of Declaratory Judgment Actions in Pharmaceutical Patent Cases"
• "Factoring the Role, Challenges, and Impact of Orange Book Listings and Delistings in Patent Portfolio Management"

In addition, two optional post-conference workshops are offered on October 17th:  a brand name master class entitled "Overpowering the Challenges in Increasing the Pharmaceutical Patent Life Cycle Through Patent Extensions" and a generics master class entitled "Adding Value to Paragraph IV Certifications and Notice Letters."

For more information or to register, please visit the conference website.

Orange Book Blog readers can save $200 by using registration code S.

ACI "FDA Boot Camp" Conference, Boston, September 22-23

American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23.

The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory competencies.  The conference features FDA regulatory and patent law experts from pharmaceutical companies and outside law firms.

Talks on the agenda include:

• The Basics: Understanding and Working with the FDA -- Jurisdiction, Functions, Organization, and Operations
• The Nature of the Approval Process
• Understanding the Clinical Trial Process for Drugs and Biologics
• Patent and IP Overview: Hatch-Waxman, Trademark Protection, and More
• Non-Patent Exclusivity (I'll be presenting this one)
• Bioequivalence: What Lawyers Need to Know
• Follow-On (Comparable or Biosimilar) Biologics

For more information or to register, please visit the conference website.

Orange Book Blog readers can save $200 on registration with code SP1.