Orange Book Blog

Momentum Event Group will be holding its inaugural "IP Counsel Exchange for Biosimilar Applicants and Sponsors" January 23-24 in New York City.  The effect of the recent Sandoz v. Amgen decision on biosimilar patent litigation strategy is expected to be a main topic of discussion.

The conference begins with an interactive working group, where participants can choose between:

• "Dissecting the European Biosimilars Experience: What Potential Sponsors and Applicants Can Learn From the Approval of the First Biosimilar Antibody in Europe" and
• "Navigating the Patent Application Process: Effective Strategies for Ensuring Your Application Obtains Approval and Can Withstand Challenges in the Emerging Biosimilar Market."

The conference continues with the following presentations:

• "Patent Caselaw Year in Review: Examining Recent Caselaw Developments Under Section 112 Addressing Written Description and Enablement and the Impact on Patent Strategies for Companies Within the Biosimilar Space"
• "Orange Book Withdrawal: How Sponsors and Applicants Can Conduct Effective IP Due Diligence and Patent Inventory Assessment in the Absence of an Established FDA Patent Listing Resource"
• "So You Think You Can Patent Dance: Effective Strategies for Best Posturing Your Product and Narrowing the Litigation Landscape"
• "Size Matters: Dissecting the Divergent Litigation Pathways of Small vs. Large Molecule Products and What Steps Your Company Should Take Now to Prepare Your Future Litigation Strategy"
• "Interactive Roundtable Discussion: Addressing the Top 5 Global IP Challenges Facing Current and Prospective Biosimilar Sponsors and Applicants"
• "Addressing the Potential Use of Trade Secrets (Or Not) in Connection with the FDA's Review of Biosimilar Applications Citing a Reference Product and BLA that Predates the BPCIA"
• "Case Study: To Collaborate or Not to Collaborate?  How Alliances Can Be Used to Strategically Bolster Your Patent Portfolio When Bringing a Biosimilar/Biobetter Product to Market"
• "Global IP Considerations, Challenges, Risks, and Opportunities for Biosimilar Applicants and Sponsors When Filing Patent Applications Abroad"

The conference concludes with your choice of one of three interative roundtable discussions:

• "Looking Beyond Year 12: How to Ensure Your Patent Strategies Are Adding Value Beyond the Statutory Period of Exclusivity"
• "Distinguishing Regulatory Pathways for Biosimilar Products: Biobetters vs. Biosimilars and Considering the Impact Your Regulatory Choice Will Have on Your IP Strategy"
• "Alternative Monetization Strategies for Your IP Portfolio: How to Drive Your Business When You Choose Not to Apply"

Orange Book Blog readers are entitled to a 10% discount on registration by using code OBB10.  For more information or to register, please visit the conference website.