Orange Book Blog

ACI "4th Advanced Forum on Biosimilars," New York City, June 5-7

ACI will be holding its "4th Advanced Forum on Biosimilars" in New York City on June 5-7.  McAndrews, Held & Malloy partner Sandra Frantzen will be speaking on the written description and enablement requirements for biologics patents.  The full agenda includes the following presentations:

• The Biosimilars Pipeline: Evaluating the Commercial Opportunity and Viability of Follow-On Products
• Overcoming the Complicated Challenges to Establishing Biosimilarity
• The Next Fronteir of Biosimilars Challenges: Naming and Substitution at the Pharmacy Level
• Two Roads Diverged in a Wood: Evaluating Whether to Go Down the Biosimilars or BLA Pathway
• In-House Keynote: Interchange or "Out of Change"--the Changing World of Biosimilars
• In-House Roundtable Debate: Companies Weigh in on the Abbreviated Pathway
• The Reality of the Market: Lessons Learned So Far from Global Biosimilars Development and Litigation
• Preparing for the Impending Reality of Biosimilars Patent Litigation: Immediate Action Plans for the First Wave
• The Post-AIA World: Revolutionizing Biosimilars Litigation Strategies in Light of Validity Assessment at the PTO
• Practical Claim Drafting and Patent Prosecution Strategies for Biosimilars and Innovators
• Exploring Opportunities to Strengthen Your Patent Portfolio Through Licensing
• The Use of Citizen Petitions in the Biosimilars Context: A Case Study of AbbVie's Petition
• Evaluating the Benefit of Trade Secret Protection Versus Patent Protection: Alternative Ways to Protect Biologic and Biosimilar Technology
• Navigating Tricky Confidentiality and Conflicts Issues in the New Biosimilars Exchange Process

In addition, two pre-conference workshops will take place on June 5: "Biologics 101: Translating the Underlying Science into a Strong Biosimilars Patent Portfolio Strategy" in the morning; and "Monoclonal Antibodies: Successful and Practical Strategies for Developing and Commercializing Antibody Therapies" in the afternoon.

Orange Book Blog readers can receive discounted registration by using code OBB 200.  For additional information or to register, please visit the conference website.

ACI "Paragraph IV Disputes" Conference, New York City, May 7-8

ACI will be holding its always-popular "Paragraph IV Disputes" conference in New York City next week, on May 7-8.  This year's conference--the 7th annual--looks better than ever.  The agenda includes the following presentations:

• Anticipating a Paragraph IV Challenge: New Considerations in Light of AIA and the Patent Cliff
• Asserting Invalidity or Non-infringement Under Paragraph IV: Exploring the ANDA Applicant's Pre-litigation Obligations and Options
• Safe Harbor or Stormy Port?: Analyzing How New 271(e)(1) Controversies Will Impact Paragraph IV Disputes
• Throwing Down the Gauntlet: The Paragraph IV Notice Letter
• Obviousness in Retrospect: Making Sense of Prior Art, Obviousness-Type Double Patenting, Inherency and New AIA Controversies
• Let the Games Begin: The Start of the Paragraph IV Law Suit -- Pleadings and Other Considerations
• A View From the Bench -- with Hon. Paul R. Michel, Hon. Gregory M. Sleet, Hon. Stanley R. Chesler, Hon. Joel A. Pisano, Hon. Tonianne Bongiovvani, and Hon. Garrett E. Brown
• Pay-for-Delay Update -- presented by Markus H. Meier, Asst. Dir., Health Care Division, Bureau of Competition, Federal Trade Commission
• Settlement of Paragraph IV Law Suits: The Industry Perspective
• Parallel and Alternate Proceedings in Paragraph IV Disputes: Seeking Simultaneous or Sole Redress Before the PTO, ITC and Other Alternative Forums -- with Hon. Garrett E. Brown, Mon. Mary Pat Thynge, Hon. Joseph A. Dickson, Hon. James Donald Smith, and Hon. Robert K. Rogers
• FDA Proceedings and Regulatory Developments Impacting Paragraph IV Litigation
• New Exclusivity Challenges: Brand Names Take Notice -- It's Not Just a Concern for Generics Anymore
• Examining New Rulings in Inducement of Infringement and Divided Infringement and Their Application to Method Claims in Hatch-Waxman Litigation
• New Developments in Damages Theories and Injunctions Relative to At-Risk Launches: Legal and Economic Assessments
• Inequitable Conduct Developments in the Courts and at the PTO: Ethical Considerations for Paragraph IV Cases

In addition to the main conference, ACI is offering two pre-conference workshops on May 6.  In the morning will be Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals; and in the afternoon, Working Group Session: Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation.  Finally, on May 9 ACI is offering a post-conference Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand Names and Generics -- A Hands-On, Practical Approach.

Orange Book Blog readers are eligible for a discounted registration rate by using code OBB 200.  For additional information or to register, please visit the conference website.