• Prepare for follow-on patent litigation and understand what mechanisms are and will be in place for resolving patent disputes;
• Analyze the impact of the 12-year exclusivity period on the financial viability of development of follow-ons;
• Develop methods for demonstrating or disproving similarity "in terms of safety, purity and potency of the product";
• Determine what safety data and technical level of support bio applicants will have to provide in order to get approval of follow-ons;
• Examine and learn from the global development of biosimiliars;
• Maximize the biologic patent lifecycle and protect the value of intellectual property for biologics;
• Investigate alternative approval methods for biosimilars including BLA applications and FD&C 505(b)2 applications; and
• Evaluate the impact of follow-ons on existing and future licensing agreements and strategic alliances.
• Overview, status and history of biosimiliars legislation in the U.S.: The inside story;
• Practical implications for the biosimilars market under the new regime;
• Current FDA position and initiatives regarding follow-on biologics;
• Defining biosimilars: Proving (or disproving) interchangeability and biosimilarity -- to be presented in part by Patent Docs author Kevin Noonan;
• An overview of dispute resolution mechanisms under PHS § 351;
• Developing procedures and strategies in preparation of follow-on litigation;
• Maximizing the biologic patent lifecycle and protecting the value of IP for biologics in light of new legislation: Written description, enablement, the doctrine of equivalents and more;
• FTC spotlight: Addressing the antitrust concerns resulting from follow-on legislation;
• Lessons learned from the development of biosimilars on the international stage;
• Understanding proposed clinical trials requirements and overcoming safety concerns associated with follow-ons;
• Developing alternative pathways for getting biosimilars on the market;
• Renegotiating and reworking licensing agreements with companies and universities in anticipation of follow-on biologics; and
• Overcoming challenges to marketing, branding, and promotion of biosimilars.
A post-conference workshop, entitled "Applying Patent Term Adjustments and Patent Term Extensions to Biosimilars to Optimize the Biologic Patent Lifecycle," will be offered from 9:00 am to 12:00 pm on June 23, 2010. The workshop will take attendees through the intricacies of the major ways of getting an extension on biologics patents, and provide attendees with the tools needed to accomplish this goal in a time of changing rules and regulations.
A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.
The registration fee for this conference is $2,195 (conference alone) or $2,795 (conference and workshop). Those registering by May 28, 2010 will receive a $300 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's Follow-on Biologics conference.