American Conference Institute (ACI) will be holding its next Paragraph IV Disputes conference on December 6-7, 2011 in San Francisco, CA. The conference will allow attendees to:
• Pinpoint patents that may be vulnerable to a Paragraph IV challenge;
• Demystify an ANDA applicant's Orange Book strategy and dissecting a challenger's obligations under Paragraph IV;
• Understand the FTC's current position on pay-for-delay settlements and anticipating any antitrust concerns stemming from agreements between brand names and generics;
• Master the intricacies of litigation with multiple ANDA filers;
• Weigh the benefits and risks of an at-risk launch and minimizing downstream risk;
• Identify the legal and ethical impact that Therasense will have on the affirmative defense of inequitable conduct;
• Explore the ramifications of increased generic versus generic litigation in the quest for the prize of 180-day exclusivity;
• Navigate the evolving case law surrounding double patenting obviousness and formulating litigation strategies based on the prior art analysis; and
• Scrutinize labeling controversies and determining whether a use code expansion is reasonable.
In particular, ACI's faculty will offer presentations on the following topics:
• Pre-suit due diligence strategies: The branded perspective on proactively anticipating Paragraph IV challenges;
• Certifying under Paragraph IV: Identifying the ANDA applicant's pre-suit considerations and obligations;
• Let the games begin: The start of the Paragraph IV law suit -- Pleadings and considerations;
• New standards and controversies in double patenting type obviousness: Repercussions for Paragraph IV challenges;
• No holds barred: Fighting for or defending against the coveted 180 day exclusivity stay;
• A view from the bench on Paragraph IV litigation;
• Carve outs and inducement controversies: Examining the intersection between a drug's patent and its label;
• The post-Therasense world: Pleading and defending against inequitable conduct allegations under the heightened standard for materiality and intent -- to be presented in part by Patent Docs author Dr. Donald Zuhn; and
• Damages and injunctions: Exploring the consequences and conundrums of launching at risk.
In addition, a pre-conference boot camp entitled "Biosimilars Through the Hatch-Waxman Lens: Anticipating Litigation Challenges and Understanding the Evolving Landscape" will be offered from 1:00 pm to 5:00 pm on December 5, 2011, and a post-conference master class entitled "Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-names and Generic Companies -- A Hands-on, Practical Approach" will be offered from 2:00 pm to 5:00 pm on December 7, 2011. The master class will offer presentations on the following topics:
• FTC keynote: Pay for delay settlements -- presented by Commissioner J. Thomas Rosch of the Federal Trade Commission; and
• Obtaining optimal terms and minimizing antitrust concerns when settling Paragraph IV disputes.
The agenda for the Paragraph IV Disputes conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $2,295 (conference alone), $2,895 (conference and either pre-conference boot camp or post-conference master class), or $3,495 (conference, pre-conference boot camp, and post-conference master class). Those registering by October 12, 2011 will receive a $300 discount and those registering by November 4, 2011 will receive a $200 discount. In addition, Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering. 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 the Paragraph IV Disputes conference.
Comments