Paragraph IV Disputes

By 2016, the pharmaceutical industry will encounter total patent losses of nearly $150 billion.(1)
Master the litigation strategies that your company needs to successfully scale the legal intricacies of this next crag of the patent cliff.

Many thought that 2012 with its record patent losses of nearly $70 billion would mark the worst year of the pharmaceutical industry’s patent cliff (2). However, the worse escarpments of the cliff may yet to be encountered. By some estimates, the industry will experience patent losses approaching $150 billion within the next three years (3). This will undoubtedly test the balance of power created by the Hatch-Waxman Act and lead to dramatic new litigation challenges for brand names and generics.

Come to this conference and meet with the leading legal minds in this area as you acquire the skills needed for the new era of extreme Hatch-Waxman litigation.

Now in its seventh iteration, American Conference Institute’s (ACI’s) Paragraph IV Disputes conference is the only event which helps both brand name and generic pharmaceutical companies make sense of changing industry dynamics precipitated by the patent cliff and other factors such as patent reform, regulatory shifts and recent and pending case law. This is the conference that not only sets the standards for Paragraph IV litigation, but also serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation.

Our faculty of respected and renowned counsel for branded and generic pharmaceutical companies will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns — the commencement of suit — fi nal adjudication and every step in between. Sessions will address the key elements of Paragraph IV litigation in addition to some of the most pressing and recent controversies in this area, including:

• The impact of patent reform on Hatch-Waxman litigation
• The boundaries of 271(e)(1) relative to infringing pre vs. post market activities
• New obviousness considerations in light of recent decisions and the AIA
• The potential effects of FDASIA and the GAIN Act on Paragraph IV Challenges
• Exclusivity concerns for brands as well as generics
• New rulings in divided infringement and inducement of infringement
• Damages theories relative to launching at risk
• The further evolution of the inequitable conduct ruling post-Therasense

Hear from leading Jurists, the PTO, FDA and the FTC.

We are also pleased to bring you the opportunity to hear from eleven renowned Jurists from the Federal Circuit; Federal District Court (Districts of Delaware and New Jersey); and Administrative Law Judges from the PTO’s Patent Trial and Appeals Board and International Trade Commission. Do not miss this opportunity to learn fi rsthand how the bench analyzes the theories of your case and how to effectively navigate alternative
forums. Additionally, a key offi cial from the Federal Trade Commission will be on hand to discuss the latest in the ‘Pay for Delay’ debate and representatives from PhRMA and GPhA will also be present to share their opinions on the matter.

Benefi t from Training Sessions, Working Groups and Master Classes Designed to Give You the Edge in the New Hatch-Waxman Landscape.

We are pleased to offer you informative and hands-on workshops which will complete
your conference and networking experience:

• Hatch-Waxman and BPCIA 101 — A Primer on IP Basics and Regulatory Fundamentals will provide you with the patent and regulatory backdrop for the more in-depth Hatch-Waxman litigation controversies discussed in the main conference;
• A Working Group Session on Assessing The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation will address how new pre- and postissuance procedures may alter certain components of Paragraph IV litigation and lead to parallel proceedings before the Federal Courts and PTO; and
• The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Name and Generics will give you practical and hands-on strategies for drafting and negotiating settlement agreements that will pass muster with the FTC

In this costly and ruthless endgame, not a moment can be lost. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563 or logging on to www.AmericanConference.com/PIVDisputesNYC.

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(1) - http://www.fi ercepharma.com/story/beware-patent-losses-climb-back-56b-2015/2012-06-20
(2) Id.
(3) Id.

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