5th Anniversary Edition on Paragraph IV Disputes

Jan. 14, 2011 - PRLog -- Patents covering critical pharmaceutical products worth more than $30 billion annually are on the precipice of expiration. **

Conquer the litigation challenges that this patent onslaught will bring for brand name and generics in the Paragraph IV arena.

American Conference Institute’s Paragraph IV Disputes conference is the undisputed source for Hatch-Waxman litigation strategies for brand-names and generics. This event — which is widely recognized for setting the standards for Paragraph IV litigation and which also serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation — is now the single forum on which brand name and generic companies can rely for answers during this turbulent time in which the balance of power designed by the Hatch-Waxman Act may completely unravel. Come to this conference and get the up-to-the minute information that you need to prepare for the new litigation confrontations to come.

Brand name pharmaceutical companies are moving closer than ever to the edge of the patent cliff.

However, generic manufacturers are facing their own hurdles as fewer opportunities for 180-day exclusivity will remain.

The industry has reached the long dreaded patent cliff of 2011. Brand name manufacturers are struggling to fill a drying pipeline and extend patent life through other statutory and regulatory conventions. Meanwhile, generics eye the ultimate Hatch-Waxman prize of 180-day exclusivity— knowing that such opportunities in the future may be short-lived as there will be few patented drug products worth coveting.

These factors have turned Paragraph IV litigation into a no-holds barred fight and have raised the monetary ante to an unprecedented level.

New legislative developments, evolving case law and mounting enforcement actions are increasing this anxiety.

Moreover, the passage of biosimilars legislation, the possible resurrection of patent reform and the never ending controversy surrounding reverse payment settlements have only added to the complexities surrounding this litigation. In this chaotic environment one thing is clear: it is more imperative than ever before for brand-name and generic drug manufacturers to have the offensive moves and defensive plays that they need to meet the evolving challenges of pharmaceutical patent endgame litigation.

Turn your IP uncertainties into opportunities.

An experienced faculty comprised of respected and renowned counsel for brand name and generic pharmaceutical companies will provide insights on all facets of Paragraph IV litigation: pre-litigation concerns – the commencement of suit – final 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 surrounding Paragraph IV cases, including:

   * Invalidity standard review
   * Double patenting obviousness
   * Inducement of infringement
   * Section 8 carve-outs
   * Inequitable conduct
   * Damages

We are also pleased to bring you the opportunity to hear from renowned federal jurists and a key official from the Federal Trade Commission. This will allow you to learn firsthand how the bench analyzes the theories of your case and what the FTC deems as “fair and foul” in the settlement of pharmaceutical patent disputes.

We will once again offer our informative and hands-on workshops:

   * 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; 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/Paragraph IV.

Read more about this at http://www.americanconference.com/blog

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