Please note that the faculty members listed for this course are subject to change prior to the actual course date.
Patent litigation between innovator and generic pharmaceutical companies is one of the most active areas of patent litigation. Patent challenges by generics have increased exponentially in recent years. As many as fifty of these so-called ANDA litigations were filed in 2008, up over 200% from just four years earlier. Why are so many filed in a given year? The value at stake in a single case can reach billions of dollars. Financial profit incentive for the first ANDA filer is a six-months market exclusivity period during which the FDA cannot approve another generic.
This one-day ANDA litigation course teaches the significant case law that has developed around current themes in these cases, provides an overview of the unique statutory framework governing ANDA cases, including Orange Book listings and the 30-months stay, and offers strategies for developing winning litigation themes. This course also teaches how latent weaknesses in pharmaceutical patents may be exploited in litigation, and how patent and regulatory law intertwine in an ANDA litigation.
The practical guidance offered by this course is essential for anyone with responsibility for any phase of pharmaceutical product patent portfolio whether in development, licensing, and litigation. It is also recommended for practitioners not currently involved in pharmaceutical patents who want to better understand the ins and outs of this hot area of litigation.
Examplary topics covered include:
- The Hatch Waxman statutory scheme
- Generics' economic incentives
- Timing of ANDA challenges
- Structural obviousness of New Chemical Entities
- Attacks on method of treatment claims
- KSR as applied to formulations and dosage forms
- At-risk launches
- Injunctions
- Settlement and FTC limitations
The legal and economic important of ANDA litigation is so great that no patent attorney should be without an understanding of best practices in this arena. For those not currently litigating pharmaceutifcal patents, this course will provide the foundation necessary to understand this important area of patent challenges. Practitioners involved with pharmaceutical patents - whether prosecution, counseling, or litigation - will learn to spot weaknesses in patents and applications before or during litigation and strengthen their positions in advance of the endgame. All participates will gain an apprecaition for the timelines in an ANDA litigation from the filing of the NDA and Organe Book listings to the "Paragraph IV notice letter' and ultimately to conclusion of litigation.