University of New Hampshire

School of Law

Pharmaceutical Patent Litigation under the Hatch Waxman Act

The Drug Price Competition and Patent Term Restoration Act (more commonly known as the Hatch Waxman Act) is the federal law that governs the regulation of generic drugs, including their approval and marketing, with the goal being to facilitate the market entry of generic drugs while preserving incentives for pioneer drug manufacturers to continue to invest in research and development of new drugs. Under Hatch Waxman, generic manufacturers may file an expedited Abbreviated New Drug Application (ANDA) and challenge another company's patent exclusivity in relation to approved drugs. Since its enactment, the amount of generic drugs approved and brought to market has increased significantly, as has the complexity and amount of litigation between generic and pioneer drug companies. This course will cover the basics of ANDA and patent litigation issues that have arisen under the Hatch Waxman Act. Students interested in IP litigation and pharmaceutical patent law will be able to build on their basic advocacy and litigation skills while developing a good understanding of the complexities of patent litigation under this important piece of federal legislation.

Students who have not taken and passed a US patent law (including pharmaceutical patent law) course and are concurrently taking Patent Law or Fundamentals of IP may speak with the professor about waiving the US patent law prerequisite. Students who have substantial patent prosecution or other patent practice experience may also be eligible for a waiver.

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