News 09 Apr. 2024
Curtis Announces New Partners and Counsels Across Offices in Spring 2024
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News 25 Jan. 2024
Counsel Mohannad A. El Murtadi Suleiman Addresses “Africanization” of International Investment Law
Event 18 Aug. 2023
Partner Borzu Sabahi Speaks at FDI Moot Shenzhen
News 25 Jul. 2023
Partner Eric Gilioli Ranked in Top 10 Influential Energy & Natural Resources Lawyers in Kazakhstan in Business Today
Client Alert 28 Dec. 2023
U.S. to Impose Secondary Sanctions on Non-U.S. Banks For Financing Russia’s Defense Industry
News 28 Aug. 2024
Curtis Recognized for Excellence in Arbitration in Chambers Latin America Guide 2025
Event 22 Aug. 2023
Partner Dr. Claudia Frutos-Peterson to Speak at Arbitration and ADR Commission of the ICC Mexico
News 15 Aug. 2023
Legal Reader Publishes Article on Dr. Majed Alotaibi’s Arrival as Senior Counsel in Curtis’ Riyadh Office
News 31 Jul. 2023
Curtis Welcomes Senior Saudi Advisor, Dr. Majed Alotaibi, to its Riyadh Office
News 24 Aug. 2023
Curtis Attorneys Quoted in CoinDesk on FTX Founder Sam Bankman-Fried’s Strategy Ahead of His Criminal Trial
Client Alert 10 Jul. 2024
EU Adopts New Restrictive Measures Against Belarus
Client Alert 26 Jun. 2024
The EU Adopts its 14th Sanctions Package Against Russia
news
Curtis Attorneys Featured in IBA Insolvency and Arbitration Working Group’s New Reports
event
Fernando Tupa to Speak on Indirect Expropriation at Investment Arbitration Seminar organized by the Instituto Peruano de Arbitraje
Intellectual Property
The Hatch-Waxman Act, more formally known as the Drug Price Competition and Patent Term Restoration Act, encourages the manufacture of generic drugs in the United States. It established the modern system of generic drug regulation in the US, and made it easier for generic drug companies to make Abbreviated New Drug Applications (ANDAs).
The Hatch Waxman Act’s period of FDA regulatory inclusivity allows a drug research company the exclusive right to produce and market a new drug for a specific period of time (usually five years). During this time, no generics are allowed to come to market.
Patent exclusivity is typically five years for a new drug marketed in the United States. Drug makers can potentially access a patent extension term of another five years, potentially extending the term of their patent to a total of 10 years. Of course, during that time, no generic drugs could be brought to market and the patent holder could potentially make billions of dollars on a profitable drug.
Attorney advertising. The material contained on this page is only a general review of the subjects covered and does not constitute legal advice. No legal or business decision should be based on its contents.
Turner P. Smith
Partner
Eric Stenshoel
Counsel
Intellectual Property Law
Intellectual Property Litigation
Media, Technology and Entertainment
Cybersecurity
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