News 11 Oct. 2023
Curtis Team Instrumental in Shareholder Approval of a New Multilateral Treaty to Transform Pan-African Housing Finance Institution Shelter Afrique into a Development Bank
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Event 23 Aug. 2023
Partner Borzu Sabahi Speaks at the 52nd IDRI Professional Accreditation & Membership Programme
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
Article 22 Aug. 2023
Fuad Zarbiyev Publishes Article in Journal of International Economic Law
Client Alert 14 Aug. 2023
The EU’s Market in Crypto Assets (MiCA) Regulation: The Highlights
Event 22 Aug. 2023
Partner Dr. Claudia Frutos-Peterson to Speak at Arbitration and ADR Commission of the ICC Mexico
Event 11 Jul. 2023
Partner Elisa Botero Speaks on the Role of the ICC in Investment Disputes
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
News 06 Mar. 2023
Russia Sanctions at the First Anniversary: An Overview of Current Sanctions in the US, UK, and EU and How Global Companies Can Navigate Evolving and Conflicting Sanctions Regimes
Client Alert 30 Aug. 2022
The EU Adopts the “Maintenance and Alignment” Sanctions Package
Client Alert 24 Jun. 2021
Update on Virtual Notarization (Executive Order 202.7) During the COVID-19 (Coronavirus) Pandemic (Updated: June 24, 2021) — U.S. Insight
Update on Virtual Witnessing (New York Executive Order 202.14) During The COVID-19 (Coronavirus) Pandemic (Updated: June 24, 2021) — U.S. Insight
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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