The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs. The informal name comes from the Act's two sponsors, representative Henry Waxman of California and senator Orrin Hatch of Utah. The United States Code (U.S.C.) is a compilation and codification of the general and permanent federal law of the United States. ... A generic drug (pl. ... Seal of the House of Representatives The United States House of Representatives (or simply the House) is one of the two chambers of the United States Congress, the other being the Senate. ... Henry Arnold Waxman (born September 12, 1939) is an American politician. ... Official language(s) English Capital Sacramento Largest city Los Angeles Area  Ranked 3rd  - Total 158,302 sq mi (410,000 km²)  - Width 250 miles (400 km)  - Length 770 miles (1,240 km)  - % water 4. ... Seal of the U.S. Senate Federal courts Supreme Court Chief Justice Associate Justices Elections Presidential elections Midterm elections Political Parties Democratic Republican Third parties State & Local government Governors Legislatures State Courts Counties, Cities, and Towns Other countries Politics Portal      Senate composition following 2006 elections The United States Senate is... Orrin Grant Hatch (born March 22, 1934) is a Republican United States Senator from Utah, serving since 1977. ... Official language(s) English Capital Salt Lake City Largest city Salt Lake City Area  Ranked 13th  - Total 84,876 sq mi (219,887 km²)  - Width 270 miles (435 km)  - Length 350 miles (565 km)  - % water 3. ...

Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) 21 U.S.C. 355(j) sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic. Section 505(j)(5)(B)(iv), the so called Paragraph IV, allows 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts. The United States Federal Food, Drug, and Cosmetic Act (FD&C) is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. ... The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and... A patent is a set of exclusive rights granted by a state to a patentee (the inventor or assignee) for a fixed period of time in exchange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which...

Hatch-Waxman Amendments grant generic manufacturers standing to mount a validity challenge without incurring the cost of entry or risking enormous damages flowing from any possible infringement. Hatch-Waxman essentially redistributes the relative risk assessments and explains the flow of settlement funds and their magnitude. Hatch-Waxman gives generics considerable leverage in patent litigation: the exposure to liability amounts to litigation costs, but pales in comparison to the immense volume of generic sales and profits. ^[1]

See also

• Research exemption
• ANDA

In patent law, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs. ... Anda is the name of two places in the Philippines: Anda, Bohol Anda, Pangasinan Anda is a location in Afghanistan Anda is a small island in Norway, home to the Anda lighthouse. ...

References

1. ^ Schering-Plough v. FTC (11th Cir. 2005)