Research exemption
Overview
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
law
Law
Law is a system of rules and guidelines which are enforced through social institutions to govern behavior, wherever possible. It shapes politics, economics and society in numerous ways and serves as a social mediator of relations between people. Contract law regulates everything from buying a bus...
, the research exemption or safe harbour exemption is an exemption to the rights conferred by patents, which is especially relevant to drugs
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
. According to this exemption, despite the patent rights, performing research
Research
Research can be defined as the scientific search for knowledge, or as any systematic investigation, to establish novel facts, solve new or existing problems, prove new ideas, or develop new theories, usually using a scientific method...
and tests for preparing regulatory approval, for instance by the FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, does not constitute infringement
Patent infringement
Patent infringement is the commission of a prohibited act with respect to a patented invention without permission from the patent holder. Permission may typically be granted in the form of a license. The definition of patent infringement may vary by jurisdiction, but it typically includes using or...
for a limited term before the end of patent term
Term of patent
The term of a patent is the maximum period during which it can be maintained into force. It is usually expressed in number of years either starting from the filing date of the patent application or from the date of grant of the patent. In most patent laws, renewal annuities or maintenance fees have...
. This exemption allows generic manufacturers to prepare generic drug
Generic drug
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its...
s in advance of the patent expiration.
In the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
, this exemption is also technically called §
Section sign
The section sign , also called the "double S", "sectional symbol" or signum sectiōnis, is a typographical character used mainly to refer to a particular section of a document, such as a legal code. It is frequently used along with the pilcrow , or paragraph sign...
271(e)(1) exemption or Hatch-Waxman exemption.
