UNITED STATES
OF AMERICA

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Patent Term
20 years from date of filing.

Pharmaceutical Patent Extension?
Yes. (35 U.S.C. 156)
A single extension of term of up to 5 years may be granted as a result of delays in first marketing of a product due to regulatory review after the patent has been issued. The extension of term may be obtained if the patent relates to the active ingredient of a human or animal drug product or a combination of such active ingredients, a medical device, a food additive or a colour additive, to methods of manufacturing or approved use of such products, and the product is subject to regulation under the Food, Drug and Cosmetics Act.

A petition for patent term extension must be filed within 60 days of the marketing approval being given, and must be filed before the patent expires.

Bolar Provision
Yes. 35 U.S.C. 271 (e)(1)
It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention…solely for uses reasonably related to the development and submission of information under Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

References
http://www.derwent.com/patentguides/gpe/us_march/htm   http://www.ladas.com/patents/biotechnology/USPharmPatentLaw/USPhar01.html
http://www.cptech.org/ip/health/research/legislation.html
http://www.uspto.gov/web/offices/pac/mpep/consolidated_laws.pdf

Prepared for IP Organisers by Dr Grace Chan, David Tadgell and Virginia Beniac-Brooks, Phillips Ormonde & Fitzpatrick - November 2007.