Drug Dev Ind Pharm. 2005 Jan;31(2):215-22.

Hatch-Waxman in the Federal Courts: from 1994--2004.

Source

Darby & Darby, PC, New York, NY, USA. pludwig@darbylaw.com

Abstract

Decisions of the federal courts play a crucial role in drug development. Litigation related to drug development and approval under the abbreviated new drug application ("ANDA") process over the past 10 years was evaluated, examining over 300 written decisions from 22 U.S. District Courts and the U.S. Court of Appeals for the Federal Circuit. These written decisions represent the majority of patent litigation between brand and generic drug manufacturers. The reported data set provides critical information for the drug development and litigation strategies of both brand and generic manufacturers. The examination also provides a realistic portrayal of the anticipated outcome if a legal action is initiated.

PMID:: 15773288; [PubMed - indexed for MEDLINE]

Publication Types, MeSH Terms, Substances

Publication Types

Review

MeSH Terms

Substances

Drugs, Generic

LinkOut - more resources

Full Text Sources

Other Literature Sources

Labome Researcher Resource - ExactAntigen/Labome

Supplemental Content

Save items

Related citations in PubMed

Unsettling drug patent settlements: a framework for presumptive illegality. [Mich Law Rev. 2009]
Unsettling drug patent settlements: a framework for presumptive illegality.
Carrier MA. Mich Law Rev. 2009 Oct; 108(1):37-80.
Old drugs, new uses: solving a Hatch-Waxman patent predicament. [Food Drug Law J. 2004]
Old drugs, new uses: solving a Hatch-Waxman patent predicament.
McPhie DC. Food Drug Law J. 2004; 59(1):155-68.
FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002). [Ann Health Law. 2003]
FDA's proposed rules on patent listing requirements for new drug and 30-month stays on ANDA approval (proposed Oct. 24, 2002).
Hui YF. Ann Health Law. 2003 Summer; 12(2):325-40, table of contents.
Review The Hatch-Waxman Act: encouraging innovation and generic drug competition. [Curr Top Med Chem. 2010]
Review The Hatch-Waxman Act: encouraging innovation and generic drug competition.
Sokal AM, Gerstenblith BA. Curr Top Med Chem. 2010; 10(18):1950-9.
Review Strategies for strengthening patent protection of pharmaceutical inventions in light of federal court decisions. [Curr Top Med Chem. 2010]
Review Strategies for strengthening patent protection of pharmaceutical inventions in light of federal court decisions.
Pillai X, Kinney WA. Curr Top Med Chem. 2010; 10(18):1929-36.

See reviews... See all...

Recent activity

Clear Turn Off Turn On

Hatch-Waxman in the Federal Courts: from 1994--2004.
Hatch-Waxman in the Federal Courts: from 1994--2004.
Drug Dev Ind Pharm. 2005 Jan ;31(2):215-22.

PubMed
Generation: a corporate-sponsored retiree health care program.
Generation: a corporate-sponsored retiree health care program.
Gerontologist. 1992 Apr ;32(2):265-9.

PubMed
Mental illness and the use of restraints in nursing homes.
Mental illness and the use of restraints in nursing homes.
Gerontologist. 1992 Apr ;32(2):164-70.

PubMed
A mutation in the saposin A coding region of the prosaposin gene in an infant pr...
A mutation in the saposin A coding region of the prosaposin gene in an infant presenting as Krabbe disease: first report of saposin A deficiency in humans.
Mol Genet Metab. 2005 Feb ;84(2):160-6.

PubMed
Hammerhead ribozymes targeted against cyclin E and E2F1 cooperate to down-regula...
Hammerhead ribozymes targeted against cyclin E and E2F1 cooperate to down-regulate coronary smooth muscle cell proliferation.
J Gene Med. 2005 Sep ;7(9):1223-34.

PubMed

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

PubMed

Result Filters

Display Settings:

Send to: