HOUSE 1344116th CongressReferred to the Subcommittee on Antitrust, Commercial, and Administrative Law.

Competitive DRUGS Act of 2019

Last Action: 3/25/2019

Actions

2019-03-25Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
2019-02-26Referred to the Subcommittee on Health.
2019-02-25Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
2019-02-25Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
2019-02-25Referred to the Committee on Ways and Means, and in addition to the Committees on Energy and Commerce, and the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
2019-02-25Referred to the Subcommittee on Health.
2019-02-25Introduced in House
2019-02-25Introduced in House

CRS Summary

As of 2019-02-25 (00)

Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019 or the Competitive DRUGS Act of 2019

This bill authorizes the Federal Trade Commission to initiate a proceeding against parties to an agreement resolving or settling a patent infringement claim in connection with the sale of a drug. Such an agreement is generally presumed to be an unfair method of competition and is a violation of this bill if the filer of the generic drug application receives something of value and agrees to limit or forgo research, development, manufacturing, marketing, or sales of the generic drug.

However, an agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market the generic drug prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on a claim that the generic drug infringes a patent. An agreement if also exempt if the agreement's pro-competitive benefits outweigh its anticompetitive effects.

The bill establishes penalties for violations of the bill.

Cosponsors (20)

EARL BLUMENAUER (D-OR)
Matt Cartwright (D-PA)
Judy Chu (D-CA)
ELIJAH CUMMINGS (D-MD)
ROSA DELAURO (D-CT)
Mark DeSaulnier (D-CA)
Raúl Grijalva (D-AZ)
Katie Hill (D-CA)
MARCY KAPTUR (D-OH)
Ro Khanna (D-CA)
Gwen Moore (D-WI)
GRACE NAPOLITANO (D-CA)
Alexandria Ocasio-Cortez (D-NY)
ELEANOR NORTON (D-DC)
Chellie Pingree (D-ME)
Mark Pocan (D-WI)
MAXINE WATERS (D-CA)
Peter Welch (D-VT)
JAMES LANGEVIN (D-RI)
John Garamendi (D-CA)

Subjects

Administrative remedies
Business expenses
Civil actions and liability
Competition and antitrust
Federal Trade Commission (FTC)
Income tax deductions
Intellectual property
Judicial review and appeals
Marketing and advertising
Prescription drugs
Research and development
Tax administration and collection, taxpayers

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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.