S. 3582Senate109th Congress (2005-2007)In Committee

Preserve Access to Affordable Generics Act

Sponsored by Herb KohlSen. Herb Kohl (D-WI)
Introduced June 27, 2006

Legislative Activity

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2 earlier actions
SenateIntro Referral Latest Action

Read twice and referred to the Committee on Commerce, Science, and Transportation. (text of measure as introduced in Senate: CR S6578)

June 27, 2006

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SenateIntro Referral

Introduced in Senate

June 27, 2006

SenateIntro Referral

Sponsor introductory remarks on measure. (CR S6577-6578)

June 27, 2006

SenateIntro Referral

Read twice and referred to the Committee on Commerce, Science, and Transportation. (text of measure as introduced in Senate: CR S6578)

June 27, 2006

Floor Debate

20 members

What members said about S. 3582 on the floor

6 Republicans14 Democrats
Orrin G. Hatch
Sen. Orrin G. HatchR-UT · Jun 27, 2006

Mr. President, I rise today to introduce the Health Savings Accounts Improvement and Expansion Act of 2006. This bill will make it easier for businesses to provide the option of an HSA to their…

Barack Obama
Sen. Barack ObamaD-IL · Sep 28, 2006

Mr. President, I rise today to introduce the Lead Poisoning Reduction Act of 2006. I am pleased that Senator Clinton is joining me in this effort. Lead is a poison we have known about for a long…

Daniel K. Akaka
Sen. Daniel K. AkakaD-HI · Sep 28, 2006

Mr. President, I rise to introduce ``The Intelligence Community Audit Act of 2006,'' with Senator Lautenberg which would reaffirm the Comptroller General of the United States and head of the…

John F. Kerry
Sen. John F. KerryD-MA · Jul 19, 2006

Mr. President, as the ranking member of the Committee on Small Business and Entrepreneurship, I am joined today by my colleagues Senators Snowe, Akaka, and Talent to introduce the Veterans…

Joseph R. Biden Jr.
Sen. Joseph R. Biden Jr.D-DE · Sep 28, 2006

Mr. President, I rise today to introduce the Homeland Security Trust Fund Act of 2006. And, I do so because it is my sincere belief, that in order to better prevent attacks here at home, we must…

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Hillary Rodham Clinton
Sen. Hillary Rodham ClintonD-NY · Sep 28, 2006

Mr. President, I am pleased today to introduce a bill that will help inform the Congress and the American people about our Nation's trade agreements. The trade policy debate here in Washington is…

Herb Kohl
Sen. Herb KohlD-WI · Sep 28, 2006

Mr. President, I rise today to introduce the Citizen Petition Fairness and Accuracy Act of 2006. This legislation will help speed the introduction of cost-saving generic drugs by preventing abuses of…

Barbara A. Mikulski
Sen. Barbara A. MikulskiD-MD · Jun 27, 2006

Mr. President, I rise today to support older Americans. Seniors today are living longer, healthier lives. We must do what we can to help them be as independent and active as possible. We have worked…

Mike DeWine
Sen. Mike DeWineR-OH · Jun 27, 2006

Mr. President, I rise today with my colleagues on the Health, Education, Labor, and Pensions Committee--Chairman Enzi, Ranking Member Kennedy, and Senator Mikulski--as we join in the introduction of…

Michael B. Enzi
Sen. Michael B. EnziR-WY · Jun 27, 2006

Mr. President, I rise today to join Senator DeWine, Senator Kennedy and Senator Mikulski in introducing the Older Americans Act Amendments of 2006. The Older Americans Act Amendments of 2006 is the…

Barack Obama
Sen. Barack ObamaD-IL · Jul 19, 2006

Mr. President, 33 years ago, this Nation faced a crisis that touched every American. In 1973, in the shadow of a war against Israel, the Arab nations of OPEC decided to embargo shipments of crude oil…

Barbara Boxer
Sen. Barbara BoxerD-CA · Sep 28, 2006

Mr. President, today I rise to introduce the Latina Health Access Act. This important legislation addresses the serious health care access barriers, and consequently higher incidences of disease and…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Jun 27, 2006

Mr. President. I am pleased to introduce, with Senators Kohl, Grassley, and Schumer, the Preserve Access to Affordable Generics Act of 2006, S. 3582. It is no secret that prescription drug prices are…

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Jeff Bingaman
Sen. Jeff BingamanD-NM · Sep 28, 2006

Mr. President, the legislation I am introducing today, entitled the ``Community Health Workers Act of 2006,'' would improve access to health education and outreach services to women in medically…

William H. Frist
Sen. William H. FristR-TN · Sep 28, 2006

Mr. President, 6 years ago, my great-nephew had some peanut butter. He was 13 months old. For most 13-month-old children, this wouldn't be an issue. But for McClain Portis, it was. You see,…

Daniel K. Akaka
Sen. Daniel K. AkakaD-HI · Jun 27, 2006

Mr. Mr. President, I rise today to introduce the Federal Supervisor Training Act, FSTA, which addresses the inconsistencies and lack of adequate training for Federal managers and supervisors,…

Craig Thomas
Sen. Craig ThomasR-WY · Sep 28, 2006

Mr. President, I am pleased to rise today to introduce the ``Access to Physical Medicine and Rehabilitation Services Improvement Act of 2006.'' This bill would improve patient access to physical…

Christopher J. Dodd
Sen. Christopher J. DoddD-CT · Sep 28, 2006

Mr. President, food allergies are an increasing food safety and public health concern in this country, especially among young children. I know first-hand just how frightening food allergies can be in…

Patrick J. Leahy
Sen. Patrick J. LeahyD-VT · Jul 19, 2006

Mr. President, recently I was pleased to introduce with Senators Kohl, Grassley and Schumer, the Preserve Access to Affordable Generics Act of 2006, S. 3582. That bill was designed to improve the…

Edward M. Kennedy
Sen. Edward M. KennedyD-MA · Jun 27, 2006

Mr. President, the Older Americans Act has been a lifeline for senior citizens across the country for 40 years, and all of us want it to continue to fulfill its important role in the years ahead.…

John D. Rockefeller IV
Sen. John D. Rockefeller IVD-WV · Jul 19, 2006

Mr. President, I rise today with Senators Schumer and Leahy to introduce an important piece of legislation for seniors, individual with disabilities, children, and anyone who is taking a brand name…

Chuck Grassley
Sen. Chuck GrassleyR-IA · Sep 28, 2006

Mr. President, I am pleased to introduce the ``Fiscal Accountability, Integrity and Responsibility in SCHIP'' or FAIR-SCHIP Act. I am pleased to be joined in this effort by Senator Johnny Isakson,…

Herb Kohl
Sen. Herb KohlD-WI · Jun 27, 2006

Mr. President, yesterday, the Supreme Court refused to consider an appeal by the Federal Trade Commission to reinstate antitrust charges against a brand-name drugmaker. This decision leaves the FTC…

Richard J. Durbin
Sen. Richard J. DurbinD-IL · Sep 28, 2006

Mr. President, when companies make headlines today it is often for all the wrong reasons: fraud, tax avoidance, profiteering, etc. Yet many of the companies that are currently providing jobs across…

Bill Text

Latest available legislative text

Reading Mode
Latest
Introduced in SenateIssued June 27, 2006

II

109th CONGRESS

2d Session

S. 3582

IN THE SENATE OF THE UNITED STATES

June 27, 2006

Mr. Kohl (for himself, Mr. Leahy, Mr. Grassley, and Mr. Schumer) introduced the following bill; which was read twice and referred to the Committee on Commerce, Science, and Transportation

A BILL

To prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

1.

Short title

This Act may be cited as the Preserve Access to Affordable Generics Act.

2.

Unfair competition

Section 5 of the Federal Trade Commission Act (15 U.S.C. 45) is amended by adding at the end the following:

(o)
(1)

It shall be considered an unfair method of competition affecting commerce under subsection (a)(1) for a person, in connection with the sale of a drug product, to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which—

(A)

an ANDA filer receives anything of value; and

(B)

the ANDA filer agrees not to research, develop, manufacture, market, or sell the ANDA product for any period of time.

(2)

Construction

Nothing in this subsection shall prohibit a resolution or settlement of patent infringement claim in which the value paid by the NDA holder to the ANDA filer as a part of the resolution or settlement of the patent infringement claim includes no more than the right to market the ANDA product prior to the expiration of the patent that is the basis for the patent infringement claim.

(3)

In this subsection:

(A)

The term ANDA means an abbreviated new drug application, as defined under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).

(B)

The term ANDA filer means a party who has filed an ANDA with the Federal Drug Administration.

(C)

The term ANDA product means the product to be manufactured under the ANDA that is the subject of the patent infringement claim.

(D)

The term drug product means a finished dosage form (e.g., tablet, capsule, or solution) that contains a drug substance, generally, but not necessarily, in association with 1 or more other ingredients, as defined in section 314.3(b) of title 21, Code of Federal Regulations.

(E)

The term NDA means a new drug application, as defined under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)).

(F)

The term NDA holder means—

(i)

the party that received FDA approval to market a drug product pursuant to an NDA;

(ii)

a party owning or controlling enforcement of the patent listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the FDA Orange Book) in connection with the NDA; or

(iii)

the predecessors, subsidiaries, divisions, groups, and affiliates controlled by, controlling, or under common control with any of the entities described in subclauses (i) and (ii) (such control to be presumed by direct or indirect share ownership of 50 percent or greater), as well as the licensees, licensors, successors, and assigns of each of the entities.

(G)

The term patent infringement means infringement of any patent or of any filed patent application, extension, reissue, renewal, division, continuation, continuation in part, reexamination, patent term restoration, patents of addition and extensions thereof.

(H)

The term patent infringement claim means any allegation made to an ANDA filer, whether or not included in a complaint filed with a court of law, that its ANDA or ANDA product may infringe any patent held by, or exclusively licensed to, the NDA holder of the drug product.

.