HR 1708
107th Congress
House
Commerce
Administrative remedies
Auditing
Civil actions and liability
Collection of accounts
Commercialization
Compensation (Law)
Congress
Congressional reporting requirements
Department of Health and Human Services
Drug industry
Drugs
Economics and Public Finance
Federal Trade Commission
Federal aid to medical research
Finance and Financial Sector
Fines (Penalties)
Government Operations and Politics
Government paperwork
Health
Affordable Prescription Drugs and Medical Inventions Act
Introduced: May 3, 2001
See on congress.gov
Everywhere this bill has been
4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 15, 2001
Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.
May 9, 2001
Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
May 3, 2001
Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, 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.
May 3, 2001
Introduced in House
Plain-English summary
Affordable Prescription Drugs and Medical Inventions Act - Amends Federal patent law to grant the Secretary of Health and Human Services and the Federal Trade Commission the right to establish compulsory licensing (without authorization of the right holder) for use of patented inventions relating to health care upon a determination that: (1) the patent holder, contractor, licensee, or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in a field of use; (2) establishing other use of the subject matter of the patent is necessary to alleviate health or safety needs which are not adequately satisfied by the patent holder, contractor, licensee, or assignee; (3) the patent holder has engaged in specified anticompetitive behavior, including excessive pricing; (4) an invention covered by a patent cannot be exploited without infringing upon the first patent, insofar as the invention claimed in the second patent involves an important technical advance; or (5) the invention claimed in the patent is needed for research purposes that would benefit the public health, and is not licensed on reasonable terms and conditions.
Requires any person engaged in the manufacture and sale of any new drug or new animal drug approved under the Federal Food, Drug, and Cosmetic Act, and for which a patent is still in effect, to report annually to the Secretary of Health and Human Services an audit of all financial information relevant to that drug's pricing nationally and internationally, including research and development costs. Establishes civil penalties for noncompliance.
What's happening now
Referred to the Subcommittee on Health, for a period to be subsequently determined by the Chairman.