Affordable Prescription Drugs and Medical Inventions Act

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.

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3 official files

• Introduced in House (text)

  Introduced in House · EN · 3 May 2001

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• Introduced in House (PDF)

  Introduced in House · EN · 3 May 2001

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• Introduced in House

  summary · EN · 3 May 2001

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