Bayh-Dole Act

• See 35 USC 203, March-in Rights Held by Government, and 35 USC 200, Policy and Objective.
• Norvir and Xalatan. - In 2004, Essential Inventions, Inc. sought compulsory licenses through the Bayh-Dole Act for Norvir (an important AIDS drug) and Xalatan (a widely-used glacoma drug). The NIH denied the request. For more information, see the Essential Inventions hompage.
• Cellpro. The Cellpro petition was denied by the Clinton Administration, and Cellpro went bankrupt.
  • NIH: Correspondence and Submissions Relating to CellPro March-In Petition.
  • CPT: CellPro and Bayh-Dole March-in Rights
• June 4, 1998, Report of the National Institutes of Health (NIH) Working Group on Research Tools. See in particular, Appendix D, regarding the US government's compulsory licensing rights under the Bayh-Dole Act, a topic that has received more attention with respect to stem cell technologies.

• 42 USC Sec 7608, to provide mandatory licensing of air pollution prevention inventions under Title 42, the Public Health and Welfare. This is from the Clean Air Act.
• December 30, 1994. Environmental Protection Agency. Mandatory Patent Licenses Under Section 308 of the Clean Air Act. Final Rule.

Black Lung-Related Inventions

• 30 USC 937

  Any grant made pursuant to this subsection shall be conditioned upon all information, uses, products, processes, patents, and other developments resulting from such research being available to the general public, except to the extent of such exceptions and limitations as the Secretary of Health and Human Services may deem necessary in the public interest.

• 42 USC Sec 2183, for atomic energy.

  (a) Declaration of public interest
  The Commission may, after giving the patent owner an opportunity for a hearing, declare any patent to be affected with the public interest if (1) the invention or discovery covered by the patent is of primary importance in the production or utilization of special nuclear material or atomic energy; and (2) the licensing of such invention or discovery under this section is of primary importance to effectuate the policies and purposes of this chapter.
  (b) Action by Commission
  Whenever any patent has been declared affected with the public interest, pursuant to subsection (a) of this section - (1) the Commission is licensed to use the invention or discovery covered by such patent in performing any of its powers under this chapter; and (2) any person may apply to the Commission for a nonexclusive patent license to use the invention or discovery covered by such patent, and the Commission shall grant such patent license to the extent that it finds that the use of the invention or discovery is of primary importance to the conduct of an activity by such person authorized under this chapter.

• The standards for compensation to the patent owner are set out in 42 USC 2187, which reads in part:

  (1) In determining a reasonable royalty fee as provided for in section 2183(b) or 2183(e) of this title, the Commission shall take into consideration (A) the advice of the Patent Compensation Board; (B) any defense, general or special, that might be pleaded by a defendant in an action for infringement; (C) the extent to which, if any, such patent was developed through federally financed research; and (D) the degree of utility, novelty, and importance of the invention or discovery, and may consider the cost to the owner of the patent of developing such invention or discovery or acquiring such patent.

• See also, Sec. 2188. Monopolistic use of patents

In 1999 the US Supreme Court held that State governments are not liable for patent for copyright infringement under the constitutional doctrine of state immunity. The case involved a suit alleging that the State of Florida had infringed a patent for methods of calculating bond payments for its student loan program. The US Supreme court held that state governments could not be sued for patent infringement under the constitutional doctrine of state sovereign immunity.

• Florida Prepaid Postsecondary Education Expense Board v. College Savings Bank et al., No. 98-531. Argued April 20, 1999-Decided June 23, 1999.
• July 27, 2000. State Sovereign Immunity and Protection of Intellectual Property, hearing before the subcommittee on courts and intellectual property of the committee on the judiciary, house of representatives.
• Eugene Volokh Sovereign Immunity and Intellectual Property, originally published at 73 Southern California Law Review 1161 (2000).

If, at the end of ninety days after the date of delivery to the original data submitter of the offer to compensate, the original data submitter and the applicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreement on the amount and terms of compensation, either person may initiate binding arbitration proceedings by requesting the Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by such Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator.

• 107th Congress.
  • November 6, 2001. HR 3235, the 'Public Health Emergency Medicines Act.' This bill gives the Secretary of Health and Human Services broad discretion to issue complusory licenses to address public health emergencies. The Secretary can set royalties according to considerations spelled out in the legislation, and he or she can license goods for export under emergency situations. Documents related to this bill:
    • CPT comment on the Public Health Emergency Medicines Act.
    • November 8, 2001. Bill Zwillick for Reuters. Bill Would Allow Emergency Bypass of Drug Patents.
  • April 27, 2001. HR 1708, the 'Affordable Prescription Drugs and Medical Inventions Act.' This bill was introduced in the US Congress by Rep. Sherrod Brown. It would establish compulsory licensing for prescription drugs, and it would require pharmaceutical companies to disclose financial information necessary to evaluate the prices charged. For a brief overview, see the summary of the Bill from Rep. Brown's office.
• 106th Congress.
  • HR 2927, the `Affordable Prescription Drugs Act.' This bill was introduced in the US Congress on September 23, 1999, and provides for compulsory licensing of certain patented medical inventions.
  • September 23, 1999. Press release by BIO. BIO Strongly Opposes Compulsory Licensing Legislation.
• 104th Congress.
  • HR 4270. Introduced on September 27, 1996. Section 6 provided a government use compulsory licensing authority with respect to materials used in medical research.
• 103rd Congress.
  • HR 4151. This was titled the `Essential Pharmaceuticals Act of 1994'. It was introduced by Represent Jerry Nadler, and aimed at making RU-486 available in the USA.
  • In a March 3, 1994, Article (the link at kff.org has since disappeared), Congressman Jerry Nadler (D-NY) was quote as saying:

    My essential pharmaceuticals bill would, rather than outright canceling a patent, provide for subjecting a patent for a pharmaceutical to a compulsory-licensing procedure, akin to that now in place with respect to music copyrights. Where [HHS] determines (1) that a patent holder 'has not taken all the reasonable steps toward the commercial marketing' of the patented drug and (2) that the 'availability of the product to the public is of vital importance to the public health or welfare,' any pharmaceutical company could manufacture and sell the drug. A company that did so would be required to pay royalties, in an amount to be determined by the Commissioner of Patents and Trademarks to represent fair compensation to the patent holder."