|Chapter IV: Misc Compulsory Licensing Programs|
Black Lung-Related Inventions
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.
(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.
(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.
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.
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.
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."