
      Notwithstanding the provisions of section 154, the term of a
    patent which encompasses within its scope a composition of matter
    or a process for using such composition shall be extended if such
    composition or process has been subjected to a regulatory review by
    the Federal Food and Drug Administration pursuant to the Federal
    Food, Drug, and Cosmetic Act leading to the publication of
    regulation permitting the interstate distribution and sale of such
    composition or process and for which there has thereafter been a
    stay of regulation of approval imposed pursuant to section 409 of
    the Federal Food, Drug, and Cosmetic Act which stay was in effect
    on January 1, 1981, by a length of time to be measured from the
    date such stay of regulation of approval was imposed until such
    proceedings are finally resolved and commercial marketing
    permitted. The patentee, his heirs, successors or assigns shall
    notify the Director within ninety days of the date of enactment of
    this section or the date the stay of regulation of approval has
    been removed, whichever is later, of the number of the patent to be
    extended and the date the stay was imposed and the date commercial
    marketing was permitted. On receipt of such notice, the Director
    shall promptly issue to the owner of record of the patent a
    certificate of extension, under seal, stating the fact and length
    of the extension and identifying the composition of matter or
    process for using such composition to which such extension is
    applicable. Such certificate shall be recorded in the official file
    of each patent extended and such certificate shall be considered as
    part of the original patent, and an appropriate notice shall be
    published in the Official Gazette of the Patent and Trademark
    Office.

Last modified: April 19, 2006