< Back to S. 1538 (98th Congress, 1983–1984)

Text of Patent Law Amendments of 1983

This bill was enacted after being signed by the President on September 24, 1984. The text of the bill below is as of Sep 24, 1984 (Passed Congress/Enrolled Bill).

PUBLIC LAW 98-417—SEPT. 24, 1984                                    98 STAT. 1585

Public Law 98-417
98th Congress
                                    An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise the procedures for new       Sept. 24, 1984
  drug appHcations, to amend title 35, United States Code, to authorize the extension
  of the patents for certain regulated products, and for other purposes.                   [S. 1538]

   Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, That this Act may                       Drug Price
be cited as the "Drug Price Competition and Patent Term Restora-                        Competition and
                                                                                        Patent Term
tion Act of 1984".                                                                      Restoration Act
                                                                                        of 1984.
      TITLE I—ABBREVIATED NEW DRUG APPLICATIONS                                         21 u s e 301 note.

   SEC. 101. Section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355) is amended by redesignating subsection (j) as subsec-
tion (k) and inserting after subsection (i) the following:
   "(jXD Any person may file with the Secretary an abbreviated
application for the approval of a new drug.
   "(2)(A) An abbreviated application for a new drug shall contain—                     Labeling.
         "(i) information to show that the conditions of use prescribed,
      recommended, or suggested in the labeling proposed for the new
      drug have been previously approved for a drug listed under
      paragraph (6) (hereinafter in this subsection referred to as a
      'listed drug');
         "(ii)(I) if the listed drug referred to in clause (i) has only one
      active ingredient, information to show that the active ingredi-
      ent of the new drug is the same as that of the listed drug;
         "(II) if the listed drug referred to in clause (i) has more than
      one active ingredient, information to show that the active ingre-
      dients of the new drug are the same as those of the listed drug,
      or
         "(III) if the listed drug referred to in clause (i) has more than
      one active ingredient and if one of the active ingredients of the
      new drug is different and the application is filed pursuant to the
      approval of a petition filed under subparagraph (C), information
      to show that the other active ingredients of the new drug are
      the same as the active ingredients of the listed drug, informa-
      tion to show that the different active ingredient is an active
      ingredient of a listed drug or of a drug which does not meet the
      requirements of section 201(p), and such other information re-                    21 u s e 321.
      specting the different active ingredient with respect to which
      the petition was filed as the Secretary may require;
         "(iii) information to show that the route of administration,
      the dosage form, and the strength of the new drug are the same
      as those of the listed drug referred to in clause (i) or, if the route
      of administration, the dosage form, or the strength of the new
      drug is different and the application is filed pursuant to the
      approval of a petition filed under subparagraph (C), such infor-
      mation respecting the route of administration, dosage form, or
      strength with respect to which the petition was filed as the
      Secretary may require;

98 STAT. 1586 PUBLIC LAW 98-417—SEPT. 24, 1984 "(iv) information to show that the new drug is bioequivalent to the listed drug referred to in clause (i), except that if the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in clause (i) and the new drug can be expected to have the same therapeu- tic effect as the listed drug when administered to patients for a condition of use referred to in clause (i); "(v) information to show that the labeling proposed for the new drug is the same as the labeling approved for the listed drug referred to in clause (i) except for changes required be- cause of differences approved under a petition filed under sub- paragraph (C) or because the new drug and the listed drug are produced or distributed by different manufacturers; "(vi) the items specified in clauses (B) through (F) of subsec- tion (b)(1); Claims. "(vii) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the listed drug referred to in clause (i) or which claims a use for such listed drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b) or (c)— "(I) that such patent information has not been filed, "(11) that such patent has expired, "(III) of the date on which such patent will expire, or "(IV) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and "(viii) if with respect to the listed drug referred to in clause (i) information was filed under subsection (b) or (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. Prohibition. The Secretary may not require that an abbreviated application contain information in addition to that required by clauses (i) through (viii). "(BXi) An applicant who makes a certification described in sub- paragraph (A)(viiXIV) shall include in the application a statement that the applicant will give the notice required by clause (ii) to— "(I) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and Claims. "(II) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice, Marketing. "(ii) The notice referred to in clause (i) shall state that an applica- tion, which contains data from bioavailability or bioequivalence studies, has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed.
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1587 "(iii) If an application is amended to include a certification de- scribed in subparagraph (A)(vii)(IV), the notice required by clause (ii) shall be given when the amended application is submitted. "(C) If a person wants to submit an abbreviated application for a new drug which has a different active ingredient or whose route of administration, dosage form, or strength differ from that of a listed drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve or disapprove a petition submitted under this subparagraph within ninety days of the date the petition is submitted. The Secretary shall approve such a petition unless the Secretary finds— "(i) that investigations must be conducted to show the safety and effectiveness of the drug or of any of its active ingredients, the route of administration, the dosage form, or strength which differ from the listed drug; or "(ii) that any drug with a different active ingredient may not be adequately evaluated for approval as safe and effective on the bsisis of the information required to be submitted in an abbreviated application. "(3) Subject to paragraph (4), the Secretary shall approve an application for a drug unless the Secretary finds— "(A) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; "(B) information submitted with the application is insufficient to show that each of the proposed conditions of use have been previously approved for the listed drug referred to in the application; "(C)(i) if the listed drug has only one active ingredient, infor- mation submitted with the application is insufficient to show that the active ingredient is the same as that of the listed drug; "(ii) if the listed drug has more than one active ingredient, information submitted with the application is insufficient to show that the active ingredients are the same as the active ingredients of the listed drug, or "(iii) if the listed drug has more than one active ingredient and if the application is for a drug which has an active ingredi- ent different from the listed drug, information submitted with the application is insufficient to show— "(I) that the other active ingredients are the same as the active ingredients of the listed drug, or "(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the requirements of section 201(p), 21 USC 321. or no petition to file an application for the drug with the different ingredient was approved under paragraph (2XC); "(D)(i) if the application is for a drug whose route of adminis- tration, dosage form, or strength of the drug is the same as the route of administration, dosage form, or strength of the listed drug referred to in the application, information submitted in the application is insufficient to show that the route of adminis- tration, dosage form, or strength is the same as that of the listed drug, or "(ii) if the application is for a drug whose route of administra- tion, dosage form, or strength of the drug is different from that of the listed drug referred to in the application, no petition to
98 STAT. 1588 PUBLIC LAW 98-417—SEPT. 24, 1984 file an application for the drug with the different route of administration, dosage form, or strength was approved under paragraph (2XC); "(E) if the application was filed pursuant to the approval of a petition under paragraph (2XC), the application did not contain the information required by the Secretary respecting the active ingredient, route of administration, dosage form, or strength which is not the same; "(F) information submitted in the application is insufficient to show that the drug is bioequivalent to the listed drug referred to in the application or, if the application was filed pursuant to a petition approved under paragraph (2)(C), information submit- ted in the application is insufficient to show that the active ingredients of the new drug are of the same pharmacological or therapeutic class as those of the listed drug referred to in paragraph (2)(A)(i) and that the new drug can be expected to have the same therapeutic effect as the listed drug when admin- istered to patients for a condition of use referred to in such paragraph; Labeling. "(G) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the listed drug referred to in the application except for changes required because of differences approved under a petition filed under paragraph (2)(C) or be- cause the drug and the listed drug are produced or distributed by different manufacturers; "(H) information submitted in the application or any other information available to the Secretary shows that (i) the inac- tive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the label- ing proposed for the drug, or (ii) the composition of the drug is unsafe under such conditions because of the tjrpe or quantity of inactive ingredients included or the manner in which the inac- tive ingredients are included; "(I) the approval under subsection (c) of the listed drug re- ferred to in the application under this subsection has been withdrawn or suspended for grounds described in the first sentence of subsection (e), the Secretary has published a notice of opportunity for hearing to withdraw approval of the listed drug under subsection (c) for grounds described in the first sentence of subsection (e), the approval under this subsection of the listed drug referred to in the application under this subsec- tion has been withdrawn or suspended under paragraph (5), or the Secretary has determined that the listed drug has been withdrawn from sale for safety or effectiveness reasons; "(J) the application does not meet any other requirement of paragraph (2)(A); or "(K) the application contains an untrue statement of material fact. "(4XA) Within one hundred and eighty days of the initial receipt of an application under paragraph (2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application. Effective dates. "(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined under the following:
PUBLIC LAW 98-417—SEPT. "2l, 1984 98 STAT. 1589 "(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective immediately, "(ii) If the applicant made a certification described in sub- clause (III) of paragraph (2)(A)(vii), the approval may be made effective on the date certified under subclause (III). "(iii) If the applicant made a certification described in sub- Claims. clause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless an action is brought for infringe- ment of a patent which is the subject of the certification before the expiration of forty-five days from the date the notice pro- vided under paragraph (2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice pro- vided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that— "(I) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, "(II) if before the expiration of such period the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or Post, p. 1603. "(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of forty-five days from the date the notice made under paragraph (2)(B)(i) is received, no action may be brought under section 2201 of title 28, United States Code, for a declaratory judgment with respect Post, p. 1597. to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. "(iv) If the application contains a certification described in subclause (IV) of paragraph (2)(AXvii) and is for a drug for which a previous application has been submitted under this subsection continuing such a certification, the application shall be made effective not earlier than one hundred and eighty days after— "(I) the date the Secretary receives notice from the appli- cant under the previous application of the first commercial marketing of the drug under the previous application, or "(II) the date of a decision of a court in an action de- scribed in clause (iii) holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier. "(C) If the Secretary decides to disapprove an application, the Hearing Secretary shall give the applicant notice of an opportunity for a opportunity.
98 STAT. 1590 PUBLIC LAW 98-417—SEPT. 24, 1984 hearing before the Secretary on the question of whether such appli- cation is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the appli- cant otherwise agree. Any such hearing shall thereafter be con- ducted on an expedited basis and the Secretary's order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs. Prohibitions. "(D)(i) If an application (other than an abbreviated new drug application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration of ten years from the date of the approval of the application under subsec- tion (b). "(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredi- ent) of which has been approved in any other application under subsection (b), is approved after the date of the enactment of this subsection, no application may be submitted under this subsection which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under this subsection after the expira- tion of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii). Claims. The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period be- ginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. "(iii) If an application submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b), is approved after the date of enact- ment of this subsection and if such application contains reports of new clinical investigations (other than bioavailability studies) essen- tial to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the conditions of approval of such drug in the subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) for such drug. "(iv) If a supplement to an application approved under subsection (b) is approved after the date of enactment of this subsection and the supplement contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supple- ment and conducted or sponsored by the person submitting the
PUBLIC LAW 98-417—SfiPf. 24, 1984 98 STAT. 1591 supplement, the Secretary may not make the approval of an applica- tion submitted under this subsection for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b). "(v) If an application (or supplement to an application) submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b), was approved during the period beginning January 1,1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted or which refers to a change approved in a supplement to the subsection (b) application effective before the expiration of two years from the date of enactment of this subsection. "(5) If a drug approved under this subsection refers in its approved application to a drug the approval of which was withdrawn or "suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under this paragraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this subsection shall be withdrawn or suspended— "(A) for the same period as the withdrawal or suspension under subsection (e) or this paragraph, or "(B) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. "(6)(A)(i) Within sixty days of the date of the enactment of this Approved-drug subsection, the Secretary shall publish and make available to the list. public— Public availability. "(I) a list in alphabetical order of the official and proprietary name of each drug which has been approved for safety and effectiveness under subsection (c) before the date of the enact- ment of this subsection; "(II) the date of approval if the drug is approved after 1981 and the number of the application which was approved; and "(III) whether in vitro or in vivo bioequivalence studies, or both such studies, are required for applications filed under this subsection which will refer to the drug published. "(ii) Every thirty days after the publication of the first list under clause (i) the Secretry shall revise the list to include each drug which has been approved for safety and effectiveness under subsec- tion (c) or approved under this subsection during the thirty-day period. "(iii) When patent information submitted under subsection (b) or (c) respecting a drug included on the list is to be published by the Secretary the Secretary shall, in revisions made under clause (ii), include such information for such drug. "(B) A drug approved for safety and effectiveness under subsection (c) or approved under this subsection shall, for purposes of this subsection, be considered to have been published under subpara- graph (A) on the date of its approval or the date of enactment, whichever is later. "(C) If the approval of a drug was withdrawn or suspended for grounds described in the first sentence of subsection (e) or was withdrawn or suspended under paragraph (5) or if the Secretary
98 STAT. 1592 PUBLIC LAW 98-417—SEPT. 24, 1984 determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list— "(i) for the same period as the withdrawal or suspension under subsection (e) or paragraph (5), or "(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. Federal A notice of the removal shall be published in the Federal Register. Register, "(7) For purposes of this subsection: publication. "(A) The term 'bioavailability' means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action. "(B) A drug shall be considered to be bioequivalent to a listed drug if— "(i) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under simi- lar experimental conditions in either a single dose or multi- ple doses; or "(ii) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the listed drug when administered at the same molar dose of the therapeutic ingredient under similar experimental con- ditions in either a single dose or multiple doses and the difference from the listed drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug.". Claims. SEC. 102. (a)(1) Section 505(b) of such Act if amended by adding at 21 u s e 355. the end the following: "The applicant shall file with the application the patent number and the expiration date of any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the Public information required by the preceding sentence. Upon approval of information. the application, the Secretary shall publish information submitted under the two preceding sentences.". (2) Section 505(c) of such Act is amended by inserting "(1)" after "(c)", by redesignating paragraphs (1) and (2) as subparagraphs (A) and (B), respectively, and by adding at the end the following: Claims. "(2) If the patent information described in subsection (b) could not be filed with the submission of an application under subsection (b) because the application was filed before the patent information was required under subsection (b) or a patent was issued after the application was approved under such subsection, the holder of an
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1593 approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the drug for which the application was submitted or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent informa- tion under subsection (b) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than thirty days after the date of the enactment of this sentence, and if the holder of an approved applica- tion could not file patent information under subsection (b) because no patent had been issued when an application was filed or ap- proved, the holder shall file such information under this subsection not later than thirty days after the date the patent involved is issued. Upon the submission of patent information under this sub- Public section, the Secretary shall publish it.". information. (3)(A) The first sentence of section 505(d) of such Act is amended 21 u s e 355. by redesignating clause (6) as clause (7) and inserting after clause (5) the following: "(6) the application failed to contain the patent information prescribed by subsection (b); or". (B) The first sentence of section 505(e) of such Act is amended by redesignating clause (4) as clause (5) and inserting after clause (3) the following: "(4) the patent information prescribed by subsection (c) was not filed within thirty days after the receipt of written notice from the Secretary specifying the failure to file such information; or". (b)(1) Section 505(a) of such Act is amended by inserting "or (j)" after "subsection (b)". (2) Section 505(c) of such Act is amended by striking out "this Ante, p. 1592. subsection" and inserting in lieu thereof "subsection Ot))". (3) The second sentence of section 505(e) of such Act is amend- ed by inserting "submitted under subsection (b) or (j)" after "an application". (4) The second sentence of section 505(e) is amended by striking Supra. out "(j)" each place it occurs in clause (1) and inserting in lieu thereof "(k)". (5) Section 505(k)(l) of such Act (as so redesignated) is amended by Ante, p. 1585. striking out "pursuant to this section" and inserting in lieu thereof "under subsection (b) or (j)". (6) Subsections (a) and (b) of section 527 of such Act are each 21 u s e 360cc. amended by striking out "505(b)" each place it occurs and inserting in lieu thereof "505". SEC. 103. (a) Section 505(b) of such Act is amended by inserting Ante, p. 1592. "(1)" after "(b)", by redesignating clauses (1) through (6) as clauses (A) through (F), respectively, and by adding at the end the following: "(2) An application submitted under paragraph (1) for a drug for eiaims. which the investigations described in clause (A) of such paragraph and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted shall also include— "(A) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the drug for which such investigations were conducted or which claims a use for such drug for which the applicant is seeking
98 STAT. 1594 PUBLIC LAW 98-417—SEPT. 24, 1984 approval under this subsection and for which information is required to be filed under paragraph (1) or subsection (c)— "(i) that such patent information has not been filed, "(ii) that such patent has expired, "(iii) of the date on which such patent will expire, or "(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the application is submitted; and "(B) if with respect to the drug for which investigations described in paragraph (1)(A) were conducted information was filed under paragraph (1) or subsection (c) for a method of use patent which does not claim a use for which the applicant is seeking approval under this subsection, a statement that the method of use patent does not claim such a use. "(3)(A) An applicant who makes a certification described in para- graph (2)(A)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— "(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and Claims. "(ii) the holder of the approved application under subsection (b) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. Marketing. "(B) The notice referred to in subparagraph (A) shall state that an application has been submitted under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of the drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid or will not be infringed. "(C) If an application is amended to include a certification de- scribed in paragraph (2)(A)(iv), the notice required by subparagraph (B) shall be given when the amended application is submitted.", Ante, p. 1592. (b) Section 505(c) of such Act (as amended by section 102(a)(2)) is amended by adding at the end the following: Effective dates. "(3) The approval of an application filed under subsection 0>) which contains a certification required by paragraph (2) of such subsection shall be made effective on the last applicable date deter- mined under the following: "(A) If the applicant only made a certification described in clause (i) or (ii) of subsection (b)(2)(A) or in both such clauses, the approval may be made effective immediately. (B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A), the approval may be made effective on the date certified under clause (iii). Claims. "(C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expira- tion of forty-five days from the date the notice provided under paragraph (3XB) is received. If such an action is brought before the expiration of such days, the approval may be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (3XB) or such shorter or longer period as the court may order because
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1595 either party to the action failed to reasonably cooperate in expediting the action, except that— "(i) if before the expiration of such period the court decides that such patent is invalid or not infringed, the approval may be made effective on the date of the court decision, "(ii) if before the expiration of such period the court decides that such patent has been infringed, the approval may be made effective on such date as the court orders under section 271(eX4)(A) of title 35, United States Code, or Post, p. 1603. "(iii) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of forty-five days from the date the notice made under paragraph (3)(B) is re- ceived, no action may be brought under section 2201 of title 28, Post, p. 1597. United States Code, for a declaratory judgment with respect to the patent. Any action brought under such section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. "(D)(i) If an application (other than an abbreviated new drug Prohibitions. application) submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), was approved during the period beginning Janu- ary 1, 1982, and ending on the date of the enactment of this subsection, the Secretary may not make the approval of another application for a drug for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investi- gations were conducted effective before the expiration of ten years from the date of the approval of the application previously approved under subsection (b). "(ii) If an application submitted under subsection (b) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after the date of the enactment of this clause, no application which refers to the drug for which the subsection (b) application was submitted and for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted may be submitted under subsection (b) before the expiration of five years from the date of the approval of the application under subsection (b), except that such an application may be submitted under subsection (b) after the expiration of four years from the date of the approval of the subsection (b)
98 STAT. 1596 PUBLIC LAW 98-417—SEPT. 24, 1984 application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (b)(2)(A). ClEiims. The approval of such an application shall be made effective in accordance with this paragraph except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (C) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. "(iii) If an application submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b), is approved after the date of the enactment of this clause and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submit- ted under subsection (b) for the conditions of approval of such drug in the approved subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) if the investigations de- scribed in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investi- gations were conducted. "(iv) If a supplement to an application approved under subsec- tion (b) is approved after the date of enactment of this clause and the supplement contains reports of new clinical investiga- tions (other than bioavailabilty studies) essential to the ap- proval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b) for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b) if the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and if the applicant has not obtained a right of reference or use from the person by or for whom the investiga- tions were conducted. "(v) If an application (or supplement to an application) sub- mitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b), was approved during the period beginning January 1, 1982, and ending on the date of the enactment of this clause, the Secretary may not make the approval of an application submit- ted under this subsection and for which the investigations described in clause (A) of subsection (b)(1) and relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not ob- tained a right of reference or use from the person by or for whom the investigations were conducted and which refers to the
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1597 drug for which the subsection (b) application was submitted effective before the expiration of two years from the date of enactment of this clause.". SEC. 104. Section 505 of such Act is amended by adding at the end Ante, p. 1585. the following: "(1) Safety and effectiveness data and information which has been Public submitted in an application under subsection (b) for a drug and availability. which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circum- stances are shown— "(1) if no work is being or will be undertaken to have the application approved, "(2) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, "(3) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, "(4) if the Secretary has determined that such drug is not a new drug, or "(5) upon the effective date of the approval of the first applica- tion under subsection (j) which refers to such drug or upon the date upon which the approval of an application under subsec- tion (j) which refers to such drug could be made effective if such an application had been submitted. "(m) For purposes of this section, the term 'patent' means a patent issued by the Patent and Trademark Office of the Department of Commerce.". SEC. 105. (a) The Secretary of Health and Human Services shall Regulations. promulgate, in accordance with the notice and comment require- 21 u s e 355 note. ments of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 505 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101, 102, and 103 of this Act, within one year of the date of enactment of this Act. (b) During the period beginning sixty days after the date of the enactment of this Act and ending on the date regulations promul- gated under subsection (a) take effect, abbreviated new drug applica- tions may be submitted in accordance with the provisions of section 314.2 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 505(c) of the Federal Food, Drug, and Cosmetic Act before the date of the enactment of this Act. Ante, pp. If any such provision is inconsistent with the requirements of 1592-1594. section 505(j) of the Federal Food, Drug, and Cosmetic Act, the Ante, p. 1592. Secretary shall consider the application under the applicable re- quirements of such section. The Secretary of Health and Human Services may not approve such an abbreviated new drug application which is filed for a drug which is described in sections 505(cX3XD) and 505(jX4XD) of the Federal Food, Drug, and Cosmetic Act except Ante, p. 1594. in accordance with such section. SEC. 106. Section 2201 of title 28, United States Code, is amended by inserting "(a)" before "In a case" and by adding at the end the following: "(b) For limitations on actions brought with respect to drug patents see section 505 of the Federal Food, Drug, and Cosmetic Act.". Ante, p. 1585.
98 STAT. 1598 PUBLIC LAW 98-417—SEPT. 24, 1984 TITLE II—PATENT EXTENSION SEC. 201. (a) Title 35 of the United States Code is amended by adding the following new section immediately after section 155A: 35 u s e 156. "§ 156. Extension of patent term Claims. "(a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expira- tion date of the patent if— "(1) the term of the patent has not expired before an applica- tion is submitted under subsection (d) for its extension; "(2) the term of the patent has never been extended; "(3) an application for extension is submitted by the owner of record of the patent or its agent and in accordance with the requirements of subsection (d); "(4) the product has been subject to a regulatory review period before its commercial marketing or use; Marketing. "(5XA) except as provided in subparagraph (B), the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial mar- keting or use of the product under the provision of law under which such regulatory review period occurred; or "(B) in the case of a patent which claims a method of manu- facturing the product which primarily uses recombinant DNA technology in the manufacture of the product, the permission for the commercial marketing or use of the product after such regulatory review period is the first permitted commercial mar- keting or use of a product manufactured under the process claimed in the patent. The product referred to in paragraphs (4) and (5) is hereinafter in this section referred to as the 'approved product*. Claims. "(b) The rights derived from any patent the term of which is extended under this section shall during the period during which the patent is extended— "(1) in the case of a patent which claims a product, be limited to any use approved for the approved product before the expira- tion of the term of the patent under the provision of law under which the applicable regulatory review occurred; "(2) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent and approved for the approved product before the expiration of the term of the patent under the provision of law under which the applicable regulatory review occurred; and "(3) in the case of a patent which claims a method of manufac- turing a product, be limited to the method of manufacturing as used to make the approved product. "(c) The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that— "(1) each period of the regulatory review period shall be reduced by any period determined under subsection (dX2XB) during which the applicant for the patent extension did not act with due diligence during such period of the regulatory review period;
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1599 "(2) after any reduction required by paragraph (1), the period of extension shall include only one-half of the time remaining in the periods described in paragraphs (l)(B)(i), (2)(B)(i), and (3)(B)(i) of subsection (g); "(3) if the period remaining in the term of a patent after the date of the approval of the approved product under the provi- sion of law under which such regulatory review occurred when added to the regulatory review period as revised under para- graphs (1) and (2) exceeds fourteen years, the period of extension shall be reduced so that the total of both such periods does not exceed fourteen years; and "(4) in no event shall more than one patent be extended for Prohibition. the same regulatory review period for any product. "(d)(1) To obtain an extension of the term of a patent under this section, the owner of record of the patent or its agent shall submit an application to the Commissioner. Such an application may only be submitted within the sixty-day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use. The application shall contain— "(A) the identity of the approved product and the Federal statute under which regulatory review occurred; "(B) the identity of the patent for which an extension is being sought and the identity of each claim of such patent which claims the approved product or a method of using or manufac- turing the approved product; "(C) information to enable the Commissioner to determine under subsections (a) and (b) the eligibility of a patent for extension and the rights that will be derived from the extension and information to enable the Commissioner and the Secretary of Health and Human Services to determine the period of the extension under subsection (g); "(D) a brief description of the activities undertaken by the applicant during the applicable regulatory review period with respect to the approved product and the significant dates appli- cable to such activities; and "(E) such patent or other information as the Commissioner may require. "(2)(A) Within sixty days of the submittal of an application for extension of the term of a patent under paragraph (1), the Commis- sioner shall notify the Secretary of Health and Human Services if the patent claims any human drug product, a medical device, or a food additive or color additive or a method of using or manufactur- ing such a product, device, or additive and if the product, device, and additive are subject to the Federal Food, Drug, and Cosmetic Act, of 21 u s e 301. the extension application and shall submit to the Secretary a copy of the application. Not later than thirty days after the receipt of an Federal application from the Commissioner, the Secretary shall review the Register, publication. dates contained in the application pursuant to paragraph (1)(C) and determine the applicable regulatory review period, shall notify the Commissioner of the determination, and shall publish in the Federal Register a notice of such determination. "(B)(i) If a petition is submitted to the Secretary under subpara- Regulations. graph (A), not later than one hundred and eighty days after the publication of the determination under subparagraph (A), upon which it may reasonably be determined that the applicant did not act with due diligence during the applicable regulatory review
98 STAT. 1600 PUBLIC LAW 98-417—SEPT. 24, 1984 period, the Secretary shall, in accordance with regulations promul- gated by the Secretary determine if the applicant acted with due diligence during the applicable regulatory review period. The Secre- tary shall make such determination not later than ninety days after Prohibition. the receipt of such a petition. The Secretary may not delegate the authority to make the determination prescribed by this subpara- graph to an office below the Office of the Commissioner of Food and Drugs. Federal "(ii) The Secretary shall notify the Commissioner of the determi- Register, nation and shall publish in the Federal Register a notice of such publication. determination together with the factual and legal basis for such Hearing. determination. Any interested person may request, within the sixty- day period beginning on the publication of a determination, the Secretary to hold an informal hearing on the determination. If such a request is made within such period, the Secretary shall hold such hearing not later than thirty days after the date of the request, or at the request of the person making the request, not later than sixty days after such date. The Secretary shall provide notice of the hearing to the owner of the patent involved and to any interested person and provide the owner and any interested person an opportu- Federal nity to participate in the hearing. Within thirty days after the Register, completion of the hearing, the Secretary shall affirm or revise the publication. determination which was the subject of the hearing and notify the Commissioner of any revision of the determination and shall publish any such revision in the Federal Register. "(3) For the purposes of paragraph (2)(B), the term 'due diligence' means that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period. "(4) An application for the extension of the term of a patent is subject to the disclosure requirements prescribed by the Commissioner. "(e)(1) A determination that a patent is eligible for extension may be made by the Commissioner solely on the basis of the representa- tions contained in the application for the extension. If the Commis- sioner determines that a patent is eligible for extension under subsection (a) and that the requirements of subsection (d) have been complied with, the Commissioner shall issue to the applicant for the extension of the term of the patent a certificate of extension, under Records. seal, for the period prescribed by subsection (c). Such certificate shall be recorded in the official file of the patent and shall be considered as part of the original patent. "(2) If the term of a patent for which an application has been submitted under subsection (d) would expire before a certificate of extension is issued or denied under paragraph (1) respecting the application, the Commissioner shall extend, until such determina- tion is made, the term of the patent for periods of up to one year if he determines that the patent is eligible for extension. "(f) For purposes of this section: "(1) The term 'product' means: "(A) A human drug product. "(B) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and 21 u s e 301. Cosmetic Act. "(2) The term 'human drug product' means the active ingredi- ent of a new drug, antibiotic drug, or human biological product (as those terms are used in the Federal Food, Drug, and
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1601 Cosmetic Act and the Public Health Service Act) including any 21 use 301; 42 salt or ester of the active ingredient, as a single entity or in USC 201 note. combination with another active ingredient. "(3) The term 'major health or environmental effects test' means a test which is reasonably related to the evaluation of the health or environmental effects of a product, which requires at least six months to conduct, and the data from which is submitted to receive permission for commercial marketing or use. Periods of analysis or evaluation of test results are not to be included in determining if the conduct of a test required at least six months. "(4XA) Any reference to section 351 is a reference to section 351 ofthe Public Health Service Act. 42 use 262. "(B) Any reference to section 503, 505, 507, or 515 is a refer- ence to section 503, 505, 507, or 515 of the Federal Food, Drug, and Cosmetic Act. 21 use 353, 355, "(5) The term 'informal hearing' has the meaning prescribed ^57,360e. for such term by section 201(y) of the Federal Food, Drug, and Cosmetic Act. 21 use 321. "(6) The term 'patent' means a patent issued by the United States Patent and Trademark Office. "(g) For purposes of this section, the term 'regulatory review period' has the following meanings: "(IXA) In the case of a product which is a human drug product, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a human drug product is the sum of— "(i) the period beginning on the date an exemption under subsection (i) of section 505 or subsection (d) of section 507 21 use 355, 357. became effective for the approved humsin drug product and ending on the date an application was initially submitted for such drug product under section 351, 505, or 507, and "(ii) the period beginning on the date the application was initially submitted for the approved human drug product under section 351, subsection (b) of section 505, or section Ante, pp. 1592, 507 and ending on the date such application was approved i^^^. under such section. "(2XA) In the case of a product which is a food additive or color additive, the term means the period described in subpara- graph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a food or color additive is the sum of—- "(i) the period beginning on the date a major health or environmental effects test on the additive was initiated and ending on the date a petition was initially submitted with respect to the product under the Federal Fodd, Drug, and Cosmetic Act requesting the issuance of a regulation for use of the product, and "(ii) the period beginning on the date a petition was initially submitted with respect to the product under the Federal Food, Drug, and Cosmetic Act requesting the issu- > ance of a regulation for use of the product, and ending on the date such regulation became effective or, if objections were filed to such regulation, ending on the date such objections were resolved and commercial marketing was
98 STAT. 1602 PUBLIC LAW 98-417—SEPT. 24, 1984 permitted or, if commercial marketing was permitted and later revoked pending further proceedings as a result of such objections, ending on the date such proceedings were finally resolved and commercial marketing was permitted. "(3)(A) In the case of a product which is a medical device, the term means the period described in subparagraph (B) to which the limitation described in paragraph (4) applies. "(B) The regulatory review period for a medical device is the sum of^ "(i) the period beginning on the date a clinical investiga- tion on humans involving the device was begun and ending on the date an application was initially submitted with 21 use 360e. respect to the device under section 515, and "(ii) the period beginning on the date an application was initially submitted with respect to the device under section 515 and ending on the date such application was approved under such Act or the period beginning on the date a notice of completion of a product development protocol was ini- tially submitted under section 515(f)(5) and ending on the date the protocol was declared completed under section 515(f)(6). "(4) A period determined under any of the preceding para- graphs is subject to the following limitations: "(A) If the patent involved was issued after the date of the enactment of this section, the period of extension deter- mined on the basis of the regulatory review period deter- mined under any such paragraph may not exceed five years. "(B) If the patent involved was issued before the date of the enactment of this section and— "(i) no request for an exemption described in para- graph (1)(B) was submitted, "(ii) no major health or environmental effects test described in paragraph (2) was initiated and no petition for a regulation or application for registration described in such paragraph was submitted, or "(iii) no clinical investigation described in paragraph (3) was begun or product development protocol described in such paragraph was submittted, before such date for the approved product the period of extension determined on the basis of the regulatory review period determined under any such paragraph may not exceed five years. "(C) If the patent involved was issued before the date of the enactment of this section and if an action described in subparagraph (B) was taken before the date of the enact- ment of this section with respect to the approved product and the commercial marketing or use of the product has not been approved before such date, the period of extension determined on the basis of the regulatory review period determined under such paragraph may not exceed two years. Fees. "(h) The Commissioner may establish such fees as the Commis- sioner determines appropriate to cover the costs to the Office of receiving and acting upon applications under this section.". (b) The analysis for chapter 14 of title 35 of the United States Code is amended by adding at the end thereof the following:
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1603 "156. Extension of patent term.". SEC. 202. Section 271 of title 35, United States Code, is amended by Marketing. adding at the end the following: "(e)(1) It shall not be an act of infringement to make, use, or sell a patented invention (other than a new animal drug or veterinary biological product (as those terms are used in the Federal Food, Drug, and Cosmetic Act and the Act of March 4, 1913)) solely for 21 u s e 301, 151 uses reasonably related to the development and submission of infor- note. mation under a Federal law which regulates the manufacture, use, or sale of drugs. "(2) It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or Ante, p. 1585. described in section 505(b)(2) of such Act for a drug claimed in a Ante, p. 1593. patent or the use of which is claimed in a patent, if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug claimed in a patent or the use of which is claimed in a patent before the expiration of such patent. "(3) In any action for patent infringement brought under this section, no injunctive or other relief may be granted which would prohibit the making, using, or selling of a patented invention under paragraph (1). "(4) For an act of infringement described in paragraph (2)— "(A) the court shall order the effective date of any approval of the drug involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed, "(B) injunctive relief may be granted against an infringer to prevent the commercial manufacture, use, or sale of an approved drug, and "(C) damages or other monetary relief may be awarded against an infringer only if there has been commercial manu- facture, use, or sale of an approved drug. The remedies prescribed by subparagraphs (A), (B), and (C) are the only remedies which may be granted by a court for an act of infringement described in paragraph (2), except that a court may award attorney fees under section 285.". 35 u s e 285. SEC. 203. Section 282 of title 35, United States Code, is amended by adding at the end the following: "Invalidity of the extension of a patent term or any portion thereof under section 156 of this title Ante, p. 1598. because of the material failure— "(1) by the applicant for the extension, or "(2) by the Commissioner, to comply with the requirements of such section shall be a defense in any action involving the infringement of a patent during the period of the extension of its term and shall be pleaded. A due diligence determination under section 156(dX2) is not subject to review in such an action.". TITLE III—AMENDMENTS TO THE TEXTILE FIBER PROD- Labeling. UCTS IDENTIFICATION ACT AND THE WOOL PRODUCTS Hosiery. LABELING ACT OF 1939 SEC. 301. Subsection (b) of section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended by adding at the end thereof the following new paragraph:
98 STAT. 1604 PUBLIC LAW 98-417—SEPT. 24, 1984 "(5) If it is a textile fiber product processed or manufactured in the United States, it be so identified.". SEC. 302. Subsection (e) of section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended to read as follows: "<e) For purposes of this Act, in addition to the textile fiber products contained therein, a package of textile fiber products in- tended for sale to the ultimate consumer shall be misbranded unless such package has affixed to it a stamp, tag, label, or other means of identification bearing the information required by subsection (b), with respect to such contained textile fiber products, or is transpar- ent to the extent it allows for the clear reading of the stamp, tag, label, or other means of identification on the textile fiber product, or in the case of hosiery items, this section shall not be construed as requiring the affixing of a stamp, tag, label, or other means of identification to each hosiery product contained in a package if (1) such hosiery products are intended for sale to the ultimate con- sumer in such package, (2) such package has affixed to it a stamp, tag, label, or other means of identification bearing, with respect to the hosiery products contained therein, the information required by subsection (b), and (3) the information on the stamp, tag, label, or other means of identification affixed to such package is equally applicable with respect to each textile fiber product contained therein.". SEC. 303. Section 4 of the Textile Fiber Products Identification Act (15 U.S.C. 70b) is amended by adding at the end thereof the follow- ing new subsections: "(i) For the purposes of this Act, a textile fiber product shall be considered to be falsely or deceptively advertised in any mail order catalog or mail order promotional material which is used in the direct sale or direct offering for sale of such textile fiber product, unless such textile fiber product description states in a clear and conspicuous manner that such textile fiber product is processed or manufactured in the United States of America, or imported, or both. "(j) For purposes of this Act, any textile fiber product shall be misbranded if a stamp, tag, label, or other identification conforming to the requirements of this section is not on or affixed to the inside center of the neck midway between the shoulder seams or, if such product does not contain a neck, in the most conspicuous place on the inner side of such product, unless it is on or affixed on the outer side of such product, or in the case of hosiery items on the outer side of such product or package.". SEC. 304. Paragraph (2) of section 4(a) of the Wool Products Labeling Act of 1939 (15 U.S.C. 68b(aX2)) is amended by adding at the end thereof the following new subparagraph: "(D) the name of the country where processed or manu- SEC. 305. Section 4 of the Wool Products Labeling Act of 1939 (15 U.S.C. 68b) is amended by adding at the end thereof the following new subsections: "(e) For the purposes of this Act, a wool product shall be consid- ered to be falsely or deceptively advertised in any mail order promotional material which is used in the direct sale or direct offering for sale of such wool product, unless such wool product description states in a clear and conspicuous manner that such wool product is processed or manufactured in the United States of Amer- ica, or imported, or both.
PUBLIC LAW 98-417—SEPT. 24, 1984 98 STAT. 1605 "(f) For purposes of this Act, any wool product shall be mis- branded if a stamp, tag, label, or other identification conforming to the requirements of this section is not on or affixed to the inside center of the neck midway between the shoulder seams or, if such product does not contain a neck, in the most conspicuous place on the inner side of such product, unless it is on or affixed on the outer side of such product or in the case of hosiery items, on the outer side of such product or package.". SEC. 306. Section 5 of the Wool Products Labeling Act of 1939 (15 U.S.C. 68c) is amended— (1) by striking out "Any person" in the first paragraph and inserting in lieu thereof "(a) Any person", (2) by striking out "Any person" in the second paragraph and inserting in lieu thereof "(b) Any person", and (3) by inserting after subsection Ot)) (as designated by this section) the following new subsection: "(c) For the purposes of subsections (a) and Ot)) of this section, any package of wool products intended for sale to the ultimate consumer shall also be considered a wool product and shall have affixed to it a stamp, tag, label, or other means of identification bearing the information required by section 4, with respect to the wool products contained therein, unless such package of wool products is transpar- ent to the extent that it allows for the clear reading of the stamp, tag, label, or other means of identification affixed to the wool product, or in the case of hosiery items this section shall not be construed as requiring the affixing of a stamp, tag, label, or other means of identification to each hosiery product contained in a package if (1) such hosiery products are intended for sale to the ultimate consumer in such package, (2) such package has affixed to it a stamp, tag, label, or other means of identification bearing, with respect to the hosiery products contained therein, the information required by subsection (4), and (3) the information on the stamp, tag, label, or other means of identification affixed to such package is equally applicable with respect to each hosiery product contained therein.". SEC. 307. The amendments made by this title shall be effective Effective date, ninety days after the date of enactment of this Act. 15 USC 68b note. Approved September 24, 1984. LEGISLATIVE HISTORY—S. 1538 (H.R. 3605): HOUSE REPORT No. 98-857 accompanying H.R. 3605, Pt. 1 (Comm. on Energy and Commerce) and Pt. 2 (Comm. on the Judiciary). SENATE REPORT No. 98-547 (Comm. on the Judiciary). CONGRESSIONAL RECORD, Vol. 130 (1984): June 29, considered and passed Senate. Sept. 6, considered and passed House, amended, in lieu of H.R. 3605. Sept. 12, Senate concurred in House amendments. WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 20, No. 39 (1984): Sept. 24, Presidential statement.