-CITE-

35 USC CHAPTER 14 - ISSUE OF PATENT 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

CHAPTER 14 - ISSUE OF PATENT

-MISC1-

Sec.

151. Issue of patent.

152. Issue of patent to assignee.

153. How issued.

154. Contents and term of patent; provisional rights.

155. Patent term extension.

155A. Patent term restoration.

156. Extension of patent term.

157. Statutory invention registration.

AMENDMENTS

1999 - Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec.

4507(6)], Nov. 29, 1999, 113 Stat. 1536, 1501A-566, inserted ";

provisional rights" after "patent" in item 154.

1984 - Pub. L. 98-622, title I, Sec. 102(b), Nov. 8, 1984, 98

Stat. 3384, added item 157.

Pub. L. 98-417, title II, Sec. 201(b), Sept. 24, 1984, 98 Stat.

1602, added item 156.

1983 - Pub. L. 98-127, Sec. 4(b), Oct. 13, 1983, 97 Stat. 833,

added item 155A.

Pub. L. 97-414, Sec. 11(b), Jan. 4, 1983, 96 Stat. 2066, added

item 155.

1965 - Pub. L. 89-83, Sec. 6, July 24, 1965, 79 Stat. 261,

substituted "Issue of patent" for "Time of issue of patent" in item

151.

-End-

-CITE-

35 USC Sec. 151 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 151. Issue of patent

-STATUTE-

If it appears that applicant is entitled to a patent under the

law, a written notice of allowance of the application shall be

given or mailed to the applicant. The notice shall specify a sum,

constituting the issue fee or a portion thereof, which shall be

paid within three months thereafter.

Upon payment of this sum the patent shall issue, but if payment

is not timely made, the application shall be regarded as abandoned.

Any remaining balance of the issue fee shall be paid within three

months from the sending of a notice thereof and, if not paid, the

patent shall lapse at the termination of this three-month period.

In calculating the amount of a remaining balance, charges for a

page or less may be disregarded.

If any payment required by this section is not timely made, but

is submitted with the fee for delayed payment and the delay in

payment is shown to have been unavoidable, it may be accepted by

the Director as though no abandonment or lapse had ever occurred.

-SOURCE-

(July 19, 1952, ch. 950, 66 Stat. 803; Pub. L. 89-83, Sec. 4, July

24, 1965, 79 Stat. 260; Pub. L. 93-601, Sec. 3, Jan. 2, 1975, 88

Stat. 1956; Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV,

Sec. 4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A-582;

Pub. L. 107-273, div. C, title III, Sec. 13206(b)(1)(B), Nov. 2,

2002, 116 Stat. 1906.)

-MISC1-

HISTORICAL AND REVISION NOTES

Based on Title 35, U.S.C., 1946 ed., Sec. 41 (R.S. 4885, amended

(1) May 23, 1908, ch. 189, 35 Stat. 246, (2) Aug. 9, 1939, Sec. 2,

ch. 619, 53 Stat. 1293).

Language is changed.

AMENDMENTS

2002 - Pub. L. 107-273 made technical correction to directory

language of Pub. L. 106-113. See 1999 Amendment note below.

1999 - Pub. L. 106-113, as amended by Pub. L. 107-273,

substituted "Director" for "Commissioner" in last par.

1975 - Pub. L. 93-601 substituted "and the delay in payment is

shown to have been unavoidable," for "within three months after the

due date and sufficient cause is shown for the late payment," in

last par.

1965 - Pub. L. 89-83 substituted provisions requiring a notice of

allowance to be sent to the applicant, the notice of allowance to

specify a sum, constituting the issue fee or a portion thereof,

which shall be paid within 3 months thereafter, the patent to issue

upon payment of this sum, the application to be deemed abandoned if

the sum is not paid, and any remaining balance of the fee to be

paid within 3 months after issuance of the patent shall lapse, and

permitting the Commissioner within 3 months after the due date of

an unpaid fee on a showing of sufficient cause to accept late

payment as though no abandonment or lapse had occurred, for

provisions which required a notice of allowance to be sent to the

applicant, the final fee to be paid within 6 months after the

notice, the patent to be issued within 3 months from the date of

the payment, and which permitted delayed payment of the issue fee

up to 1 year.

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L.

106-113, set out as a note under section 1 of this title.

EFFECTIVE DATE OF 1975 AMENDMENT

Amendment by Pub. L. 93-601 effective Jan. 2, 1975, with

examiners-in-chief in office on such date to continue with existing

appointment, see section 4(b) of Pub. L. 93-601, set out as a note

under section 3 of this title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-83 effective three months after July 24,

1965, see section 7(a) of Pub. L. 89-83, set out as a note under

section 41 of this title.

ACCEPTANCE OF LATE PAYMENT OF ISSUE FEES BY COMMISSIONER

Section 4(a) of Pub. L. 93-601 provided that: "The Commissioner

of Patents [now Under Secretary of Commerce for Intellectual

Property and Director of the United States Patent and Trademark

Office] may, in accordance with Section 3 of this Act [amending

this section], accept late payment of issue fees, the payment of

which was governed by the provisions of Public Law 89-93 [probably

should refer to Public Law 89-83, which amended sections 41, 112,

and 151 of this title and section 1113 of Title 15, Commerce and

Trade]; Provided: the term of the patent for which late payment of

such an issue fee is accepted shall expire earlier than the time

specified in Section 154 of Title 35, United States Code by a

period equal to the delay between the time the application became

abandoned or the patent lapsed for failure to pay the issue fee and

the time the late payment is accepted after enactment of this Act

[Jan. 2, 1975]; Further Provided: no patent with respect to which

the issue fee was governed by the provisions of PL 89-83 and for

which a late payment of the issue fee is accepted under the

authority created by Section 3 of this Act, shall abridge or affect

the right of any person or his successors in business who made,

purchased or used anything covered by the patent, after the date of

the application became abandoned or patent lapsed for failure to

pay the issue fee but prior to the grant or restoration of the

patent, to continue the use of or to sell to others to be used or

sold, the specific thing so made, purchased, or used. A court

before which such matter is in question may provide for the

continued manufacture, use or sale of the thing made, purchased or

used as specified, or for the manufacture, use or sale of which

substantial preparation was made after the date the application

became abandoned or patent lapsed for failure to pay the fee but

prior to the grant or restoration of the patent, and it may also

provide for the continued practice of any process covered by the

patent, practiced, or for the practice of which substantial

preparation was made, after the date the application became

abandoned or patent lapsed for failure to pay the issue fee but

prior to the grant or restoration of the patent, to the extent and

under such terms as the court deems equitable for the protection of

investments made or business commenced before the grant or

restoration of the patent."

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 41, 154, 267 of this

title.

-End-

-CITE-

35 USC Sec. 152 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 152. Issue of patent to assignee

-STATUTE-

Patents may be granted to the assignee of the inventor of record

in the Patent and Trademark Office, upon the application made and

the specification sworn to by the inventor, except as otherwise

provided in this title.

-SOURCE-

(July 19, 1952, ch. 950, 66 Stat. 804; Pub. L. 93-596, Sec. 1, Jan.

2, 1975, 88 Stat. 1949.)

-MISC1-

HISTORICAL AND REVISION NOTES

Based on Title 35, U.S.C., 1946 ed., Sec. 44 (R.S. 4895).

Language is changed and the reference to reissue is omitted in

view of the general provision in section 251.

AMENDMENTS

1975 - Pub. L. 93-596 substituted "Patent and Trademark Office"

for "Patent Office".

EFFECTIVE DATE OF 1975 AMENDMENT

Amendment by Pub. L. 93-596 effective Jan. 2, 1975, see section 4

of Pub. L. 93-596, set out as a note under section 1111 of Title

15, Commerce and Trade.

-End-

-CITE-

35 USC Sec. 153 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 153. How issued

-STATUTE-

Patents shall be issued in the name of the United States of

America, under the seal of the Patent and Trademark Office, and

shall be signed by the Director or have his signature placed

thereon and shall be recorded in the Patent and Trademark Office.

-SOURCE-

(July 19, 1952, ch. 950, 66 Stat. 804; Pub. L. 93-596, Sec. 1, Jan.

2, 1975, 88 Stat. 1949; Pub. L. 106-113, div. B, Sec. 1000(a)(9)

[title IV, Sec. 4732(a)(10)(A)], Nov. 29, 1999, 113 Stat. 1536,

1501A-582; Pub. L. 107-273, div. C, title III, Secs. 13203(c),

13206(b)(1)(B), Nov. 2, 2002, 116 Stat. 1902, 1906.)

-MISC1-

HISTORICAL AND REVISION NOTES

Based on Title 35, U.S.C., 1946 ed., Sec. 39 (R.S. 4883, amended

(1) Feb. 18, 1888, ch. 15, 25 Stat. 40, (2) April 11, 1903, ch.

417, 32 Stat. 95, (3) Feb. 18, 1922, ch. 58, Sec. 5, 42 Stat. 391).

The phrases referring to the attesting officers and to the

recording of the patents are broadened.

AMENDMENTS

2002 - Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical

correction to directory language of Pub. L. 106-113. See 1999

Amendment note below.

Pub. L. 107-273, Sec. 13203(c), struck out "and attested by an

officer of the Patent and Trademark Office designated by the

Director," after "signature placed thereon".

1999 - Pub. L. 106-113, as amended by Pub. L. 107-273, Sec.

13206(b)(1)(B), substituted "Director" for "Commissioner" in two

places.

1975 - Pub. L. 93-596 substituted "Patent and Trademark Office"

for "Patent Office" wherever appearing.

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L.

106-113, set out as a note under section 1 of this title.

EFFECTIVE DATE OF 1975 AMENDMENT

Amendment by Pub. L. 93-596 effective Jan. 2, 1975, see section 4

of Pub. L. 93-596, set out as a note under section 1111 of Title

15, Commerce and Trade.

-End-

-CITE-

35 USC Sec. 154 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 154. Contents and term of patent; provisional rights

-STATUTE-

(a) In General. -

(1) Contents. - Every patent shall contain a short title of the

invention and a grant to the patentee, his heirs or assigns, of

the right to exclude others from making, using, offering for

sale, or selling the invention throughout the United States or

importing the invention into the United States, and, if the

invention is a process, of the right to exclude others from

using, offering for sale or selling throughout the United States,

or importing into the United States, products made by that

process, referring to the specification for the particulars

thereof.

(2) Term. - Subject to the payment of fees under this title,

such grant shall be for a term beginning on the date on which the

patent issues and ending 20 years from the date on which the

application for the patent was filed in the United States or, if

the application contains a specific reference to an earlier filed

application or applications under section 120, 121, or 365(c) of

this title, from the date on which the earliest such application

was filed.

(3) Priority. - Priority under section 119, 365(a), or 365(b)

of this title shall not be taken into account in determining the

term of a patent.

(4) Specification and drawing. - A copy of the specification

and drawing shall be annexed to the patent and be a part of such

patent.

(b) Adjustment of Patent Term. -

(1) Patent term guarantees. -

(A) Guarantee of prompt patent and trademark office

responses. - Subject to the limitations under paragraph (2), if

the issue of an original patent is delayed due to the failure

of the Patent and Trademark Office to -

(i) provide at least one of the notifications under section

132 of this title or a notice of allowance under section 151

of this title not later than 14 months after -

(I) the date on which an application was filed under

section 111(a) of this title; or

(II) the date on which an international application

fulfilled the requirements of section 371 of this title;

(ii) respond to a reply under section 132, or to an appeal

taken under section 134, within 4 months after the date on

which the reply was filed or the appeal was taken;

(iii) act on an application within 4 months after the date

of a decision by the Board of Patent Appeals and

Interferences under section 134 or 135 or a decision by a

Federal court under section 141, 145, or 146 in a case in

which allowable claims remain in the application; or

(iv) issue a patent within 4 months after the date on which

the issue fee was paid under section 151 and all outstanding

requirements were satisfied,

the term of the patent shall be extended 1 day for each day

after the end of the period specified in clause (i), (ii),

(iii), or (iv), as the case may be, until the action described

in such clause is taken.

(B) Guarantee of no more than 3-year application pendency. -

Subject to the limitations under paragraph (2), if the issue of

an original patent is delayed due to the failure of the United

States Patent and Trademark Office to issue a patent within 3

years after the actual filing date of the application in the

United States, not including -

(i) any time consumed by continued examination of the

application requested by the applicant under section 132(b);

(ii) any time consumed by a proceeding under section

135(a), any time consumed by the imposition of an order under

section 181, or any time consumed by appellate review by the

Board of Patent Appeals and Interferences or by a Federal

court; or

(iii) any delay in the processing of the application by the

United States Patent and Trademark Office requested by the

applicant except as permitted by paragraph (3)(C),

the term of the patent shall be extended 1 day for each day

after the end of that 3-year period until the patent is issued.

(C) Guarantee or adjustments for delays due to interferences,

secrecy orders, and appeals. - Subject to the limitations under

paragraph (2), if the issue of an original patent is delayed

due to -

(i) a proceeding under section 135(a);

(ii) the imposition of an order under section 181; or

(iii) appellate review by the Board of Patent Appeals and

Interferences or by a Federal court in a case in which the

patent was issued under a decision in the review reversing an

adverse determination of patentability,

the term of the patent shall be extended 1 day for each day of

the pendency of the proceeding, order, or review, as the case

may be.

(2) Limitations. -

(A) In general. - To the extent that periods of delay

attributable to grounds specified in paragraph (1) overlap, the

period of any adjustment granted under this subsection shall

not exceed the actual number of days the issuance of the patent

was delayed.

(B) Disclaimed term. - No patent the term of which has been

disclaimed beyond a specified date may be adjusted under this

section beyond the expiration date specified in the disclaimer.

(C) Reduction of period of adjustment. -

(i) The period of adjustment of the term of a patent under

paragraph (1) shall be reduced by a period equal to the

period of time during which the applicant failed to engage in

reasonable efforts to conclude prosecution of the

application.

(ii) With respect to adjustments to patent term made under

the authority of paragraph (1)(B), an applicant shall be

deemed to have failed to engage in reasonable efforts to

conclude processing or examination of an application for the

cumulative total of any periods of time in excess of 3 months

that are taken to respond to a notice from the Office making

any rejection, objection, argument, or other request,

measuring such 3-month period from the date the notice was

given or mailed to the applicant.

(iii) The Director shall prescribe regulations establishing

the circumstances that constitute a failure of an applicant

to engage in reasonable efforts to conclude processing or

examination of an application.

(3) Procedures for patent term adjustment determination. -

(A) The Director shall prescribe regulations establishing

procedures for the application for and determination of patent

term adjustments under this subsection.

(B) Under the procedures established under subparagraph (A),

the Director shall -

(i) make a determination of the period of any patent term

adjustment under this subsection, and shall transmit a notice

of that determination with the written notice of allowance of

the application under section 151; and

(ii) provide the applicant one opportunity to request

reconsideration of any patent term adjustment determination

made by the Director.

(C) The Director shall reinstate all or part of the

cumulative period of time of an adjustment under paragraph

(2)(C) if the applicant, prior to the issuance of the patent,

makes a showing that, in spite of all due care, the applicant

was unable to respond within the 3-month period, but in no case

shall more than three additional months for each such response

beyond the original 3-month period be reinstated.

(D) The Director shall proceed to grant the patent after

completion of the Director's determination of a patent term

adjustment under the procedures established under this

subsection, notwithstanding any appeal taken by the applicant

of such determination.

(4) Appeal of patent term adjustment determination. -

(A) An applicant dissatisfied with a determination made by

the Director under paragraph (3) shall have remedy by a civil

action against the Director filed in the United States District

Court for the District of Columbia within 180 days after the

grant of the patent. Chapter 7 of title 5 shall apply to such

action. Any final judgment resulting in a change to the period

of adjustment of the patent term shall be served on the

Director, and the Director shall thereafter alter the term of

the patent to reflect such change.

(B) The determination of a patent term adjustment under this

subsection shall not be subject to appeal or challenge by a

third party prior to the grant of the patent.

(c) Continuation. -

(1) Determination. - The term of a patent that is in force on

or that results from an application filed before the date that is

6 months after the date of the enactment of the Uruguay Round

Agreements Act shall be the greater of the 20-year term as

provided in subsection (a), or 17 years from grant, subject to

any terminal disclaimers.

(2) Remedies. - The remedies of sections 283, 284, and 285 of

this title shall not apply to acts which -

(A) were commenced or for which substantial investment was

made before the date that is 6 months after the date of the

enactment of the Uruguay Round Agreements Act; and

(B) became infringing by reason of paragraph (1).

(3) Remuneration. - The acts referred to in paragraph (2) may

be continued only upon the payment of an equitable remuneration

to the patentee that is determined in an action brought under

chapter 28 and chapter 29 (other than those provisions excluded

by paragraph (2)) of this title.

(d) Provisional Rights. -

(1) In general. - In addition to other rights provided by this

section, a patent shall include the right to obtain a reasonable

royalty from any person who, during the period beginning on the

date of publication of the application for such patent under

section 122(b), or in the case of an international application

filed under the treaty defined in section 351(a) designating the

United States under Article 21(2)(a) of such treaty, the date of

publication of the application, and ending on the date the patent

is issued -

(A)(i) makes, uses, offers for sale, or sells in the United

States the invention as claimed in the published patent

application or imports such an invention into the United

States; or

(ii) if the invention as claimed in the published patent

application is a process, uses, offers for sale, or sells in

the United States or imports into the United States products

made by that process as claimed in the published patent

application; and

(B) had actual notice of the published patent application

and, in a case in which the right arising under this paragraph

is based upon an international application designating the

United States that is published in a language other than

English, had a translation of the international application

into the English language.

(2) Right based on substantially identical inventions. - The

right under paragraph (1) to obtain a reasonable royalty shall

not be available under this subsection unless the invention as

claimed in the patent is substantially identical to the invention

as claimed in the published patent application.

(3) Time limitation on obtaining a reasonable royalty. - The

right under paragraph (1) to obtain a reasonable royalty shall be

available only in an action brought not later than 6 years after

the patent is issued. The right under paragraph (1) to obtain a

reasonable royalty shall not be affected by the duration of the

period described in paragraph (1).

(4) Requirements for international applications. -

(A) Effective date. - The right under paragraph (1) to obtain

a reasonable royalty based upon the publication under the

treaty defined in section 351(a) of an international

application designating the United States shall commence on the

date of publication under the treaty of the international

application, or, if the publication under the treaty of the

international application is in a language other than English,

on the date on which the Patent and Trademark Office receives a

translation of the publication in the English language.

(B) Copies. - The Director may require the applicant to

provide a copy of the international application and a

translation thereof.

-SOURCE-

(July 19, 1952, ch. 950, 66 Stat. 804; Pub. L. 89-83, Sec. 5, July

24, 1965, 79 Stat. 261; Pub. L. 96-517, Sec. 4, Dec. 12, 1980, 94

Stat. 3018; Pub. L. 100-418, title IX, Sec. 9002, Aug. 23, 1988,

102 Stat. 1563; Pub. L. 103-465, title V, Sec. 532(a)(1), Dec. 8,

1994, 108 Stat. 4983; Pub. L. 104-295, Sec. 20(e)(1), Oct. 11,

1996, 110 Stat. 3529; Pub. L. 106-113, div. B, Sec. 1000(a)(9)

[title IV, Secs. 4402(a), 4504], Nov. 29, 1999, 113 Stat. 1536,

1501A-557, 1501A-564; Pub. L. 107-273, div. C, title III, Secs.

13204, 13206(a)(8), Nov. 2, 2002, 116 Stat. 1902, 1904.)

-MISC1-

HISTORICAL AND REVISION NOTES

Based on Title 35, U.S.C., 1946 ed., Sec. 40 (R.S. 4884, amended

May 23, 1930, ch. 312, Sec. 1, 46 Stat. 376).

The reference to plants is omitted for inclusion in another

section and the reference to the title is shortened since the title

is of no legal significance.

The wording of the granting clause is changed to "the right to

exclude others from making, using, or selling", following language

used by the Supreme Court, to render the meaning clearer.

"United States" is defined in section 100.

-REFTEXT-

REFERENCES IN TEXT

The date of the enactment of the Uruguay Round Agreements Act,

referred to in subsec. (c)(1), (2)(A), is the date of enactment of

Pub. L. 103-465, which was approved Dec. 8, 1994.

-MISC2-

AMENDMENTS

2002 - Subsec. (b)(4)(A). Pub. L. 107-273, Sec. 13206(a)(8),

struck out ", United States Code," after "title 5".

Subsec. (d)(4)(A). Pub. L. 107-273, Sec. 13204, amended subsec.

(d)(4)(A) as in effect on Nov. 29, 2000, by substituting "the date

of" for "the date on which the Patent and Trademark Office receives

a copy of the" and "publication in the English language" for

"international application in the English language".

1999 - Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4504(1)],

inserted "; provisional rights" after "patent" in section

catchline.

Subsec. (b). Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec.

4402(a)], amended heading and text of subsec. (b) generally. Prior

to amendment, text provided for interference delay or secrecy

orders, extensions for appellate review, a limitations period, and

a maximum period of 5 years duration for all extensions.

Subsec. (d). Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec.

4504(2)], added subsec. (d).

1996 - Subsec. (c)(2). Pub. L. 104-295 substituted "acts" for

"Acts" in introductory provisions.

1994 - Pub. L. 103-465 amended section catchline and text

generally. Prior to amendment, text read as follows: "Every patent

shall contain a short title of the invention and a grant to the

patentee, his heirs or assigns, for the term of seventeen years,

subject to the payment of fees as provided for in this title, of

the right to exclude others from making, using, or selling the

invention throughout the United States and, if the invention is a

process, of the right to exclude others from using or selling

throughout the United States, or importing into the United States,

products made by that process,, referring to the specification for

the particulars thereof. A copy of the specification and drawings

shall be annexed to the patent and be a part thereof."

1988 - Pub. L. 100-418 inserted "and, if the invention is a

process, of the right to exclude others from using or selling

throughout the United States, or importing into the United States,

products made by that process," after "United States".

1980 - Pub. L. 96-517 substituted "payment of fees" for "payment

of issue fees".

1965 - Pub. L. 89-83 added "subject to the payment of issue fees

as provided for in this title".

EFFECTIVE DATE OF 1999 AMENDMENT

Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec.

4405(a)], Nov. 29, 1999, 113 Stat. 1536, 1501A-560, provided that:

"The amendments made by sections 4402 and 4404 [amending this

section, sections 156 and 282 of this title, and section 1295 of

Title 28, Judiciary and Judicial Procedure] shall take effect on

the date that is 6 months after the date of the enactment of this

Act [Nov. 29, 1999] and, except for a design patent application

filed under chapter 16 of title 35, United States Code, shall apply

to any application filed on or after the date that is 6 months

after the date of the enactment of this Act."

Amendment by section 1000(a)(9) [title IV, Sec. 4504] of Pub. L.

106-113 effective Nov. 29, 2000, applicable only to applications

(including international applications designating the United

States) filed on or after that date, and additionally applicable to

any pending application filed before Nov. 29, 2000, if such pending

application is published pursuant to a request of the applicant

under such procedures as may be established by the Director, see

section 1000(a)(9) [title IV, Sec. 4508] of Pub. L. 106-113, as

amended, set out as a note under section 10 of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Section 534 of title V of Pub. L. 103-465 provided that:

"(a) In General. - Subject to subsection (b), the amendments made

by this subtitle [subtitle C (Secs. 531-534) of title V of Pub. L.

103-465, amending this section and sections 41, 104, 111, 119, 156,

172, 173, 252, 262, 271, 272, 287, 292, 295, 307, 365, and 373 of

this title] take effect on the date that is one year after the date

on which the WTO Agreement enters into force with respect to the

United States [Jan. 1, 1995].

"(b) Patent Applications. -

"(1) In general. - Subject to paragraph (2), the amendments

made by section 532 [amending this section and sections 41, 111,

119, 156, 172, 173, 365, and 373 of this title] take effect on

the date that is 6 months after the date of the enactment of this

Act [Dec. 8, 1994] and shall apply to all patent applications

filed in the United States on or after the effective date.

"(2) Section 154(a)(1). - Section 154(a)(1) of title 35, United

States Code, as amended by section 532(a)(1) of this Act, shall

take effect on the effective date described in subsection (a).

"(3) Earliest filing. - The term of a patent granted on an

application that is filed on or after the effective date

described in subsection (a) and that contains a specific

reference to an earlier application filed under the provisions of

section 120, 121, or 365(c) of title 35, United States Code,

shall be measured from the filing date of the earliest filed

application."

EFFECTIVE DATE OF 1988 AMENDMENT

Amendment by Pub. L. 100-418 effective 6 months after Aug. 23,

1988, and, subject to enumerated exceptions, applicable only with

respect to products made or imported after such effective date, see

section 9006 of Pub. L. 100-418, set out as a note under section

271 of this title.

EFFECTIVE DATE OF 1980 AMENDMENT

Amendment by Pub. L. 96-517 effective Dec. 12, 1980, see section

8(a) of Pub. L. 96-517, set out as a note under section 41 of this

title.

EFFECTIVE DATE OF 1965 AMENDMENT

Amendment by Pub. L. 89-83 effective three months after July 24,

1965, see section 7(a) of Pub. L. 89-83, set out as a note under

section 41 of this title.

REGULATIONS

Section 532(a)(2) of Pub. L. 103-465 authorized the Commissioner

of Patents and Trademarks to prescribe regulations for further

limited reexamination of applications pending 2 years or longer and

for examination of more than 1 independent and distinct invention

in applications pending 3 years or longer, as of the effective date

of section 154(a)(2) of this title, and to establish appropriate

related fees.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 103, 122, 155, 155A, 156,

282, 284, 374 of this title; title 28 section 1295.

-End-

-CITE-

35 USC Sec. 155 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 155. Patent term extension

-STATUTE-

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.

-SOURCE-

(Added Pub. L. 97-414, Sec. 11(a), Jan. 4, 1983, 96 Stat. 2065;

amended Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec.

4732(a)(6), (10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A-582;

Pub. L. 107-273, div. C, title III, Sec. 13206(b)(1)(B), Nov. 2,

2002, 116 Stat. 1906.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in text, is

act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is

classified generally to chapter 9 (Sec. 301 et seq.) of Title 21,

Food and Drugs. Section 409 of the Federal Food, Drug, and Cosmetic

Act is classified to section 348 of Title 21. For complete

classification of this Act to the Code, see section 301 of Title 21

and Tables.

Date of enactment of this section, referred to in text, means

date of enactment of Pub. L. 97-414, which was approved Jan. 4,

1983.

-MISC1-

AMENDMENTS

2002 - Pub. L. 107-273 made technical correction to directory

language of Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec.

4732(a)(10)(A)]. See 1999 Amendment note below.

1999 - Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec.

4732(a)(10)(A)], as amended by Pub. L. 107-273, substituted

"Director shall promptly" for "Commissioner shall promptly".

Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(6)],

substituted "notify the Director" for "notify the Commissioner of

Patents and Trademarks".

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L.

106-113, set out as a note under section 1 of this title.

-End-

-CITE-

35 USC Sec. 155A 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 155A. Patent term restoration

-STATUTE-

(a) Notwithstanding section 154 of this title, the term of each

of the following patents shall be extended in accordance with this

section:

(1) Any patent which encompasses within its scope a composition

of matter which is a new drug product, if during the regulatory

review of the product by the Federal Food and Drug Administration

-

(A) the Federal Food and Drug Administration notified the

patentee, by letter dated February 20, 1976, that such

product's new drug application was not approvable under section

505(b)(1) of the Federal Food, Drug and Cosmetic Act;

(B) in 1977 the patentee submitted to the Federal Food and

Drug Administration the results of a health effects test to

evaluate the carcinogenic potential of such product;

(C) the Federal Food and Drug Administration approved, by

letter dated December 18, 1979, the new drug application for

such product; and

(D) the Federal Food and Drug Administration approved, by

letter dated May 26, 1981, a supplementary application covering

the facility for the production of such product.

(2) Any patent which encompasses within its scope a process for

using the composition of matter described in paragraph (1).

(b) The term of any patent described in subsection (a) shall be

extended for a period equal to the period beginning February 20,

1976, and ending May 26, 1981, and such patent shall have the

effect as if originally issued with such extended term.

(c) The patentee of any patent described in subsection (a) of

this section shall, within ninety days after the date of enactment

of this section, notify the Director of the number of any patent so

extended. On receipt of such notice, the Director shall confirm

such extension by placing a notice thereof in the official file of

such patent and publishing an appropriate notice of such extension

in the Official Gazette of the Patent and Trademark Office.

-SOURCE-

(Added Pub. L. 98-127, Sec. 4(a), Oct. 13, 1983, 97 Stat. 832;

amended Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV, Sec.

4732(a)(7), (10)(A)], Nov. 29, 1999, 113 Stat. 1536, 1501A-582;

Pub. L. 107-273, div. C, title III, Sec. 13206(b)(1)(B), Nov. 2,

2002, 116 Stat. 1906.)

-REFTEXT-

REFERENCES IN TEXT

Section 505(b)(1) of the Federal Food, Drug and Cosmetic Act,

referred to in subsec. (a)(1)(A), is classified to section

355(b)(1) of Title 21, Food and Drugs.

The date of enactment of this section, referred to in subsec.

(c), is the date of enactment of Pub. L. 98-127, which was approved

Oct. 13, 1983.

-MISC1-

AMENDMENTS

2002 - Subsec. (c). Pub. L. 107-273 made technical correction to

directory language of Pub. L. 106-113, Sec. 1000(a)(9) [title IV,

Sec. 4732(a)(10)(A)]. See 1999 Amendment note below.

1999 - Subsec. (c). Pub. L. 106-113, Sec. 1000(a)(9) [title IV,

Sec. 4732(a)(10)(A)], as amended by Pub. L. 107-273, substituted

"Director shall confirm" for "Commissioner shall confirm".

Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec. 4732(a)(7)],

substituted "notify the Director" for "notify the Commissioner of

Patents and Trademarks".

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L.

106-113, set out as a note under section 1 of this title.

-End-

-CITE-

35 USC Sec. 156 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 156. Extension of patent term

-STATUTE-

(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

expiration date of the patent, which shall include any patent term

adjustment granted under section 154(b), if -

(1) the term of the patent has not expired before an

application is submitted under subsection (d)(1) for its

extension;

(2) the term of the patent has never been extended under

subsection (e)(1) of this section;

(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 paragraphs (1) through (4) of subsection (d);

(4) the product has been subject to a regulatory review period

before its commercial marketing or use;

(5)(A) except as provided in subparagraph (B) or (C), the

permission for the commercial marketing or use of the product

after such regulatory review period is the first permitted

commercial marketing or use of the product under the provision of

law under which such regulatory review period occurred;

(B) in the case of a patent which claims a method of

manufacturing 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

marketing or use of a product manufactured under the process

claimed in the patent; or

(C) for purposes of subparagraph (A), in the case of a patent

which -

(i) claims a new animal drug or a veterinary biological

product which (I) is not covered by the claims in any other

patent which has been extended, and (II) has received

permission for the commercial marketing or use in

non-food-producing animals and in food-producing animals, and

(ii) was not extended on the basis of the regulatory review

period for use in non-food-producing animals,

the permission for the commercial marketing or use of the drug or

product after the regulatory review period for use in

food-producing animals is the first permitted commercial

marketing or use of the drug or product for administration to a

food-producing animal.

The product referred to in paragraphs (4) and (5) is hereinafter in

this section referred to as the "approved product".

(b) Except as provided in subsection (d)(5)(F), the rights

derived from any patent the term of which is extended under this

section shall during the period during which the term of the patent

is extended -

(1) in the case of a patent which claims a product, be limited

to any use approved for the product -

(A) before the expiration of the term of the patent -

(i) under the provision of law under which the applicable

regulatory review occurred, or

(ii) under the provision of law under which any regulatory

review described in paragraph (1), (4), or (5) of subsection

(g) occurred, and

(B) on or after the expiration of the regulatory review

period upon which the extension of the patent was based;

(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 product -

(A) before the expiration of the term of the patent -

(i) under any provision of law under which an applicable

regulatory review occurred, and

(ii) under the provision of law under which any regulatory

review described in paragraph (1), (4), or (5) of subsection

(g) occurred, and

(B) on or after the expiration of the regulatory review

period upon which the extension of the patent was based; and

(3) in the case of a patent which claims a method of

manufacturing a product, be limited to the method of

manufacturing as used to make -

(A) the approved product, or

(B) the product if it has been subject to a regulatory review

period described in paragraph (1), (4), or (5) of subsection

(g).

As used in this subsection, the term "product" includes an 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 (d)(2)(B)

during which the applicant for the patent extension did not act

with due diligence during such period of the regulatory review

period;

(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 (1)(B)(i), (2)(B)(i),

(3)(B)(i), (4)(B)(i), and (5)(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 provision

of law under which such regulatory review occurred when added to

the regulatory review period as revised under paragraphs (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 under

subsection (e)(1) for 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 Director. Except as provided in

paragraph (5), 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 manufacturing the

approved product;

(C) information to enable the Director 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 Director and the Secretary of Health

and Human Services or the Secretary of Agriculture 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

applicable to such activities; and

(E) such patent or other information as the Director may

require.

(2)(A) Within 60 days of the submittal of an application for

extension of the term of a patent under paragraph (1), the Director

shall notify -

(i) the Secretary of Agriculture if the patent claims a drug

product or a method of using or manufacturing a drug product and

the drug product is subject to the Virus-Serum-Toxin Act, and

(ii) the Secretary of Health and Human Services if the patent

claims any other drug product, a medical device, or a food

additive or color additive or a method of using or manufacturing

such a product, device, or additive and if the product, device,

and additive are subject to the Federal Food, Drug, and Cosmetic

Act,

of the extension application and shall submit to the Secretary who

is so notified a copy of the application. Not later than 30 days

after the receipt of an application from the Director, the

Secretary receiving the application shall review the dates

contained in the application pursuant to paragraph (1)(C) and

determine the applicable regulatory review period, shall notify the

Director 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 making the

determination under subparagraph (A), not later than 180 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

period, the Secretary making the determination shall, in accordance

with regulations promulgated by such Secretary, determine if the

applicant acted with due diligence during the applicable regulatory

review period. The Secretary making the determination shall make

such determination not later than 90 days after the receipt of such

a petition. For a drug product, device, or additive subject to the

Federal Food, Drug, and Cosmetic Act or the Public Health Service

Act, the Secretary may not delegate the authority to make the

determination prescribed by this clause to an office below the

Office of the Director (!1) of Food and Drugs. For a product

subject to the Virus-Serum-Toxin Act, the Secretary of Agriculture

may not delegate the authority to make the determination prescribed

by this clause to an office below the Office of the Assistant

Secretary for Marketing and Inspection Services.

(ii) The Secretary making a determination under clause (i) shall

notify the Director of the determination and shall publish in the

Federal Register a notice of such determination together with the

factual and legal basis for such determination. Any interested

person may request, within the 60-day period beginning on the

publication of a determination, the Secretary making the

determination to hold an informal hearing on the determination. If

such a request is made within such period, such Secretary shall

hold such hearing not later than 30 days after the date of the

request, or at the request of the person making the request, not

later than 60 days after such date. The Secretary who is holding

the hearing 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 opportunity to participate in the

hearing. Within 30 days after the completion of the hearing, such

Secretary shall affirm or revise the determination which was the

subject of the hearing and shall notify the Director 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 Director.

(5)(A) If the owner of record of the patent or its agent

reasonably expects that the applicable regulatory review period

described in paragraph (1)(B)(ii), (2)(B)(ii), (3)(B)(ii),

(4)(B)(ii), or (5)(B)(ii) of subsection (g) that began for a

product that is the subject of such patent may extend beyond the

expiration of the patent term in effect, the owner or its agent may

submit an application to the Director for an interim extension

during the period beginning 6 months, and ending 15 days, before

such term is due to expire. The application shall contain -

(i) the identity of the product subject to regulatory review

and the Federal statute under which such review is occurring;

(ii) the identity of the patent for which interim extension is

being sought and the identity of each claim of such patent which

claims the product under regulatory review or a method of using

or manufacturing the product;

(iii) information to enable the Director to determine under

subsection (a)(1), (2), and (3) the eligibility of a patent for

extension;

(iv) a brief description of the activities undertaken by the

applicant during the applicable regulatory review period to date

with respect to the product under review and the significant

dates applicable to such activities; and

(v) such patent or other information as the Director may

require.

(B) If the Director determines that, except for permission to

market or use the product commercially, the patent would be

eligible for an extension of the patent term under this section,

the Director shall publish in the Federal Register a notice of such

determination, including the identity of the product under

regulatory review, and shall issue to the applicant a certificate

of interim extension for a period of not more than 1 year.

(C) The owner of record of a patent, or its agent, for which an

interim extension has been granted under subparagraph (B), may

apply for not more than 4 subsequent interim extensions under this

paragraph, except that, in the case of a patent subject to

subsection (g)(6)(C), the owner of record of the patent, or its

agent, may apply for only 1 subsequent interim extension under this

paragraph. Each such subsequent application shall be made during

the period beginning 60 days before, and ending 30 days before, the

expiration of the preceding interim extension.

(D) Each certificate of interim extension under this paragraph

shall be recorded in the official file of the patent and shall be

considered part of the original patent.

(E) Any interim extension granted under this paragraph shall

terminate at the end of the 60-day period beginning on the date on

which the product involved receives permission for commercial

marketing or use, except that, if within that 60-day period the

applicant notifies the Director of such permission and submits any

additional information under paragraph (1) of this subsection not

previously contained in the application for interim extension, the

patent shall be further extended, in accordance with the provisions

of this section -

(i) for not to exceed 5 years from the date of expiration of

the original patent term; or

(ii) if the patent is subject to subsection (g)(6)(C), from the

date on which the product involved receives approval for

commercial marketing or use.

(F) The rights derived from any patent the term of which is

extended under this paragraph shall, during the period of interim

extension -

(i) in the case of a patent which claims a product, be limited

to any use then under regulatory review;

(ii) in the case of a patent which claims a method of using a

product, be limited to any use claimed by the patent then under

regulatory review; and

(iii) in the case of a patent which claims a method of

manufacturing a product, be limited to the method of

manufacturing as used to make the product then under regulatory

review.

(e)(1) A determination that a patent is eligible for extension

may be made by the Director solely on the basis of the

representations contained in the application for the extension. If

the Director determines that a patent is eligible for extension

under subsection (a) and that the requirements of paragraphs (1)

through (4) of subsection (d) have been complied with, the Director

shall issue to the applicant for the extension of the term of the

patent a certificate of extension, under 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)(1) would expire before a certificate

of extension is issued or denied under paragraph (1) respecting the

application, the Director shall extend, until such determination 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 drug product.

(B) Any medical device, food additive, or color additive

subject to regulation under the Federal Food, Drug, and

Cosmetic Act.

(2) The term "drug product" means the active ingredient of -

(A) a new drug, antibiotic drug, or human biological product

(as those terms are used in the Federal Food, Drug, and

Cosmetic Act and the Public Health Service Act), or

(B) a new animal drug or veterinary biological product (as

those terms are used in the Federal Food, Drug, and Cosmetic

Act and the Virus-Serum-Toxin Act) which is not primarily

manufactured using recombinant DNA, recombinant RNA, hybridoma

technology, or other processes involving site specific genetic

manipulation techniques,

including any salt or ester of the active ingredient, as a single

entity or in 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.

(4)(A) Any reference to section 351 is a reference to section

351 of the Public Health Service Act.

(B) Any reference to section 503, 505, 512, or 515 is a

reference to section 503, 505, 512, or 515 of the Federal Food,

Drug, and Cosmetic Act.

(C) Any reference to the Virus-Serum-Toxin Act is a reference

to the Act of March 4, 1913 (21 U.S.C. 151-158).

(5) The term "informal hearing" has the meaning prescribed for

such term by section 201(y) (!2) of the Federal Food, Drug, and

Cosmetic Act.

(6) The term "patent" means a patent issued by the United

States Patent and Trademark Office.

(7) The term "date of enactment" as used in this section means

September 24, 1984, for a human drug product, a medical device,

food additive, or color additive.

(8) The term "date of enactment" as used in this section means

the date of enactment of the Generic Animal Drug and Patent Term

Restoration Act for an animal drug or a veterinary biological

product.

(g) For purposes of this section, the term "regulatory review

period" has the following meanings:

(1)(A) In the case of a product which is a new drug, antibiotic

drug, or human biological product, the term means the period

described in subparagraph (B) to which the limitation described

in paragraph (6) applies.

(B) The regulatory review period for a new drug, antibiotic

drug, or human biological 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

(!2) became effective for the approved product and ending on

the date an application was initially submitted for such drug

product under section 351, 505, or 507,(!2) and

(ii) the period beginning on the date the application was

initially submitted for the approved product under section 351,

subsection (b) of section 505, or section 507 (!2) and ending

on the date such application was approved under such section.

(2)(A) In the case of a product which is a food additive or

color additive, the term means the period described in

subparagraph (B) to which the limitation described in paragraph

(6) 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 Food, 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 issuance 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 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 (6) applies.

(B) The regulatory review period for a medical device is the

sum of -

(i) the period beginning on the date a clinical investigation

on humans involving the device was begun and ending on the date

an application was initially submitted with 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 initially

submitted under section 515(f)(5) and ending on the date the

protocol was declared completed under section 515(f)(6).

(4)(A) In the case of a product which is a new animal drug, the

term means the period described in subparagraph (B) to which the

limitation described in paragraph (6) applies.

(B) The regulatory review period for a new animal drug product

is the sum of -

(i) the period beginning on the earlier of the date a major

health or environmental effects test on the drug was initiated

or the date an exemption under subsection (j) of section 512

became effective for the approved new animal drug product and

ending on the date an application was initially submitted for

such animal drug product under section 512, and

(ii) the period beginning on the date the application was

initially submitted for the approved animal drug product under

subsection (b) of section 512 and ending on the date such

application was approved under such section.

(5)(A) In the case of a product which is a veterinary

biological product, the term means the period described in

subparagraph (B) to which the limitation described in paragraph

(6) applies.

(B) The regulatory period for a veterinary biological product

is the sum of -

(i) the period beginning on the date the authority to prepare

an experimental biological product under the Virus-Serum-Toxin

Act became effective and ending on the date an application for

a license was submitted under the Virus-Serum-Toxin Act, and

(ii) the period beginning on the date an application for a

license was initially submitted for approval under the

Virus-Serum-Toxin Act and ending on the date such license was

issued.

(6) A period determined under any of the preceding paragraphs

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 determined

on the basis of the regulatory review period determined 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 paragraph

(1)(B) or (4)(B) was submitted and no request for the

authority described in paragraph (5)(B) was submitted,

(ii) no major health or environmental effects test

described in paragraph (2)(B) or (4)(B) 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 submitted,

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 enactment 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 or in the case of an

approved product which is a new animal drug or veterinary

biological product (as those terms are used in the Federal

Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin Act),

three years.

(h) The Director may establish such fees as the Director

determines appropriate to cover the costs to the Office of

receiving and acting upon applications under this section.

-SOURCE-

(Added Pub. L. 98-417, title II, Sec. 201(a), Sept. 24, 1984, 98

Stat. 1598; amended Pub. L. 100-670, title II, Sec. 201(a)-(h),

Nov. 16, 1988, 102 Stat. 3984-3987; Pub. L. 103-179, Secs. 5, 6,

Dec. 3, 1993, 107 Stat. 2040, 2042; Pub. L. 103-465, title V, Sec.

532(c)(1), Dec. 8, 1994, 108 Stat. 4987; Pub. L. 105-115, title I,

Sec. 125(b)(2)(P), Nov. 21, 1997, 111 Stat. 2326; Pub. L. 106-113,

div. B, Sec. 1000(a)(9) [title IV, Secs. 4404, 4732(a)(10)(A)],

Nov. 29, 1999, 113 Stat. 1536, 1501A-560, 1501A-582; Pub. L.

107-273, div. C, title III, Sec. 13206(a)(9), (b)(1)(B), Nov. 2,

2002, 116 Stat. 1904, 1906.)

-REFTEXT-

REFERENCES IN TEXT

The Virus-Serum-Toxin Act, referred to in subsecs. (d)(2)(A)(i),

(B)(i), (f)(2)(B), (4)(C), and (g)(5)(B), (6)(C), is the eighth

paragraph under the heading "Bureau of Animal Industry" of act Mar.

4, 1913, ch. 145, 37 Stat. 828, as amended, which is classified

generally to chapter 5 (Sec. 151 et seq.) of Title 21, Food and

Drugs. For complete classification of this Act to the Code, see

Short Title note set out under section 151 of Title 21 and Tables.

The Federal Food, Drug, and Cosmetic Act, referred to in subsecs.

(d)(2)(A)(ii), (B)(ii), (f), and (g)(2)(B), (3)(B)(ii), (6)(C), is

act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is

classified generally to chapter 9 (Sec. 301 et seq.) of Title 21.

For complete classification of this Act to the Code, see section

301 of Title 21 and Tables.

The Public Health Service Act, referred to in subsecs.

(d)(2)(B)(i) and (f)(2)(A), is act July 1, 1944, ch. 373, 58 Stat.

682, as amended, which is classified generally to chapter 6A (Sec.

201 et seq.) of Title 42, The Public Health and Welfare. For

complete classification of this Act to the Code, see Short Title

note set out under section 201 of Title 42 and Tables.

Sections 503, 505, 512, and 515 of the Federal Food, Drug, and

Cosmetic Act, referred to in subsecs. (f)(4)(B) and (g)(1)(B),

(3)(B), are classified, respectively, to sections 353, 355, 360b,

and 360e of Title 21, Food and Drugs. Section 507 of the Act,

referred to in subsec. (g)(1)(B), was classified to section 357 of

Title 21, prior to repeal by Pub. L. 105-115, title I, Sec.

125(b)(1), Nov. 21, 1997, 111 Stat. 2325.

Section 201 of the Federal Food, Drug, and Cosmetic Act, referred

to in subsec. (f)(5), which is classified to section 321 of Title

21, was subsequently amended, and section 201(y) no longer defines

the term "informal hearing". However, such term is defined

elsewhere in that section.

Section 351 of the Public Health Service Act, referred to in

subsecs. (f)(4)(A) and (g)(1)(B)(i), (ii), is classified to section

262 of Title 42, The Public Health and Welfare.

The date of enactment of the Generic Animal Drug and Patent Term

Restoration Act, referred to in subsec. (f)(8), is the date of

enactment of Pub. L. 100-670, which was approved Nov. 16, 1988.

The date of the enactment of this section, referred to in subsec.

(g)(6), is the date of the enactment of Pub. L. 98-417, which was

approved Sept. 24, 1984.

-MISC1-

AMENDMENTS

2002 - Subsec. (b)(3)(B). Pub. L. 107-273, Sec. 13206(a)(9)(A),

substituted "paragraph" for "paragraphs".

Subsec. (d). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical

correction to directory language of Pub. L. 106-113, Sec.

1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note

below.

Subsec. (d)(2)(B)(i). Pub. L. 107-273, Sec. 13206(a)(9)(B),

substituted "below the Office" for "below the office".

Subsec. (e). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical

correction to directory language of Pub. L. 106-113, Sec.

1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note

below.

Subsec. (g)(6)(B)(iii). Pub. L. 107-273, Sec. 13206(a)(9)(C),

substituted "submitted" for "submittted".

Subsec. (h). Pub. L. 107-273, Sec. 13206(b)(1)(B), made technical

correction to directory language of Pub. L. 106-113, Sec.

1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note

below.

1999 - Subsec. (a). Pub. L. 106-113, Sec. 1000(a)(9) [title IV,

Sec. 4404], in introductory provisions, inserted ", which shall

include any patent term adjustment granted under section 154(b),"

after "the original expiration date of the patent".

Subsecs. (d), (e), (h). Pub. L. 106-113, Sec. 1000(a)(9) [title

IV, Sec. 4732(a)(10)(A)], as amended by Pub. L. 107-273, Sec.

13206(b)(1)(B), substituted "Director" for "Commissioner" wherever

appearing.

1997 - Subsec. (f)(4)(B). Pub. L. 105-115, Sec. 125(b)(2)(P),

struck out "507," after "505," in two places.

1994 - Subsec. (a)(2). Pub. L. 103-465 inserted "under subsection

(e)(1) of this section" after "extended".

1993 - Subsec. (a)(1). Pub. L. 103-179, Sec. 6(1)(A), substituted

"subsection (d)(1)" for "subsection (d)".

Subsec. (a)(3). Pub. L. 103-179, Sec. 6(1)(B), substituted

"paragraphs (1) through (4) of subsection (d)" for "subsection

(d)".

Subsec. (b). Pub. L. 103-179, Sec. 6(2), substituted "Except as

provided in subsection (d)(5)(F), the rights" for "The rights" in

introductory provisions.

Subsec. (c)(4). Pub. L. 103-179, Sec. 5(1), substituted "extended

under subsection (e)(1)" for "extended".

Subsec. (d)(1). Pub. L. 103-179, Sec. 5(2), substituted "Except

as provided in paragraph (5), such" for "Such" in second sentence.

Subsec. (d)(5). Pub. L. 103-179, Sec. 5(3), added par. (5).

Subsec. (e)(1). Pub. L. 103-179, Sec. 6(3)(A), substituted

"paragraphs (1) through (4) of subsection (d)" for "subsection

(d)".

Subsec. (e)(2). Pub. L. 103-179, Sec. 6(3)(B), substituted

"subsection (d)(1)" for "subsection (d)".

1988 - Subsec. (a)(5)(A). Pub. L. 100-670, Sec. 201(a)(1),

inserted "or (C)" after "in subparagraph (B)".

Subsec. (a)(5)(C). Pub. L. 100-670, Sec. 201(a)(2), (3), added

subpar. (C).

Subsec. (b). Pub. L. 100-670, Sec. 201(b), amended subsec. (b)

generally. Prior to amendment, subsec. (b) read as follows: "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

expiration 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

manufacturing a product, be limited to the method of

manufacturing as used to make the approved product."

Subsec. (c)(2). Pub. L. 100-670, Sec. 201(c), substituted

"(3)(B)(i), (4)(B)(i), and (5)(B)(i)" for "and (3)(B)(i)".

Subsec. (d)(1)(C). Pub. L. 100-670, Sec. 201(d), inserted "or the

Secretary of Agriculture" after "and Human Services".

Subsec. (d)(2)(A). Pub. L. 100-670, Sec. 201(e), amended subpar.

(A) generally. Prior to amendment, subpar. (A) read as follows:

"Within sixty days of the submittal of an application for extension

of the term of a patent under paragraph (1), the Commissioner 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 manufacturing such a

product, device, or additive and if the product, device, and

additive are subject to the Federal Food, Drug, and Cosmetic Act,

of the extension application and shall submit to the Secretary a

copy of the application. Not later than thirty days after the

receipt of an application from the Commissioner, the Secretary

shall review the 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."

Subsec. (d)(2)(B). Pub. L. 100-670, Sec. 201(f), amended subpar.

(B) generally. Prior to amendment, subpar. (B) read as follows:

"(i) If a petition is submitted to the Secretary under

subparagraph (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

period, the Secretary shall, in accordance with regulations

promulgated by the Secretary determine if the applicant acted with

due diligence during the applicable regulatory review period. The

Secretary shall make such determination not later than ninety days

after the receipt of such a petition. The Secretary may not

delegate the authority to make the determination prescribed by this

subparagraph to an office below the Office of the Commissioner of

Food and Drugs.

"(ii) The Secretary shall notify the Commissioner of the

determination and shall publish in the Federal Register a notice of

such determination together with the factual and legal basis for

such 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 opportunity to participate in the hearing. Within thirty

days after the completion of the hearing, the Secretary shall

affirm or revise the 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."

Subsec. (f)(1)(A). Pub. L. 100-670, Sec. 201(g)(1), struck out

"human" before "drug product".

Subsec. (f)(2). Pub. L. 100-670, Sec. 201(g)(1), amended par. (2)

generally. Prior to amendment, par. (2) read as follows: "The term

'human drug product' means the active ingredient of a new drug,

antibiotic drug, or human biological product (as those terms are

used in the Federal Food, Drug, and Cosmetic Act and the Public

Health Service Act) including any salt or ester of the active

ingredient, as a single entity or in combination with another

active ingredient."

Subsec. (f)(4)(B), (C). Pub. L. 100-670, Sec. 201(g)(2), which

directed general amendment of subpars. (B) and (C) of par. (4), was

executed by amending subpar. (B) generally, and adding subpar. (C)

as probable intent of Congress in light of absence of subpar. (C)

in par. (4). Prior to amendment, subpar. (B) read as follows: "Any

reference to section 503, 505, 507, or 515 is a reference to

section 503, 505, 507, or 515 of the Federal Food, Drug, and

Cosmetic Act."

Subsec. (f)(7), (8). Pub. L. 100-670, Sec. 201(g)(3), added pars.

(7) and (8).

Subsec. (g)(1)(A). Pub. L. 100-670, Sec. 201(h)(1)(A), (2),

substituted "new drug, antibiotic drug, or human biological

product" for "human drug product" and "paragraph (6)" for

"paragraph (4)".

Subsec. (g)(1)(B). Pub. L. 100-670, Sec. 201(h)(1)(B),

substituted "new drug, antibiotic drug, or human biological

product" for "human drug product" in introductory provisions and

"product" for "human drug product" in cls. (i) and (ii).

Subsec. (g)(2)(A), (3)(A). Pub. L. 100-670, Sec. 201(h)(3),

substituted "paragraph (6)" for "paragraph (4)".

Subsec. (g)(4), (5). Pub. L. 100-670, Sec. 201(h)(4), added pars.

(4) and (5). Former par. (4) redesignated (6).

Subsec. (g)(6). Pub. L. 100-670, Sec. 201(h)(4), redesignated

former par. (4) as (6).

Subsec. (g)(6)(B)(i). Pub. L. 100-670, Sec. 201(h)(5)(A),

substituted "paragraph (1)(B) or (4)(B) was submitted and no

request for the authority described in paragraph (5)(B) was

submitted" for "paragraph (1)(B) was submitted".

Subsec. (g)(6)(B)(ii). Pub. L. 100-670, Sec. 201(h)(5)(B),

substituted "paragraph (2)(B) or (4)(B)" for "paragraph (2)".

Subsec. (g)(6)(C). Pub. L. 100-670, Sec. 201(h)(5)(C), inserted

"or in the case of an approved product which is a new animal drug

or veterinary biological product (as those terms are used in the

Federal Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin Act),

three years" after "exceed two years".

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by section 1000(a)(9) [title IV, Sec. 4404] of Pub. L.

106-113 effective on date that is 6 months after Nov. 29, 1999,

and, except for design patent application filed under chapter 16 of

this title, applicable to any application filed on or after such

date, see section 1000(a)(9) [title IV, Sec. 4405(a)] of Pub. L.

106-113, set out as a note under section 154 of this title.

Amendment by section 1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]

of Pub. L. 106-113 effective 4 months after Nov. 29, 1999, see

section 1000(a)(9) [title IV, Sec. 4731] of Pub. L. 106-113, set

out as a note under section 1 of this title.

EFFECTIVE DATE OF 1994 AMENDMENT

Amendment by Pub. L. 103-465 effective 6 months after Dec. 8,

1994, and applicable to all patent applications filed in the United

States on or after that effective date, with provisions relating to

earliest filed patent application, see section 534(b)(1), (3) of

Pub. L. 103-465, set out as a note under section 154 of this title.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 273, 282 of this title.

-FOOTNOTE-

(!1) So in original. Probably should be "Commissioner".

(!2) See References in Text note below.

-End-

-CITE-

35 USC Sec. 157 01/06/03

-EXPCITE-

TITLE 35 - PATENTS

PART II - PATENTABILITY OF INVENTIONS AND GRANT OF PATENTS

CHAPTER 14 - ISSUE OF PATENT

-HEAD-

Sec. 157. Statutory invention registration

-STATUTE-

(a) Notwithstanding any other provision of this title, the

Director is authorized to publish a statutory invention

registration containing the specification and drawings of a

regularly filed application for a patent without examination if the

applicant -

(1) meets the requirements of section 112 of this title;

(2) has complied with the requirements for printing, as set

forth in regulations of the Director;

(3) waives the right to receive a patent on the invention

within such period as may be prescribed by the Director; and

(4) pays application, publication, and other processing fees

established by the Director.

If an interference is declared with respect to such an application,

a statutory invention registration may not be published unless the

issue of priority of invention is finally determined in favor of

the applicant.

(b) The waiver under subsection (a)(3) of this section by an

applicant shall take effect upon publication of the statutory

invention registration.

(c) A statutory invention registration published pursuant to this

section shall have all of the attributes specified for patents in

this title except those specified in section 183 and sections 271

through 289 of this title. A statutory invention registration shall

not have any of the attributes specified for patents in any other

provision of law other than this title. A statutory invention

registration published pursuant to this section shall give

appropriate notice to the public, pursuant to regulations which the

Director shall issue, of the preceding provisions of this

subsection. The invention with respect to which a statutory

invention certificate is published is not a patented invention for

purposes of section 292 of this title.

(d) The Director shall report to the Congress annually on the use

of statutory invention registrations. Such report shall include an

assessment of the degree to which agencies of the Federal

Government are making use of the statutory invention registration

system, the degree to which it aids the management of federally

developed technology, and an assessment of the cost savings to the

Federal Government of the use of such procedures.

-SOURCE-

(Added Pub. L. 98-622, title I, Sec. 102(a), Nov. 8, 1984, 98 Stat.

3383; amended Pub. L. 106-113, div. B, Sec. 1000(a)(9) [title IV,

Sec. 4732(a)(10)(A), (11)], Nov. 29, 1999, 113 Stat. 1536,

1501A-582, 1501A-583; Pub. L. 107-273, div. C, title III, Sec.

13206(b)(1)(B), Nov. 2, 2002, 116 Stat. 1906.)

-MISC1-

AMENDMENTS

2002 - Subsecs. (a), (c). Pub. L. 107-273 made technical

correction to directory language of Pub. L. 106-113, Sec.

1000(a)(9) [title IV, Sec. 4732(a)(10)(A)]. See 1999 Amendment note

below.

1999 - Subsecs. (a), (c). Pub. L. 106-113, Sec. 1000(a)(9) [title

IV, Sec. 4732(a)(10)(A), as amended by Pub. L. 107-273, substituted

"Director" for "Commissioner" wherever appearing.

Subsec. (d). Pub. L. 106-113, Sec. 1000(a)(9) [title IV, Sec.

4732(a)(11)], substituted "Director" for "Secretary of Commerce".

EFFECTIVE DATE OF 1999 AMENDMENT

Amendment by Pub. L. 106-113 effective 4 months after Nov. 29,

1999, see section 1000(a)(9) [title IV, Sec. 4731] of Pub. L.

106-113, set out as a note under section 1 of this title.

EFFECTIVE DATE

Section 102(c) of Pub. L. 98-622 provided that: "The amendments

made by this section [enacting this section and item 157 in the

table of sections of this chapter] shall take effect six months

after the date of enactment of this Act [Nov. 8, 1984]."

TERMINATION OF REPORTING REQUIREMENTS

For termination, effective May 15, 2000, of provisions in subsec.

(d) of this section relating to annual reports to Congress, see

section 3003 of Pub. L. 104-66, as amended, set out as a note under

section 1113 of Title 31, Money and Finance, and page 51 of House

Document No. 103-7.

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in section 111 of this title.

-End-