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119th Congress

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119th Congress

Title 35 — Patents

Part III · Chapter 28 — Infringement of Patents

§ 271. Infringement of patent

Statutory text

(a)

Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

(b)

Whoever actively induces infringement of a patent shall be liable as an infringer.

(c)

Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.

(d)

No patent owner otherwise entitled to relief for infringement or contributory infringement of a patent shall be denied relief or deemed guilty of misuse or illegal extension of the patent right by reason of his having done one or more of the following: (1) derived revenue from acts which if performed by another without his consent would constitute contributory infringement of the patent; (2) licensed or authorized another to perform acts which if performed without his consent would constitute contributory infringement of the patent; (3) sought to enforce his patent rights against infringement or contributory infringement; (4) refused to license or use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.

(e)
(1)

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States 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 ) which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

(2)

It shall be an act of infringement to submit—

(A)

an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent,

(B)

an application under section 512 of such Act or under the Act of (21 U.S.C. 151–158) for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is claimed in a patent or the use of which is claimed in a patent, or

(C)
(i)

with respect to a patent that is identified in the list of patents described in section 351(l)(3) of the Public Health Service Act (including as provided under section 351(l)(7) of such Act), an application seeking approval of a biological product, or

(ii)

if the applicant for the application fails to provide the application and information required under section 351(l)(2)(A) of such Act, an application seeking approval of a biological product for a patent that could be identified pursuant to section 351(l)(3)(A)(i) of such Act,

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, veterinary biological product, or biological product 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, offering to sell, or selling within the United States or importing into the United States 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 or veterinary biological product 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, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product,

(C)

damages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, veterinary biological product, or biological product, and

(D)

the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, as defined in section 351(k)(6) of the Public Health Service Act, in an action for infringement of the patent under section 351(l)(6) of such Act, and the biological product has not yet been approved because of section 351(k)(7) of such Act.

The remedies prescribed by subparagraphs (A), (B), (C), and (D) 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.

(5)

Where a person has filed an application described in paragraph (2) that includes a certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and neither the owner of the patent that is the subject of the certification nor the holder of the approved application under subsection (b) of such section for the drug that is claimed by the patent or a use of which is claimed by the patent brought an action for infringement of such patent before the expiration of 45 days after the date on which the notice given under subsection (b)(3) or (j)(2)(B) of such section was received, the courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought by such person under section 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed.

(6)
(A)

Subparagraph (B) applies, in lieu of paragraph (4), in the case of a patent—

(i)

that is identified, as applicable, in the list of patents described in section 351(l)(4) of the Public Health Service Act or the lists of patents described in section 351(l)(5)(B) of such Act with respect to a biological product; and

(ii)

for which an action for infringement of the patent with respect to the biological product—

(I)

was brought after the expiration of the 30-day period described in subparagraph (A) or (B), as applicable, of section 351(l)(6) of such Act; or

(II)

was brought before the expiration of the 30-day period described in subclause (I), but which was dismissed without prejudice or was not prosecuted to judgment in good faith.

(B)

In an action for infringement of a patent described in subparagraph (A), the sole and exclusive remedy that may be granted by a court, upon a finding that the making, using, offering to sell, selling, or importation into the United States of the biological product that is the subject of the action infringed the patent, shall be a reasonable royalty.

(C)

The owner of a patent that should have been included in the list described in section 351(l)(3)(A) of the Public Health Service Act, including as provided under section 351(l)(7) of such Act for a biological product, but was not timely included in such list, may not bring an action under this section for infringement of the patent with respect to the biological product.

(f)
(1)

Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(2)

Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.

(g)

Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use, offer to sell, or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after—

(1)

it is materially changed by subsequent processes; or

(2)

it becomes a trivial and nonessential component of another product.

(h)

As used in this section, the term “whoever” includes any State, any instrumentality of a State, and any officer or employee of a State or instrumentality of a State acting in his official capacity. Any State, and any such instrumentality, officer, or employee, shall be subject to the provisions of this title in the same manner and to the same extent as any nongovernmental entity.

(i)

As used in this section, an “offer for sale” or an “offer to sell” by a person other than the patentee, or any designee of the patentee, is that in which the sale will occur before the expiration of the term of the patent.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

  1. July 19, 1952, ch. 950, 66 Stat. 811 · 66 Stat. 811

    Enacted · 35 U.S.C. § 271

    July 19, 1952, ch. 950, 66 Stat. 811

    Source evidence

    Code source credit
    July 19, 1952, ch. 950, 66 Stat. 811

  2. Drug Price Competition and Patent Term Restoration Act of 1984

    Pub. L. 98–417 title II § 202 · 98 Stat. 1585

    Added · 35 U.S.C. § 271(e)

    Pub. L. 98–417 added subsec. (e)

    Source evidence

    Code amendment note
    Subsec. (e). Pub. L. 98–417 added subsec. (e).

    Enacted provision · exact public law section
    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 USC 301, 151 note. uses reasonably related to the development and submission of information 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 patent or the use of which is claimed in a Ante, p. 1593. 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 manufacture, 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 USC 285.

  3. Patent Law Amendments Act of 1984

    Pub. L. 98–622 title I § 101(a) · 98 Stat. 3383

    Added · 35 U.S.C. § 271(f)

    Pub. L. 98–622 added subsec. (f)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 98–622 added subsec. (f).

    Enacted provision · exact public law section
    (a) Section 271 of title 35, United States Code, is amended Ante, p. 1603. by adding at the end thereof the following new subsection: “(f) (1) Whoever without authority supplies or causes to be supplied in or from the United States all or a substantial portion of the components of a patented invention, where such components are uncombined in whole or in part, in such manner as to actively induce the combination of such components outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer. “(2) Whoever without authority supplies or causes to be supplied in or from the United States any component of a patented invention that is especially made or especially adapted for use in the invention and not a staple article or commodity of commerce suitable for substantial noninfringing use, where such component is uncombined in whole or in part, knowing that such component is so made or adapted and intending that such component will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States, shall be liable as an infringer.”.

  4. Process Patent Amendments Act of 1988

    Pub. L. 100–418 title IX § 9003 · 102 Stat. 1107

    Added · 35 U.S.C. § 271(g)

    Pub. L. 100–418 added subsec. (g)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 100–418 added subsec. (g).

    Enacted provision · exact public law section
    SEC. 9003. INFRINGEMENT FOR IMPORTATION. USE, OR SALE. Section 271 of title 35, United States Code, is amended by adding at the end the following new subsection: “(g) Whoever without authority imports into the United States or sells or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, sale, or use of the product occurs during the term of such process patent. In an action for infringement of a process patent, no remedy may be granted for infringement on account of the noncommercial use or retail sale of a product unless there is no adequate remedy under this title for infringement on account of the importation or other use or sale of that product. A product which is made by a patented process will, for purposes of this title, not be considered to be so made after— “(1) it is materially changed by subsequent processes; or “(2) it becomes a trivial and nonessential component of another product.”.

  5. Generic Animal Drug and Patent Term Restoration Act

    Pub. L. 100–670 § 201(i)(1) · 102 Stat. 3971

    Inserted · 35 U.S.C. § 271(e)(1)

    Pub. L. 100–670, § 201(i)(1), inserted “which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques” after “March 4, 1913)” and “or veterinary biological products” after “sale of drugs”

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 100–670, § 201(i)(1), inserted “which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques” after “March 4, 1913)” and “or veterinary biological products” after “sale of drugs”.

    Enacted provision · exact public law section
    (1) Section 271(e)(1) is amended— (A) by inserting before the last close parenthesis the following: “which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques”, and (B) by inserting before the period the following: “or veterinary biological products”.

  6. Generic Animal Drug and Patent Term Restoration Act

    Pub. L. 100–670 § 201(i)(2) · 102 Stat. 3971

    Amended · 35 U.S.C. § 271(e)(2)

    Pub. L. 100–670, § 201(i)(2), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a 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.”

    Source evidence

    Code amendment note
    Subsec. (e)(2). Pub. L. 100–670, § 201(i)(2), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a 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.”

    Enacted provision · exact public law section
    (2) Section 271(e)(2) is amended to read as follows: “(2) It shall be an act of infringement to submit— “(A) an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a patent or the use of which is claimed in a patent, or “(B) an application under section 512 of such Act or under the Act of March 4, 1913 (21 U.S.C. 151–158) for a drug or veterinary biological product which is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques and which is claimed in a 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 or veterinary biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.”.

  7. Generic Animal Drug and Patent Term Restoration Act

    Pub. L. 100–670 § 201(i)(3) · 102 Stat. 3971

    Inserted · 35 U.S.C. § 271(e)(4)

    Pub. L. 100–670, § 201(i)(3), inserted “or veterinary biological product” after “drug” in subpars. (A) to (C)

    Source evidence

    Code amendment note
    Subsec. (e)(4). Pub. L. 100–670, § 201(i)(3), inserted “or veterinary biological product” after “drug” in subpars. (A) to (C).

    Enacted provision · exact public law section
    (3) Section 271(e)(4) is amended by inserting “or veterinary 35 USC 271. biological product” after “drug” each place it occurs.

  8. Pub. L. 100–703 title II § 201 · 102 Stat. 4674

    Added · 35 U.S.C. § 271(d)

    Pub. L. 100–703 added cls. (4) and (5)

    Source evidence

    Code amendment note
    Subsec. (d). Pub. L. 100–703 added cls. (4) and (5).

    Enacted provision · exact public law section
    SEC. 201. PERMISSIBLE ACTS BY PATENT OWNER. Section 271(d) of title 35, United States Code, is amended by striking out the period at the end thereof and inserting in lieu thereof the following: “; (4) refused to license or use any rights to the patent; or (5) conditioned the license of any rights to the patent or the sale of the patented product on the acquisition of a license to rights in another patent or purchase of a separate product, unless, in view of the circumstances, the patent owner has market power in the relevant market for the patent or patented product on which the license or sale is conditioned.”.

  9. Patent and Plant Variety Protection Remedy Clarification Act

    Pub. L. 102–560 § 2(a)(1) · 106 Stat. 4230

    Added · 35 U.S.C. § 271(h)

    Pub. L. 102–560 added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 102–560 added subsec. (h).

    Enacted provision · exact public law section
    (1) Section 271 of title 35, United States Code, is amended by adding at the end the following: “(h) As used in this section, the term ‘whoever’ includes any State, any instrumentality of a State, and any officer or employee of a State or instrumentality of a State acting in his official capacity. Any State, and any such instrumentality, officer, or employee, shall be subject to the provisions of this title in the same manner and to the same extent as any nongovernmental entity.”.

  10. Pub. L. 103–465 § 533(a)(1) · 108 Stat. 4809

    Inserted · 35 U.S.C. § 271(a)

    Pub. L. 103–465, § 533(a)(1), inserted “, offers to sell,” after “uses” and “or imports into the United States any patented invention” after “the United States”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 103–465, § 533(a)(1), inserted “, offers to sell,” after “uses” and “or imports into the United States any patented invention” after “the United States”.

    Enacted provision · exact public law section
    (1) in subsection (a)— (A) by inserting “, offers to sell,” after “uses”; and (B) by inserting “or imports into the United States any patented invention” after “the United States”;

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  11. Pub. L. 103–465 § 533(a)(2) · 108 Stat. 4809

    Substituted · 35 U.S.C. § 271(c)

    Pub. L. 103–465, § 533(a)(2), substituted “offers to sell or sells within the United States or imports into the United States” for “sells”

    Source evidence

    Code amendment note
    Subsec. (c). Pub. L. 103–465, § 533(a)(2), substituted “offers to sell or sells within the United States or imports into the United States” for “sells”.

    Enacted provision · exact public law section
    (2) in subsection (c), by striking “sells” and inserting “offers to sell or sells within the United States or imports into the United States”;

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  12. Pub. L. 103–465 § 533(a)(3)(A) · 108 Stat. 4809

    Substituted · 35 U.S.C. § 271(e)(1)

    Pub. L. 103–465, § 533(a)(3)(A), substituted “offer to sell, or sell within the United States or import into the United States” for “or sell”

    Source evidence

    Code amendment note
    Subsec. (e)(1). Pub. L. 103–465, § 533(a)(3)(A), substituted “offer to sell, or sell within the United States or import into the United States” for “or sell”.

    Enacted provision · exact public law section
    (A) in paragraph (1), by striking “or sell” and inserting “offer to sell, or sell within the United States or import into the United States”;

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  13. Pub. L. 103–465 § 533(a)(3)(B) · 108 Stat. 4809

    Substituted · 35 U.S.C. § 271(e)(3)

    Pub. L. 103–465, § 533(a)(3)(B), substituted “offering to sell, or selling within the United States or importing into the United States” for “or selling”

    Source evidence

    Code amendment note
    Subsec. (e)(3). Pub. L. 103–465, § 533(a)(3)(B), substituted “offering to sell, or selling within the United States or importing into the United States” for “or selling”.

    Enacted provision · exact public law section
    (B) in paragraph (3), by striking “or selling” and inserting “offering to sell, or selling within the United States or importing into the United States”;

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  14. Pub. L. 103–465 § 533(a)(3)(C) · 108 Stat. 4809

    Substituted · 35 U.S.C. § 271(e)(4)(B); 35 U.S.C. § 271(e)(4)(C)

    Pub. L. 103–465, § 533(a)(3)(C), (D), substituted “offer to sell, or sale within the United States or importation into the United States” for “or sale”

    Source evidence

    Code amendment note
    Subsec. (e)(4)(B), (C). Pub. L. 103–465, § 533(a)(3)(C), (D), substituted “offer to sell, or sale within the United States or importation into the United States” for “or sale”.

    Enacted provision · exact public law section
    (C) in paragraph (4)(B), by striking “or sale” and inserting “offer to sell, or sale within the United States or importation into the United States”; and

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  15. Pub. L. 103–465 § 533(a)(4) · 108 Stat. 4809

    1. Substituted · 35 U.S.C. § 271(g)

      Pub. L. 103–465, § 533(a)(4), substituted “offers to sell, sells,” for “sells”

    2. Substituted · 35 U.S.C. § 271(g)

      Pub. L. 103–465, § 533(a)(4), substituted “importation, offer to sell, sale,” for “importation, sale,”

    3. Substituted · 35 U.S.C. § 271(g)

      Pub. L. 103–465, § 533(a)(4), substituted “other use, offer to sell, or” for “other use or”

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 103–465, § 533(a)(4), substituted “offers to sell, sells,” for “sells”, “importation, offer to sell, sale,” for “importation, sale,”, and “other use, offer to sell, or” for “other use or”.

    Enacted provision · exact public law section
    (4) in subsection (g)— (A) by striking “sells” and inserting “offers to sell, sells,”; (B) by striking “importation, sale,” and inserting “importation, offer to sell, sale,”; and (C) by striking “other use or” and inserting “other use, offer to sell, or”; and

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  16. Pub. L. 103–465 § 533(a)(5) · 108 Stat. 4809

    Added · 35 U.S.C. § 271(i)

    Pub. L. 103–465, § 533(a)(5), added subsec. (i)

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 103–465, § 533(a)(5), added subsec. (i).

    Enacted provision · exact public law section
    (5) by adding at the end the following: “(i) As used in this section, an ‘offer for sale’ or an ‘offer to sell’ by a person other than the patentee, or any designee of the patentee, is that in which the sale will occur before the expiration of the term of the patent.”.

    Effective date note
    Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [Jan. 1, 1995], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

  17. Medicare Prescription Drug, Improvement, and Modernization Act of 2003

    Pub. L. 108–173 title XI § 1101(d) · 117 Stat. 2066

    Added · 35 U.S.C. § 271(e)(5)

    Pub. L. 108–173 added par. (5)

    Source evidence

    Code amendment note
    Subsec. (e)(5). Pub. L. 108–173 added par. (5).

    Enacted provision · exact public law section
    (d) Infringement Actions.— Section 271(e) of title 35, United States Code, is amended by adding at the end the following: “(5) Where a person has filed an application described in paragraph (2) that includes a certification under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), and neither the owner of the patent that is the subject of the certification nor the holder of the approved application under subsection (b) of such section for the drug that is claimed by the patent or a use of which is claimed by the patent brought an action for infringement of such patent before the expiration of 45 days after the date on which the notice given under subsection (b)(3) or (j)(2)(B) of such section was received, the courts of the United States shall, to the extent consistent with the Constitution, have subject matter jurisdiction in any action brought by such person under section 2201 of title 28 for a declaratory judgment that such patent is invalid or not infringed.” .

  18. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(A)(iv) · 124 Stat. 119

    Substituted · 35 U.S.C. § 271(e)(2)

    Pub. L. 111–148, § 7002(c)(1)(A)(iv), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (e)(2). Pub. L. 111–148, § 7002(c)(1)(A)(iv), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” in concluding provisions.

    Enacted provision · exact public law section
    (iv) in the matter following subparagraph (C) (as added by clause (iii)), by striking “or veterinary biological product” and inserting “, veterinary biological product, or biological product”;

  19. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(A)(i) · 124 Stat. 119

    Added · 35 U.S.C. § 271(e)(2)(C)

    Pub. L. 111–148, § 7002(c)(1)(A)(i)–(iii), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (e)(2)(C). Pub. L. 111–148, § 7002(c)(1)(A)(i)–(iii), added subpar. (C).

    Enacted provision · exact public law section
    (i) in subparagraph (A), by striking “or” at the end;

  20. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(B)(iv) · 124 Stat. 119

    Substituted · 35 U.S.C. § 271(e)(4)

    Pub. L. 111–148, § 7002(c)(1)(B)(iv), substituted “(C), and (D)” for “and (C)” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (e)(4). Pub. L. 111–148, § 7002(c)(1)(B)(iv), substituted “(C), and (D)” for “and (C)” in concluding provisions.

    Enacted provision · exact public law section
    (iv) in the matter following subparagraph (D) (as added by clause (iii)), by striking “and (C)” and inserting “(C), and (D)”; and

  21. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(B)(i) · 124 Stat. 119

    1. Substituted · 35 U.S.C. § 271(e)(4)(B)

      Pub. L. 111–148, § 7002(c)(1)(B)(i), substituted “, veterinary biological product, or biological product” for “or veterinary biological product”

    2. Struck · 35 U.S.C. § 271(e)(4)(B)

      Pub. L. 111–148, § 7002(c)(1)(B)(i), struck out “and” at end

    Source evidence

    Code amendment note
    Subsec. (e)(4)(B). Pub. L. 111–148, § 7002(c)(1)(B)(i), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” and struck out “and” at end.

    Enacted provision · exact public law section
    (i) in subparagraph (B), by— (I) striking “or veterinary biological product” and inserting “, veterinary biological product, or biological product”; and (II) striking “and” at the end;

  22. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(B)(ii) · 124 Stat. 119

    Substituted · 35 U.S.C. § 271(e)(4)(C)

    Pub. L. 111–148, § 7002(c)(1)(B)(ii), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” and “, and” for period at end

    Source evidence

    Code amendment note
    Subsec. (e)(4)(C). Pub. L. 111–148, § 7002(c)(1)(B)(ii), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” and “, and” for period at end.

    Enacted provision · exact public law section
    (ii) in subparagraph (C), by— (I) striking “or veterinary biological product” and inserting “, veterinary biological product, or biological product”; and (II) striking the period and inserting “, and”;

  23. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(B)(iii) · 124 Stat. 119

    Added · 35 U.S.C. § 271(e)(4)(D)

    Pub. L. 111–148, § 7002(c)(1)(B)(iii), added subpar. (D)

    Source evidence

    Code amendment note
    Subsec. (e)(4)(D). Pub. L. 111–148, § 7002(c)(1)(B)(iii), added subpar. (D).

    Enacted provision · exact public law section
    (iii) by inserting after subparagraph (C) the following: “(D) Courts. the court shall order a permanent injunction prohibiting any infringement of the patent by the biological product involved in the infringement until a date which is not earlier than the date of the expiration of the patent that has been infringed under paragraph (2)(C), provided the patent is the subject of a final court decision, as defined in section 351(k)(6) of the Public Health Service Act, in an action for infringement of the patent under section 351(l)(6) of such Act, and the biological product has not yet been approved because of section 351(k)(7) of such Act.” ; and

  24. Biologics Price Competition and Innovation Act of 2009

    Pub. L. 111–148 § 7002(c)(1)(C) · 124 Stat. 119

    Added · 35 U.S.C. § 271(e)(6)

    Pub. L. 111–148, § 7002(c)(1)(C), added par. (6)

    Source evidence

    Code amendment note
    Subsec. (e)(6). Pub. L. 111–148, § 7002(c)(1)(C), added par. (6).

    Enacted provision · exact public law section
    (C) by adding at the end the following: “(6) (A) Applicability. Subparagraph (B) applies, in lieu of paragraph (4), in the case of a patent— “(i) that is identified, as applicable, in the list of patents described in section 351(l)(4) of the Public Health Service Act or the lists of patents described in section 351(l)(5)(B) of such Act with respect to a biological product; and “(ii) for which an action for infringement of the patent with respect to the biological product— “(I) was brought after the expiration of the 30-day period described in subparagraph (A) or (B), as applicable, of section 351(l)(6) of such Act; or “(II) was brought before the expiration of the 30-day period described in subclause (I), but which was dismissed without prejudice or was not prosecuted to judgment in good faith. “(B) In an action for infringement of a patent described in subparagraph (A), the sole and exclusive remedy that may be granted by a court, upon a finding that the making, using, offering to sell, selling, or importation into the United States of the biological product that is the subject of the action infringed the patent, shall be a reasonable royalty. “(C) The owner of a patent that should have been included in the list described in section 351(l)(3)(A) of the Public Health Service Act, including as provided under section 351(l)(7) of such Act for a biological product, but was not timely included in such list, may not bring an action under this section for infringement of the patent with respect to the biological product.” .

26 of 27 references resolved to an enrolled provision · 1 partial

Notes

Historical and Revision Notes

The first paragraph of this section is declaratory only, defining infringement.

Paragraphs (b) and (c) define and limit contributory infringement of a patent and paragraph (d) is ancillary to these paragraphs, see preliminary general description of bill. One who actively induces infringement as by aiding and abetting the same is liable as an infringer, and so is one who sells a component part of a patented invention or material or apparatus for use therein knowing the same to be especially made or especially adapted for use in the infringement of the patent except in the case of a staple article or commodity of commerce having other uses. A patentee is not deemed to have misused his patent solely by reason of doing anything authorized by the section.

Editorial Notes

References in Text

The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (e)(1), (2), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to chapter 9 (§ 301 et seq.) of Title 21, Food and Drugs. Sections 505 and 512 of the Act are classified to sections 355 and 360b, respectively, of Title 21. For complete classification of this Act to the Code, see section 301 of Title 21 and Tables.

Act of , referred to in subsec. (e)(1), (2), is act Mar. 4, 1913, ch. 145, 37 Stat. 828. The provisions of such act relating to viruses, etc., applicable to domestic animals, popularly known as the Virus-Serum-Toxin Act, are contained in the eighth paragraph under the heading “Bureau of Animal Industry” of act , at 37 Stat. 832, and are classified generally to chapter 5 (§ 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.

Section 351 of the Public Health Service Act, referred to in subsec. (e)(2)(C), (4)(D), (6)(A), (C), is classified to section 262 of Title 42, The Public Health and Welfare.

Amendments1984–2010 · 6 rounds

2010

Subsec. (e)(2). Pub. L. 111–148, § 7002(c)(1)(A)(iv), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” in concluding provisions.

Subsec. (e)(2)(C). Pub. L. 111–148, § 7002(c)(1)(A)(i)–(iii), added subpar. (C).

Subsec. (e)(4). Pub. L. 111–148, § 7002(c)(1)(B)(iv), substituted “(C), and (D)” for “and (C)” in concluding provisions.

Subsec. (e)(4)(B). Pub. L. 111–148, § 7002(c)(1)(B)(i), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” and struck out “and” at end.

Subsec. (e)(4)(C). Pub. L. 111–148, § 7002(c)(1)(B)(ii), substituted “, veterinary biological product, or biological product” for “or veterinary biological product” and “, and” for period at end.

Subsec. (e)(4)(D). Pub. L. 111–148, § 7002(c)(1)(B)(iii), added subpar. (D).

Subsec. (e)(6). Pub. L. 111–148, § 7002(c)(1)(C), added par. (6).

2003

Subsec. (e)(5). Pub. L. 108–173 added par. (5).

1994

Subsec. (a). Pub. L. 103–465, § 533(a)(1), inserted “, offers to sell,” after “uses” and “or imports into the United States any patented invention” after “the United States”.

Subsec. (c). Pub. L. 103–465, § 533(a)(2), substituted “offers to sell or sells within the United States or imports into the United States” for “sells”.

Subsec. (e)(1). Pub. L. 103–465, § 533(a)(3)(A), substituted “offer to sell, or sell within the United States or import into the United States” for “or sell”.

Subsec. (e)(3). Pub. L. 103–465, § 533(a)(3)(B), substituted “offering to sell, or selling within the United States or importing into the United States” for “or selling”.

Subsec. (e)(4)(B), (C). Pub. L. 103–465, § 533(a)(3)(C), (D), substituted “offer to sell, or sale within the United States or importation into the United States” for “or sale”.

Subsec. (g). Pub. L. 103–465, § 533(a)(4), substituted “offers to sell, sells,” for “sells”, “importation, offer to sell, sale,” for “importation, sale,”, and “other use, offer to sell, or” for “other use or”.

Subsec. (i). Pub. L. 103–465, § 533(a)(5), added subsec. (i).

1992

Subsec. (h). Pub. L. 102–560 added subsec. (h).

1988

Subsec. (d). Pub. L. 100–703 added cls. (4) and (5).

Subsec. (e)(1). Pub. L. 100–670, § 201(i)(1), inserted “which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques” after “)” and “or veterinary biological products” after “sale of drugs”.

Subsec. (e)(2). Pub. L. 100–670, § 201(i)(2), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “It shall be an act of infringement to submit an application under section 505(j) of the Federal Food, Drug, and Cosmetic Act or described in section 505(b)(2) of such Act for a drug claimed in a 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.”

Subsec. (e)(4). Pub. L. 100–670, § 201(i)(3), inserted “or veterinary biological product” after “drug” in subpars. (A) to (C).

Subsec. (g). Pub. L. 100–418 added subsec. (g).

1984

Subsec. (e). Pub. L. 98–417 added subsec. (e).

Subsec. (f). Pub. L. 98–622 added subsec. (f).

Statutory Notes and Related Subsidiaries

Effective Date of 1994 Amendment

Amendment by Pub. L. 103–465 effective on date that is one year after date on which the WTO Agreement enters into force with respect to the United States [], with provisions relating to earliest filed patent application, see section 534(a), (b)(3) of Pub. L. 103–465, set out as a note under section 154 of this title.

Effective Date of 1992 Amendment

Amendment by Pub. L. 102–560 effective with respect to violations that occur on or after , see section 4 of Pub. L. 102–560, set out as a note under section 2541 of Title 7, Agriculture.

Effective Date of 1988 Amendment

Pub. L. 100–703, title II, § 202, , 102 Stat. 4676, provided that: “The amendment made by this title [amending this section] shall apply only to cases filed on or after the date of the enactment of this Act [].”

Pub. L. 100–418, title IX, § 9006, , 102 Stat. 1566, provided that:

“(a)

In General.—

The amendments made by this subtitle [subtitle A (§§ 9001–9007) of title IX of Pub. L. 100–418, enacting section 295 of this title and amending this section and sections 154 and 287 of this title] take effect 6 months after the date of enactment of this Act [] and, subject to subsections (b) and (c), shall apply only with respect to products made or imported after the effective date of the amendments made by this subtitle.

“(b)

Exceptions.—

The amendments made by this subtitle shall not abridge or affect the right of any person or any successor in business of such person to continue to use, sell, or import any specific product already in substantial and continuous sale or use by such person in the United States on , or for which substantial preparation by such person for such sale or use was made before such date, to the extent equitable for the protection of commercial investments made or business commenced in the United States before such date. This subsection shall not apply to any person or any successor in business of such person using, selling, or importing a product produced by a patented process that is the subject of a process patent enforcement action commenced before , before the International Trade Commission, that is pending or in which an order has been entered.

“(c)

Retention of Other Remedies.—

The amendments made by this subtitle shall not deprive a patent owner of any remedies available under subsections (a) through (f) of section 271 of title 35, United States Code, under section 337 of the Tariff Act of 1930 [19 U.S.C. 1337], or under any other provision of law.”

Effective Date of 1984 Amendment

Amendment by Pub. L. 98–622 applicable only to the supplying, or causing to be supplied, of any component or components of a patented invention after , see section 106(c) of Pub. L. 98–622, set out as a note under section 103 of this title.

Reports to Congress; Effect on Domestic Industries of Process Patent Amendments Act of 1988

Pub. L. 100–418, title IX, § 9007, , 102 Stat. 1567, provided that the Secretary of Commerce was to make annual reports to Congress covering each of the successive five 1-year periods beginning 6 months after , on the effect of the amendments made by subtitle A (§§ 9001–9007) of title IX of Pub. L. 100–418, enacting section 295 of this title and amending sections 154, 271, and 287 of this title, on those domestic industries that submit complaints to the Department of Commerce alleging that their legitimate sources of supply have been adversely affected by the amendments.

Credits

1952–2010 · 10 acts
  1. 1952July 19, 1952, ch. 950, 66 Stat. 811
  2. 1984Pub. L. 98–417, title II, § 202, , 98 Stat. 1603
  3. 1984Pub. L. 98–622, title I, § 101(a), , 98 Stat. 3383
  4. 1988Pub. L. 100–418, title IX, § 9003, , 102 Stat. 1563
  5. 1988Pub. L. 100–670, title II, § 201(i), , 102 Stat. 3988
  6. 1988Pub. L. 100–703, title II, § 201, , 102 Stat. 4676
  7. 1992Pub. L. 102–560, § 2(a)(1), , 106 Stat. 4230
  8. 1994Pub. L. 103–465, title V, § 533(a), , 108 Stat. 4988
  9. 2003Pub. L. 108–173, title XI, § 1101(d), , 117 Stat. 2457
  10. 2010Pub. L. 111–148, title VII, § 7002(c)(1), , 124 Stat. 815.
Show as published

(July 19, 1952, ch. 950, 66 Stat. 811; Pub. L. 98–417, title II, § 202, , 98 Stat. 1603; Pub. L. 98–622, title I, § 101(a), , 98 Stat. 3383; Pub. L. 100–418, title IX, § 9003, , 102 Stat. 1563; Pub. L. 100–670, title II, § 201(i), , 102 Stat. 3988; Pub. L. 100–703, title II, § 201, , 102 Stat. 4676; Pub. L. 102–560, § 2(a)(1), , 106 Stat. 4230; Pub. L. 103–465, title V, § 533(a), , 108 Stat. 4988; Pub. L. 108–173, title XI, § 1101(d), , 117 Stat. 2457; Pub. L. 111–148, title VII, § 7002(c)(1), , 124 Stat. 815.)

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