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 March 4, 1913, 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 Mar. 4, 1913, 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.

Amendments

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 “March 4, 1913)” 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 [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.

Effective Date of 1992 Amendment

Amendment by Pub. L. 102–560 effective with respect to violations that occur on or after Oct. 28, 1992, 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, Nov. 19, 1988, 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 [Nov. 19, 1988].”

Pub. L. 100–418, title IX, § 9006, Aug. 23, 1988, 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 [Aug. 23, 1988] 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 January 1, 1988, 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 January 1, 1987, 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 Nov. 8, 1984, 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, Aug. 23, 1988, 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 Aug. 23, 1988, 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.