35 U.S.C. § 295
Section 295 · Presumption: Product made by patented process
Amended 2 times on record
Applied in 18 court decisions — leading case Creative Compounds, LLC v. Starmark Laboratories (2011)
Most recently applied in Amgen Inc. v. Sandoz Inc. (July 2015)
How often courts cite this section
Court decisions citing this, by year.Markers show enactment, consequential amendments, and circuit splits over this section — watch for a citation surge after a change or a disagreement. The dip in the last several years is a data-coverage gap, not a real trend — our corpus holds fewer opinions from the most recent years, so recent citations are undercounted.
In actions alleging infringement of a process patent based on the importation, sale, or use of a product which is made from a process patented in the United States, if the court finds—
(1) that a substantial likelihood exists that the product was made by the patented process, and
(2) that the plaintiff has made a reasonable effort to determine the process actually used in the production of the product and was unable to so determine,
the product shall be presumed to have been so made, and the burden of establishing that the product was not made by the process shall be on the party asserting that it was not so made.
Editorial notes U.S. Code · Office of the Law Revision Counsel
Amendment of Section
Pub. L. 103–465, title V, §§533(b)(7), 534(a), (b)(3), Dec. 8, 1994, 108 Stat. 4989, 4990, provided that, 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, this section is amended by striking “sale, or use” and inserting “sale, offer for sale, or use”.
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
Section 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 an Effective Date of 1988 Amendment note under section 271 of this title.