U.S. Code » Title 35 » Part PART III— PATENTS AND PROTECTION OF PATENT RIGHTS › Chapter CHAPTER 29— REMEDIES FOR INFRINGEMENT OF PATENT, AND OTHER ACTIONS

35 U.S.C. § 295

Presumption: Product made by patented process

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In actions alleging infringement of a process patent based on the importation, sale, offer for 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.(Added Pub. L. 100–418, title IX, § 9005(a), Aug. 23, 1988, 102 Stat. 1566; amended Pub. L. 103–465, title V, § 533(b)(7), Dec. 8, 1994, 108 Stat. 4990.)Editorial NotesAmendments

1994—Pub. L. 103–465 substituted “sale, offer for sale, or use” for “sale, or use” in introductory provisions.

Statutory Notes and Related SubsidiariesEffective 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.

Notes of Decisions
Cited in 25 cases (4 in the last 5 years), 1994–2025 · leading case: Bayer Ag & Bayer Corp. v. Housey Pharm., Inc., 340 F.3d 1367 (Fed. Cir. 2003).
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Bayer Ag & Bayer Corp. v. Housey Pharm., Inc., 340 F.3d 1367 (Fed. Cir. 2003). · cites it 2× “The factual basis of Housey’s infringement claim as stated in the counterclaim was that: Pursuant to 35 U.S.C. § 295 , this Court may presume that a product was made [by Housey’s] patented methods where there is a substantial likelihood that it was so made by and [Housey] has…”
Novo Nordisk of North Am., Inc., Novo Nordisk Pharm., Inc., & Novo Nordisk, A/s v. Genentech, Inc., 77 F.3d 1364 (Fed. Cir. 1996). · cites it 2× “Pursuant to 35 U.S.C. § 295 (1994), the accused infringer's product is presumed to have been made by the patented process if the trial court finds that (1) a substantial likelihood exists that the product was made by the patented process, and (2) the patentee made a reasonable…”
Creative Compounds, LLC v. Starmark Labs., 651 F.3d 1303 (Fed. Cir. 2011). “” 35 U.S.C. § 295 . If both conditions are met, “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.”
Kemin Foods, L.C. v. Pigmentos Vegetales Del Centro S.A. De C.V., 240 F. Supp. 2d 963 (S.D. Iowa 2003). · cites it 5× “Therefore, 35 U.S.C. § 295 applies: In actions alleging infringement of a process patent based on the importation, sale, offer for sale, or use of a product which is made from a process patented in the United States, if the courts finds - (1) that a substantial likelihood exists…”
Kemin Foods, L.C. v. Pigmentos Vegetales Del Centro S.A. De C.V., 464 F.3d 1339 (Fed. Cir. 2006). · cites it 2× “In response, Kemin requested that the district court apply 35 U.S.C. § 295 and thereby shift the burden of proof to PI-VEG with respect to the claim of infringement of process claim 1 of the '564 patent.”
Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015). · cites it 2× “2011) (citing 35 U.S.C. § 295 ). AMGEN INC. v. SANDOZ INC.”
Aventis Pharm., Inc. v. Barr Labs., Inc., 411 F. Supp. 2d 490 (D.N.J. 2006). · cites it 2× “§ 271 (g), Teva, have infringed the process patent, Plaintiffs seek to invoke the burden-shifting effect of 35 U.S.C. § 295 : In actions alleging infringement of a process patent based on the importation, sale, offer for sale, or use of a product which is made from a process…”
Mcdavid Knee Guard, Inc. v. Nike USA, Inc., 683 F. Supp. 2d 740 (N.D. Ill. 2010). · cites it 3× “Because the exact process performed in Method 1 is unclear from the record, McDavid urges the court to apply a presumption of infringement under 35 U.S.C. § 295 . Section 295 provides that a product is presumed to infringe a patented process if: (1) a substantial likelihood…”
Pfizer Inc. v. F & S Alloys & Minerals Corp., 856 F. Supp. 808 (S.D.N.Y. 1994). · cites it 2× “35 U.S.C. § 295 (1994). Applied to this case, the statute requires that initially Pfizer must establish by a preponderance of the evidence that there is a substantial likelihood that Anhui uses Pfizer’s patented process to manufacture maltol and ethyl maltol and that Pfizer has…”
CVI/Beta Ventures, Inc. v. TURA LP, 905 F. Supp. 1171 (E.D.N.Y 1995). “35 U.S.C. § 295 . With respect to certain frame components, the jury was instructed pursuant to Section 295 that they should presume, subject to proof to the contrary by the defendants, that the accused frames were subjected to the required heat treatment.”
Lg Display Co., Ltd. v. Au Optronics Corp., 709 F. Supp. 2d 311 (D. Del. 2010). “Whether AUO Infringes Claim 9 of LGD’s '371 Patent LGD’s infringement argument related to the '374 patent is based upon the application of 35 U.S.C. § 295 . In full, Section 95 provides: Presumption: Product made by patented process In actions alleging infringement of a process…”
LG Display Co. v. AU Optronics Corp., 265 F.R.D. 199 (D. Del. 2010). “Specifically, LGD contends that it has satisfied the elements of 35 U.S.C. § 295 such that a presumption of infringement by AUO exists, and therefore, the burden of proof should be shifted to AUO to rebut this presumption.”
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