March, 29th, 2024

Under U.S. law, anyone who uses a system that is likely to have been made by a patented process, and who does not demonstrate that the system was not made by the patented process, is liable for “direct” infringement of the patent. 35 U.S.C. 271(g) and 295 explain this:

(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.
35 U.S.C. Sec. 271 Infringement of patent (United States Code (2024 Edition)).

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.
35 U.S.C. Sec. 295 Presumption: Product made by patented process (United States Code (2024 Edition)).

U.S. courts have disagreed on whether to read the statute textually or to import into the plain language a supposed Congressional intent to limit the statute to imported goods. Some courts have cabined the statute to ignore the “sale, offer for sale, or use” aspects and focus only on “the importation” of a finished product. See, e.g., Lubrizol Specialty Prods., Inc. v. Flowchem LLC, 165 F.Supp.3d 534 (S.D. Tex. 2016). Cf. McRO, Inc. v. Namco Bandai Games Am., Inc., 23 F.Supp.3d 1113 (C.D. Cal. 2013), quoting S.Rep. No. 100–83 (1987), reprinted in 9–25 Chisum on Patents 100–60 (2013): “[b]ecause of our obligations under the GATT treaty to refrain from trade discrimination, the process patent bill was crafted to apply equally to the use or sale of a product made by a process patented in this country whether the product was made (and the process used) in this country or in a foreign country.” (emphasis omitted). See, also, United Gen. Supply Co. v. 2NDS In Bldg. Materials, Inc., CIVIL ACTION NO. 15-1975 (W.D. La. Feb 07, 2017) (“The plain language of Section 271(g) is not limited to instances where the manufacture of the product via an infringing process is performed abroad.”).

Meanwhile, the Federal Circuit, which typically is the court that says what patent law means, has held that “Section 271(g) prohibits the unauthorized importation into the United States, or sale or use within the United States, of a ‘product which is made by a process patented in the United States.’…” Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610 (Fed. Cir. 2015) (emphasis added).

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