- BASICS: “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.” 35 U.S.C. § 271(g); see also id. § 154(a)(1); Zoltek II (Fed. Cir. 03/14/12) (explaining purpose and legislative history). Must compare imported product to product that would be produced by claimed processes, and look to patent to measure whether differences are material. Amgen (Fed. Cir. 09/15/09) (aff’g jury verdict that changes not material).
- Title 19 (ITC) Has Similar Provision: Barring “importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee of articles that . . . are made, produced, processed, or mined under, or by means of, a process covered by the claims of a valid and enforceable United States patent.” 19 U.S.C. § 1337(a)(1)(B)(ii). Exceptions do not apply to ITC proceedings. Kinik (Fed. Cir. 05/13/04) (but not considering impact of GATT treaty 1998 national treatment rules). The safe harbor provided by Sec. 271(e)(1) does apply in ITC to import of products made by patented process. Amgen (Fed. Cir. 04/30/09).
- TIPS:
a) “a product”
- Information Is Not A Product Under Sec. 271(g). Bayer (Fed. Cir. 08/22/03) (“in order for a product to have been ‘made by a process patented in the United States’ it must have been a physical article that was ‘manufactured’ and … the production of information is not covered”); cf. Clearcorrect (Fed. Cir. 11/10/15) (2-1) (citing Bayer with approval as consistent with holding that “article” in ITC Sec. 337 statute is limited to a tangible, material thing, not intangibles such as transmission of digital data; asserted “article” was transmission of “digital models, digital data and treatment plans, expressed as digital data sets, which are virtual three-dimensional models of the desired positions of the patients’ teeth at various stages of orthodontic treatment”), rehearing en banc denied (Fed. Cir. 03/31/16) (Newman, J. dissenting); NTP (Fed. Cir. 08/02/05) (Sec. 271(g) does not apply to methods of transmitting information in the form of emails. “Because the ‘transmission of information,’ like the ‘production of information,’ does not entail the manufacturing of a physical product, section 271(g) does not apply to the asserted method claims in this case any more than it did in Bayer.”).
b) “made by a patented process”
- Testing And Quality Control Is Not Making A Product: “Make” in Sec. 271(g) has its ordinary meaning, namely, like “manufacture,” the “creation or bringing into existence of something” and “extends to the creation or transformation of a product, such as by synthesizing, combining components, or giving raw materials new properties.” But does not extend “to methods of testing a final product or intermediate substance to ensure that the intended product or substance has in fact been made” or has certain qualities. Momenta Pharm II (Fed. Cir. 11/10/15) (2-1) (aff’g Summ. J. of no Sec. 271(g) infringement; patented method generates information about products that have already been made without transforming them); Bayer (Fed. Cir. 08/22/03) (“in order for a product to have been ‘made by a process patented in the United States’ it must have been a physical article that was ‘manufactured’ and … the production of information is not covered”).
- Identifying What Product To Make Is Not Making A Product: Under Sec. 271(g), “the process must be used directly in the manufacture of the product, and not merely as a predicate process to identify the product to be manufactured.” Bayer (Fed. Cir. 08/22/03) (using the patented method to identify which substance to include in a drug does not use that process to make the drug. “A drug that was identified as useful through the use of a patented process is [not] a ‘product which [was] made by[that] process;’” and “processes of identification and generation of data are not steps in the manufacture of a final drug product.”).
- Method Of Making A Plasmid Also Makes The Intended Protein Expressed By That Plasmid: Based on legislative history precisely on point, Sec. 271(g) applies to importation or sale of protein (hormone) expressed by a plasmid (replicable cloning vehicle) made by patented method. Bio-Technology (Fed. Cir. 04/08/96).
- A Single Entity Need Not Perform, Direct Or Control All Steps Of The Patented Process: Because liability under section 271(g) is not predicated on direct infringement of the patented process and “the statutory language as a whole is clear that practicing a patented process abroad cannot create liability under § 271(g), whether that process is practiced by a single entity is immaterial to the infringement analysis.” Syngenta Crop (Fed. Cir. 12/18/19) (vacating jury verdict and D. Ct. judgment of non-infringement based on incorrect interpretation of the statute).
c) sec. 295 shifting burden of proof
- Burden May Shift To Accused To Prove Non-Infringement: When infringement alleged under Sec. 271(g), if 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 so to 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. § 295; see Creative Compounds (Fed. Cir. 06/24/11) (aff’g Summ. J. of infringement where defendant failed to provide documentation on its foreign supplier’s manufacturing process).
d) sec. 287(b) restriction on damages
- Special Restrictions on Damages: Infringer accused under Sec. 271(g), may be exempt from pre-suit damages unless that infringer “(A) practiced the patented process; (B) owns or controls, or is owned or controlled by, the person who practiced the patented process; or (C) had knowledge before the infringement that a patented process was used to make the product . . . .” 35 U.S.C. § 287(b).