Jennewein Biotechnologie GmbH v. Int. Trade Comm. (Glycosyn LLC as Intervenor)
Docket No. 2020-2220 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-2220.OPINION.9-17-2021_1836421.pdf)
DYK, PROST, HUGHES
September 17, 2021
Brief Summary: ITC claim construction and finding of infringement under the DOE affirmed.
Summary: Jennewein appealed ITC’s claim construction and finding of infringement of Glycosyn’s US 9,970,018 related to methods for using E. coli and lactose to produce fucosylated oligosaccharides (“2-FL”) found in human milk. The E. coli of the ‘018 claims have an inactivated or deleted endogenous b-galactosidase (b-gal) gene and “an functional exogenous b-galactosidase gene” and a b-gal activity of “between 0.05 and 200 units.” Glycosyn filed a complaint with the ITC, alleging “that Jennewein violated [section] 1337(a)(1)(B) by importing 2’-FL produced by a process covered by the ‘018 patent.” The FC panel opinion explains that the three allegedly infringing E. coli strains lack an endogenous b-gal gene, “two of the strains, #1540 and #2410, comprise the gene fragments lacZα and lacZΩ, which when expressed together produce β-galactosidase, resulting in β-galactosidase activity”, the expression of which is controlled using temperature, and “[t]he third strain, TTFL12, lacks a functional β-galactosidase gene as it comprises the lacZα gene fragment but not the lacZΩ gene fragment” and “does not use lactose to produce 2’-FL”. The #1540 and #2410 strains are FDA approved but the TTFL12 strain is not. The ITC’s Administrative Law Judge (ALJ) construed the claims and found the 1540 and 2410 strains, but not TTFL12, infringed under the doctrine of equivalents (DOE). The ITC “affirmed the ALJ’s finding of infringement under the doctrine of equivalents, agreeing that the combination of the lacZα and lacZΩ gene fragments in Jennewein’s #1540 and #2410 strains is equivalent to an ‘exogenous functional β-galactosidase gene’” (e.g., “the exogenous nature of lacZΩ” (not present in TTFL12), “any difference between the claim term ‘an exogenous functional β-galactosidase gene’ and the accused products is insubstantial”). Jennewein unsuccessfully argued in this appeal that the ITC erred by not subtracting the activity of a negative b-gal expression control (e.g., “[t]he temperature regulator controlling expression of the lacZΩ gene fragment in Jennewein’s #1540 and #2410 strains can “leak,’”, “the two negative control strains selected by Jennewein had higher Miller unit values than the #1540 and #2410 strains”). The FC panel also agreed with the ITC that “the combination of the lacZα and lacZΩ gene fragments in Jennewein’s #1540 and #2410 strains is equivalent to a ‘functional β-galactosidase gene’” and disagreed with Jennewein that the fragments were not exogenous (e.g., “the combination itself does not originate from within the organism”). The FC panel also saw “nothing suggesting that the recited β-galactosidase activity must be present substantially throughout 2’-FL production and retrieval” in the claims. written description, or prosecution history (Primos, FC 2006 (cannot exclude preferred embodiments); MobileMedia, FC 2015; Schindler, FC 2010 (no “unequivocal disavowal”)). The ITC decision was therefore affirmed.