On September 17, 2021, the U.S. Court of Appeals for the Federal Circuit issued its opinion affirming the ITC's finding of a violation of section 337 in Certain Human Milk Oligosaccharides and Methods of Producing the Same (Inv. No. 337-TA-1120).

By way of background, the underlying investigation was based on an April 2, 2018 complaint filed by Glycosyn LLC of Waltham, Massachusetts ("Glycosyn") alleging a violation of section 337 by Respondent Jennewein Biotechnologie GmbH of Germany ("Jennewein") for the unlawful importation/sale of certain human milk oligosaccharides made by a process that infringes one or more claims of U.S. Patent Nos. 9,970,018 ("the '018 patent") and 9,453,230 ("the '230 patent").  See our April 2, 2018 and June 15, 2018 posts for more details regarding the complaint and Notice of Investigation.

On October 3, 2019, ALJ Cameron Elliot had issued a final initial determination ("ID") finding a violation of section 337 by virtue of two of Jennewein's three accused E. coli strains engineered for making fucosylated human milk oligosaccharides (specifically, 2'-fucosyllactose, or "2'-FL") infringing claims 1-3, 5, 8, 10, 12, 18, and 24-28 of the '018 patent under the doctrine of equivalents.  The ID left open the question of whether a third Jennewein accused strain infringed any claims of the '018 patent, noting that "the discovery on [the third accused strain] was not adequate" to adjudicate infringement.  The ID further found that the domestic industry requirement was satisfied for the '018 patent and that Jennewein failed to establish the invalidity of any of the asserted claims of the '018 patent.  In January 2020, the Commission decided to review the ID in part, and in May 2020 issued its decision affirming the ALJ's finding of infringement under the doctrine of equivalents with respect to two of Jennewein's three accused E. coli strains.  Unlike the ID, the Commission found that it could adjudicate infringement of the third Jennewein accused strain, and that "Glycosyn failed to satisfy its burden of establishing infringement."  Accordingly, the Commission issued a limited exclusion order against the 2'-FL produced by the two infringing Jennewein's strains (the #1540 and #2410 strains), but not as applied to the 2'-FL produced by the third Jennewein's strain (TTFL12).

On appeal, Jennewein argued that the Commission erred in (1) its finding that Jennewein's #1540 and #2410 strains infringe the asserted claims of the '018 patent; and (2) its construction of the limitation "the level of β-galactosidase activity comprises between 0.05 and 200 units" in the '018 patent.

According to the opinion, the Federal Circuit found that substantial evidence supports the Commission's determination that that Jennewein's accused #1540 and #2410 strains infringe the asserted claims.  For example, regarding whether Jennewein's #1540 and #2410 strains satisfy the claim limitation requiring that "the level of β-galactosidase activity comprises between 0.05 and 200 units," Jennewein argued that the plain meaning of the claim language required that the Miller unit readings reflect the activity of the inserted β-galactosidase gene and not activity from a different source.  Therefore, Jennewein argued that to assess infringement, a negative control strain lacking a functional β-galactosidase gene must be used to ensure that the measured β-galactosidase activity of the accused strain is from the inserted β-galactosidase gene, and not from another source or from background noise.  The Court found that the Commission reasonably concluded that the inclusion of a negative control strain was unnecessary to measure the amount of Miller unit activity, noting that Jennewein's proposed testing with negative control strains produced unreliable results, and that in light of Jennewein's unreliable presented test results, the Commission properly credited Glycosyn's testing of the #1540 and #2410 strains, finding that Glycosyn's testing hewed more closely to the Miller protocol.

With respect to the Commission's finding that Jennewein's #1540 and #2410 strains satisfied the "exogenous functional β-galactosidase gene" claim limitation, at least under the doctrine of equivalents, Jennewein argued that even though the lacZΩ gene fragment is exogenous to the #1540 and #2410 strains, the lacZa gene fragment is not exogenous but endogenous, making the combination of lacZa and lacZΩ gene fragments endogenous because the combination does not originate outside of the host strain.  The Court disagreed with Jennewein's characterization, noting that the combination of lacZa and lacZΩ gene fragments does not exist in the original strain used to make the #1540 and #2410 strains, and therefore the combination itself does not originate from within the organism, making it exogenous.  Accordingly, the Court found that substantial evidence supported the Commission's finding that the fragment is exogenous and therefore satisfies the claim limitation.

Finally, the Court rejected Jennewein's argument that the Commission erred in its interpretation of the limitation "the level of β-galactosidase activity comprises between 0.05 and 200 units."  Jennewein argued that the limitation required that the modified bacterium's level of β-galactosidase activity be "within the claimed range substantially throughout 2'-FL production and retrieval."  Reviewing the Commission's claim construction de novo, the Court rejected Jennewein's arguments and affirmed the construction adopted by the Commission.  Turning first to the claim itself, the Court noted that the plain language supported the Commission's interpretation and that there was nothing in the claims to support Jennewein's proposed limitation.  Further, the Court found that both the written description and prosecution history support the Commission's interpretation.

Having found that the Commission's finding of infringement under the doctrine of equivalents was supported by substantial evidence, and affirming the Commission's claim construction de novo, the Federal Circuit affirmed the decision of the Commission in all respects, allowing for the issuance of its limited exclusion order.

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