JENNEWEIN BIOTECHNOLOGIE loses appeal of ITC ruling at CAFC

Yhe Finnigan case is cited:

The Commission’s final determinations are reviewed under the Administrative Procedure Act. 5 U.S.C. § 706; Honeywell Int’l, Inc. v. Int’l Trade Comm’n, 341 F.3d 1332, 1338 (Fed. Cir. 2003). We review the Commission’s legal determinations de novo and its factual findings for substantial evidence. See Finnigan Corp. v. Int’l Trade Comm’n, 180 F.3d 1354, 1361–62 (Fed. Cir. 1999); Linear Tech. Corp. v. Int’l Trade Comm’n, 566 F.3d 1049, 1060 (Fed. Cir. 2009).


One issue was "how" to do a measurement:

We first consider Jennewein’s argument that its #1540 and #2410 strains do not produce any β-galactosidase activity, let alone at the level recited in the claims. Patent infringement, whether literal or under the doctrine of equivalents, is a question of fact, which we review for substantial evidence. See Linear Tech., 566 F.3d at 1060. The patent owner bears the burden to prove infringement by a preponderance of the evidence. See Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d 1331, 1349 (Fed. Cir. 2010).
Here, substantial evidence supports the Commission’s finding that Jennewein’s #1540 and #2410 strains literally meet the limitation requiring that “the level of β-galactosidase activity comprises between 0.05 and 200 units.” To assess infringement of the claimed activity range, all parties acknowledge that the Miller protocol is the appropriate test. See, e.g., Reply Br. 5. Yet the parties disagree on how to conduct the assay. Jennewein argues that the plain meaning of the claim language requires that the Miller unit readings reflect the activity of the inserted βgalactosidase gene and not activity from a different source. Therefore, to assess infringement, Jennewein asserts that a negative control strain lacking a functional β-galactosidase gene must be used to ensure that the measured βgalactosidase activity of an accused strain is from the inserted β-galactosidase gene, not from another source or from background noise. Per Jennewein, the Commission erred by not requiring a negative control strain in the Miller assay.

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Moreover, communications between Jennewein and a third-party company it hired to conduct infringement testing suggest that the two negative control strains preferred by Jennewein are not suitable. See Appellee’s Br. 38–39 (“‘unfortunately, the Miller activity at your 1540 (30 °C) batch is still above 0.05 after subtracting [a third possible negative control strain],’ and ‘if we subtract [one of the two previously discussed negative control strains] instead of the [third possible negative control strain] as reference, the value would fall below 0.05’” (quoting J.A. 51523–51524) (cleaned up)). Because of these communications, the Commission found that “Jennewein sought a control strain that would minimize the measured Miller Units.” Initial Determination, 2019 WL 5677974, at *35. Substantial evidence supports this finding.

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See Spansion, Inc., 629 F.3d at 1344 (noting that under the substantial evidence test, we “must affirm a Commission determination if it is reasonable and supported by the record as a whole, even if some evidence detracts from the Commission’s conclusion” (internal quotation marks omitted)); see also Nutrinova Nutrition Specialties & Food Ingredients GmbH v. Int’l Trade Comm’n, 224 F.3d 1356, 1359 (Fed. Cir. 2000) (discussing that as an appellate court, we are not “to reweigh the evidence and reexamine the credibility of the witnesses”). Once the Commission concluded a negative control was not needed, it credited Glycosyn’s testing of Jennewein’s #1540 and #2410 strains, finding “Glycosyn’s testing simply hewed more closely to the Miller protocol, i.e., the terms in which the invention is defined.”8 Initial Determination, 2019 WL 5677974, at *37. The Commission then determined that “a large majority of [the] samples exhibit[ed] Miller Unit activities within the claimed range.” Id.

As to disclaimer,

See Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d 1275, 1285 (Fed. Cir. 2010) (“The doctrine of prosecution disclaimer attaches where an applicant, whether by amendment or by argument, unequivocally disavowed a certain meaning to obtain his patent.” (internal quotation marks omitted)); see also id. (“An argument made to an examiner constitutes a disclaimer only if it is clear and unmistakable.” (internal quotation marks omitted)).