Jennewein Biotechnologie Gmbh v. Itc
20-2220
| Fed. Cir. | Sep 17, 2021Background
- Glycosyn owns U.S. Patent No. 9,970,018 covering methods and engineered E. coli for producing fucosylated human milk oligosaccharides (e.g., 2'-FL); the engineered bacterium must lack endogenous lacZ but include an exogenous functional β‑galactosidase gene with activity of 0.05–200 Miller units.
- The patent teaches that a low but detectable β‑galactosidase level preserves an intracellular lactose pool during production yet can remove residual lactose after fermentation to ease purification.
- Jennewein imported 2'-FL made using three engineered E. coli strains: #1540 and #2410 (contain lacZα and lacZΩ fragments that together produce β‑galactosidase activity, temperature‑regulated) and TTFL12 (lacks lacZΩ and does not use lactose).
- Glycosyn sued at the ITC under 19 U.S.C. § 1337 alleging infringement of the '018 patent; the ALJ construed claims and found #1540/#2410 infringed under the doctrine of equivalents but left TTFL12 undecided; the Commission later affirmed infringement for #1540/#2410 and found TTFL12 noninfringing, issuing a limited exclusion order for 2'-FL from #1540/#2410.
- Primary factual disputes on appeal concerned (1) how to measure β‑galactosidase activity (whether to subtract a negative control), (2) whether the lacZα+lacZΩ combination satisfies an "exogenous functional β‑galactosidase gene" limitation, and (3) whether the claimed 0.05–200 Miller‑unit range requires the activity to be present substantially throughout production and retrieval.
Issues
| Issue | Plaintiff's Argument (Glycosyn) | Defendant's Argument (Jennewein) | Held |
|---|---|---|---|
| Proper measurement of β‑galactosidase activity (Miller assay) | Use standard Miller protocol absolute readings; no subtraction of a negative‑control strain; Glycosyn's tests show values in range | Must subtract background using a negative control strain to isolate activity from the inserted gene; otherwise readings may reflect noise | Commission and court: substantial evidence supports using Miller protocol controls without subtracting a negative control; Glycosyn's data show #1540/#2410 within 0.05–200 units |
| "Exogenous functional β‑galactosidase gene" claim term | The lacZα + lacZΩ combination in #1540/#2410 is equivalent to an exogenous functional gene; lacZΩ is exogenous and the combination does not preexist in the host | lacZα is endogenous in the host so the combination is not exogenous and cannot meet the claim | Commission and court: the combination is exogenous (lacZΩ is exogenous; lacZα originates from phage introduced by human manipulation); doctrine of equivalents applies |
| Temporal scope of 0.05–200 Miller‑unit limitation | The claim requires the bacterium provided to exhibit the recited Miller‑unit activity (an inherent property); no continuous/throughout‑production requirement | The activity must be within the claimed range substantially throughout 2'-FL production and retrieval | Commission and court: no temporal limitation; claim covers the bacterium's measurable activity at some point (continuous monitoring not required); retrieving product from lysed cells is contemplated |
| Final remedy (limited exclusion order) | Exclude 2'-FL produced by infringing strains (#1540/#2410) | Appeal contesting construction and infringement findings | Affirmed: limited exclusion order upheld for products from #1540/#2410; TTFL12 not covered |
Key Cases Cited
- Teva Pharms. USA, Inc. v. Sandoz, Inc., 574 U.S. 318 (2015) (standard for reviewing claim construction; de novo for intrinsic evidence)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claims read in view of the specification)
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (claims are part of an integrated written instrument)
- Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d 1331 (Fed. Cir. 2010) (patent owner burden to prove infringement by preponderance)
- Finnigan Corp. v. Int’l Trade Comm’n, 180 F.3d 1354 (Fed. Cir. 1999) (standard of review for Commission factual findings)
- Linear Tech. Corp. v. Int’l Trade Comm’n, 566 F.3d 1049 (Fed. Cir. 2009) (review of Commission legal determinations de novo and factual findings for substantial evidence)
- Primos, Inc. v. Hunter’s Specialties, Inc., 451 F.3d 841 (Fed. Cir. 2006) (avoid claim constructions that exclude preferred embodiments)
- Hill‑Rom Servs., Inc. v. Stryker Corp., 755 F.3d 1367 (Fed. Cir. 2014) (reject narrowing claims absent specification or prosecution history support)
- Schindler Elevator Corp. v. Otis Elevator Co., 593 F.3d 1275 (Fed. Cir. 2010) (prosecution disclaimer requires clear and unmistakable disavowal)
- Nutrinova Nutrition Specialties & Food Ingredients GmbH v. Int’l Trade Comm’n, 224 F.3d 1356 (Fed. Cir. 2000) (appellate court should not reweigh evidence; substantial evidence standard)