Bio-Rad Laboratories, Inc. v. International Trade Commission (10X Genomics Inc.)
10X Genomics Inc. v. International Trade Commission (Bio-Rad Laboratories, Inc.)
Docket No. 2020-1475, -1605 (http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/20-1475.OPINION.5-28-2021_1784059.pdf)
NEWMAN, LOURIE, DYK
May 28, 2021
Brief Summary: ITC claim construction and infringement (no and yes) findings affirmed.
Summary: Bio-Rad and 10X each appealed portions of International Trade Commission (ITC) decision finding infringement of Bio-Rad’s US 9,500,664; 9,636,682; and 9,649,635 regarding systems for generating microscopic droplets including an aqueous “sample-containing fluid” and a non-aqueous “background fluid” for use in microfluidics (on “chips”). 10X’s accused infringing products (GEM Chips and Chip GB) relate to next-generation sequencing platforms and were developed by three former Bio-Rad employees. The FC panel explained that ITC decisions are reviewed for substantial evidence and that it “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” (Spansion, FC 2010).
Bio-Rad appealed the ITC decision that Chip GB does not infringe the ‘664 patent, arguing that the Administrative Law Judge (ALJ) incorrectly determined the ChipGB “does not include a ‘sample well, a sample channel, sample-containing droplets, or the claimed ‘droplet generation region’” because it “does not involve a ‘sample’” and that “because the claims recite structural limitations (e.g., wells and channels), infringement of the claims cannot depend on the substances inside those wells and channels.” The FC panel agreed with the ALJ’s claim construction and infringement determination, concluding “that BioRad failed to meet its burden of showing that the monomer solution in the Chip GB is a ‘sample’” and distinguishing “between ‘samples’ and ‘reagents’” (e.g., “[t]he ’664 patent consistently makes clear that a sample is not a reagent”, “a reagent is not a part of a sample, nor is it the same thing as a sample in the context of the patent”) and no infringement because “the monomer in the Chip GB is not a sample” (e.g., “10X does not analyze the monomers, but rather uses them to make the gel beads that go into reagent kits”, “not clear that Bio-Rad raised” the structural limitations to the ITC but also that “it fails because it is premised on rewriting the claims in an oversimplified form and removing all limitations that differentiate the recited structures from each other”, “[i]nventors are masters of their claims, and the words they use to describe and claim their invention are decisive and binding”, “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard, FC 1990)).
10X appealed the decision that its GEM Chips “directly infringe the asserted patents and that it induces and/or contributes to its customers’ infringement of the ’682 and ’635 patents.” The FC panel found that 10X was not presenting any new claim construction arguments and that the ALJ correctly construed the “droplet-generating region” (e.g., claim language, specification support, no improper claim differentiation, rejecting “10X’s attempt to impose an unclaimed limitation”). The FC panel also affirmed the ITC’s direct infringement decision underlying its findings of induced (§ 271(b), Sanofi (FC 2017)) and contributory (§ 271(c), Commil (US 2015)) infringement (e.g., 10X had knowledge of the patents, “10X failed to point to any real available noninfringing uses”, “precedent…focuses on the real way in which the accused product is made, used, and sold” (Fujitsu, FC 2010; Golden Blount, FC 2006)).