Bio-Rad Labs., Inc. v. Int'l Trade Comm'n

• Citation: 998 F.3d 1320
• Decision Date: 28 May 2021
• Docket Number: 2020-1475, 2020-1605
• Parties: BIO-RAD LABORATORIES, INC., Appellant v. INTERNATIONAL TRADE COMMISSION, Appellee 10X Genomics Inc., Intervenor 10X Genomics Inc., Appellant v. International Trade Commission, Appellee Bio-Rad Laboratories, Inc., Intervenor
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

998 F.3d 1320

BIO-RAD LABORATORIES, INC., Appellant

v.INTERNATIONAL TRADE COMMISSION, Appellee

10X Genomics Inc., Intervenor

10X Genomics Inc., Appellant

v.International Trade Commission, Appellee

Bio-Rad Laboratories, Inc., Intervenor

2020-1475, 2020-1605

United States Court of Appeals, Federal Circuit.

Decided: May 28, 2021

Brian C. Cannon, Quinn Emanuel Urquhart & Sullivan, LLP, Redwood Shores, CA, argued for Bio-Rad Laboratories, Inc. Also represented by Kevin P.B. Johnson ; David Leon Bilsker, Andrew Edward Naravage, Nathan Sun, San Francisco, CA; Sean Gloth, II, New York, NY; S. Alex Lasher, Washington, DC.

Ronald Traud, Office of the General Counsel, United States International Trade Commission, Washington, DC, argued for International Trade Commission. Also represented by Dominic L. Bianchi, Wayne W. Herrington.

Nicholas P. Groombridge, Paul, Weiss, Rifkind, Wharton & Garrison LLP, New York, NY, argued for 10X Genomics Inc. Also represented by Jennifer Deneault, Jennifer H. Wu, Josephine Young ; Saurabh Gupta, Washington, DC.

Before Newman, Lourie, and Dyk, Circuit Judges.

Lourie, Circuit Judge.

In this consolidated appeal, Bio-Rad Laboratories, Inc. ("Bio-Rad") and 10X Genomics, Inc. ("10X") each challenge a portion of a decision by the United States International Trade Commission ("Commission") regarding Bio-Rad's allegations that 10X violated section 337 of the Tariff Act of 1930, 19 U.S.C. § 1337, by importing into the United States certain microfluidic chips. See Comm'n Opinion, In the Matter of Certain Microfluidic Devices , USITC Inv. No. 337-TA-1068, 2020 WL 225020 (Jan. 10, 2020) (" Commission Opinion "). Specifically, Bio-Rad challenges the Commission's determination that 10X did not infringe the claims of U.S. Patent 9,500,664 (the " ’664 patent") by importing its "Chip GB." 10X challenges the Commission's determination that it infringes the claims of the ’664 patent as well as U.S. Patents 9,636,682 (the " ’682 patent") and 9,649,635 (the " ’635 patent") by importing its "GEM Chips." For the reasons discussed below, we affirm the Commission's decision with respect to both appeals.

BACKGROUND

I. Background of the Patented Technology

The ’664, ’682, and ’635 patents (collectively, the "asserted patents") relate generally to the field of microfluidics, and specifically to the generation of microscopic droplets. A microscopic droplet is a contiguous amount of one type of fluid that is encapsulated within a different fluid. Typically, the inner fluid is aqueous or water-based, while the outer fluid is oil. The two fluids—which make up the two phases of the droplet—are immiscible. In the context of the disclosed inventions in this case, the asserted patents refer to the aqueous fluid in the droplet as the "sample-containing fluid." In contrast, the non-aqueous fluid is referred to as the "background fluid."¹

The use of aqueous droplets in oil allows isolation of materials because each droplet is partitioned from others, and thus chemical reactions can be conducted within each droplet. For example, as indicated by the ’664 patent, each droplet acts as a mini-test tube in which a fluid can be subjected to chemical reactions. See, e.g. , ’664 patent col. 4 l. 52–col. 5 l. 2. An emulsion, which is a collection of droplets, provides the ability to perform a high volume of chemical reactions in parallel. Microfluidic technology has applications in numerous fields of research, including life sciences.

The asserted patents are directed to systems and methods for generating microscopic droplets by using a microfluidic device commonly referred to as a "chip." A chip typically consists of a monolithic piece of substrate having a number of input and output wells connected by microfluidic channels, which are hair-width pathways through which fluids flow. See, e.g. , Bio-Rad Labs., Inc. v. 10X Genomics Inc. , 967 F.3d 1353, 1360 (Fed. Cir. 2020). The use of chips to generate microscopic droplets by intersecting microfluidic channels was known before the priority dates of the asserted patents. See id. (describing use of microfluidic chips in connection with patents claiming priority from applications filed as early as 2002). The asserted patents in this case, however, are directed to specific chip architectures that, for example, allow for "improved techniques for the generation, mixing, incubation, splitting, sorting, and detection of droplets." ’664 patent col. 2 ll. 25–27.

The chips used in the systems and methods of the patents comprise input wells, including a "sample well" to hold the sample-containing fluid and a "background fluid well" to hold the background fluid.² The wells are connected to microfluidic channels, which intersect each other at a "droplet-generation region," where the droplets are formed.

For purposes of this consolidated appeal, claim 1 of the ’664 patent is representative of the asserted claims of that patent, and the same is true for claim 14 of the ’682 patent and claim 1 of the ’635 patent, respectively. The representative claims read as follows:

1. A system for forming a plurality of sample -containing droplets suspended in a background fluid, comprising:

a substrate having a bottom surface and a top surface;

a sample well, a background fluid well, and a droplet well each having an upper region protruding from the top surface of the substrate;

a network of channels formed in the bottom surface of the substrate and fluidically interconnecting the sample well, the background fluid well, and the droplet well; and

a droplet generation region defined by the network of channels and configured to generate sample -containing droplets suspended in the background fluid;

wherein the droplet generation region is defined by the intersection of a first channel, a second channel, and a third channel;

wherein the first channel is configured to transport sample -containing fluid from the sample well to the droplet generation region, the second channel is configured to transport background fluid from the background fluid well to the droplet generation region, and the third channel is configured to transport sample -containing droplets from the droplet generation region to the droplet well; and

wherein the substrate and the upper region of each well are injection molded as a single piece.

’664 patent col. 43 l. 55–col. 44 l. 13 (emphases added).

14. A system for generating droplets, comprising:

a device including a row of sample wells each configured to receive sample-containing fluid, a row of continuous-phase wells each configured to receive continuous-phase fluid, and a row of droplet wells, the device also including a corresponding channel network for each sample well, the channel network including a droplet-generation region and fluidically connecting the sample well to one of the continuous-phase wells and one of the droplet wells;

a holder for the device;

a gasket configured to be attached directly to the holder, such that the gasket extends over each sample well, each continuous-phase well, and each droplet well; and

an instrument configured to

(a) receive an assembly including the device, the holder, and the gasket,

(b) engage the gasket with a manifold, and

(c) apply positive pressure and/or negative pressure to the device via the manifold, such that sample-containing fluid flows from each sample well to the corresponding droplet-generation region , continuous-phase fluid flows from each continuous-phase well to the corresponding droplet-generation region , and sample-containing droplets flow from each droplet-generation region to the corresponding droplet well.

’682 patent col. 34 ll. 20–45 (emphases added).

1. A system to form and concentrate an emulsion, comprising:

a device including a sample well configured to receive sample-containing fluid, a continuous-phase well configured to receive continuous-phase fluid, and a droplet well, the device also including a channel network having a first channel, a second channel, and third channel that meet one another in a droplet-generation region ; and

an instrument configured to operatively receive the device and to create

(a) a first pressure differential to drive sample-containing fluid from the sample well to the droplet-generation region via the first channel, continuous-phase fluid from the continuous-phase well to the droplet-generation region via the second channel, and sample-containing droplets from the droplet-generation region to the droplet well via the third channel, such that the droplet well collects an emulsion including sample-containing droplets disposed in continuous-phase fluid, and

(b) a second pressure differential to decrease a volume fraction of continuous-phase fluid in the emulsion, after the emulsion has been collected in the droplet well, by selectively driving continuous-phase fluid, relative to sample-containing droplets, from the droplet well via the third channel.

’635 patent col. 33 ll. 29–55 (emphases added). The parties appear to agree that the terms "sample" and "droplet-generation region" have consistent meanings throughout the claims of the ’664, ’682 and ’635 patents.

II. The Parties

The parties in this case have a long history together, which we have discussed in prior opinions. See Bio-Rad Labs., Inc. v. 10X Genomics Inc. , 967 F.3d 1353 (Fed. Cir. 2020) ; Bio-Rad Labs., Inc. v. ITC , 996 F.3d 1302, No. 2020-1785 (Fed. Cir. Apr. 29, 2021). Here, we briefly include the portions of that history most relevant to this appeal.

The asserted patents arise out of research conducted by inventors at a company called QuantaLife, Inc. Three of the inventors—Drs. Kevin Ness, Donald Masquelier, and Benjamin Hindson³ —were among the founders of QuantaLife in 2008. In 2011, Bio-Rad purchased QuantaLife for approximately $160 million. See Order No. 15: Initial Determination Granting Complainants’ Motion for Summary Determination that the Doctrine of Assignor Estoppel Precludes Respondent from Challenging the Validity of the Asserted Patents, In the...