Wednesday, June 02, 2021

CAFC affirms ITC in Bio-Rad case

Some background:

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 Matter of Certain Microfluidic Devices, USITC Inv. No. 337-TA-1068, 2018 WL 2003443, at *4 (Mar. 5, 2018) (“Assignor Estoppel Opinion”). With the purchase, Bio-Rad acquired QuantaLife’s patent rights, see id., presumably including QuantaLife’s rights to provisional patent applications from which the ’664, ’682, and ’635 patents claim priority. See J.A. 422, 475, 512. At the time of the purchase, Drs. Ness, Masquelier, and Hindson became employees of Bio-Rad, and over the following two years they executed assignments to Bio-Rad of their rights to the applications that later issued as the ’664, ’682, and ’635 patents. Assignor Estoppel Opinion, 2018 WL 2003443, at *5–6.

Not long after Bio-Rad acquired QuantaLife, Drs. Hindson and Ness left Bio-Rad to start 10X, and Dr. Masquelier joined 10X shortly thereafter as its fifth employee. Id. at *7. 10X has developed technology and products in the field of microfluidics that are designed for use with commercial next-generation sequencing platforms, with the goal of achieving DNA and RNA sequencing at the single cell level. Drs. Hindson, Ness, and Masquelier were all “extensively involved with the design, implementation, and/or manufacture” of 10X’s products. Id.

The meaning of the word "sample" is at issue!

10X further argues that the “hallmark” of a sample in the context of the ’664 patent is that there is something within it that is tested and analyzed. See 10X Br. at 27 (citing the ’664 patent’s definition of “analyte,” which is “a component(s) or potential component(s) of a sample that is analyzed in a test”). While 10X concedes that it performs quality control testing on a small subset of droplets, it argues that the monomers are not tested or analyzed in such a way as to make them samples because “they are an already-known starting material for an already-known polymerization reaction.” See 10X Br. at 30. Moreover, 10X argues, because the monomer solution was carefully designed with particular concentrations of ingredients to form gel beads, the composition is known and does not need to be tested.

The compelling factor here is the distinction between “samples” and “reagents.” The ’664 patent consistently makes clear that a sample is not a reagent, beginning with the opening sentences of the introduction section. See ’664 patent col. 1 ll. 26–31 (“Many biomedical applications rely on high-throughput assays of samples combined with reagents. For example, in research and clinical applications, high-throughput genetic tests using target-specific reagents can provide high-quality information about samples . . . .” (emphases added)). The patent goes on to list definitions that lead to the unavoidable conclusion that a compound cannot simultaneously be a sample and a reagent. For example, within the definition of “sample,” the patent states that “[a] sample is the general subject of interest for a test that analyzes an aspect of the sample, such as an aspect related to at least one analyte that may be present in the sample.” Id. at col. 8 ll. 37–40. Similarly, the term “analyte” is defined as “a component(s) or potential component(s) of a sample that is analyzed in a test.” Id. at col. 9 ll. 1–2. And the term “test” is defined as “a procedure(s) and/or reaction(s) used to characterize a sample, and any signal(s), value(s), data, and/or result(s) obtained from the procedure(s) and/or reaction(s).” Id. at col. 8 ll. 7–9. Thus, the patent describes a relationship between a sample, the analyte(s) it contains, and the test(s) performed to analyze it. In contrast, the patent defines a “reagent” as “a compound, set of compounds, and/or composition that is combined with a sample in order to perform a particular test(s) on the sample.” Id. at col. 9 ll. 19–21 (emphasis added). Thus, a reagent is not a part of a sample, nor is it the same thing as a sample in the context of the patent. The ALJ’s findings reflect a correct determination that, while the term “sample” is defined broadly in the patent, the definition of “sample” is not so broad as to include reagents within its scope.


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