Wuhan Healthgen Biotechnology Corp. v. International Trade Commission

United States Court of Appeals
for the Federal Circuit
______________________
WUHAN HEALTHGEN BIOTECHNOLOGY CORP.,
Appellant
v.
INTERNATIONAL TRADE COMMISSION,
Appellee
VENTRIA BIOSCIENCE INC.,
Intervenor
______________________
2023-1389
______________________
Appeal from the United States International Trade
Commission in Investigation No. 337-TA-1238.
______________________
Decided: February 7, 2025
______________________
ERIK R. P UKNYS , Finnegan, Henderson, Farabow, Gar-
rett & Dunner, LLP, Washington, DC, argued for appel-
lant. Also represented by J. MICHAEL J AKES , RYAN
VALENTINE M CD ONNELL , ELIZABETH N IEMEYER , J ASON L EE
ROMRELL ; MICHAEL K UDRAVETZ, Boston, MA.
RONALD T RAUD, Office of the General Counsel, United
States International Trade Commission, Washington, DC,
argued for appellee. Also represented by D OMINIC L.
BIANCHI, WAYNE W. H ERRINGTON.
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 2
T HOMAS P. HENEGHAN, Husch Blackwell LLP, Madison,
WI, argued for intervenor. Also represented by J ENNIFER
E. HOEKEL , St. Louis, MO; BEAU J ACKSON , Kansas City,
MO; MATTHEW K AMPS, Chicago, IL.
______________________
Before M OORE, Chief Judge, CHEN, Circuit Judge, and
MURPHY , District Judge.1
MOORE, Chief Judge.
Wuhan Healthgen Biotechnology Corp. (Healthgen)
appeals a final determination from the International Trade
Commission (Commission) finding (1) Healthgen’s clinical
grade albumin products infringe claims 1 and 11–13 of U.S.
Patent No. 10,618,951; and (2) Intervenor Ventria Biosci-
ence Inc. (Ventria) satisfied the economic prong of the do-
mestic industry requirement under subparagraph (a)(3) of
19 U.S.C. § 1337 (Section 337). Because substantial evi-
dence supports the Commission’s findings, we affirm.
BACKGROUND
Cell culture media supplies essential nutrients for cells
to grow in an artificial environment. This media often con-
tains albumin, a protein produced in an animal’s liver,
which raises contamination and ethical concerns. As a re-
sult, recombinant albumin has been used as an alternative.
Recombinant technology involves inserting a gene of inter-
est into a host cell to produce a desired protein the cell
would not normally produce, allowing for large-scale pro-
duction of proteins without relying on animal sources.
1 Honorable John F. Murphy, District Judge, United
States District Court for the Eastern District of Pennsylva-
nia, sitting by designation.
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 3
Ventria owns the ’951 patent, which is directed, in part,
to cell culture media containing recombinant human serum
albumin (rHSA) produced in a genetically modified plant.
’951 patent at 31:37–41, 39:11–13. Claim 1 is representa-
tive and recites:
1. A cell culture media supplement or complete me-
dia composition for improving the growth of a cell
in cell culture comprising:
a recombinant mammalian albumin wherein said
albumin is:
i) produced in a transgenic plant;
ii) has less than 1 EU of endotoxin/mg of albu-
min; and
iii) less than 2% aggregated albumin.
Id. at 123:44–51 (emphasis added).
Healthgen imports clinical and medium grade rHSA
products. Ventria filed a complaint with the Commission
alleging Healthgen’s importation activities violated § 337
because its imported products infringed the ’951 patent.
Ventria relied on its six rHSA products—Cellastim, Exbu-
min, OptiPEAK, OptiVERO, ITSE+A, and Optibumin—to
satisfy the economic prong of the domestic industry re-
quirement and asserted all six products practice the ’951
patent.
The Commission instituted an investigation, and the
Administrative Law Judge (ALJ) issued an initial determi-
nation finding Healthgen violated § 337 by importing clin-
ical and medium grade rHSA products that infringe claims
1 and 11–13 of the ’951 patent. J.A. 145–68. The ALJ also
found Ventria satisfied the domestic industry requirement
under subsections (A), (B), and (C) of § 337(a)(3) based on
all six rHSA products and, in the alternative, based on
Optibumin alone. J.A. 211–22.
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 4
Healthgen petitioned the Commission for review. The
Commission affirmed the ALJ’s finding of infringement as
to Healthgen’s clinical grade products, but not its medium
grade products. J.A. 25–53. The Commission affirmed the
ALJ’s finding that Ventria satisfied the domestic industry
requirement based on Optibumin alone without further
analysis, but took no position on Ventria’s five other rHSA
products. J.A. 54–55.
Healthgen appeals. We have jurisdiction pursuant to
28 U.S.C. § 1295(a)(6).
D ISCUSSION
I. Infringement
We review the Commission’s legal conclusions de novo
and its factual findings for substantial evidence. Roku, Inc.
v. Int’l Trade Comm’n, 90 F.4th 1367, 1372 (Fed. Cir. 2024).
Infringement is a question of fact. Kinik Co. v. Int’l Trade
Comm’n, 362 F.3d 1359, 1361 (Fed. Cir. 2004).
The Commission found2 Healthgen’s clinical grade
products infringe the ’951 patent because they contain less
than 2% aggregated albumin. J.A. 17–19, 27–32. The
Commission relied on Healthgen’s SEC-HPLC3 data,
which show the products had at most 1.1% aggregated al-
bumin. J.A. 3371–72.
2 We refer to the findings on review in the Infringe-
ment and Domestic Industry sections as those of the Com-
mission, whether made by the ALJ or the Commission,
because the Commission adopted the ALJ’s findings not in-
consistent with the Commission’s opinion. J.A. 4.
3 SEC-HPLC (Size Exclusion Chromatography High
Performance Liquid Chromatography) is a technique used
to separate proteins based on their size. J.A. 17.
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 5
Healthgen argues the Commission erred in relying on
SEC-HPLC data because the data does not reflect aggre-
gated albumin levels at the time of importation. Appel-
lant’s Br. 44–51. Rather, the data, measured in China one
day after manufacture, reflects when aggregated albumin
is lowest and fails to account for increased aggregation dur-
ing storage and shipping such that the products are no
longer infringing upon importation. Id.
The Commission’s finding is supported by substantial
evidence. It is undisputed SEC-HPLC is a reliable and ap-
propriate test to measure aggregation levels and the meas-
ured 1.1% aggregated albumin meets the “less than 2%
aggregated albumin” claim limitation. Appellant’s Br. 12,
48; Appellee’s Br. 16. The Commission found aggregated
albumin levels in Healthgen’s products do not increase
above 2% during storage and shipping. J.A. 29–30, 36–37;
J.A. 161. This finding is supported by expert testimony
that neither storage alone nor shipment according to com-
mon practice would induce additional aggregation, J.A.
1453 at 452:5–16, peer-reviewed literature discussing ag-
gregation increase under extreme stressor conditions, J.A.
3380, and Healthgen’s communications to customers ex-
plaining stability test results show its products remain sta-
ble under its storage and shipping practices, see, e.g., J.A.
3137–39; J.A. 5035; J.A. 7029.
Healthgen contends the peer-reviewed literature sug-
gests aggregation is caused by storage and shipping, and
its communications to customers are about stability and
quality which are untethered to the “less than 2% aggre-
gated albumin” limitation. Appellant’s Br. 46–47, 49–50.
Even accepting Healthgen’s claim that aggregated albumin
levels do increase, Healthgen did not show this aggregation
would rise to noninfringing levels before importation. Ap-
pellant’s Br. 48–49 (claiming aggregated albumin in-
creased to greater than 2%, despite acknowledging “it is
unclear precisely how much it had increased upon the prod-
uct’s arrival in the United States”). Healthgen’s most
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 6
concrete evidence for increased aggregated albumin is com-
paring SEC-HPLC data taken in September 2020 with Re-
ducing SDS-PAGE4 data taken in June 2021. Id.; compare
J.A. 3372, with J.A. 3297. The same batch that measured
1.1% aggregated albumin in China using SEC-HPLC meas-
ured 1.81% nine months later in the United States using
Reducing SDS-PAGE. J.A. 3372; J.A. 3297. However, the
Reducing SDS-PAGE data is not inconsistent with a find-
ing that the imported products are infringing because
1.81% aggregated albumin still meets the “less than 2% ag-
gregated albumin” limitation. There is thus substantial ev-
idence for the Commission’s finding of noninfringement.
Spansion, Inc. v. Int’l Trade Comm’n, 629 F.3d 1331, 1344
(Fed. Cir. 2010) (“[We] must affirm a Commission determi-
nation if it is reasonable and supported by the record as a
whole, even if some evidence detracts from the Commis-
sion’s conclusion.” (quoting Nippon Steel Corp. v. United
States, 458 F.3d 1345, 1352 (Fed. Cir. 2006) (internal quo-
tation marks omitted))).
The Commission also relied on Reducing SDS-PAGE
data as an alternative basis for finding infringement. J.A.
19–25, 32–36. Because we affirm the finding of infringe-
ment based on SEC-HPLC data, we need not reach the
Commission’s alternative basis.
4 Similar to SEC-HPLC, Reducing SDS-PAGE (So-
dium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis)
is a technique used to separate proteins based on their size.
J.A. 19–20. But unlike SEC-HPLC, Reducing SDS-PAGE
alters the sample before analysis by first using a surfactant
(SDS) to denature the proteins and then using a reducing
agent to break the disulfide bonds holding protein subunits
together. J.A. 20, 24.
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 7
II. Domestic Industry
Whether the domestic industry requirement is satis-
fied “typically presents issues of both law and fact.” John
Mezzalingua Assocs., Inc. v. Int’l Trade Comm’n, 660 F.3d
1322, 1327 (Fed. Cir. 2011). Whether investments are
“substantial” enough to satisfy this requirement is a ques-
tion of fact. Id. We review the Commission’s substantiality
finding for substantial evidence. Roku, 90 F.4th at 1372.
To demonstrate a patent infringement-based violation
of § 337, a complainant must show “an industry in the
United States, relating to the articles protected by the pa-
tent . . . exists or is in the process of being established.” 19
U.S.C. § 1337(a)(2). This domestic industry requirement
has a technical prong and an economic prong. InterDigital
Commc’ns, LLC v. Int’l Trade Comm’n, 707 F.3d 1295, 1298
(Fed. Cir. 2013). Healthgen conceded Optibumin practices
the ’951 patent and thus satisfies the technical prong. Ap-
pellant’s Br. 64; J.A. 54. The economic prong considers
whether “there is in the United States, with respect to the
articles protected by the patent, . . . (A) significant invest-
ment in plant and equipment; (B) significant employment
of labor or capital; or (C) substantial investment in its ex-
ploitation, including engineering, research and develop-
ment, or licensing.” 19 U.S.C. § 1337(a)(3). Only one of
subsections (A), (B), or (C) needs to be satisfied to meet the
economic prong. Roku, 90 F.4th at 1370 n.1. A “quantita-
tive analysis” is required to determine whether invest-
ments are “significant.” Lelo Inc. v. Int’l Trade Comm’n,
786 F.3d 879, 883 (Fed. Cir. 2015).
The Commission found Ventria’s Optibumin invest-
ments in plant and equipment costs under subsection (A),
labor costs under subsection (B), and research and devel-
opment costs under subsection (C) are significant and sub-
stantial because, inter alia, 100% of those investments
occur in the United States. J.A. 54; J.A. 219–20. A sales-
based allocation method was used to calculate the
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 8
investments under each subsection. J.A. 211–12. The
Commission also found Ventria’s Optibumin investments
are significant and substantial based on a comparison of
the investments to Optibumin’s revenue. J.A. 54; J.A. 220.
Healthgen argues Ventria’s Optibumin investments are
too small to be significant or substantial under § 337(a)(3),
and low Optibumin revenue, when coupled with small in-
vestments, artificially creates high investment-to-revenue
ratios. Appellant’s Br. 64–73.
The Commission’s findings are supported by substan-
tial evidence. That it may have been relatively inexpensive
for Ventria to develop and produce its patented product
does not alone preclude a finding that Ventria did in fact
establish a domestic industry in that product. It is undis-
puted all of Ventria’s investments and activities related to
researching, developing, and commercially producing Opti-
bumin occurred within the United States. Appellant’s Br.
68–69; Appellee’s Br. 36–37. Comparing the cost of foreign
to domestic manufacturing to determine the percentage of
additional value created by domestic Optibumin operations
in the final product yields a value added of 100%. J.A. 219–
20. The investment-to-revenue ratio can indicate whether
an investment is significant and substantial. A high ratio
signals the company is investing heavily in the industry
despite comparatively low revenue, highlighting the indus-
try’s importance and value to the company, which can be
predictive of a significant market. See, e.g., J.A. 1699 at
697:5–17; J.A. 220–21.
Healthgen contends the Commission relies on qualita-
tive factors to overcome Ventria’s quantitatively small
Optibumin investments in violation of our precedent. Ap-
pellant’s Br. 64–65, 67–69; see also Lelo, 786 F.3d at 885
(“Qualitative factors cannot compensate for quantitative
data that indicate insignificant investment and employ-
ment.”). We do not agree. In Lelo, we recognized the com-
parison of domestic investments to total (i.e., domestic plus
foreign) investments as a valid quantitative analysis for
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WUHAN HEALTHGEN BIOTECHNOLOGY CORP . v. ITC 9
assessing the significance of investments. 786 F.3d at 883–
84 (citing Certain Concealed Cabinet Hinges and Mounting
Plates, Inv. No. 337-TA-289, 1990 WL 10608981, Comm’n
Op. at 11–12 (Jan. 8, 1990)). We also recognized the value
added by domestic operations as a quantitative factor in
the assessment. Id. at 884 (citing Certain Male Prophylac-
tic Devices, Inv. No. 337-TA-546, USITC Pub. 4005,
Comm’n Op. at 24–26 (June 21, 2007)).
Small market segments can still be significant and sub-
stantial enough to satisfy the domestic industry require-
ment. A finding of domestic industry cannot hinge on a
threshold dollar value or require a rigid formula; rather,
the analysis requires a holistic review of all relevant con-
siderations that is very context dependent. Bally/Midway
Mfg. Co. v. Int’l Trade Comm’n, 714 F.2d 1117, 1123 (Fed.
Cir. 1983) (“There is nothing in the statute which requires
that an industry must be of any particular size.” (cleaned
up)); Certain Printing and Imaging Devices, Inv. No. 337-
TA-690, 2011 WL 1303160, Comm’n Op. at 27 (Feb. 17,
2011) (explaining whether investment activities are signif-
icant or substantial “is not evaluated according to any rigid
mathematical formula,” but rather requires “an examina-
tion of the facts in each investigation, the article of com-
merce, and the realities of the marketplace”); 134 CONG.
REC . S10711-01, 1988 WL 174536 (Aug. 3, 1988) (“Smaller
businesses should not be denied the right to seek relief
merely because they may have made smaller financial in-
vestments than large companies . . . .”). Though the dollar
amounts of Ventria’s Optibumin investments are small,
the Commission found all of the investments are domestic,
all market activities occur within the United States, and
the high investment-to-revenue ratios indicate this is a val-
uable market. J.A. 219–21. Under these circumstances,
there is substantial evidence for the Commission’s finding
that the domestic industry requirement is satisfied.
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CONCLUSION
We have considered Healthgen’s remaining arguments
and find them unpersuasive. For the reasons given above,
we affirm.
AFFIRMED
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