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`UNITED STATES INTERNATIONAL TRADE COMMISSION
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`Washington, D.C.
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`INV. NO. 337-TA-1207
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`In the Matter of
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`CERTAIN PRE-FILLED SYRINGES FOR
`INTRAVITREAL INJECTION AND
`COMPONENTS THEREOF
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`ORDER NO. 31:
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`INITIAL DETERMINATION GRANTING COMPLAINANTS’
`MOTION FOR SUMMARY DETERMINATION AS TO DIRECT
`INFRINGEMENT AND THE ECONOMIC AND TECHNICAL
`PRONGS OF THE DOMESTIC INDUSTRY REQUIREMENT
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`
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`(April 2, 2021)
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`On February 18, 2021, complainants Novartis Pharma AG, Novartis Pharmaceuticals
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`Corporation, and Novartis Technology LLC (collectively, “Novartis”) filed a motion (“Mot.”),
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`supporting memorandum (“Memo”), and a chart of undisputed material facts (“UMF”) seeking
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`findings on summary determination that (1) respondent Regeneron Pharmaceuticals, Inc.’s
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`(“Regeneron”) EYLEA® prefilled syringe and/or its administration to patients directly infringes
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`claims 1, 3–6, 11–13, 16, 17, and 20–25 of U.S. Patent No. 9,220,631 (“the ’631 patent”);1
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`(2) Novartis’s BEOVU® prefilled syringe practices claims 1, 3–7, 16–17, 22, and 23 of the ’631
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`patent; and (3) Novartis has satisfied the economic prong of the domestic industry requirement
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`under 19 U.S.C. § 1337(a)(3)(B). Motion Docket No. 1207-021. Regeneron filed a brief in partial
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`opposition (“Opp’n”) and a response to Novartis’s chart of undisputed material facts (“RUMF”)
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`1 A copy of the ’631 patent is attached as Exhibit 1 to the pending motion.
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`PUBLIC VERSION
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`Novartis Exhibit 2090.001
`Regeneron v. Novartis, IPR2021-00816
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`

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`on March 1, 2021. The Commission Investigative Staff (“Staff”) filed a response supporting the
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`pending motion (“Staff Resp.”) on March 1, 2021.2
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`I.
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`Legal Standards
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`Summary determination is appropriate when there is no genuine issue as to any material
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`fact and the moving party is entitled to a determination as a matter of law. See 19 C.F.R. § 210.18.
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`In determining whether there is a genuine issue of material fact, “the evidence must be viewed in
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`the light most favorable to the party opposing the motion with doubts resolved in favor of the non-
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`movant.” Crown Operations Int’l, Ltd v. Solutia, Inc., 289 F.3d 1367, 1375 (Fed. Cir. 2002)
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`(citations omitted).
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`In a section 337 investigation, the complainant bears the burden of proving infringement
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`of the asserted patent claims by a preponderance of the evidence. See Spansion, Inc. v. Int’l Trade
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`Comm’n, 629 F.3d 1331, 1349 (Fed. Cir. 2010). This standard “requires proving that infringement
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`was more likely than not to have occurred.” Warner-Lambert Co. v. Teva Pharm. USA, Inc., 418
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`F.3d 1326, 1341 n.15 (Fed. Cir. 2005).
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`Literal infringement is a question of fact. Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d
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`1323, 1332 (Fed. Cir. 2008). “Literal infringement requires the patentee to prove that the accused
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`device contains each limitation of the asserted claim(s). If any claim limitation is absent, there is
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`2 After briefing for the pending motion was complete, Novartis filed an unopposed motion seeking
`partial termination of this investigation based on withdrawal of the complaint with respect to
`asserted claims 18, 19, and 20 of the ’631 patent. I granted this motion in an initial determination
`that was not reviewed by the Commission. Order No. 29 (Mar. 17, 2021), unreviewed, Comm’n
`Notice (Apr. 1, 2021). As claim 20 has been terminated from this investigation, this order will
`consider Novartis’s arguments that I should find infringement of claims 1, 3–6, 11–13, 16, 17, and
`21–25 of the ’631 patent on summary determination.
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`2
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`PUBLIC VERSION
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`Novartis Exhibit 2090.002
`Regeneron v. Novartis, IPR2021-00816
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`no literal infringement as a matter of law.” Bayer AG v. Elan Pharm. Research Corp., 212 F.3d
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`1241, 1247 (Fed. Cir. 2000).
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`“An infringement analysis entails two steps. The first step is determining the meaning and
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`scope of the patent claims asserted to be infringed. The second step is comparing the properly
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`construed claims to the device accused of infringing.” Markman v. Westview Instruments, Inc., 52
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`F.3d 967, 976 (Fed. Cir. 1995) (en banc) (internal citations omitted), aff’d, 517 U.S. 370 (1996).
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`Claim construction resolves legal disputes between the parties regarding claim scope. See Eon
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`Corp. IP Holdings v. Silver Spring Networks, 815 F.3d 1314, 1319 (Fed. Cir. 2016).
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`For a patent-based complaint, a violation of section 337 can be found “only if an industry
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`in the United States, relating to the articles protected by the patent . . . concerned, exists or is in
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`the process of being established.” 19 U.S.C. § 1337(a)(2). The complainant bears the burden of
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`establishing that the domestic industry requirement is satisfied. John Mezzalingua Assocs., Inc. v.
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`Int’l Trade Comm’n, 660 F.3d 1322, 1331 (Fed. Cir. 2011). The domestic industry requirement
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`of section 337 is often described as having an economic prong and a technical prong. InterDigital
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`Commc’ns, LLC v. Int'l Trade Comm’n, 707 F.3d 1295, 1298 (Fed. Cir. 2013); Certain Stringed
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`Musical Instruments and Components Thereof, Inv. No. 337-TA-586, Comm’n Op. at 12–14,
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`USITC Pub. No. 4120 (Dec. 2009). “The technical prong concerns whether complainant practices
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`at least one claim of the asserted patents. The economic prong concerns domestic activities with
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`respect to the patent or patented article.” Certain Printing and Imaging Devices and Components
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`Thereof, Inv. No. 337-TA-690, Comm’n Op. at 25, USITC Pub. No. 4289 (Nov. 2011) (“Certain
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`Printing and Imaging Devices”).
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`Section 337(a)(3) sets forth the following economic criteria for determining whether the
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`economic prong of the domestic industry requirement is satisfied in such investigations:
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`3
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`PUBLIC VERSION
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`Novartis Exhibit 2090.003
`Regeneron v. Novartis, IPR2021-00816
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`[A]n industry in the United States shall be considered to exist if there is in
`the United States, with respect to the articles protected by the patent,
`copyright, trademark, mask work, or design concerned –
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`(A)
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`significant investment in plant and equipment;
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`(B) significant employment of labor or capital; or
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`(C) substantial investment in its exploitation, including engineering,
`research and development, or licensing.
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`19 U.S.C. § 1337(a)(3). Given that these criteria are listed in the disjunctive, satisfaction of any
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`one of them will be sufficient to meet the economic prong of the domestic industry requirement.
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`See Certain Printing and Imaging Devices, Comm’n Op. at 26.
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`The technical prong of the domestic industry requirement is satisfied when the complainant
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`in a patent-based section 337 investigation establishes that it is practicing or exploiting the patents
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`at issue. See 19 U.S.C. § 1337(a)(2) and (3). “The test for satisfying the ‘technical prong’ of the
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`industry requirement is essentially [the] same as that for infringement, i.e., a comparison of
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`domestic products to the asserted claims.” Alloc, Inc. v. Int’l Trade Comm’n, 342 F.3d 1361, 1375
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`(Fed. Cir. 2003). To prevail, the patentee must establish by a preponderance of the evidence that
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`the domestic product practices one or more valid claims of the patent. See id.; Spansion, 629 F.3d
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`at 1349. It is sufficient to show that the products practice any claim of that patent, not necessarily
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`an asserted claim of that patent. See Certain Male Prophylactic Devices, Inv. No. 337-TA-546,
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`Comm’n Op. at 38 (Aug. 1, 2007).
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`II.
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`Claim Construction
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`There are no claim construction disputes between the parties requiring resolution before a
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`finding of infringement can be made. Accordingly, I decline to construe any claim terms at this
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`summary determination stage.
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`4
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`PUBLIC VERSION
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`Novartis Exhibit 2090.004
`Regeneron v. Novartis, IPR2021-00816
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`III. Economic Prong of the Domestic Industry Requirement
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`A.
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`Novartis’s Domestic Expenditures
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`Novartis’s economic activities in the United States are related to its VEGF-antagonist drug
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`brolucizumab, which is marketed under the name “BEOVU.” UMF Nos. 31, 71. BEOVU comes
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`in two presentations for delivering the drug to a patient: a vial and a prefilled syringe. UMF Nos.
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`31–32. The vial presentation has already been approved by the FDA and the prefilled syringe
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`presentation is pending approval from the FDA. UMF Nos. 32–33. Novartis is seeking FDA
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`approval for the prefilled syringe presentation through a supplemental biologics license application
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`that relies on the underlying data contained in the original biologics license application filed on
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`the vial presentation. UMF No. 37. To prove satisfaction of the economic prong of the domestic
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`industry requirement, Novartis relies on investments in labor and capital related to research and
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`development efforts for BEOVU, including clinical trials and the related FDA approval process.
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`Memo at 14–20.
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`I
`I
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`Novartis has a Medical Affairs Team in the United States consisting of
`with various medical and science backgrounds who “coordinat[e] clinical trials and assess[] the
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` employees
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`impact of data collected.” UMF Nos. 42–43; see Mot. Ex. 11 (Expert Report of Christopher
`I
` full-time
`equivalent clinical development employees who perform work related to ongoing clinical studies
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`Bakewell) ¶¶ 71–76 (“Bakewell Rpt.”). Novartis also employs approximately
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`for BEOVU in the United States. UMF No. 46; see Bakewell Rpt. ¶¶ 84, 92. These employees
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`support Novartis’s seven ongoing clinical trials for BEOVU, which are spread across at least 200
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`clinical sites in the United States. UMF No. 49; see Bakewell Rpt. ¶¶ 90–92. Novartis also incurs
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`external project-related study costs and logistics expenses such as scientific meeting costs, lab
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`5
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`PUBLIC VERSION
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`Novartis Exhibit 2090.005
`Regeneron v. Novartis, IPR2021-00816
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`PUBLIC VERSION
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`services, lab materials, drng substance cost, and drng product cost. UMF Nos. 51- 52; see
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`Bakewell Rpt. ,i,i 94-95.
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`fu addition to investments related to clinical ti·ials, Novaitis relies on investments in its
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`FDA regulato1y affairs team focused on BEOVU. UMF No. 55; see Bakewell Rpt. ,i 66. These
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`employees are responsible for seeking FDA regulato1y approval to market BEOVU in the United
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`States, including prepai111g the FDA biologics applications, prepai·ing suppo1t ing documentation,
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`and interacting with the FDA. UMF Nos. 57- 60; see Bakewell Rpt. ,i,i 106-19.
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`The amounts ofNovait is 's undisputed3 domestic expenditures are Sllilllllarized in the table
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`below:
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`Investment Category
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`Allocated Amount
`2018 to May 2020
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`Record Support
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`Clinical Trial and
`Development Personnel
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`Clinical Trials Capital
`fuvestments
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`FDA Regulato1y Affairs
`Personnel
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`Total
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`-
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`See also Bakewell Rpt. ,i 129.
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`UMF Nos. 46, 49, 50
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`UMFNos. 49, 51- 54
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`UMF Nos. 55- 62
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`3 Novait is also claims domestic investments in connection with its medical affairs personnel, but
`Regeneron disputes whether all of these investments ai·e appropriately allocated to BEOVU.
`Compare UMF Nos. 42- 45 with RUMF Nos. 42-45. As Novartis's other investments demonsti·ate
`significant employment of domestic labor and capital with respect to BEOVU, I need not consider
`the investments related to the medical affairs personnel at this sunnna1y detennination stage.
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`6
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`Novartis Exhibit 2090.006
`Regeneron v. Novartis, IPR2021-00816
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`B.
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`Analysis
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`The undisputed evidence demonstrates that Novartis’s approximately
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` of
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`expenditures in labor and capital are quantitatively and qualitatively significant. A comparison of
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`Novartis’s domestic and foreign activities bears this out. Although clinical trials are more
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`expensive inside the United States than outside the United States, the
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` Novartis’s
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`clinical trial investments are made in the United States. UMF Nos. 41, 65. Comparing Novartis’s
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`-
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`investments to its return on those investments also confirms their significance. Novartis’s expert
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`Christopher Bakewell calculated that Novartis’s investments in BEOVU, on an average monthly
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`basis, account for approximately
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` of BEOVU’s average monthly revenue from the relevant
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`time period. Bakewell Rpt. ¶ 163; UMF No. 66. A comparison of Novartis’s clinical trial
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`-
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`investments to industry averages also demonstrates the significance of Novartis’s industry.
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`Clinical trials that support FDA approval of a new drug cost an average of $19 million and
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`ophthalmology studies average approximately $50 million, while Novartis has spent more than
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` on BEOVU trials in the United States. See Bakewell Rpt. ¶ 166.
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`Regeneron argues that Novartis has not shown satisfaction of the economic prong of the
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`domestic industry requirement because, while Novartis relies on BEOVU prefilled syringes for its
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`technical prong showing, all Novartis’s claimed investments are for BEOVU vials. Opp’n at 7–9.
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`Regeneron also argues that “BEOVU is a stand-alone commercial drug product that is neither
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`claimed nor described, nor necessary for the exploitation of the ’631 patent.” Opp’n at 9–14.4
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`4 Regeneron additionally contends that “Novartis is not entitled to a remedy” because the BEOVU
`prefilled syringe is not FDA approved. Opp’n at 17–18. This argument is not germane to the
`violation issues presented for summary determination and is more properly considered in the
`context of my recommended determination on remedy, bond, and the public interest.
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`7
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`PUBLIC VERSION
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`Novartis Exhibit 2090.007
`Regeneron v. Novartis, IPR2021-00816
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`Regeneron’s arguments are not persuasive. The relevant question is whether investments
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`in the BEOVU vial presentation are investments “with respect to the article[] protected by the
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`[’631] patent,” as required by statute. See 19 U.S.C. § 1337(a)(3). Commission precedent, applied
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`to the undisputed facts of record, shows that the answer to that question is yes.
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`The Commission “has credited domestic investments when they are made with respect to
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`an essential, necessary, and/or integral part of the article covered by the patent claims and/or where
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`the investment is central to enabling exploitation of the article covered by the patent claims.”
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`Certain Magnetic Tape Cartridges & Components Thereof (“Magnetic Tape Cartridges”), Inv.
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`No. 337-TA-1058, Comm’n Op. at 50 (Apr. 9, 2019); see also id. at 53 (“The Commission has
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`defined the domestic industry to include investments necessary to bring to market the patented
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`technology as embodied in the asserted domestic industry products.”). In Magnetic Tape
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`Cartridges, the Commission credited investments in unpatented tape drives because the drives
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`were necessary to exploit patented tape cartridges. Id. at 50. In so doing, the Commission found
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`that the tape drives were “necessary to bring the patented technology to the consumer market.” Id.
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`at 56; see also id. at 57 (stating complainants are “entitled to rely on expenses that [are] needed to
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`ensure that the patented articles could be used by consumers”).
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`By contrast, in Video Game Systems, the Commission rejected the complainant’s reliance
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`on investments to build theme park facades for a “MagiQuest” attraction. Certain Video Game
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`Systems and Wireless Controllers and Components Thereof (“Video Game Systems”), Inv. No.
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`337-TA-770, Comm’n Op. at 68 (Oct. 28, 2013). In Video Game Systems, the patented technology
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`was limited to a toy wand used to interact with specific parts of the attraction. Although the
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`Commission agreed that in “certain circumstances, the realities of the marketplace require a
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`modification of the principle that the domestic industry is defined by the patented article,” the
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`8
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`PUBLIC VERSION
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`Novartis Exhibit 2090.008
`Regeneron v. Novartis, IPR2021-00816
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`Commission found no evidence that the “realities of the marketplace” required an “elaborate
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`amusement park attraction” in order to use or sell complainant’s “toy wand” product. Id. at
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`66–70. The Commission determined that the complainant could at best rely on expenses relating
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`to specific components within the attraction which were “central to enabling [the complainant] to
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`exploit the technology of the claimed toy wands.” Id. at 70.
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`The Breathing Treatment Systems investigation credited some investments in unpatented
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`articles but rejected others. See Certain Sleep-Disordered Breathing Treatment Systems and
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`Components Thereof (“Breathing Treatment Systems”), Inv. No. 337-TA-890, Final ID at 147–50
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`(Sep. 16, 2014), unreviewed in relevant part, Comm’n Op. at 45 n.13 (Jan. 16, 2016). The systems
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`at issue involved patented masks, patented H5i humidifiers, and unpatented S9 flow generators.
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`The Commission credited domestic investments in the unpatented S9 flow generator because the
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`flow generator was “central to enabling [the complainant] to exploit the patented technology of
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`the H5i humidifier.” Id. at 147. The humidifier was “designed to work only with the S9 flow
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`generator” and could not practice the patent claims at issue without an S9 flow generator. Id. at
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`147, 149. But for other patents directed to respiratory masks, the Commission found that the S9
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`flow generator and H5i humidifier investments were “not central to enabling [complainant] to
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`exploit” the patented mask technology; the masks were compatible with other products and were
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`marketed and sold separately from the S9 flow generator and H5i humidifier. Id. at 147.
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`In the Sonar Imaging Devices investigation, the complainant relied on labor and capital
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`investments related to “software updates” used in the complainant’s “head units.” Certain Marine
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`Sonar Imaging Devices, Including Downscan and Sidescan Devices, Products Containing the
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`Same, and Components Thereof (“Sonar Imaging Devices”), Inv. No. 337-TA-921, Comm’n Op.
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`at 59 (Jan. 6, 2016). The head units needed to be combined with other components to practice
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`9
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`PUBLIC VERSION
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`Novartis Exhibit 2090.009
`Regeneron v. Novartis, IPR2021-00816
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`certain dependent claims of the relevant asserted patent, and the software updates could be used
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`with products that were not patented. Id. The Commission noted that the complainant was not
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`required to show that its domestic investment “related to only the patented product.” Id. at 60
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`n.31. The Commission explained that the fact that investments benefited other products in addition
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`to the domestic industry product did not diminish the fact that the complainant’s investment was
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`related to the domestic-industry articles. Id. at 60.
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`Here, the relevant facts are not in dispute. The patent claims at issue require a “VEGF-
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`antagonist” in a syringe. The BEOVU prefilled syringe would not be an “article[] protected by
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`the patent” without a VEGF-antagonist, and it is undisputed that brolucizumab is a VEGF-
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`antagonist. UMF Nos. 31, 71. Brolucizumab is thus an “essential, necessary, and/or integral part
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`of the article covered by the patent claims” and investments in brolucizumab are properly credited
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`towards Novartis’s domestic industry. See Magnetic Tape Cartridges, Comm’n Op. at 50. Much
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`like the relationship between the patented “H5i humidifier” and unpatented “S9 flow generator”
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`in Breathing Treatment Systems, the BEOVU prefilled syringe is sold with brolucizumab and
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`“cannot function on its own, and cannot practice the claims . . . without” brolucizumab. See
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`Breathing Treatment Systems, Final ID at 149.
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`The fact the Novartis’s investments in brolucizumab benefit both the vial presentation and
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`the prefilled syringe presentation of BEOVU does not change the conclusion. Before any medical
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`syringe prefilled with an active ingredient can be marketed in the United States, that active
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`ingredient must be subjected to clinical trials and obtain FDA approval. See Mot. Ex. 5 (Brown
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`Decl.) ¶¶ 16–17, 19; Mot. Ex. 16 (Desai Decl.) ¶¶ 10, 12–13. The clinical studies Novartis
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`conducted before BEOVU was approved by the FDA in vial form were directed to FDA approval
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`of the brolucizumab drug itself, and not the glass vial in which brolucizumab was presented. See
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`10
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`PUBLIC VERSION
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`Novartis Exhibit 2090.0010
`Regeneron v. Novartis, IPR2021-00816
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`UMF No. 49; Mot. Ex. 36 (Depo. Tr. of Dr. Seth Kaplan) at 225:4–11. Like the “tape drives” at
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`issue in Magnetic Tape Cartridges, the “effects” at issue in Video Game Systems, and the “S9 flow
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`generator” at issue in Breathing Treatment Systems, Novartis’s investments in brolucizumab were
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`central to bringing to market the ’631 patented technology as embodied in the BEOVU prefilled
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`syringe. See Magnetic Tape Cartridges, Comm’n Op. at 53; Video Game Systems, Comm’n Op.
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`at 69–70; Breathing Treatment Systems, Final ID at 147. The fact that Novartis’s investments
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`resulted in another product along the way—the vial form of BEOVU—does not negate the fact
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`that these investments are also investments with respect to the BEOVU prefilled syringe. See
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`Sonar Imaging Devices, Comm’n Op. at 59.
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`Regeneron relies on Breathing Treatment Systems to support its argument that investments
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`in the BEOVU vial presentation should not be considered for the economic prong analysis, but
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`Regeneron ignores important facts in that investigation. See Opp’n at 10 (citing Breathing
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`Treatment Systems, Final ID at 150). In Breathing Treatment Systems, the Commission considered
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`two different scenarios for the same unpatented “S9 flow generator.” The Commission did not
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`include investments in the S9 when considering the industry related to patents covering respiratory
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`masks because the masks could be used with systems that did not include the S9. Breathing
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`Treatment Systems at 147. On the other hand, the Commission included S9 investments as part of
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`an industry related to a patent covering “H5i humidifiers” because the H5i did not work without
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`the S9. Id. at 149. Regeneron focuses on the former scenario and ignores the latter, but the latter
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`is the most relevant here. The Commission credited investments that were central to exploitation
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`of the patented humidifier technology, and I must do the same here for investments central to
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`Novartis’s patented syringe. Investments in clinical trials and FDA approval for brolucizumab
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`were central to allowing Novartis to exploit the patented BEOVU prefilled syringe. See Certain
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`11
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`PUBLIC VERSION
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`Novartis Exhibit 2090.0011
`Regeneron v. Novartis, IPR2021-00816
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`Strontium-Rubidium Radioisotope Infusion Systems, and Components Thereof Including
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`Generators, Inv. No. 337-TA‑1110, Final ID at 143 (Aug. 1, 2019) (unreviewed in relevant part);
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`see also Certain Salinomycin Biomass and Preparations Containing Same, Inv. No. 337-TA-370,
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`USITC Pub. 2978 (July 1996), Final ID at 128 (not reviewed); Certain Diltiazem Hydrocholoride
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`and Diltiazem Preparations Containing Same, Inv. No. 337-TA-348, USITC Pub. 2902 (June
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`1995), Final ID at 120–28 (unreviewed in relevant part). Those investments are properly
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`considered to be part of the domestic industry and, as analyzed above, those investments are
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`significant.
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`IV.
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`Infringement
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`Novartis provides claim charts demonstrating how each limitation of asserted claims 1,
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`3–6, 11–13, 16, 17, and 21–25 of the ’631 patent is satisfied by the Regeneron EYLEA® prefilled
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`syringe product and users of EYLEA® prefilled syringe. Memo at 21–26. Neither Regeneron nor
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`Staff disputes that EYLEA® prefilled syringe satisfies the limitations of claims 1, 3–6, 11–13, 16,
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`17, and 21–23, or that physicians administering EYLEA® prefilled syringe perform each step of
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`method claims 24 and 25. Opp’n at 18; Staff Resp. at 27–28; Mot. Ex. 38 (Email from counsel for
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`Regeneron to counsel for Novartis dated Jan. 21, 2021); UMF Nos. 5–6; RUMF Nos. 5–6.
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`The undisputed evidence therefore demonstrates that Regeneron directly infringes claims
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`1, 3–6, 11–13, 16, 17, and 21–23 of the ’631 patent by importing and selling EYLEA® prefilled
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`syringes. There is also no dispute that physicians and others directly infringe method claims 24
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`and 25 by administering EYLEA® prefilled syringe to patients.
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`V.
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`Technical Prong of the Domestic Industry Requirement
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`Novartis provides claim charts demonstrating how its BEOVU® prefilled syringe product
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`practices each limitation of claims 1, 3–7, 16–17, 22, and 23 of the ’631 patent. Memo at 27–30.
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`12
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`PUBLIC VERSION
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`Novartis Exhibit 2090.0012
`Regeneron v. Novartis, IPR2021-00816
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`Neither Regeneron nor Staff disputes that BEOVU® prefilled syringe practices these limitations.
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`Opp’n at 1; Staff Resp. at 28–19; UMF No. 68; RUMF No. 68.
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`The undisputed evidence therefore demonstrates that BEOVU® prefilled syringe practices
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`each limitation of claims 1, 3–7, 16–17, 22, and 23 of the ’631 patent. The technical prong of the
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`domestic industry requirement is therefore satisfied.
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`VI.
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`Initial Determination and Order
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`In view of the undisputed facts above, it is my initial determination that Novartis has shown
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`significant employment of labor and capital within the United States with respect to articles
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`protected by the ’631 patent; direct infringement of claims 1, 3–6, 11–13, 16, 17, and 21–25 of the
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`’631 patent; and satisfaction of the technical prong of the domestic industry requirement as to
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`claims 1, 3–7, 16–17, 22, and 23 of the ’631 patent.
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`Motion No. 1207-021 for summary determination is therefore granted.
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`This initial determination, along with supporting documentation, is hereby certified to the
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`Commission. Pursuant to 19 C.F.R. § 210.42(h), this initial determination shall be the
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`determination of the Commission unless a party files a petition for review of the initial
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`determination pursuant to 19 C.F.R. § 210.43(a), or the Commission, pursuant to 19 C.F.R.
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`§ 210.44, orders, on its own motion, a review of the initial determination or certain issues herein.
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`Within two days of the date of this document, the parties shall jointly submit a single
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`proposed public version with any proposed redactions indicated in red. If the parties submit
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`excessive redactions, they may be required to provide declarations from individuals with personal
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`knowledge, justifying each proposed redaction and specifically explaining why the information
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`sought to be redacted meets the definition for confidential business information set forth in
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`19 C.F.R. § 201.6(a). To the extent possible, the proposed redactions should be made
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`13
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`PUBLIC VERSION
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`Novartis Exhibit 2090.0013
`Regeneron v. Novartis, IPR2021-00816
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`electronically, in a single PDF file using the “Redact Tool” within Adobe Acrobat. The proposed
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`redactions should be submitted as “marked” but not yet “applied.” The proposed redactions should
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`be submitted via email to Cheney337@usitc.gov and not filed on EDIS.
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`SO ORDERED.
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`Clark S. Cheney
`Administrative Law Judge
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`14
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`PUBLIC VERSION
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`Novartis Exhibit 2090.0014
`Regeneron v. Novartis, IPR2021-00816
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`CERTAIN PRE-FILLED SYRINGES
`FOR INTRAVITREAL INJECTION
`AND COMPONENTS THEREOF
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`Inv. No. 337-TA-1207
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`PUBLIC CERTIFICATE OF SERVICE
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`I, Lisa R. Barton, hereby certify that the attached INITIAL DETERMINATION has
`been served via EDIS upon the Commission Investigative Attorney, W. Peter Guarnieri, Esq.,
`and the following parties as indicated, on April 7, 2021.
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`On Behalf of Complainants Novartis Pharma AG, Novartis
`Pharmaceuticals Corporation, and Novartis Technology LLC:
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`Elizabeth J. Holland, Esq.
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Email: EHolland@goodwinlaw.com
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`On Behalf of Respondent Regeneron Pharmaceuticals, Inc.:
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`Anish R. Desai, Esq.
`WEIL, GOTSHAL & MANGES LLP
`767 5th Avenue
`New York, NY 10153
`Email: anish.desai@weil.com
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`Lisa R. Barton, Secretary
`U.S. International Trade Commission
`500 E Street, SW, Room 112
`Washington, DC 20436
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`☐ Via Hand Delivery
`☐ Via Express Delivery
`☐ Via First Class Mail
`☒ Other: Email Notification
`of Availability for Download
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`Novartis Exhibit 2090.0015
`Regeneron v. Novartis, IPR2021-00816
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