Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1362; Certain Liquid Transfer Devices With an Integral Vial Adapter

H347235 March 27, 2026 OT:RR:BSTC:EOE H347235 RPR CATEGORY: 19 U.S.C. § 1337; Unfair Competition Christopher J. Lutz Armis IP Law, L.L.C. P.O. Box 1564 Westborough, MA 01581 VIA EMAIL: chris.lutz@armisiplaw.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1362; Certain Liquid Transfer Devices With an Integral Vial Adapter Dear Mr. Lutz, Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (“EOE Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling letter holding that Summit International Medical Technologies Inc. (“Summit” or “Ruling Requester”) has not met its burden to show that its redesigned versions of liquid transfer devices (“articles at issue”) are not subject to the limited exclusion order (“LEO”) that the U.S. International Trade Commission (“ITC” or “Commission”) issued as a result of Investigation No. 337-TA-1362 (“the 1362 investigation”) under Section 337 of the Tariff of 1930, as amended, 19 U.S.C. § 1337. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision pertaining to section 337 exclusion orders. This ruling letter is the result of a request for an administrative ruling under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The proceeding involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, Summit, the Ruling Requester and a respondent in the 1362 investigation; and (2) West Pharmaceutical Services, Inc. and West Pharma Services, IL, Ltd. (collectively, “West”), the patent 1 owner and complainant in the 1362 investigation (together, the “parties”). See, e.g., 19 C.F.R. § 177.1(c). The parties were asked to clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in their submissions. See 19 C.F.R. §§ 177.2, 177.8. If there is additional information in this ruling letter not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, the parties are asked to contact the EOE Branch within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. § 177.8(a)(3). Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by, for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. § 177.8(a)(3). See, e.g., 19 C.F.R. § 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act (“FOIA”), as amended (5 U.S.C. § 552), the Trade Secrets Act (18 U.S.C. § 1905), and the Privacy Act of 1974, as amended (5 U.S.C. § 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. § 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is appropriately tailored and supported by evidence establishing that: the information in question is customarily kept private or closely-held and either that the government provided an express or implied assurance of confidentiality when the information was shared with the government or there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (concluding that “[a]t least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is ‘confidential’ within the meaning of exemption 4.”); see also U.S. Department of Justice, Office of Information Policy (OIP): Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (updated 10/7/2019); and OIP Guidance: Exemption 4 after the Supreme Court’s Ruling in Food Marketing Institute v. Argus Leader Media (updated 10/4/2019). I. BACKGROUND A. ITC Investigation No. 337-TA-1362 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1362 on May 11, 2023, based on a complaint filed by West Pharmaceutical Services, Inc. of Exton, Pennsylvania and West Pharma. Services IL, Ltd. of Ra’anana, Israel. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 843955, Public Commission Opinion (Feb. 20, 2025) (“Comm’n Op.”) at 2 (citing 88 Fed. Reg. 30342 (May 11, 2023)). The complaint, as supplemented, alleged a violation of section 337 by reason of infringement of claim 1 of U.S. 2 Patent No. 10,688,295 (“the ’295 patent”), the claim of U.S. Design Patent No. D767,124 (“the D’124 patent”); the claim of U.S. Design Patent No. D765,837 (“the D’837 patent”); the claim of U.S. Design Patent No. D630,732 (“the D’732 patent”); and U.S. Trademark Registration No. 5,810,583 (“the ’583 mark”). Id. at 3. The notice of investigation named four respondents: Advcare Medical, Inc. of New Taipei City, Taiwan (“Advcare”), Dragon Heart Medical Devices Co., Ltd. Of Kaiping City, China (“Dragon Heart Devices”), Dragon Heart Medical, Inc. of Addison, Illinois (“Dragon Heart”), and Summit International Medical Technologies, Inc. of Franklin, Massachusetts (“Summit”). Id. The Commission’s Office of Unfair Import Investigations (“OUII”) was also named as a party in the investigation. Id. The 1362 investigation was terminated as to Dragon Heart Devices but not as to the other Dragon Heart respondent. Id. The ’583 mark and the three asserted design patents (the D’124 patent, the D’837 patent, and the D’732 patent) were terminated from the investigation by withdrawal. Id. Accordingly, the ’295 patent was the only asserted intellectual property right remaining in this investigation, and the remaining respondents in the investigation were Summit, Advcare, and Dragon Heart (collectively, “respondents”). Id. On March 15, 2024, the presiding Administrative Law Judge (“ALJ”) issued a final initial determination, Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA- 1362, EDIS Doc. ID 816231, Public Final Initial Determination (March 15, 2024) (“FID”) finding a violation of section 337. Comm’n Op. at 4. Specifically, the ALJ determined that a violation of section 337 occurred in the importation into the United States, the sale for importation, or the sale within the United States after importation, of the accused products due to infringement of claim 1 of the ’295 patent. Id. On May 16, 2024, the Commission issued a notice in which it determined to review in part the FID. Id. Specifically, the Commission determined to review the FID’s findings with respect to standing and jurisdiction as well as the ALJ’s preclusion of the respondents’ and OUII’s invalidity arguments. Id. The Commission determined not to review the remaining findings in the FID, including the findings on claim construction, infringement, and the technical prong of the domestic industry requirement. Id. On November 8, 2024, the ALJ issued a Remand ID finding that claim 1 of the ’295 patent is not invalid for lack of written description under 35 U.S.C. § 112. Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 836774, Remand ID (Nov. 8, 2024) (“Remand ID”); Comm’n Op. at 5. The respondents and OUII subsequently filed petitions for review. Comm’n Op. at 5. On December 20, 2024, the Commission determined to review the Remand ID. Id. On February 20, 2025, the Commission affirmed the Remand ID and found a violation of section 337 with respect to the ’295 patent. Id. at 2. The Commission also determined that the appropriate remedy was a LEO directed to the respondents and a cease and desist order directed to Summit. Id. at 17. In the LEO, the Commission ordered that “[c]ertain liquid transfer devices with an integral vial adapter that infringe claim 1 of the ’295 patent and are manufactured abroad by, or on behalf 3 of, or imported by or on behalf of respondents or any of their affiliated companies, parents, subsidiaries, agents, or other related business entities, or its successors or assigns, are excluded from entry for consumption into the United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption, for the remaining terms of the Asserted Patents, except under license from, or with the permission of, the patent owner or as provided by law.” Certain Liquid Transfer Devices With an Integral Vial Adapter, Inv. No. 337-TA-1362, EDIS Doc. ID 842456, Limited Exclusion Order (Feb. 3, 2025) at 2, ¶1 (“1362 LEO”). 2. The Patents and Claims in the 1362 LEO As noted above, the 1362 LEO prohibits the unlicensed entry for consumption of liquid transfer devices with an integral vial adapter that infringe claim 1 of the ’295 patent. Id. at 2, ¶1. The Commission further defined the articles covered by the LEO as “liquid transfer devices that have a trifurcated connector body, with one end including an integral vial adapter, and wherein the integral vial adapter has a diameter of 13mm or 20mm and may only be used with a vial.” Id. at 2, ¶2. a. Claim 1 of the ’295 Patent The ’295 patent is titled “Liquid Transfer Devices for Use With Infusion Liquid Containers” and describes a device that can be used with an administration set to administer medicine intravenously to a patient. FID at 7; ’295 patent at (54) and 3:34-46. The ’295 patent has only one claim, which is reproduced below: 1. A liquid transfer device configured for use with each of an infusion liquid container containing an infusion liquid and having an intravenous (IV) port for administering the infusion liquid, a vial including a vial bottle sealed by a vial stopper and containing a medicament additive, and an infusion set including an IV spike for sealing insertion into an IV port and a connector for administration purposes to a patient, the liquid transfer device comprising: (Claim Limitation 1.0) i) an integral trifurcated connector body; (Claim Limitation 1.1) ii) a single IV spike defining a first end of the integral trifurcated connector body for sealing insertion into the infusion liquid container's IV port, (Claim Limitation 1.2) iii) an integral vial adapter extending from a second end of the integral trifurcated connector body for telescopically mounting on the vial, said integral vial adapter including a puncturing cannula for puncturing the vial stopper upon said mounting of said vial adapter onto the vial for flow communication therewith, and (Claim Limitation 1.3) iv) an administration port extending from a third end of the integral trifurcated connector body and constituted by a substitute IV port for sealingly receiving the infusion set’s IV spike, (Claim Limitation 1.4) 4 the integral trifurcated connector body connecting said single IV spike in direct and continuous fluid communication with said integral vial adapter and (Claim Limitation 1.5) connecting said single IV spike in direct and continuous fluid communication with said administration port, (Claim Limitation 1.6) thereby enabling initial introduction of the medicament additive from the vial to the infusion liquid container through the vial adapter and the single IV spike for mixing with the infusion liquid to form a medicated infusion liquid, and subsequent administration of the medicated infusion liquid to a patient from the infusion liquid container through the single IV spike and the administration port to the infusion set. (Claim Limitation 1.7) FID at 8-9 (citing ’295 patent at 6:2-35). The FID adopted the claim limitation labels that West utilized in its initial post-hearing brief. Id. at 8, n.4. ’295 patent at Fig. 5B. The ALJ described the use of the invention taught by the ’295 patent as: [t]he patent teaches that the liquid transfer device illustrated in Figure 6 includes a “trifurcated connector body” 21 that can connect to three components. Id. at 2:25- 5 28, 4:29-31, 4:56-5:18. First, “an infusion liquid bag” 10 (an IV bag) is connected by pushing a spike 22 into the IV bag through a port 11. Id. at 4:56-5:18. Second, a vial 19 containing medication is connected by a vial adapter 102 Id. The patent explains that the medication can be transferred from the vial to the infusion liquid bag “by squeezing the infusion liquid bag 10 to urge infusion liquid into the vial 19 and then inverting the infusion liquid bag 10 such that the vial contents drain thereinto.” ’295 patent at 4:60-63. Finally, an infusion set 112 is connected via an administration port 43. Id. An infusion set may comprise tubing, clamps, and other components that will ultimately be connected to a patient’s IV catheter or the like. See, e.g., id. at 3:54-61. FID at 7-8. 3. The Products from the Underlying Investigation The accused products in the underlying investigation consist of “liquid transfer devices that have a trifurcated connector body, with one end including an integral vial adapter, and wherein the integral vial adapter has a diameter of 13mm or 20mm and may only be used with a vial.” Comm’n Op. at 7. The products specifically were Summit’s “Vial Direct to Bag” 20-millimeter admixture device and “Vial Direct to Bag” 13-millimeter device. Id. Depictions of the accused products from the FID, are inserted below: FID at 25. 6 Id. at 50. Id. at 51. 7 The parties stipulated that (i) Advcare sold these articles for importation, (ii) Dragon Heart was the importer, and (iii) Summit sold the articles after importation. Id. at 5-6. Ultimately, these products were found to practice each limitation in claim 1 of the ’295 patent. Id. at 65. Addressing limitation 1.2, West contended that the products satisfied this limitation while OUII contended the products did not satisfy this limitation due to the lack of an “integral trifurcated connector body.” Id. at 38. The respondents did not specifically address limitation 1.2. Id. Finding the connector body to be trifurcated for the reasons discussed under limitation 1.1, the ALJ found that the accused products satisfied limitation 1.2. Id. at 38-39. Similarly, with respect to limitation 1.3, West contended that the products satisfied this limitation while OUII contended the products did not satisfy this limitation due to the lack of an “integral trifurcated connector body.” Id. at 39. The respondents did not specifically address limitation 1.3. Id. Finding the connector body to be trifurcated for the reasons discussed under limitation 1.1, the ALJ found that the accused products satisfied limitation 1.3. Id. With regards to limitation 1.4, West contended the products satisfy the limitation while the respondents did not specifically address limitation 1.4. Id. at 39-40. OUII argued that the accused products did not satisfy this limitation because they could not receive an IV spike unless a tab on the administration port was twisted off. Id. at 39-49. The ALJ rejected this argument reasoning that the twist-off tab was simply another feature above and beyond what was required to satisfy the claim, finding that the accused products satisfied limitation 1.4. Id. at 48-49. Next, addressing limitation 1.5, West contended the products satisfied the limitation. Id. at 49. OUII contended the accused products did not satisfy the “integral trifurcated connector body,” an argument that was rejected by the ALJ as discussed in limitation 1.1. Id. The respondents contended the accused products did not satisfy the “direct and continuous fluid communication” aspect of limitation 1.5. Id. In particular, the respondents argued that limitation 1.5 required fluid to flow in both channels of their device at the same time, while fluid only flowed in one channel during medication administration. Id. at 52-53. The ALJ rejected this argument, noting that even accepting the respondents’ argument there was direct and continuous fluid communication in both channels, even though the flow in one of the channels was primarily air. Id. at 54-55. The ALJ next addressed the domestic industry requirement. Id. at 65-72. With regards to the economic prong, the ALJ noted that West’s motion for summary determination had been granted because it had established, at a minimum, that it was in the process of establishing a domestic industry. Id. at 66. With regards to the technical prong, the respondents and OUII raised arguments that West’s product did not practice claim 1 of the ’295 patent for the same reasons they argued the accused products did not satisfy the limitations of claim 1. Id. at 66-71. The ALJ found that West’s domestic industry product satisfied each limitation of claim 1 for the same reasons that the accused products satisfied each limitation of claim 1. Id. Accordingly, the ALJ found both prongs of the domestic industry requirement to be satisfied. Id. at 72. As a result of the above findings, the ALJ issued an initial determination that a violation of section 337 had occurred. Id. In its decision to review the FID in part, the Commission did not review the ALJ’s findings as to claim construction, infringement, nor the technical prong of the domestic industry requirement, but instead focused on arguments raised as to standing, jurisdiction, and the ALJ’s preclusion of 8 certain arguments. Comm’n Op. at 4. The Commission ultimately determined that West had established a violation of section 337 by the respondents and issued an LEO directed to the respondents and a cease and desist order directed to Summit. Comm’n Op. at 17. B. 19 C.F.R. Part 177 Ruling Request 1. Procedural History On April 22, 2025, Summit submitted a letter to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177 (“Ruling Request”). In the same letter, Summit stated it had provided a copy of the Ruling Request to West’s counsel. Summit requested an administrative ruling that its redesigned infusion vial adapters presented in the Ruling Request, containing an additional valve along the channel between the vial and connector body, avoid infringing the ’295 patent and fall outside the 1362 LEO. Ruling Request at 7-8. On April 22, 2025, the EOE Branch confirmed receipt of the Ruling Request submitted by Summit and requested a preliminary meeting with the parties to discuss procedural aspects of the inter partes process. EOE Branch email to Parties, dated April 22, 2025.