RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1411; Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same

HQ H361286 September 14, 2026 OT:RR:BSTC:EOE H361286 JW CATEGORY: 19 U.S.C. § 1337; Unfair Competition Brian Larivee Polsinelli 1401 Eye Street N.W. Suite 800 Washington, D.C. 20005 VIA EMAIL: [email protected]; [email protected]; [email protected] RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1411; Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same Dear Mr. Larivee: Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement (EOE) Branch, Regulations and Rulings, U.S. Customs and Border Protection (CBP) issues this ruling letter in response to the request, dated June 3, 2026, from Biofrontera Inc., Biofrontera Pharma GmbH, and Biofrontera Bioscience GmbH (collectively, “Respondents” or “Biofrontera”) for an administrative ruling, which included Exhibits 1 to 27 (collectively, “Ruling Request”). We find that the articles at issue, as described below, are not subject to the limited exclusion order (LEO) issued in U.S. International Trade Commission (ITC or “Commission”) Investigation No. 337-TA- 1411 (“the underlying investigation” or “the 1411 investigation”), pursuant to Section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“Section 337”). We 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 from CBP under 19 C.F.R. Part 177 that the EOE Branch 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, Biofrontera, the ruling requester and respondents in the 1411 investigation;
and (2) Sun Pharmaceutical Industries, Inc. (“Sun Pharma” or “Complainant”), the complainant in the 1411 investigation. See 19 C.F.R. § 177.1(c). The parties were asked to clearly identify confidential information with [[red brackets]] in their submissions to CBP. See, e.g., EOE Branch Email to Parties, dated June 8, 2026; see also 19 C.F.R. §§ 177.2 and 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 directed to contact CBP 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 November 18, 2022); and OIP Guidance: Exemption 4 after the Supreme Court’s Ruling in Food Marketing Institute v. Argus Leader Media (updated October 4, 2019). I. BACKGROUND A. ITC Investigation No. 337-TA-1411 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1411 on August 1, 2024, based on a complaint filed by Sun Pharma. Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same, Inv. No. 337-TA-1411, Commission Opinion (May 6, 2026) (“Comm’n Op.”) at 3 (citing 89 Fed. Reg. 62790 (Aug. 1, 2024)). The complaint, as supplemented, alleged a violation of Section 337 based on the importation into the United States, the sale for importation, and the sale within the United States after importation of certain photodynamic therapy systems, components thereof, and 2
pharmaceutical products used in combination with the same by reason of infringement of certain claims of U.S. Patent Nos. 11,446,512 (“the ’512 patent”) and 11,697,028 (“the ’028 patent”) (collectively, “the Asserted Patents”). Id. The Notice of Investigation named the following parties as respondents: Biofrontera Inc.; Biofrontera Pharma GmbH; Biofrontera Bioscience GmbH; and Biofrontera AG. Id. The Commission’s Office of Unfair Import Investigations was not a party in the investigation. Id. On November 20, 2024, the Commission amended the complaint and notice of investigation to add infringement allegations as to claims 17 and 18 of the ’512 patent. Id. (citing Order No. 8 (Oct. 22, 2024), unreviewed by Comm’n Notice (Nov. 20, 2024)). On March 4, 2025, the Administrative Law Judge (ALJ) issued an order construing certain claim terms (Order No. 18), including the claim term “nested hinges on inner side surfaces.” Id. (citing Order No. 18 at 29-35). On September 30, 2025, the ALJ issued the final initial determination (FID), finding a violation of Section 337. Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same, Inv. No. 337-TA-1411, Initial Determination on Violation of Section 337 and Recommendation on Remedy and Bond (September 30, 2025) at 143 to 144. Specifically, the FID found, inter alia, that the accused product, the RhodoLED XL, alone or in combination with the pharmaceutical product Ameluz, infringed claims 1, 3, 5, 8, 17-18, and 20 of the ’512 patent and claims 1, 2, 4, 16, 17, and 19-21 of the ’028 patent. Id. at 143. On January 28, 2026, the Commission determined to review the FID in part, including the construction of the claim term “nested hinges.” Comm’n Op. at 6 (citing 91 Fed. Reg. at 4630). Ultimately, the Commission determined that Complainant established a violation of Section 337 by Respondents with respect to claims 1, 3, 5, 8, 17, 18, and 20 of the ’512 patent and claims 1, 2, 4, 16, 17, and 19-21 of the ’028 patent. Id. at 63. As such, the Commission terminated the investigation with a finding of a violation of Section 337. Id. The Commission also determined that the appropriate remedy was, inter alia, an LEO. Id. However, the Commission suspended enforcement of the order as to the ’028 patent pending resolution of the U.S. Patent and Trademark Office Patent Trial and Appeal Board’s (USPTO) final written decision (FWD) finding claims 1, 1 2, 4-6, 16, 17, and 19-21 of the ’028 patent unpatentable as obvious. In the LEO, the Commission ordered: Certain photodynamic therapy systems, components thereof, and pharmaceutical products used in combination with the same that infringe one or more of claims 1, 3, 5, 8, 17-18, and 20 of U.S. Patent No. 11,446,512 or claims 1, 2, 4, 16, 17, and 1 Subsequently, on July 29, 2026, the USPTO issued a decision vacating the FWD in its entirety. On July 31, 2026, Sun Pharma submitted a letter requesting the Commission lift the partial suspension of the remedial orders as to the ’028 patent in light of the USPTO decision to vacate the FWD. On September 1, 2026, the Commission determined to grant Sun Pharma’s request to lift the partial suspension of the remedial orders as to the ’028 patent. 3
19-21 of U.S. Patent No. 11,697,028 and are manufactured abroad by, or on behalf 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; and except for parts necessary to service and repair covered articles purchased by consumers prior to the date this Order becomes final within the meaning of 19 U.S.C. § 1337(j)(4), and except for covered articles that are replacements for covered articles purchased by consumers prior to the date this Order becomes final within the meaning of 19 U.S.C. § 1337(j)(4), provided that replacement is pursuant to a warranty for the replaced article. Certain Photodynamic Therapy Systems, Components Thereof, and Pharmaceutical Products Used in Combination with the Same, Inv. No. 337-TA-1411, Limited Exclusion Order (May 6, 2026) (“1411 LEO”) at ¶ 1. The Commission further defined that: [C]ertain photodynamic therapy systems, components thereof, and pharmaceutical products used in combination with the same subject to this exclusion order (i.e., “covered articles”) are as follows: illuminators for photodynamic therapy with light sources on at least five panels, assembled or disassembled, replacement parts, and 5-aminolevulinic acid used in combination with the illuminators for photodynamic therapy. 2 Id. at ¶ 2. 2. The Patents and Claims in the 1411 LEO The asserted patent claims in the 1411 LEO are claims 1, 3, 5, 8, 17-18, and 20 of the ’512 patent and claims 1, 2, 4, 16, 17, and 19-21 of the ’028 patent. 1411 LEO at 2, ¶ 1. a. The ’512 Patent The ’512 patent is titled “Adjustable illuminator for photodynamic therapy and diagnosis.” FID at 3. Of claims 1, 3, 5, 8, 17-18, and 20 of the ’512 patent, claims 1, 8, and 20 are the only independents claim. The text of each is reproduced below: Claim 1 1. [p] A system for photodynamically diagnosing or treating a patient, comprising: 2 On May 20, 2026, Respondents filed a petition for reconsideration. On September 9, 2026, the Commission denied that petition. 4
[a] an illuminator comprising at least five panels connected by nested hinges on inner side surfaces of adjacent panels, [b] light sources disposed on surfaces of the at least five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, [c] one of the at least five panels positioned as a center panel configured to face the treatment surface, and two or more of the at least five panels being configured to be angled relative to the center panel, [d] wherein each of the at least five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 4 (citing the ’512 patent at claim 1) (emphasis added). Claim 8 8. [p] A method of photodynamically diagnosing or treating a patient, comprising: [a] administering 5-aminolevulinic acid (ALA) to the patient; [b] positioning an illuminator proximate to the patient, the illuminator comprising at least five panels connected by nested hinges on inner side surfaces of adjacent panels; and [c] uniformly illuminating a treatment surface of the patient with light sources disposed on the at least five panels of the illuminator, [d] wherein each of the at least five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 4 to 5 (citing the ’512 patent at claim 8) (emphasis added). Claim 20 20. [p] A system for photodynamically diagnosing or treating a patient, comprising: [a] an illuminator comprising at least five panels connected by nested hinges on inner side surfaces of adjacent panels, the nested hinges being configured so as to allow continuous illumination across the at least five panels, 5
[b] light sources disposed on surfaces of the at least five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, [c] one of the at least five panels positioned as a center panel configured to face the treatment surface, and two or more of the at least five panels being configured to be angled relative to the center panel, [d] wherein each of the at least five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 5 (citing the ’512 patent at claim 20) (emphasis added). The Commission construed the claim term “nested hinges on inner side surfaces of adjacent panels” in the ’512 patent to mean “hinges that fit on inner side surfaces of adjacent panels.” Comm’n Op. at 18 to 23. b. The ’028 Patent The ’028 patent is also titled “Adjustable illuminator for photodynamic therapy and diagnosis.” FID at 6. Of claims 1, 2, 4, 16, 17, and 19-21 of the ’028 patent, claims 1, 16, 20, and 21 are the only independents claim. The text of each is reproduced below: Claim 1 1. [p] A system for photodynamically diagnosing or treating a patient, comprising: [a] an illuminator comprising five panels connected by hinged structures on inner side surfaces of adjacent panels; and [b] light sources disposed on surfaces of the five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, [c] one of the five panels being positioned as a center panel configured to face the treatment surface, and two or more of the five panels being configured to be angled relative to the center panel, [d] wherein the five panels are positioned to allow treatment within approximately four inches of the treatment surface, and [e] wherein each of the five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher 6
intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 6 (citing the ’028 patent at claim 1) (emphasis added). Claim 16 16. [p] A system for photodynamically diagnosing or treating a patient, comprising: [a] a mobile base supported by at least four wheels; [b] a pillar perpendicular to the base; [c] a controller disposed to be supported by the pillar; [d] an arm mounted to a top portion of the pillar; and [e] an illuminator connected at an end of the arm, [f] the arm being hinged to allow adjustment of a position of the illuminator relative to the base, [g] the illuminator comprising: five panels connected by hinged structures to allow continuous illumination across the five panels, wherein the five panels are individually configurable to control illumination from each of the five panels, [h][a] light sources disposed on surfaces of the five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, the light sources being configured to output light uniformly during at least part of a time when the treatment surface is illuminated, [h][b] each of the five panels having two first edges and two second edges shorter than the two first edges, the light sources arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges, and [i] one or more fans mounted to at least one of the five panels. FID at 7 to 8 (citing the ’028 patent at claim 16) (emphasis added). Claim 20 20. [p] A system for photodynamically diagnosing or treating a patient, comprising: [a] an illuminator comprising five panels connected by hinged structures on inner side surfaces of adjacent panels, wherein the illuminator is configured to output light at a variable irradiance density during treatment; and 7
[b] light sources disposed on surfaces of the five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, [c] one of the five panels being positioned as a center panel configured to face the treatment surface, and two or more of the five panels being configured to be angled relative to the center panel, [d] wherein the five panels are positioned to allow treatment within approximately four inches of the treatment surface, and [e] wherein each of the five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 8 (citing the ’028 patent at claim 20) (emphasis added). Claim 21 21. [p] A system for photodynamically diagnosing or treating a patient, comprising: [a] an illuminator comprising five panels connected by hinged structures on inner side surfaces of adjacent panels; and [b] light sources disposed on surfaces of the five panels, the illuminator being configured to uniformly illuminate a treatment surface of the patient via the light sources, [c] one of the five panels being positioned as a center panel configured to face the treatment surface, and two or more of the five panels being configured to be angled relative to the center panel, [d] wherein the five panels are positioned to allow treatment within approximately four inches of the treatment surface, [e] wherein the five panels are individually configurable to control illumination from each of the five panels, and [f] wherein each of the five panels has two first edges and two second edges shorter than the two first edges, and the light sources are arranged such that a higher intensity of light is emitted proximate the second edges compared to the intensity of light emitted not proximate the second edges. FID at 8 to 9 (citing the ’028 patent at claim 21) (emphasis added). 8
B. 19 C.F.R. Part 177 Ruling Request 1. Procedural History On June 3, 2026, Biofrontera filed a submission with CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177, which included Exhibits 1 to 27. Biofrontera requested a ruling from CBP that its redesign of the RhodoLED® XL device “designed with [[ ]]” is outside the scope of the 1411 LEO. See, e.g., Ruling Request at 1 and 17. Biofrontera also noted that a redacted version of the request and public exhibits were provided to Sun Pharma. See Biofrontera Email to EOE Branch, dated June 3, 2026. On June 11, 2026, the EOE Branch had an initial conference call with Biofrontera and Sun Pharma. See EOE Branch Email to Parties, dated June 8, 2026. On June 17, 2026, a copy of the executed nondisclosure agreement between Biofrontera and Sun Pharma was provided to the EOE Branch and Biofrontera also noted that it would provide Sun Pharma a confidential copy of the ruling and exhibits. Biofrontera Email to EOE Branch, 3 dated June 17, 2026. Subsequently, on June 18, 2026, the EOE Branch set a schedule for this inter partes proceeding that was in line with the jointly proposed schedule from the parties. See EOE Branch Email to Parties, dated June 18, 2026. On July 7, 2026, the parties jointly requested a one-week extension to the dates in the schedule, which the EOE Branch agreed to on July 8, 2026, except for the proposed oral discussion date as the EOE Branch was unavailable that day. See Biofrontera Email to EOE Branch, dated July 7, 2026 and EOE Branch Email to Parties, dated July 8, 2026. The modified oral discussion date of August 10, 2026 was later confirmed on July 16, 2026. See Biofrontera Email to EOE Branch, dated July 16, 2026 and EOE Branch Email to Parties, dated July 16, 2026. On July 20, 2026, Sun Pharma provided its response to the Ruling Request, which included Exhibits A to D (collectively, “Sun Pharma Response”). On July 27, 2026, Biofrontera provided its reply, which included Exhibits 28 to 31 (collectively, “Biofrontera Reply”). On August 3, 2026, Sun Pharma provided its sur-reply, which included Exhibits E to M (collectively, “Sun Pharma Sur-Reply”). On August 10, 2026, the EOE Branch had an oral discussion with the parties and each of the parties provided PowerPoints as part of their participation in the oral discussion (“Biofrontera PowerPoint” and “Sun Pharma PowerPoint,” respectively). Following the oral discussion, on August 24, 2026, Biofrontera provided a post oral discussion submission, which included Exhibit 32 (collectively, “Biofrontera Post Oral Discussion Submission”) and Sun Pharma likewise provided a post oral discussion submission that included Exhibit N (collectively, “Sun Pharma Post Oral Discussion Submission”). 3 The date and time for the oral discussion was confirmed in a later email from the EOE Branch, dated June 24, 2026. 9

II. ISSUE Whether Biofrontera has met its burden to show that the articles at issue do not infringe claims 1, 3, 5, 8, 17-18, and 20 of the ’512 patent or claims 1, 2, 4, 16, 17, and 19-21 of the ’028 patent and thus are not subject to the 1411 LEO. See, e.g., Ruling Request at 1. III. LEGAL FRAMEWORK A. Section 337 Exclusion Order Administration The Commission shall investigate any alleged violation of Section 337 to determine, with respect to each investigation conducted by it under this section, whether there is a violation of this section. See 19 U.S.C. § 1337(b)(1) and (c). If the Commission determines, as a result of an investigation under this section, that there is a violation of this section, it shall direct that the articles concerned, imported by any person violating the provision of this section, be excluded from entry into the United States unless the Commission finds based on consideration of the public interest that such articles should not be excluded from entry. See 19 U.S.C. § 1337(d)(1). When the Commission determines there is a violation of Section 337, it generally issues one of two types of exclusion orders: (1) a limited exclusion order or (2) a general exclusion order. See Fuji Photo Film Co., Ltd. v. ITC, 474 F.3d 1281, 1286 (Fed. Cir. 2007). Both types of orders direct CBP to bar infringing products from entering the country. See Yingbin-Nature (Guangdong) Wood Indus. Co. v. ITC, 535 F.3d 1322, 1330 (Fed Cir. 2008). “A limited exclusion order is ‘limited’ in that it only applies to the specific parties before the Commission in the investigation. In contrast, a general exclusion order bars the importation of infringing products by everyone, regardless of whether they were respondents in the Commission's investigation.” Id. A general exclusion order is appropriate only if two exceptional circumstances apply. See Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1356. A general exclusion order may only be issued if (1) “necessary to prevent circumvention of a limited exclusion order,” or (2) “there is a pattern of violation of this section and it is difficult to identify the source of infringing products.” 19 U.S.C. § 1337(d)(2); see Kyocera, 545 F.3d at 1356 (“If a complainant wishes to obtain an exclusion order operative against articles of non-respondents, it must seek a GEO [general exclusion order] by satisfying the heightened burdens of §§ 1337(d)(2)(A) and (B).”). In addition to the action taken above, the Commission may issue an order under 19 U.S.C. § 1337(i) directing CBP to seize and forfeit articles attempting entry in violation of an exclusion order if their owner, importer, or consignee previously had articles denied entry on the basis of that exclusion order and received notice that seizure and forfeiture would result from any future attempt to enter articles subject to the same. An exclusion order under § 1337(d)—either limited or general—and a seizure and forfeiture order under § 1337(i) apply at the border only and are operative against articles presented for customs examination or articles conditionally released from customs custody but still subject to a timely demand for redelivery. See 19 U.S.C. §§ 1337(d)(1) (“The Commission shall notify the Secretary of the Treasury of its action under this subsection directing such exclusion from entry, and upon receipt of such notice, the Secretary shall, through the proper officers, refuse such entry.”); id., at (i)(3) (“Upon the attempted entry of articles subject 15
to an order issued under this subsection, the Secretary of the Treasury shall immediately notify all ports of entry of the attempted importation and shall identify the persons notified under paragraph (1)(C).”). Significantly, unlike district court injunctions, the Commission can issue a general exclusion order that broadly prohibits entry of articles that violate Section 337 of the Tariff Act of 1930 without regard to whether the persons importing such articles were parties to, or were related to parties to, the investigation that led to issuance of the general exclusion order. See Vastfame Camera, Ltd. v. ITC, 386 F.3d 1108, 1114 (Fed. Cir. 2004). The Commission also has recognized that even limited exclusion orders have broader applicability beyond just the parties found to infringe during an investigation. See Certain GPS Devices and Products Containing Same, Inv. No. 337-TA-602, Comm’n Op. at 17, n. 6, Doc ID 317981 (Jan. 2009) (“We do not view the Court’s opinion in Kyocera as affecting the issuance of LEOs [limited exclusion orders] that exclude infringing products made by respondents found to be violating Section 337, but imported by another entity. The exclusionary language in this regard that is traditionally included in LEOs is consistent with 19 U.S.C. § 1337(a)(1)(B)–(D) and 19 U.S.C. § 1337(d)(1).”). Moreover, “[t]he Commission has consistently issued exclusion orders coextensive with the violation of Section 337 found to exist.” See Certain Erasable Programmable Read Only Memories, Inv. No. 337-TA-276, Enforcement Proceeding, Comm’n Op. at 11, Doc ID 43536 (Aug. 1991) (emphasis added). “[W]hile individual models may be evaluated to determine importation and [violation], the Commission’s jurisdiction extends to all models of [violative] products that are imported at the time of the Commission’s determination and to all such products that will be imported during the life of the remedial orders.” See Certain Optical Disk Controller Chips and Chipsets, Inv. No. 337-TA-506, Comm’n Op. at 56–57, USITC Pub. 3935, Doc ID 287263 (July 2007). B. Patent Infringement Determining patent infringement requires two steps. Advanced Steel Recovery, LLC v. X-Body Equip., Inc., 808 F.3d 1313, 1316 (2015). The first is to construe the limitations of the asserted claims and the second is to compare the properly construed claims to the accused product. Id. To establish literal infringement, every limitation recited in a claim must be found in the accused product whereas, under the doctrine of equivalents, infringement occurs when there is equivalence between the elements of the accused product and the claimed elements of the patented invention. Microsoft Corp. v. GeoTag, Inc., 817 F.3d 1305, 1313 (Fed. Cir. 2016). One way to establish equivalence is by showing, on an element-by-element basis, that the accused product performs substantially the same function in substantially the same way with substantially the same result as each claim limitation of the patented invention, which is often referred to as the function- way-result test. See Intendis GmbH v. Glenmark Pharms., Inc., 822 F.3d 1355, 1361 (Fed. Cir. 2016). As for the first step above, “claim construction is a matter of law.” SIMO Holdings, Inc. v. H.K. uCloudlink Network Tech., Ltd., 983 F.3d 1367, 1374 (Fed. Cir. 2021). Moreover, the ultimate construction of a claim limitation is a legal conclusion, as are interpretations of the patent’s intrinsic evidence (the patent claims, specifications, and prosecution history). UltimatePointer, L.L.C. v. Nintendo Co., 816 F.3d 816, 822 (Fed. Cir. 2016) (citing Teva Pharms. 16
USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831, 841(2015)). “Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.” Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc). “In some cases, the ordinary meaning of claim language as understood by a person of skill in the art may be readily apparent even to lay judges.” Id. at 1314. In others, courts look to public sources such as “the words of the claims themselves, the remainder of the specification, the prosecution history, and extrinsic evidence concerning relevant scientific principles, the meaning of technical terms, and the state of the art.” Id. “To begin with, the context in which a term is used in the asserted claim can be highly instructive.” Phillips, 415 F.3d at 1314 (“To take a simple example, the claim in this case refers to ‘steel baffles,’ which strongly implies that the term ‘baffles’ does not inherently mean objects made of steel.”). The context in which a claim term is used also includes the full chain of dependence as well as the remaining suite of claims and the written description. See Inline Plastics Corp. v. EasyPak, LLC, 799 F.3d 1364, 1371 (Fed. Cir. 2015) (“Since the specification explicitly mentions the ‘alternative’ . . . there can be no debate concerning the application of the doctrine of claim differentiation.”). The second step to establish infringement involves a comparison of the claims, as properly construed, to the accused product, which is a question of fact. Apple Inc. v. Samsung Elecs. Co., Ltd., 839 F.3d 1034, 1040 (Fed. Cir. 2016) (en banc). We apply this two-step analysis below. IV. INFRINGEMENT ANALYSIS The infringement question related to the articles at issue is focused on the claimed “nested hinges” in the asserted claims of the ’512 patent and the claimed “hinged structures” in the asserted claims of the ’028 patent. See e.g., Ruling Request at 23; Biofrontera Post Oral Discussion Submission at 1. The claim term “nested hinges on inner side surfaces of adjacent panels” appears in every asserted independent claim of the ’512 patent (claims 1, 8, and 20). Comm’n Op. at 18 to 19. The claim term “hinged structures” appears in every asserted independent claim of the ’028 4 patent (claims 1, 16, 20, and 21). For the reasons below, we find that Biofrontera has met its burden to show that the articles at issue do not infringe the asserted claims of the ’512 patent or the asserted claims of the ’028 patent. Summary of Biofrontera’s Position 4 The remaining asserted claims of the ’512 patent and the ’028 patent depend from the independent claims identified. Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1553 (Fed. Cir. 1989) (“One who does not infringe an independent claim cannot infringe a claim dependent on (and thus containing all the limitations of) that claim.”) (internal citation omitted). 17
Biofrontera asserts that the articles at issue do not have the claimed “nested hinges” in the asserted claims of the ’512 patent or the claimed “hinged structures” in the asserted claims of the ’028 patent. See e.g., Biofrontera Post Oral Discussion Submission at 1. Biofrontera argues that the articles at issue have “[[ ]], instead of hinges.” Id. Biofrontera does not contend that any other limitations in the asserted claims of the asserted patents are not met. See e.g., Biofrontera PowerPoint at 4. The ’512 patent For the asserted claims of the ’512 patent, which all require “nested hinges,” Biofrontera argues that “the plain and ordinary meaning of the term ‘hinges’ requires a rotatable functionality. In other words, the claimed ‘hinges’ element should be construed to encompass rotatable components but does not encompass [[ ]]” Ruling Request at 29. In so arguing, Biofrontera acknowledges that “[t]he Commission did not expressly construe the term ‘hinges,’” but pointed out the Commission said, “[t]he specification explains that the nested hinges ‘are mounted to the inner side surfaces of the adjacent panels . . . to allow for rotation of the panels.’” Id. at 27 (citing Comm’n Op. at 22). Biofrontera further states that “the Commission’s explanation [above] is consistent with the specification’s description of hinges” pointing out that: Here, the specification repeatedly and exclusively refers to hinges as being “rotatable.” See, e.g., Ex. 8 (’512 Patent) at 3:52-54 (“The illuminator includes a -10e, each of which main body 100, which preferably has five individual panels 10a are connected in a rotatable manner via nested hinges 50”); 4:45-56 (“As shown in FIGS. 1A-1B and 2A-2B, the panels 10a-10e are rotatably connected by hinges 50”); 4:63-66 (“As shown in further detail in FIGS. 3A-3B, between the tabs 23 are the nested hinges 50, which are mounted to the inner side surfaces of adjacent , 10b) to allow for rotation of the panels”). panels (e.g., 10a Id. (emphasis in the original). Biofrontera additionally notes that “the specification repeatedly explains that the purpose of connecting the panels via hinges is to allow the panels to rotate so that they can be adjusted to conform to different treatment areas.” Id. at 28 (citing e.g., Exhibit 8 of Ruling Request (’512 Patent) at 7:48-67 (“The adjustable illuminator of the present invention allows for an infinite amount of configurations that can be adapted for the targeted treatment area.”) and id. at 1:67-2:5 (“These panels are coupled together so as to be rotatable relative to each other. By incorporating multiple, rotatable panels, the overall size and shape of the area that is illuminated can be changed according to the intended treatment area”)). Biofrontera also states “[t]hat hinges must be rotatable in view of the specification is also consistent with the plain and ordinary meaning of the term hinge,” citing as examples: “dictionaries published before the priority date of the ’512 patent [that] define ‘hinge’ to require rotation or movement.” Ruling Request at 28 (citing Exhibit 21 of Ruling Request (American Heritage Dictionary) at 830 (defining “hinge” to mean “[a] jointed or flexible device that allows the turning or pivoting of apart, such as a door or lid, on a stationary frame”); Exhibit 22 of Ruling Request (Webster’s Unabridged Dictionary) at 905 (defining “hinge” to mean “a jointed device or flexible 18
piece on which a door, gate, shutter, lid, or other attached part turns, swings, or moves”); Exhibit 23 of Ruling Request (Merriam Webster’s Collegiate Dictionary) at 588 (defining “hinge” to mean “a jointed or flexible device on which a door, lid, or other swinging part turns”). Biofrontera further points out that in the underlying investigation: Complainant and the ALJ agreed that the claimed hinges must be rotatable. For example, Complainant argued that “the friction hinges and strain relief structures 5 are hinged structures[ ] because they are rotatable and connect two adjacent panels.” Ex. 24 (Complainant’s Pre-Hearing Brief) at 90-91; see also Ex. 25 (Complainant’s Post-Hearing Brief) at 48 (“[E]ach of the five panels of RhodoLED® XL are connected by one or more hinged structures on inner side surfaces of adjacent panels; specifically, two friction hinges and one strain relief structure are rotatable and connects adjacent panels”) (emphasis added). The ALJ agreed with Complainant, stating that the RhodoLED® XL’s panels include “two friction hinges and one strain relief structure [that] are rotatable and connects adjacent panels.” See, e.g., Ex. 4 (FID) at 54. Id. at 28 to 29 (emphasis in the original). Following the assertion that “the plain and ordinary meaning of the term ‘hinges’ requires a rotatable functionality,” see e.g., Ruling Request at 27, Biofrontera argues that the articles at issue do not infringe the asserted claims of the ’512 patent because they do not contain the that cannot be rotated. Id. at 29 to 30, 33. claimed “hinges” but rather Specifically, Biofrontera states “[[ ]]” Id. at 29 to 30 (citing Exhibits 11, 13 and 26 to Ruling Request). Biofrontera explains: 5 We note “hinged structures” was related to the asserted claims in the ’028 patent. 19
]] Id. at 31 to 32 (citing Exhibits 11 to 14 to Ruling Request). The ’028 patent For the asserted claims of the ’028 patent, which all require “hinged structures,” Biofrontera argues that the while Commission did not construe “hinged structures,” “[u]nder the Commission’s construction of ‘nested hinges,’ both terms [i.e., ‘nested hinges’ and ‘hinged structures’] require a rotatable functionality that does not encompass [[ ]]” Ruling Request at 35. Biofrontera states that the “minor differences” between the claim terms “nested hinges” and “hinged structures” “do not result in a different scope or meaning for the hinge claim terms in both Asserted Patents.” Id. at 36. In support, Biofrontera points out that: The Commission addressed both claim terms as carrying the same scope and meaning in the context of its obviousness analysis. See, e.g., Comm’n Op. at 28-33 (referring to the “nested hinges” and “hinged structures” claim terms as one “limitation”). Specifically, the Commission referred to both the “nested hinges” and “hinged structures” limitations of the Asserted Patents as “the ‘hinges’ limitations,” showing that the Commission understood both limitations to refer to “hinges.” See, id. at 32. e.g., Id. (emphasis in original). And: For example, in the context of infringement issues, the ALJ found that “[a]s discussed above with respect to ’512 patent limitation 1[a],” which recites the nested hinges claim term, “each of the five panels of RhodoLED® XL are connected by one or more hinged structures on inner side surfaces of adjacent panels.” See, e.g., Ex. 4 (FID) at 54. The ALJ went on to explain that the RhodoLED® XL’s friction hinges infringe the “hinged structures” claim element for the same reasons that they infringe the “nested hinges” claim element. See, e.g., id. at 54 (“Specifically, two friction hinges and one strain relief structure are rotatable and connects adjacent panels … RhodoLED® XL meets this limitation 20
for the same reasons as discussed above with respect to the ’512 patent limitation 1[a]”) (emphasis added). Id. at 36 to 37. Biofrontera also states that while the specification of the ’028 patent discusses “hinges” and “nested hinges” it is silent on “hinged structures.” Id. at 37. Biofrontera also notes that “dictionaries define the term ‘hinged’ to mean ‘including one or more hinges.’” Id. (emphasis in the original) (citing Exhibit 21 to Ruling Request (American Heritage Dictionary) (defining ‘hinged’ to mean “[t]o attach by or equip with or as if with hinges or a hinge”)). In light of all this, Biofrontera concludes that “the plain and ordinary meaning of the term ‘hinged structures’ requires ‘hinges’ with a rotatable functionality [and] the claimed ‘hinged structures’ element should be construed to encompass rotatable hinges but does not encompass [[ ]]” Id. In line with the above, Biofrontera asserts that the articles at issue do not infringe the asserted claims of the ’028 patent “because all five panels of the device [[ ]] rather than hinges (i.e., ‘hinged structures’)[.]” Id. Additionally, Biofrontera notes that: [W]ith respect to the ’028 patent, the ALJ determined that an additional component of the RhodoLED® XL device, referred to as a “strain relief structure,” infringes the “hinged structures” claim element. See, e.g., Ex. 4 (FID) at 54 (holding that “each of the five panels of RhodoLED® XL are connected by one or more hinged structures on inner side surfaces of adjacent panels. Specifically, two friction hinges and one strain relief structure are rotatable and connects adjacent panels”). Id. at 41 (emphasis in original). Biofrontera also explains that: [T]he ALJ’s determination that the strain relief structure infringes the “hinged structures” claim element but not the “nested hinges” claim element does not indicate that the ALJ viewed these claim terms as encompassing a different scope. Rather, the ALJ’s infringement findings were in response to Complainant’s arguments—Complainant argued that the strain relief structure infringes the “hinged structures” claim element of the ’028 patent but did not make the same argument with respect to the “nested hinges” element of the ’512 patent. Compare, see also Ex. 4 (FID) at 19-25, 54. e.g., Ex. 25 at 11-22 with id. at 48; Id. (emphasis in original). Nevertheless, Biofrontera states that the articles at issue “[[ ]]” Id. Specifically, Biofrontera notes that for the articles at issue “the strain relief structure [[ ]]” Id. at 43. On point one, Biofrontera adds that for the articles at issue “[[ ]]” Id. at 43 to 21

Sun Pharma PowerPoint at 2. Each argument will be addressed and discussed in greater detail in the sections below. EOE Branch Analysis As noted above, Biofrontera only contends that the articles at issue do not meet the “nested 6 hinges” limitation in the asserted claims of the ’512 patent and the “hinged structures” limitation in the asserted claims of the ’028 patent. Thus, the focus of the infringement analysis is whether the articles at issue have the claimed “hinges” or “hinged structures.” Hinges in the ’512 Patent We find that the articles at issue do not have the claimed “hinges” and thus do not infringe the asserted claims of the ’512 patent. Biofrontera asserts that “the plain and ordinary meaning of a hinge is that it includes a rotatable functionality, consistent with the Commission’s (and ALJ’s) discussion of the Hinge Claim Terms, the specification of the Asserted Patents, and common dictionary definitions.” 7 Biofrontera Post Oral Discussion Submission at 2. Sun Pharma counters that the Commission did not construe “nested hinges” to “necessarily incorporate[ ] a new rotatability-only limitation.” See e.g., Sun Pharma Sur Reply at 1. Sun Pharma points out the Commission’s “construction . . . was expressly directed to where the hinges fit and how they fit compactly to reduce or eliminate optical dead space.” Sun Pharma Response at 10. Sun Pharma argues that Biofrontera is raising a “new claim construction” for “hinges” and that “CBP’s role is to apply the Commission’s 6 For the ’512 patent, there is no dispute that the articles at issue meet the “nested” and “on inner side surfaces of adjacent panels” portions of the limitation. Biofrontera Reply at 1. Biofrontera only contends that the articles at issue do not have “hinges.” Id. 7 While the ALJ found that “neither party introduce[d] evidence that ‘nested hinges’ is a term that has a plain meaning to either laypersons or a person of ordinary skill in the art,” it was found that the word “nested” has a plain and ordinary meaning. Comm’n Op. at 19. 24
findings, not to adopt narrowing constructions the respondent failed to secure during the Investigation.” See e.g., id. at 11; Sun Pharma PowerPoint at 7 to 9. Sun Pharma is correct. The Commission did not reach the issue of whether a hinge includes a rotatable functionality. The Commission construed the claim term “nested hinges on inner side surfaces of adjacent panels” to mean “hinges that fit on inner side surfaces.” Comm’n Op. at 22 (emphasis added). As Biofrontera points out, “[t]he construction preserves the noun ‘hinges.’” Biofrontera Reply at 2. However, there was no explicit construction from the Commission of the term “hinges.” See e.g., Comm’n Op. at 18 to 22; see also Biofrontera Reply at 4 citing Exhibit 3 (Order No. 18) at 2 to Ruling Request (“Order No. 18 expressly recognized that terms not in dispute need not be separately construed. Order No. 18 at 2 (citing Vanderlande Industries Nederland BV v. International Trade Commission, 366 F.3d 1311, 1323 (Fed. Cir. 2004)”). We further agree with Sun Pharma that our role is to apply the Commission’s findings in the administration of an exclusion order. However, there is no explicit construction from the Commission of the term “hinges” for us to apply here. Instead, as noted above, the Commission preserved the noun “hinges” in the construction of the claim term “nested hinges on inner side surfaces of adjacent panels” in the ’512 patent. Further, whether the term “hinges” includes a “rotatable functionality” was not an issue contested in the underlying investigation as the frictional hinges in the legacy article permitted rotation and Biofrontera did not contest those were not “hinges.” See e.g., FID at 19 (“Biofrontera argues that RhodoLED®-XL hinges are not ‘on’ inner side surfaces of adjacent panels because the hinge flanges extend ‘through’ the panel’s shell and bolt to an interior portion of the panel’s support structure.”) (emphasis added). Hence, we are not precluded from determining for purposes of this ruling whether “hinges” include a “rotatable functionality.” See e.g., Corning Gilbert, Inc. v. United States, 37 C.I.T. 155, 165-166 (Ct. Int’l Trade, 2013) (rejecting CBP’s argument that it “was precluded from engaging in claim construction because the ITC itself did not construe the claims” and noting that “[t]he ITC did not construe the claims of the [patent] because no party contested the terms comprising those claims during the [underlying investigation.]”). Thus, as explained below, we agree with Biofrontera that the claimed “hinges” includes a “rotatable functionality.” See e.g., Biofrontera Post Oral Discussion Submission at 2. This position does not conflict with the Commission’s findings from the underlying investigation. For example, in discussing the hinges limitation, the Commission noted, “[t]he specification explains that the nested hinges ‘are mounted to the inner side surfaces of the adjacent panels . . . to allow for rotation of the panels.’” Comm’n Op. at 22 (alteration in the original) (citation omitted) (emphasis added). Other areas in the specification also support the position that the term “hinges” include a “rotatable functionality.” Sun Pharma argues: Biofrontera [cannot] manufacture such a limitation from the specification’s permissive description of exemplary embodiments in which the nested hinges “allow for rotation of the panels,” ’512 patent at 4:64-66 — a description of what one disclosed configuration permits, not a definitional statement of what every “hinge” must do[.] 25
Sun Pharma Response at 11. While we agree with Sun Pharma that exemplary embodiments in the specification are generally not limiting, Biofrontera points out that “[h]ere, the specification repeatedly and exclusively refers to hinges as being ‘rotatable.’” Ruling Request at 27 (citing Exhibit 8 (’512 Patent) to Ruling Request at 3:52-54 (“The illuminator includes a main body 100, which preferably has five individual panels 10a-10e, each of which are connected in a rotatable manner via nested hinges 50”); 4:45-56 (“As shown in FIGS. 1A-1B and 2A-2B, the panels 10a- 10e are rotatably connected by hinges 50”); 4:63-66 (“As shown in further detail in FIGS. 3A- 3B, between the tabs 23 are the nested hinges 50, which are mounted to the inner side surfaces of adjacent panels (e.g., 10a, 10b) to allow for rotation of the panels”). We agree. The specification also states that “[t]he panels are further joined at their edges by hinges so as to be rotatable to achieve a desired configuration.” The ’512 patent at 2:7-9 (emphasis added). In further support, Biofrontera provides that “the specification repeatedly explains that the purpose of connecting the panels via hinges is to allow the panels to rotate so that they can be adjusted to conform to different treatment areas.” Ruling Request at 28 (citing e.g., Exhibit 8 of Ruling Request (’512 Patent) at 7:48-67). For example, the Abstract of the ’512 patent states, “[t]he plurality of first panels and the at least one second panel are rotatably connected.” (emphasis added). The Summary of the ’512 patent also says, “[t]hese panels are coupled together so as to be rotatable relative to each other. By incorporating multiple, rotatable panels, the overall size and shape of the area that is illuminated can be changed according to the intended treatment area.” The ’512 patent at 1-2:67- 4 (emphasis added). It also notes, “[t]he panels are further joined at their edges by hinges so as to be rotatable to achieve a desired configuration.” The ’512 patent at 2:7-9 (emphasis added). The Detailed Description further includes, “The adjustable illuminator of the present invention allows for an infinite amount of configurations that can be adapted for the targeted treatment area.” The ’512 patent at 7:47-49. As explained, the specification consistently and uniformly describes the rotatability of the hinges. These statements were not only tied to exemplary embodiments, but also discussed “hinges” generally ands “[t]he adjustable illuminator of the present invention” as opposed to “an embodiment of the present invention.” As such, we find the intrinsic evidence conclusively establishes that “hinges” include a “rotatable functionality” or allow for rotation of the panels. See e.g., Chewy, Inc. v. IBM, 94 F.4th 1354, 1359 (Fed. Cir. 2004) (“The written description of the ’849 patent supports the district court's construction. The written description consistently describes the invention as including pre-fetching of advertising objects.”); Verizon Servs. Corp. v. Vonage Holdings Corp., 503 F.3d 1295, 1308 (Fed. Cir. 2007) (“When a patent thus describes the features of the ‘present invention’ as a whole, this description limits the scope of the invention.”); Honeywell Int’l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed. Cir. 2006) (“[o]n at least four occasions, the written description refers to [only one particular component] as ‘this invention’ or the ‘present invention'”). Biofrontera and Sun Pharma both provided extrinsic evidence, such as dictionary definitions. However, as the intrinsic evidence establishes the meaning of the claim, we need not reach the extrinsic evidence. See e.g., Comm’n Op. at 18 (“If the intrinsic evidence does not establish the meaning of a claim, then extrinsic evidence may be considered.”); see also FID at 14 to 15 (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996) (“The 26
patent specification ‘is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term.’”). Having established that “hinges” include a “rotatability functionality”, we next turn to whether the articles at issue contain the claimed “hinges.” Biofrontera contends that the articles at issue do not have the claimed “hinges” as “[[ ]]” Ruling Request at 29 to 30 (citing Exhibits 11, 13 and 26 to Ruling Request). We agree. Biofrontera has provided compelling evidence that the cannot be rotated. This was shown through Biofrontera’s engineering drawings of [[ ]], illustrations and photographs of the final RhodoLED® XL-C design, a video depicting the [[ ]] no longer attached to two adjacent panels, a declaration from the CEO of Biofrontera explaining that the RhodoLED® XL-C’s design is final, a declaration from Biofrontera’s expert witness explaining why the RhodoLED® XL-C does not infringe the asserted claims, and a fully assembled RhodoLED® XL-C with the [[ ]] design. This evidence amongst others support Biofrontera’s position that the are not rotatable such that they are not the claimed “hinges” in the ’512 patent. As Biofrontera summarizes: The record depicts [[ ]]. RR Exs. 13-14, 26-27; Opp. Ex. D ¶ 16 [[ (describing ]] RR at 17-20; RR Exs. 11-14. Biofrontera Reply at 5. We agree with this summation and conclude the articles at issue do not have the claimed “hinges,” and as such, do not infringe the asserted claims of the ’512 patent. Sun Pharma takes no position as to whether the articles at issue infringe and contain the claimed “hinges.” See e.g., Oral Discussion Tr. (Ex. 32) at 76:11-77:22 (Sun Pharma: “We're not saying that the -- what they have submitted can be conclusively determined that it is a hinge or it’s not a hinge.”). Rather, Sun Pharma only argues that Biofrontera has not met its burden of showing noninfringement and that the ruling request is premature. Sun Pharma PowerPoint at 2. . Sun Pharma argues that there is an “incomplete record” as, for example, Biofrontera has not provided “uniformity evidence.” See e.g., Sun Pharma Response at 8 to 9. Sun Pharma states that without this, “CBP therefore cannot determine from the current submission whether Biofrontera’s proposed article is the same kind of uniformly illuminating PDT device addressed by the Commission, whether Biofrontera will receive FDA clearance or approval for this redesigned device, or whether the proposed mechanical changes materially alter optical 27
performance.” Id. at 9. Even assuming these points are true, they have no bearing on the question of whether the articles at issue have “hinges” such that there is infringement. Indeed, the “uniformity evidence” appears to be more relevant to a separate claim limitation, i.e., 1[b], which includes “the illuminator being configured to uniformly illuminate[.]” See e.g., FID at 25. However, Biofrontera does not dispute that the “uniformly illuminate” limitation is met. Thus, this “uniformity evidence” is inapposite to the question of whether the are “hinges.” Sun Pharma also states that “Biofrontera offers no testing, no stiffness or compliance analysis, and no expert opinion establishing that render the panel joints incapable of articulation or flexure.” Sun Pharma Response at 13. While Biofrontera later provided an expert declaration, expert testimony may not be required when the physical evidence is straightforward. For example, in another Commission investigation, the FID noted: Respondents argue that “this is exclusively attorney argument; Dr. Trumper never provided this explanation or explained what it means to be a ‘hollowed-out space’ in the context of the accused devices.” RRB at 21. Respondents further argue that “Complainants point to only attorney argument to supplement Dr. Trumper’s conclusory testimony that structures highlighted in yellow and green are ‘cavities’” and that this “‘because I said so’ testimony is insufficient” to carry Cooler Master’s burden to show this limitation is satisfied. Id. at 22 (citing NexStep, Inc. v. Comcast Cable Commc’ns, LLC, 119 F.4th 1355, 1374 (Fed. Cir. 2024)). Certain Liquid Coolers for Electronic Components In Computers, Components Thereof, Devices for Controlling Same, And Products Containing Same, Inv. No. 337-TA-1394, Initial Determination on Violation of Section 337 and Recommendation on Remedy and Bond (March 21, 2025) (“1394 FID”) at 16 to 17. This argument was found to be unpersuasive and the FID stated, inter alia: Expert testimony is not necessarily required for a factfinder to determine that an accused product satisfies a claim limitation. See, e.g., Lee v. Mike’s Novelties, Inc., 543 F. App’x 1010, 1016 (Fed. Cir. 2013) (“[n]o expert testimony was required” where jurors could handle and assess the physical evidence of the accused product); see also Union Carbide Corp. v. Am. Can Co., 724 F.2d 1567, 1573 (Fed. Cir. 1984) (no expert testimony needed to explain technology involving plastic bags in the validity context). Id. at 17. Thus, in instances where there is straightforward evidence, more detailed expert testimony may not be required. See e.g., id. at 18 (“Here, photographs of the SilverStone PF240 show the claimed first cavity and second cavity. More detailed testimony from Dr. Trumper is not required to understand that straightforward evidence.”). Here, the primary question is whether the permit rotation. Multiple pieces of evidence provided by Biofrontera directly address this point. Accordingly, outside of what Biofrontera provided, we find that more detailed testimony from an expert would be of limited value in determining whether rotation is permitted. 28
Indeed, when given the opportunity to inspect the RhodoLED® XL-C, even Sun Pharma only sent a paralegal and not an “expert.” See e.g., Exhibit N to Sun Pharma Post Oral Discussion Submission (89: 14-16 Sun Pharma: “[W]hen we went to inspect, first of all, this is a Desmarais, LLP paralegal who went to inspect.”). Sun Pharma makes no assertions concerning whether the paralegal was able to rotate the panels, but again states that “it’s really Biofrontera's burden to be able to come up with the evidence to show all of those testing and protocol and design, and that's where they fall short.” Id. at 90:10- 15. There is no dispute that the issuance of an exclusion order by the Commission “effectively shift[s] the burden of proof on infringement issues to require a company seeking to import goods to prove that its product does not infringe, despite the fact that, in general, the burden of proof is on the patentee to prove, by a preponderance of the evidence, that a given article does infringe[.]” Certain Integrated Circuit Telecommunication Chips, Inv. No. 337-TA-337, Comm’n Op. at 21, n.14, USITC Pub. 2670, Doc ID 217024 (Aug. 1993) (emphasis in original) (citing Sealed Air Corp. v. U.S. Int’l Trade Comm’n, 645 F.2d 976, 988–89 (C.C.P.A. 1981)). The term “burden of proof” encompasses “two separate burdens: the ‘burden of persuasion’ (specifying which party loses if the evidence is balanced), as well as the ‘burden of production’ (specifying which party must come forward with evidence at various stages in the litigation).” Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 100-101, fn.4 (2011). The burden of persuasion is “the ultimate burden assigned to a party who must prove something to a specified degree of certainty[.]” Technology Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008); see also Microsoft Corp., 564 U.S. at 106 (“A standard of proof . . . can apply only to a burden of persuasion.”) (citation omitted). Following the issuance of an exclusion order by the Commission, the “would-be importers of potentially infringing articles, as a condition of entry” bear the burden of persuasion to establish noninfringement under a preponderance of the evidence standard. See, e.g., Hyundai Elecs. Indus. Co. v. U.S. Int'l Trade Comm'n, 899 F.2d 1204, 1210 (Fed. Cir. 1990); Certain Integrated Circuit Telecommunication Chips, Inv. No. 337-TA-337, Comm’n Op. at 21, n.14, USITC Pub. 2670, Doc ID 217024 (Aug. 1993), (emphasis in original) (citing Sealed Air Corp. v. U.S. Int’l Trade Comm’n, 645 F.2d 976, 988–89 (C.C.P.A. 1981)). However, even though here the burden of persuasion remains on Biofrontera to establish that the articles at issue do not infringe the asserted patent claims, there are times when the burden of production may shift to Sun Pharma. See, e.g., Ecolab, Inc. v. Amerikem Labs., Inc., 98 F. Supp. 2d 569, 583 (D.N.J. 2000) (overruled on other grounds) (“Ecolab’s compelling evidence of infringement shifts the burden of production and obliges Envirochem to point to the existence of any genuine issues of material fact.”). As another example, we note Wuhan Healthgen Biotechnology Corp. v. Int’l Trade Comm'n, 127 F.4th 1334, 1337 (Fed. Cir. 2025). In the underlying ITC investigation, the Commission concluded that Healthgen’s products infringed in that “aggregated albumin levels in Healthgen's products do not increase above 2% during storage and shipping.” Id. at 1336-37. This finding was supported by expert testimony, peer-reviewed literature, and Healthgen’s communications to customers. Id. at 1337. Healthgen contested the interpretation of the literature and its communications to customers. Id. However, on appeal, even though, in the underlying ITC investigation, the burden of persuasion was not on respondent Healthgen to show noninfringement, but upon the complainant patentee to show infringement, the 29
Court nonetheless stated that “[e]ven accepting Healthgen's claim that aggregated albumin levels do increase, Healthgen did not show this aggregation would rise to noninfringing levels before importation.” Id. (emphasis added). So too here, it is undisputed that the burden was on Biofrontera to show that its redesigned products do not infringe. Yet, in light of the ample evidence Biofrontera’s provided to support the alleged non-infringement of the redesign, as well as the opportunity for Sun Pharma to inspect the RhodoLED® XL-C, Sun Pharma failed to rebut Biofrontera’s position that the negated rotatable functionality. We find that Biofrontera has met its burden of production as well as its burden of persuasion in showing the articles at issue do not have the claimed “hinges” and thus do not 8 infringe the asserted claims of the ’512 patent. Hinged Structures in the ’028 Patent We also find that the articles at issue do not meet the claimed “connected by hinged structures” and thus do not infringe the asserted claims of the ’028 patent. Biofrontera asserts that the claimed “hinged structures” do not result in a different scope or meaning as the claimed “hinges” in the ’512 patent. Ruling Request at 36. The Commission did not construe “hinged structures” in the underlying investigation. See e.g., Ruling Request at 36; Sun Pharma Response at 10. However, as Biofrontera notes, in the context of the obviousness analysis, the Commission addressed “nested hinges” and “hinged structures” together, implying that these terms have similar scope and meaning. See e.g., Ruling Request at 36 (citing Comm’n Op. at 28-33 (referring to the “nested hinges” and “hinged structures” claim terms as one “limitation”)); see also id. (citing Comm’n Op. at 32 “Specifically, the Commission referred to both the ‘nested hinges’ and ‘hinged structures’ limitations of the Asserted Patents as ‘the ‘hinges’ limitations,’ showing that the Commission understood both limitations to refer to ‘hinges.’”). The FID similarly implied that these claim terms have similar scope and meaning. See e.g., FID at 54 (“As discussed above with respect to ’512 patent limitation 1[a], each of the five panels of RhodoLED® XL are connected by one or more hinged structures on inner side surfaces of adjacent panels. Specifically, two friction hinges and one strain relief structure are rotatable and connects adjacent panels. [ ] In all other respects, RhodoLED® XL meets this limitation for the same reasons as discussed above with respect to the ’512 patent limitation 1[a].”). This is further consistent with the specification of the ’028 patent which, as Biofrontera notes, “is silent as to the phrase ‘hinged structures’; the only possible support for this undisclosed term is the specification’s discussion of ‘hinges’ and ‘nested hinges.’” Ruling Request at 37. Accordingly, we find that “hinged structures” also includes a “rotatable functionality” and as discussed above with respect to “hinges” in the in the articles at issue also are not “hinged ’512 patent, we find that the structures.” 8 We also find that Biofrontera has shown a prima facie case that the doctrine does not apply to its new or modified article. See e.g., Ruling Request at 33 to 35. Sun Pharma’s inducement arguments are also unpersuasive as claims, 8, 17, and 18 all still require “hinges.” See e.g., Exhibit N to Sun Pharma Post Oral Discussion Submission (123: 14-16 Sun Pharma: In the context of claim 8, “I agree with you that with this – with this limitation, you still have an illuminator connected by nested hinges.” As discussed above, we find that the articles at issue do not have the claimed “hinges.” 30

infringe simply because it is possible to alter it in a way that would satisfy all the limitations of a patent claim,” and reasoning that the accused camera “was not rotatable within its housing unless [it was] altered, at least to the extent of removing or loosening the set screws that secure the camera to the housing.” Id. at 1555-56 (citation omitted). Here, the redesigned articles would require multiple steps of modification:Biofrontera’s redesign will not have “hinges” or “hinged structures” unless they are altered, e.g., and screwing in the original friction hinges. See also Accent Packaging, 707 F.3d at 1327 (“Screws are a widely used fastener, but their use does not, by itself, evidence an instruction or intention that the Pinnacle be altered or dissembled in any way prior to operation.”). Accordingly, we are satisfied that court precedent supports the position that the potential for modification does not render the redesigned article infringing, as the “hinges” or “hinged structures” limitation will not be met unless there is alteration. See also Nazomi Commc'ns, Inc. v. Nokia Corp.,739 F.3d 1339, 1346 (Fed. Cir. 2014) (finding no infringement where the accused “products . . .do not infringe without modification”). We conclude that Biofrontera has met its burden to show that the articles at issue do not have the claimed “connected by hinged structures” and do not infringe the asserted claims of the 9 ’028 patent. Sun Pharma Argument: Request is Premature Sun Pharma also argues that “[t]he ‘redesign’ is prospective and not fixed and final.” Sun Pharma Response at 8. Sun Pharma also states: Biofrontera has provided no manufacturing specifications for production units, no bill of materials, no quality-control, and no FDA documentation ensuring that every imported unit will embody the described modifications. Biofrontera has not provided any declaration from any engineer or corporate officer attesting that the design is final. Nor has Biofrontera provided any evidence that this new design has been submitted for FDA review or that it has reworked its instructions to providers for using the device. Id. Biofrontera as part of its reply provided a declaration from its CEO stating, inter alia: 9 We also find that Biofrontera has shown a prima facie case that the doctrine does not apply to its new or modified article. See e.g., Ruling Request at 46 to 48. Sun Pharma’s argument related to claim 16 is also unpersuasive as this claim still require “connected by hinged structures.” See e.g., Sun Pharma Response at 16. Further, many of the arguments overlapped for the ’512 patent and the ’028 patent. Thus, to the extent, those arguments were addressed in either the context of the ’512 patent or the ’028 patent, they were not duplicated. 32

Software Components Thereof & Prods. Containing Same, Inv. No. 337-TA-1281, Initial Determination, at 22 (Oct. 24, 2022) (indicating that the fact “a change could be made in the future . . . is not sufficient for a finding that a redesign cannot be adjudicated” and noting that the Commission used the word “sufficiently” and not “completely”) not reviewed in relevant part, Comm’n Notice at 3 (Jan. 12, 2023). These investigations support a finding that Biofrontera’s redesign is sufficiently fixed. Not only did Biofrontera submit a declaration, but Biofrontera also manufactured a physical sample of the redesign. Biofrontera further included numerous photos and a video. See e.g., Exhibits 11 to 14; 17 to 20 of Ruling Request. Moreover, as Biofrontera states: Here, the transaction is defined by concrete structural features: [[ ]]. RR at 17-23; RR Exs. 11-20, 26-27. Biofrontera confirms that these are the fixed features on which it seeks a ruling. A materially different production unit would not be protected. 19 C.F.R. § 177.9(b)(1). Biofrontera Reply at 14. Accordingly, Sun Pharma’s argument that this ruling request is premature fails to be persuasive. V. CERTIFICATION This ruling finds that the articles at issue are not subject to the 1411 LEO. Entry for consumption of the articles at issue into the United States will be conditioned on the drafting and submission of a certification pursuant to paragraph 4 of the 1411 LEO, which states: At the discretion of CBP and pursuant to the procedures it establishes, persons seeking to import articles may be required to certify that they are familiar with the terms of this Order, that they have made appropriate inquiry, and thereupon state that, to the best of their knowledge and belief, the products being imported are not excluded from entry under paragraph 1 of this Order. At its discretion, CBP may require persons who have provided the certification described in this paragraph to furnish such records or analyses as are necessary to substantiate the certification. ¶ 4 of 1411 LEO. Of note, an importer’s ability to enter for consumption into the United States an article addressed in a ruling under 19 C.F.R. Part 177 that resulted from an inter partes proceeding has previously been conditioned by CBP to require a certification drafted with the participation of the complainant. See e.g., HQ H329187, dated July 18, 2023. Here, Complainant provided Appendix A as part of its Post Oral Discussion Submission (see p. 15), detailing the conditions it believes a 34
certification should require. While we may not ultimately require every single condition set forth in Appendix A, we will take Complainant’s concerns into consideration. Moreover, any material deviation of imported articles from the articles at issue in this ruling will result in applicability of this ruling. See e.g., 19 C.F.R. § 177.9. VI. HOLDING We find that Biofrontera has met its burden to show that the articles at issue do not infringe the asserted claims of the ’512 patent and the ’028 patent, and thus, are not subject to the 1411 LEO, as explained above. The decision is limited to the specific facts set forth herein. If articles differ in any material way from the articles at issue described above, or if future importations vary from the facts stipulated to herein, this decision shall not be binding on CBP as provided for in 19 C.F.R. §§ 177.2(b)(1), (2), (4), and 177.9(b)(1) and (2). Sincerely, V131&9 !'13,56 YNYQLY 8! YNY LY N DYL RKHL NDYL V9&5` hjhdljalif RKHL id`jd`jd mjf jj Alaina van Horn Chief, Intellectual Property Enforcement Branch/ Exclusion Order Enforcement Branch CC: Betty Chen and Tuhin Ganguly [email protected]; [email protected]; [email protected] 35