Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd.

• Court: Court of Appeals for the Federal Circuit
• Decided: April 23, 2025
• Docket: 23-2386
• Status: Unpublished

Opinion

Case: 23-2386 Document: 82 Page: 1 Filed: 04/23/2025

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

METACEL PHARMACEUTICALS LLC, Plaintiff-Appellant

v.

RUBICON RESEARCH PRIVATE LTD., Defendant-Appellee ______________________

2023-2386 ______________________

Appeal from the United States District Court for the District of New Jersey in No. 2:21-cv-19463-EP-JRA, Judge Evelyn Padin. ______________________

Decided: April 23, 2025 ______________________

MATTHEW ZAPADKA, Arnall Golden Gregory LLP, Washington, DC, argued for plaintiff-appellant. Also rep- resented by KEVIN M. BELL.

TIMOTHY H. KRATZ, Kratz & Barry LLP, Atlanta, GA, argued for defendant-appellee. Also represented by GEORGE BARRY, III; MICHAEL PATRICK HOGAN, Philadel- phia, PA; R TOUHEY MYER, Wilmington, DE. ______________________ Case: 23-2386 Document: 82 Page: 2 Filed: 04/23/2025

Before LOURIE, CHEN, and HUGHES, Circuit Judges. LOURIE, Circuit Judge. Metacel Pharmaceuticals LLC (“Metacel”) appeals from a final judgment of the United States District Court for the District of New Jersey granting summary judgment of no infringement of U.S. Patent 10,610,502 (“the ’502 pa- tent”) in favor of Rubicon Research Private Ltd. (“Rubi- con”). See Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd., No. 21-cv-19463, 2023 WL 5939903 (D.N.J. Sept. 12, 2023) (“Reconsideration Decision”); Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd., No. 21-cv-19463 (D.N.J. July 6, 2023) (“Summary Judgment Decision”), J.A. 6010–19. 1 For the following reasons, we affirm. BACKGROUND Metacel holds the FDA-approved New Drug Applica- tion (“NDA”) 208193 for an oral solution of baclofen at a dosage strength of 5 mg/5 mL, which is sold under the brand name Ozobax®. 2 Ozobax is indicated for the

1 The Summary Judgment Decision is presently sealed under a confidentiality order of the district court. However, at oral argument, counsel for Rubicon indicated that the confidentiality order is no longer necessary since Rubicon’s product is now on the market. See Oral Arg. 0:26–0:47, available at https://oralarguments.cafc.us courts.gov/default.aspx?fl=23-2386_04082025.mp3 (coun- sel for Rubicon explaining that because “the Rubicon prod- uct is now on the market” and “everything is unredacted,” the court is free to openly discuss the contents of its label). We therefore cite the Summary Judgment Opinion and cor- responding exhibits directly where applicable. 2 Metacel’s 5 mg/5 mL dosage strength version of Ozobax is no longer being marketed in the United States and is currently listed in the discontinued section of FDA’s Orange Book. Case: 23-2386 Document: 82 Page: 3 Filed: 04/23/2025

METACEL PHARMACEUTICALS LLC v. 3 RUBICON RESEARCH PRIVATE LTD.

treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Metacel’s sole Orange Book listing is the ’502 patent, which Metacel describes there as a method of treating spasticity. The claims of the ’502 patent are directed to a method of treating a known condition (i.e., muscle spasms) with an old compound (i.e., baclofen), and, as relevant here, are distinguished from the prior art by simply reciting an oral solution formulation stored according to a particular temperature condition. The ’502 patent contains two claims. Independent claim 1 recites: 1. A method of relaxing muscles or treating spas- ticity in a subject in need thereof comprising ad- ministering to the subject an effective amount of an aqueous oral solution comprising (i) baclofen, (ii) a buffer comprising citric acid, a salt of citric acid, or any combination thereof, and (iii) optionally one or more preservatives, wherein . . . the oral solution is stored . . . at from about 2 to about 8° C. ’502 patent col. 10 ll. 48–59 (emphasis added). The issues on appeal relate solely to claim 1’s refrigerated storage con- dition limitation, i.e., storage “at from about 2 to about 8° C.” Id. at col. 10 ll. 57–59. Rubicon holds the now-approved Abbreviated New Drug Application (“ANDA”) 214445 to market and sell a generic version of the 5 mg/5 mL formulation of Ozobax. As part of its ANDA submission, Rubicon included a pro- posed container label and package insert, both of which in- cluded the following storage instruction for its product: Store at 20° to 25°C (68° to 77°F); excursions per- mitted to 15° to 30°C (59° to 86°F) [See USP Con- trolled Room Temperature]. It can also be stored at 2°C to 8°C (36°F to 46°F). Case: 23-2386 Document: 82 Page: 4 Filed: 04/23/2025

J.A. 603 (proposed container label) (emphasis added); J.A. 623 (package insert). 3 Rubicon also provided a paragraph IV certification with its ANDA, certifying, in part, that Metacel’s ’502 patent would not be infringed by the use or sale of Rubicon’s product as described in its ANDA and sub- sequently provided Metacel with the required notice of that certification. 4 J.A. 2007. Metacel timely brought suit under 35 U.S.C. § 271(e)(2)(A) pursuant to the Hatch-Waxman Act, 5 alleg- ing that the product described in Rubicon’s ANDA would infringe the ’502 patent. J.A. 42–43. As relevant here, Metacel alleged that Rubicon’s proposed container labeling and package insert (collectively, Rubicon’s “proposed label- ing”) would induce downstream users, such as physicians, pharmacists, and patients, to store Rubicon’s ANDA prod- uct at a temperature from about 2° to 8°C, as claimed. Id. Rubicon denied Metacel’s infringement allegations in its answer, J.A. 55, and noninfringement contentions, J.A. 590, 592. And following discovery, Rubicon moved for sum- mary judgment of noninfringement. See J.A. 517–20 (mo- tion); see also J.A. 525–68 (brief in support of motion). Rubicon argued that there was no genuine dispute of ma- terial fact that its proposed ANDA labeling would not in- duce infringement of the ’502 patent. See id. at 559. In Rubicon’s view, a finding of induced infringement would re- quire a label to instruct or encourage, and not merely per- mit, infringement. See id.; see also J.A. 5981–82. Thus, it

3 One minor semantic difference is that the package insert states that the “Product” can be refrigerated, while the container label simply states that “It” (referring to the product) can be refrigerated. 4 21 U.S.C. § 355(j)(2)(A)(vii)(IV), (B)(i). 5 The Drug Price Competition and Patent Term Res- toration Act of 1984, codified at 21 U.S.C. § 355(b)(2), is re- ferred to as the “Hatch–Waxman Act.” Case: 23-2386 Document: 82 Page: 5 Filed: 04/23/2025

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contended that, because its proposed labeling instructed room temperature storage, and only optionally mentioned refrigeration, its labeling could not induce infringement of claim 1 as a matter of law. Id. Metacel opposed the motion, arguing that “at least two express statements in Rubicon’s ANDA contradict Rubi- con’s argument.” J.A. 5953. Specifically, Metacel argued that Rubicon’s ANDA explained that “[t]here is no differ- ence in [Rubicon’s] storage temperature statement com- pare[d]” to Ozobax’s label, and that Rubicon’s “[s]torage [s]tatement contained in its ANDA filing also instructs” storage “at from about 2 to about 8° C.” Id. (citation omit- ted). Implicit in those arguments is that the Ozobax label prescribes a storage condition that reads on claim 1 of the ’502 patent. The district court granted Rubicon’s motion. It ex- plained that “[t]he label is what matters, because that is what the downstream users—either a healthcare practi- tioner or patient—will rely upon.” Summary Judgment De- cision, J.A. 6017 (citing HZNP Meds. LLC v. Actavis Lab’ys UT, Inc., 940 F.3d 680, 701–02 (Fed. Cir. 2019)). It there- fore held that, because Rubicon’s proposed labeling in- structs room temperature storage and only optionally allows refrigeration, “infringement will not occur because downstream users will read and follow the label, not the ANDA paperwork.” Id. at 6018. The district court also re- jected Metacel’s non-label evidence and related arguments as insufficient to create a genuine issue of material fact be- cause Rubicon’s statements to FDA are nonpublic and therefore could not induce a downstream user to infringe the ’502 patent. Id. at 6017. Metacel then filed a motion for reconsideration, lodging similar arguments on the merits. See J.A. 6023–26 (mo- tion); see also J.A. 6027–47 (brief in support of motion). It also asserted, for the first time, that it was prejudiced by the district court’s consideration of Rubicon’s summary Case: 23-2386 Document: 82 Page: 6 Filed: 04/23/2025

judgment arguments, which were not adequately noticed or briefed in violation of the district’s local patent rules. J.A. 6034–38. The district court denied Metacel’s motion, adhering to its original judgment and once again rejecting Metacel’s arguments regarding its non-label evidence, at least in part, because “Metacel plainly misrepresent[ed] the breadth of Rubicon’s FDA submission.” Reconsidera- tion Decision, at *3. The district court also rejected Meta- cel’s notice arguments because Metacel had failed to raise any such arguments in its opposition to summary judg- ment and could not do so for the first time in its motion for reconsideration. Id. at *2–3. The district court entered its final judgment accordingly. J.A. 1–3. Metacel timely appealed, and we have jurisdiction un- der 28 U.S.C. § 1295(a)(1). DISCUSSION Metacel contends on appeal that the district court erred in granting summary judgment of no induced in- fringement for two principal reasons. First, Metacel ar- gues that the district court overlooked or misinterpreted evidence that demonstrated that genuine issues of mate- rial fact remained regarding whether Rubicon’s proposed labeling would induce infringement of the ’502 patent’s storage condition limitation. Second, Metacel argues that it was prejudiced by the district court’s consideration of Ru- bicon’s non-infringement arguments regarding the storage condition limitation on summary judgment because those arguments were not adequately noticed or briefed in viola- tion of the district court’s local patent rules and the Federal Rules of Civil Procedure. We disagree. The district court properly granted sum- mary judgment of no induced infringement because there is no genuine dispute that Rubicon’s proposed ANDA label clearly instructs room temperature storage while only op- tionally permitting refrigeration. Metacel’s nonpublic statements to FDA do not supplant Rubicon’s proposed Case: 23-2386 Document: 82 Page: 7 Filed: 04/23/2025

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labeling, which is directed to the public, to create a genuine issue of fact. Regardless, those statements were not pre- sented by Metacel in their full context and, when consid- ered fully, support Rubicon’s position of no induced infringement. The district court also did not abuse its dis- cretion in rejecting Metacel’s notice arguments as belated. We will address each of Metacel’s arguments in turn. We review the grant of summary judgment de novo, ac- cording to the law of the regional circuit, which in this case is the Third Circuit. Frolow v. Wilson Sporting Goods Co., 710 F.3d 1303, 1308 (Fed. Cir. 2013). Summary judgment is only appropriate if the movant “shows that there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255 (1986). All reasonable inferences are drawn in favor of the nonmovant. Anderson, 477 U.S. at 255. “We apply our own law, however, with respect to patent law issues.” Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1376 (Fed. Cir. 2024). The key factor in this appeal is that it is inducement of a method claim that is at issue. The relevant statute pro- vides that “[w]hoever actively induces infringement of a pa- tent shall be liable as an infringer.” 35 U.S.C. § 271(b). Within the “ANDA context, it is well-established that mere knowledge of possible infringement by others does not amount to inducement; specific intent and action to induce infringement must be proven.” Takeda Pharms. U.S.A., Inc. v. West-Ward Pharm. Corp., 785 F.3d 625, 631 (Fed. Cir. 2015) (internal quotation marks and citation omitted). For cases involving method of use patents, we therefore “examine whether the proposed label ‘encourage[s], recom- mend[s], or promote[s] infringement.’” HZNP, 940 F.3d at 701–02 (alterations in original) (quoting Takeda, 785 F.3d at 631). Labels that “[m]erely describ[e] the infringing use . . . will not suffice.” Id. at 702. Case: 23-2386 Document: 82 Page: 8 Filed: 04/23/2025

Claim 1 of the ’502 patent requires that the claimed oral solution is stored “at from about 2 to about 8°C,” i.e., refrigerated. ’502 patent col. 10 ll. 58–59. Rubicon’s pro- posed label does not encourage refrigeration. Instead, it instructs downstream users to store the product “at 20° to 25°C,” i.e., room temperature. J.A. 603, 623. The proposed label’s allowance of refrigeration, stating that the product “can also be stored at 2°C to 8°C,” merely describes the tem- perature range for refrigeration if the downstream user chooses to refrigerate. Id. Stated otherwise, the label in- dicates that if a downstream user decides to refrigerate the product, despite instructions to store the product at room temperature (which is noninfringing), then it should store the product at temperatures from 2°C to 8°C. That is not inducement. Rubicon’s proposed labeling is similar to that at issue in HZNP, where the prescribing information provided a “subsequent application” warning in an “‘if/then’ manner: if the user wants to cover the treated area with clothing or apply another substance over it, then the patient should wait until the area is dry.” HZNP, 940 F.3d at 702. In HZNP, we concluded that such a permissive statement “does not encourage infringement, particularly where the label does not require subsequent application.” Id. The same logic applies here: because there is no genuine dis- pute that Rubicon’s proposed labeling does not instruct re- frigeration and, in fact, instructs downstream users otherwise, the proposed labeling cannot indicate a specific intent to induce downstream users. Moreover, that some such users may infringe does not help Metacel either. See Takeda, 785 F.3d at 631 (“The mere existence of direct in- fringement by physicians . . . is not sufficient for induce- ment.”). Metacel points to Rubicon’s nonpublic communications with FDA and other testimony as circumstantial evidence to show a genuine issue of specific intent, see Metacel Br. 42–43, and to suggest that the label is ambiguous and Case: 23-2386 Document: 82 Page: 9 Filed: 04/23/2025

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requires consideration of expert testimony, see id. at 37, 40, 43. We agree that, given the proper facts, circumstantial evidence may lend support to a finding of specific intent in drug label cases. See AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010). But still, “[t]he per- tinent question is whether the proposed label instructs us- ers to perform the patented method.” Id.; see, e.g., Grunenthal GmbH v. Alkem Lab’ys Ltd., 919 F.3d 1333, 1339–40 (Fed. Cir. 2019) (affirming no inducement where the label included but did “not specifically encourage” in- fringing application). And as we have explained, even “vague label language cannot be combined with speculation about how physicians may act to find inducement.” Takeda, 785 F.3d at 632. Thus, where, as here, a label is unambiguous, circumstantial evidence cannot override its plain language. See, e.g., Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1324 (Fed. Cir. 2012) (circum- stantial evidence, including FDA materials, offered to show specific intent could not overcome the label’s clear omission of any such instruction, precluding an inducement finding); see also HZNP, 940 F.3d at 701 (affirming grant of sum- mary judgment of no induced infringement based only on the ANDA label). Metacel’s circumstantial evidence, even when consid- ered, fails to create a genuine issue of material fact regard- ing Rubicon’s specific intent to induce infringement. First, Rubicon’s FDA submissions are not available to down- stream users and therefore cannot cause inducement. Sec- ond, Metacel did not present those FDA submissions in their full context. For example, Metacel points to an FDA submission that states “[t]here is no difference in [Rubi- con’s] storage temperature statement compare[d] to [Ozo- bax].” Metacel Opening Br. 42. Notably, however, Metacel omitted the table provided directly beneath that statement that contains a “[j]ustification of [d]ifferences” column, wherein Rubicon explains that its proposed labeling is dif- ferent from Ozobax’s label (and thus different from claim 1 Case: 23-2386 Document: 82 Page: 10 Filed: 04/23/2025

of the ’502 patent) because its ANDA product, unlike Ozo- bax, could be stored at room temperature “per acceptable long term stability data.” J.A. 11. Metacel’s expert testimony is also unpersuasive be- cause it relies on downstream users turning to Metacel’s own Ozobax label as evidence of Rubicon’s specific intent to induce: “Metacel presented uncontested expert testimony that a pharmacist, after reading Rubicon’s ANDA product label, which explicitly lists two contradictory storage con- ditions, would ‘defer to the storage instructions for the ref- erence listed drug (i.e., Metacel’s drug or the RLD).’” 6 Metacel Opening Br. 43 (quoting Metacel’s expert’s testi- mony). That is not persuasive. Metacel cites no case law or other authority to convince us otherwise. Finally, we turn to Metacel’s notice arguments. “Ap- plying Third Circuit law, we review a district court’s grant or denial of a motion for reconsideration for an abuse of dis- cretion.” Golden Bridge Tech., Inc. v. Apple Inc., 758 F.3d 1362, 1367 (Fed. Cir. 2014). We see no abuse of discretion in the district court’s rejection of those arguments as be- lated because they were raised for the first time as part of Metacel’s motion for reconsideration. See id. at 1369 (af- firming denial of reconsideration of summary judgment based on an argument raised for the first time in the mo- tion for reconsideration); SmartGene, Inc. v. Advanced Bi- ological Lab’ys, SA, 555 F. App’x 950, 954 (Fed. Cir. 2014) (affirming that arguments not in a party’s summary judg- ment briefing were deemed forfeited on reconsideration). We therefore do not disturb the district court’s judgment on that basis.

6 The RLD stands for Reference Listed Drug. Case: 23-2386 Document: 82 Page: 11 Filed: 04/23/2025

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CONCLUSION We have considered Metacel’s remaining arguments and find them unpersuasive. For the foregoing reasons, we affirm. AFFIRMED