The Federal Circuit affirmed a District Court decision that the label for a generic drug obtained from an ANDA would not induce infringement by reciting optional drug storage conditions the read on the NDA holder's Orange Book-listed patents, in Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (non-precedential).
The matter arose in ANDA litigation over Rubicon's generic version of Metacel's Ozobax® product (an oral solution of baclofen at a dosage strength of 5 mg/5 mL; in a footnote the opinion states that this version of the drug is no longer available in the U.S.). The drug is used to treat spasticity consequent to multiple sclerosis including "relief of flexor spasms and concomitant pain, clonus, and muscular rigidity." The Orange Book-listed patent asserted by Metacel, U.S. Patent No. 10,610,502, contains two claims, claim 1 reciting:
1. A method of relaxing muscles or treating spasticity in a subject in need thereof comprising administering 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.
(where the italicized language was at issue and being the purported patentable distinction over the prior art). For its part, Rubicon's label for its ANDA-approved generic version of Metacel's drug contained these storage temperature specifications:
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. It can also be stored at 2°C to 8°C (36°F to 46°F).
(where again the italicized language was at issue). The distinctions in storage temperature formed inter alia the basis for Rubicon's assertions in its Paragraph IV letter that its generic drug would not infringe the '502 patent under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), (B)(i).
The language in Rubicon's label was the basis for Metacel's infringement allegations that Rubicon's generic product would induce physicians and other healthcare providers to infringe the '502 patent. Rubicon countered by filing a summary judgment motion asserting that there was no genuine issue of material fact that its product would not infringe. Rubicon distinguished its label by arguing that inducement of infringement under 35 U.S.C. § 271(b) required the label to "to instruct or encourage, and not merely permit, infringement." According to Rubicon, storage at temperatures encompassed in Metacel's claim language was optional and the label recommended room temperature storage conditions. Metacel countered that Rubicon in its ANDA filing had made statements to the effect that "[t]here is no difference in [Rubicon's] storage temperature statement compare[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."
The District Court granted Rubicon's motion for summary judgment, based on users being guided by the label and not by statements in Rubicon's ANDA, citing HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., 940 F.3d 680, 701–02 (Fed. Cir. 2019). After denying Metacel's request for reconsideration based on there being genuine issues of material fact and alleged procedural defects, the District Court entered judgment and this appeal followed.
The Federal Circuit affirmed, in an opinion by Judge Lourie joined by Judges Chen and Hughes. Because the question before the Court was summary judgment, the panel applied the law of the Third Circuit, under Frolow v. Wilson Sporting Goods Co., 710 F.3d 1303, 1308 (Fed. Cir. 2013), while reserving questions limited to patent law to Federal Circuit law under Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., 104 F.4th 1370, 1376 (Fed. Cir. 2024). Metacel argued that the District Court had neglected to consider evidence that raised genuine issues of material fact and reasserted its procedural objections that had failed before the District Court. Neither argument prevailed before the Federal Circuit.
On the merits, the panel held that there was no genuine issue of material fact regarding the label instructing users that storage at temperatures reading on the '502 patent claims was optional. The standard for inducement applied by the Court was that the ANDA applicant's label must "'encourage, recommend, or promote infringement" under HZNP Meds. LLC v. Actavis Lab'ys UT, Inc., and not "merely describe the infringing use." By its plain language, claim 1 of the '502 patent requires refrigeration while the panel appreciated Rubicon's label not to so encourage refrigeration. According to the opinion:
[T]he label indicates 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 [emphases in opinion].
This interpretation was similar to the issues before the Court in HZNP Meds. LLC, according to the opinion in its "if/then" factual posture. Permissive statements such as these "do[] not encourage infringement, particularly where the label does not require subsequent application," under HZNP Meds. LLC according to the Court.
Like the District Court, the panel also disregarded any statements limited to Rubicon's ANDA. While acknowledging that "given the proper facts, circumstantial evidence may lend support to a finding of specific intent in drug label cases," under AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042, 1060 (Fed. Cir. 2010), the "pertinent question is whether the proposed label instructs users to perform the patented method," under AstraZeneca LP and Grunenthal GmbH v. Alkem Lab'ys Ltd., 919 F.3d 1333, 1339–40 (Fed. Cir. 2019). Circumstantial evidence cannot override plain language where the label is unambiguous according to the Court, citing Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1324 (Fed. Cir. 2012), and that is the situation here. The Court also considered, as did the District Court, that the statements purported by Metacel to raise material fact issues were not available to the individuals who would be induced (i.e., healthcare workers). And the panel agreed with the District Court that Metacel had not presented this evidence in full (omitting disclosure that did not support their argument, for example). Finally, regarding these arguments, the panel discounted Metacel's expert testimony because it relied on Metacel's label as evidence of Rubicon's intent to induce infringement.
On the procedural questions under Third Circuit law, the panel was unpersuaded by Metacel's arguments that the District Court abused its discretion in denying Metacel's reconsideration request. This decision was based on Metacel raising the issue for the first time in its reconsideration motion.
Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd. (Fed. Cir. 2025)
Nonprecedential disposition
Panel: Circuit Judges Lourie, Chen, and Hughes
Opinion by Circuit Judge Lourie
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