Ozobax® (baclofen)
Case Name: Metacel Pharms. LLC v. Rubicon Rsch. Priv. Ltd., No. 2023-2386, 2025 WL 1178384 (Fed. Cir. Apr. 23, 2025) (Circuit Judges Lourie, Chen, and Hughes presiding; Opinion by Lourie) (Appeal from D.N.J., Padin, J.)
Drug Product and Patent(s)-in-Suit: Ozobax® (baclofen); U.S. Patent No. 10,610,502 (“the ’502 patent”)
Nature of the Case and Issue(s) Presented: Ozobax is indicated for treatment of spasticity resulting from multiple sclerosis, and particularly flexor spasms and concomitant pain, clonus, and muscular rigidity. While the use of baclofen to treat spasticity has long been known, the ’502 patent was distinguished from the prior art by reciting an oral solution of baclofen stored “at from about 2 to about 8° C.” Rubicon held an approved ANDA to market a generic baclofen. In its ANDA submission, Rubicon included a proposed label which contained the following storage instructions: “Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). It can also be stored at 2°C to 8°C (36°F to 46°F)” (emphasis added). Rubicon’s ANDA also included a paragraph IV certification for the ’502 patent. Metacel timely filed suit under 35 U.S.C. § 271(e)(2)(A), alleging that Rubicon’s label would induce infringement of the ’502 patent.
After discovery, Rubicon moved for summary judgement, arguing that there was no genuine dispute of material fact that its proposed label would not induce infringement of the ’502 patent because the label merely permitted infringement, and did not instruct it. The district court granted Rubicon’s motion, rejecting Metacel’s argument that certain statements in Rubicon’s ANDA indicated that Rubicon had the specific intent to induce infringement of the ’502 patent. Metacel filed a motion for reconsideration, forwarding similar arguments and adding a claim that Rubicon’s summary judgement arguments were inadequately noticed under the local rules. The district court denied Metacel’s motion, including because Metacel had failed to raise its notice arguments in its opposition to summary judgment. Metacal appealed to the Federal Circuit, which affirmed the district court’s decision.
Why Rubicon Prevailed: On appeal, Metacel again argued that the district court had failed to account for statements in Rubicon’s ANDA which allegedly created a genuine issue of material fact regarding infringement, and that Rubicon’s summary judgement arguments were not properly noticed. The Federal Circuit rejected each of these arguments in turn.
The Federal Circuit explained that, because Rubicon’s “FDA submissions are not available to downstream users[,]” they “cannot cause inducement[.]” The Federal Circuit also emphasized that, in ANDA cases involving method-of-use patents, “the pertinent question is whether the proposed label instructs users to perform the patented method. . . . [W]here, as here, a label is unambiguous, circumstantial evidence cannot override its plain language.” Looking therefore at the language of Rubicon’s label, the court agreed that there was no genuine dispute of material fact that Rubicon’s label would not induce infringement because Rubicon’s label only allowed, and did not instruct, the storage of its baclofen formulation at 2° C to 8° C. The Federal Circuit explained, “[l]abels that merely describe the infringing use . . . will not suffice” to establish indirect infringement.
Regarding Metacel’s argument that it had not received proper notice of Rubicon’s summary judgment arguments, the Federal Circuit reviewed the district court’s denial of Metacel’s motion for reconsideration for abuse of discretion. Given that Metacel had first raised it notice argument in its motion for reconsideration, and not its opposition to Rubicon’s motion for summary judgment, the Federal Circuit found that there was no basis to “disturb the district court's judgment” on this issue.
