Metacel v. Rubicon, decided April 23, 2025

Case Citation: METACEL PHARMACEUTICALS LLC v. RUBICON RESEARCH PRIVATE LTD., No. 2023-2386 (Fed. Cir. April 23, 2025) (nonprecedential)

Court: United States Court of Appeals for the Federal Circuit

Lower Court: United States District Court for the District of New Jersey (No. 2:21-cv-19463-EP-JRA, Judge Evelyn Padin)

Date of Decision: April 23, 2025

Issue Presented: Did the District Court err in granting summary judgment of non-infringement in favor of Rubicon, finding that Rubicon's proposed labeling for its generic baclofen oral solution would not induce infringement of Metacel's U.S. Patent No. 10,610,502 ('502 patent), particularly concerning the refrigerated storage condition claimed in the patent?

Holding: No. The Federal Circuit affirmed the District Court's grant of summary judgment of no induced infringement, finding that Rubicon's proposed ANDA label clearly instructs room temperature storage and only optionally permits refrigeration, thus not encouraging, recommending, or promoting infringement of the '502 patent's refrigerated storage limitation. The court also upheld the rejection of Metacel's belated notice arguments raised in its motion for reconsideration.

Facts:

• Metacel holds FDA approval (NDA 208193) for Ozobax®, an oral solution of baclofen (5 mg/5 mL) indicated for treating spasticity.

• Metacel's sole Orange Book listing for Ozobax is the '502 patent, which claims a method of treating spasticity using an aqueous oral solution of baclofen with a specific buffer, optionally preservatives, and importantly, stored at from about 2 to about 8°C.

• Claim 1 of the '502 patent recites: "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."

• Rubicon filed an ANDA (214445) to market a generic version of Ozobax (5 mg/5 mL).

• Rubicon's proposed container label and package insert included the storage instruction: "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)."

• Rubicon provided a paragraph IV certification stating its product would not infringe the '502 patent and notified Metacel.

• Metacel sued Rubicon under 35 U.S.C. § 271(e)(2)(A) (Hatch-Waxman Act), alleging that Rubicon's proposed labeling would induce downstream users (physicians, pharmacists, patients) to store the generic product at 2° to 8°C, thus infringing the '502 patent.

• The District Court granted summary judgment of non-infringement for Rubicon, stating that "[t]he label is what matters, because that is what the downstream users—either a healthcare practitioner or patient—will rely upon." The court reasoned that instructing room temperature storage with an optional mention of refrigeration does not induce infringement.

• Metacel's motion for reconsideration, arguing misapplication of local patent rules and reasserting its merits arguments, was denied.

Main Themes and Important Ideas/Facts:

1. Induced Infringement of Method Claims: The central issue revolves around whether Rubicon's proposed label "encourage[s], recommend[s], or promote[s] infringement" of Metacel's method claim, which includes a refrigerated storage limitation. The court emphasized that "[w]hoever actively induces infringement of a patent shall be liable as an infringer" (35 U.S.C. § 271(b)) and that in the ANDA context, "specific intent and action to induce infringement must be proven." Simply describing an infringing use is insufficient.

2. Importance of Labeling in Inducement: The court underscored the primacy of the product label in determining inducement in the pharmaceutical context. As the District Court noted, "[t]he label is what matters, because that is what the downstream users...will rely upon." The Federal Circuit agreed, stating that "Metacel’s nonpublic statements to FDA do not supplant Rubicon’s proposed labeling, which is directed to the public, to create a genuine issue of fact."

3. Permissive vs. Instructive Language: The court distinguished between permissive language ("can also be stored at 2°C to 8°C") and instructive language ("Store at 2° to 8°C"). Rubicon's label clearly instructs storage at room temperature (20° to 25°C) and merely allows for refrigeration. This permissive language does not rise to the level of encouraging or recommending the patented infringing storage method. The court drew a parallel to the HZNP Meds. LLC v. Actavis Lab'ys UT, Inc. case, where a permissive "if/then" warning did not constitute inducement.

4. "Rubicon’s proposed label does not encourage refrigeration. Instead, it instructs downstream users to store the product 'at 20° to 25°C,' i.e., room temperature...The proposed label’s allowance of refrigeration, stating that the product 'can also be stored at 2°C to 8°C,' merely describes the temperature range for refrigeration if the downstream user chooses to refrigerate...That is not inducement."

5. Rejection of Non-Label Evidence: The court rejected Metacel's arguments based on Rubicon's nonpublic communications with the FDA and expert testimony. The court reasoned that statements made to the FDA, not accessible to downstream users, cannot induce infringement. Furthermore, the court found that Metacel selectively presented these communications out of context.

6. "Rubicon’s FDA submissions are not available to downstream users and therefore cannot cause inducement. Second, 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 [Rubicon’s] storage temperature statement compare[d] to [Ozobax].' 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 different from Ozobax’s label (and thus different from claim 1 of the ’502 patent) because its ANDA product, unlike Ozobax, could be stored at room temperature 'per acceptable long term stability data.'"

7. Unpersuasiveness of Expert Testimony: Metacel's expert testimony, suggesting pharmacists would default to Ozobax's (the Reference Listed Drug's) storage instructions (which align with the '502 patent) despite Rubicon's label, was deemed unpersuasive. The court found no legal basis for this argument.

8. "Metacel presented uncontested expert testimony that a pharmacist, after reading Rubicon’s ANDA product label, which explicitly lists two contradictory storage conditions, would ‘defer to the storage instructions for the reference listed drug (i.e., Metacel’s drug or the RLD).’...That is not persuasive. Metacel cites no case law or other authority to convince us otherwise."

9. Belated Notice Arguments: The Federal Circuit upheld the District Court's denial of Metacel's motion for reconsideration concerning alleged violations of local patent rules and Federal Rules of Civil Procedure. These arguments were raised for the first time in the motion for reconsideration and were therefore considered belated and forfeited.

10. "We see no abuse of discretion in the district court’s rejection of those arguments as belated because they were raised for the first time as part of Metacel’s motion for reconsideration."

Significance: This case reinforces the principle that inducement of patent infringement in the pharmaceutical ANDA context hinges on the language of the proposed product label. Permissive language that merely describes a potential infringing use, as opposed to instructing or encouraging it, is generally insufficient to establish induced infringement. Non-public communications with regulatory agencies typically do not establish the requisite intent to induce. Additionally, parties must raise procedural arguments in a timely manner at the district court level and cannot generally introduce them for the first time in a motion for reconsideration.

Full opinion