In the ever-evolving world of pharmaceutical patent law, a recent Federal Circuit decision offers some clarity on when a generic drug label might be considered to induce patent infringement. The case, Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd., centered around the storage instructions on the label of Rubicon’s generic version of Metacel’s Ozobax® (an oral baclofen solution).
Metacel held a patent (U.S. Patent No. 10,610,502) with a claim that included storing the baclofen solution at a refrigerated temperature of 2 to 8°C. When Rubicon sought approval for its generic version through an ANDA, its label included the standard room temperature storage instructions but also stated the product “can also be stored at 2°C to 8°C.”
Metacel argued that this optional refrigeration instruction would lead doctors and other healthcare providers to infringe their patented method. However, both the District Court and the Federal Circuit disagreed, ultimately affirming the lower court’s decision that Rubicon’s label wouldn’t induce infringement.
The Key Takeaway: Permissive Language Isn’t Inducement
The Federal Circuit’s reasoning hinged on the distinction between encouraging or recommending infringement versus merely permitting it. In their view, Rubicon’s label primarily directed users to store the drug at room temperature, a non-infringing condition. The statement about refrigeration was presented as an option, not a directive.
Judge Lourie, writing for the panel, stated that the label indicated 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.”
This aligns with previous Federal Circuit precedent, notably the HZNP Meds. LLC v. Actavis Lab’ys UT, Inc. case, which established that permissive statements in a label don’t necessarily encourage infringement, especially when the label doesn’t mandate the potentially infringing use.
ANDA Filings Don’t Dictate Label Interpretation
Interestingly, Metacel also pointed to statements Rubicon made in its ANDA filing regarding the storage temperature. However, the court, like the District Court, focused solely on the language of the actual drug label that healthcare professionals would see. The court emphasized that the pertinent question is whether the label instructs users to perform the patented method.
Plain Language Prevails
The court also noted that when the label language is clear and unambiguous, circumstantial evidence (like statements in the ANDA) cannot override its plain meaning.
What This Means for Generic Drug Labels
This decision reinforces the idea that generic drug manufacturers have some leeway in including optional information on their labels without automatically being held liable for inducing patent infringement. As long as the label’s primary instructions guide towards non-infringing uses and any mention of potentially infringing uses is clearly presented as a permissible option rather than a recommendation, it’s less likely to be considered inducement.
This case serves as a reminder that the specific wording of a drug label is crucial in determining potential patent infringement liability in the generic drug context.