Galderma Labs., L.P. v. Lupin Inc
Authored by: Jeremy J. Gustrowsky
In a recent decision, the Federal Circuit affirmed that Lupin Inc.’s proposed generic version of Oracea® does not infringe Galderma Laboratories’ patents covering the branded drug. Oracea® is a once-daily capsule used to treat rosacea, containing a specific mix of immediate-release (IR) and delayed-release (DR) doxycycline. Galderma holds U.S. Patent Nos. 7,749,532 and 8,206,740, which claim a composition of about 30 mg IR and about 10 mg DR doxycycline. Lupin’s generic, however, is labeled as containing 22 mg IR and 18 mg DR.
Galderma argued that Lupin’s product actually functions as a 30 mg IR and 10 mg DR product because some of the DR portion releases too early, based on laboratory dissolution tests at pH 4.5. However, the district court found—and the Federal Circuit agreed—that these tests did not accurately reflect how the drug behaves in the human body. Expert testimony showed that the fasted stomach’s pH is much lower (around 1-2), and the pH 4.5 stage in the test is more representative of the small intestine, where the DR portion is supposed to release. As a result, Galderma’s infringement theory was not supported by the evidence.
The court also rejected Galderma’s arguments that the district court improperly added limitations to the patent claims or made errors in considering certain evidence. Instead, the Federal Circuit found that the lower court simply made factual findings about how the generic product works, which were supported by the record. Additionally, Galderma’s attempt to show infringement under the doctrine of equivalents failed because the evidence did not show that Lupin’s product matched the patented composition in function, way, and result.
The court’s decision here highlights the importance of real-world drug behavior and credible scientific evidence in pharmaceutical patent disputes. Simply showing that a generic product is bioequivalent or that it releases some drug in a lab test is not enough—patentees must prove that the generic meets all claim limitations as they would occur in the body.