Oracea® (doxycycline USP)
Case Name: Galderma Labs., L.P. v. Lupin Inc., No. 2024-1664, 2024 WL 4998071 (Fed. Cir. Dec. 6, 2024) (Circuit Judges Moore, Linn, and Prost presiding; Opinion by Moore, C.J.) (Appeal from D. Del., Bibas, J.)
Drug Product and Patent(s)-in-Suit: Oracea® (doxycycline USP); U.S. Patents Nos. 7,749,532 (“the ’532 patent”) and 8,206,740 (“the ’740 patent”)
Nature of the Case and Issue(s) Presented: Oracea is indicated for the treatment of papules and pustules associated with rosacea. The patents-in-suit that share a common specification are directed to a once-daily, oral pharmaceutical composition of about 30 mg immediate release (“IR”) and about 10 mg delayed release (“DR”) doxycycline. The IR portion is designed to release its doxycycline immediately upon ingestion, and the DR portion is designed to release its doxycycline at a delayed time when it reaches an environment with a pH higher than 4.5. Lupin’s prescribing information described its product as a 40 mg capsule, containing 22 mg IR and 18 mg DR doxycycline. Galderma argued that Lupin’s product infringed the 30 mg IR, 10 mg DR limitations because about 8 mg of Lupin’s DR portion was actually an IR portion, resulting in a 30 mg IR, 10 mg DR product. According to Galderma, Lupin’s formulation actually contained 30 mg of IR due to the DR portion having a “weak enteric coat.” The district court disagreed and found that Lupin’s formulation did not infringe. The Federal Circuit affirmed.
Why Lupin Prevailed: On appeal, Galderma argued that the district court erred by (i) disregarding controlling data in Lupin’s ANDA, specifically the two-stage dissolution test, (ii) imposing limitations not present in the claims, and (iii) not finding infringement under the doctrine of equivalents.
Galderma argued the two-stage dissolution test proved that Lupin’s formulation released about 8 mg of doxycycline from the labeled DR portion at pH 4.5. Galderma believed that this was relevant to infringement because evidence at trial showed pH 4.5 was present in the stomach at the time of administration of Lupin’s product, thereby making it IR doxycycline. But the Federal Circuit explained that the district court rejected Galderma’s argument because it improperly drew conclusions about in vivo behavior from the two-stage in vitro dissolution test. For this reason, the Federal Circuit explained that the district court did not clearly err.
Galderma next argued that the district court required it to prove additional limitations not found in the claims of the patents-in-suit. Specifically, Galderma argued that the district court improperly imposed a pH limitation to differentiate between the IR and ER portions of Lupin’s formulation. The Federal Circuit rejected this argument, finding that the district court’s reliance on pH ranges was limited to its analysis of whether the two-stage dissolution test represented in vivo behavior for Lupin’s product. The Federal Circuit concluded that the district court did not impose additional claim limitations.
Galderma also argued that the district court erred by not finding infringement under the doctrine of equivalents. For both the “function, way, result” test and the “insubstantial differences” test, Galderma argued that the two-stage in vitro dissolution test in combination with the in vivo bioequivalence data resulted in doctrine-of-equivalents infringement. But because the district court did not clearly err in finding Galderma did not prove the two-stage dissolution test represented relevant in vivo conditions, the Federal Circuit concluded that the district court did not clearly err in rejecting Galderma’s doctrine-of-equivalents infringement theory.
