Federal Circuit IP
Galderma Laboratories, L.P. v. Lupin Inc.
Federal Circuit 2024-1664
December 04, 2024
(Moore, Linn, Prost)
Summary: The Federal Circuit upheld the District of Delaware’s ruling that Lupin’s abbreviated new drug application (ANDA) for a delayed release generic did not infringe Galderma’s patent on the delayed release formulation under the doctrine of equivalents. This decision was made despite an FDA determination of bioequivalence, as the generic did not meet all claim limitations under in vivo conditions.
Background:
- Galderma Laboratories holds U.S. Patent Nos. 7,749,532 and 8,206,740 on a specific 30 mg immediate release and 10 mg delayed release formulation of the antibiotic doxycycline, marketed as Oracea.
- Lupin filed an ANDA showing that a 22 mg immediate release and 18 mg delayed release generic formulation was bioequivalent under in vivo
- Galderma sued Lupin alleging that the generic infringed under the doctrine of equivalents.
- The District of Delaware determined that 22 mg immediate release and 18 mg delayed release were not insubstantially different from 30 mg immediate release and 10 mg delayed release, and that merely showing the same result did not establish the same function and way of the function-way-result test.
Key Issue:
- Whether bioequivalence demonstrates equivalence under the doctrine of equivalence.
Applicable Rule/Statute:
- The doctrine of equivalents is “limitation specific, not focused only on the claim as a whole.” VLSI Tech. LLC v. Intel Corp., 87 F.4th 1332, 1342 (Fed. Cir. 2023).
- The doctrine of equivalence asks “whether a substitute element matches the function, way, and result of the claimed element,” or whether there are only “insubstantial differences.” Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 40 (1997).
Holding:
- No clear error in district court finding that bioequivalence evidence did not prove infringement under the doctrine of equivalents because evidence did not prove the two-stage dissolution test represented relevant in vivo conditions such that the data correlated to the Asserted Claims’ requirements.
- Bioequivalence does not per se show equivalence under the DOE when it only shows the same result.
Takeaways:
- Be careful with ambiguous claim limitations (g., immediate release portion, delayed release portion). Use dependent claims to present more concrete infringement positions.
- Disclosing and claiming in vivo conditions is difficult and prone to error, present alternatives and fallbacks.
- Frame evidence (g., bioequivalence tests) to design-around claims.