The Federal Circuit recently affirmed a district court ruling in Galderma Laboratories, L.P. v. Lupin Inc., a patent dispute over the rosacea treatment Oracea®. The decision highlights key issues in Hatch-Waxman litigation, including claim construction, infringement analysis, and the doctrine of equivalents.

Background: The Patents and ANDA Dispute

Galderma Laboratories owns patents for Oracea®, medication used to treat rosacea. The formula is designed to release most of the drug immediately (30 mg of the 40 mg total amount) and then the rest later, helping to maintain steady levels in the body.

Lupin Inc. applied for FDA approval to sell a generic version of Oracea®. Their version had a different mix—22 mg released immediately and 18 mg released later. This led Galderma to sue, claiming that Lupin’s product violated their patents.

Key Patent Law Issues Addressed

1. Claim Construction and Functional Limitations

The court first addressed the proper interpretation of the “immediate-release” and “delayed-release” terms. It affirmed the district court’s functional definitions:

• Immediate-Release (IR): A portion of the composition that releases doxycycline upon administration without any delayed or extended effect.
• Delayed-Release (DR): A portion that postpones release through coating or another mechanism.

This distinction became crucial in determining whether Lupin’s product met the specific claimed composition of 30 mg IR and 10 mg DR doxycycline.

2. Direct Infringement and ANDA Specification

Galderma argued that, despite Lupin’s labeling of 22 mg IR and 18 mg DR, a weak enteric coating caused some DR doxycycline to release earlier than intended, effectively creating a 30 mg IR and 10 mg DR composition.

The court rejected this argument, emphasizing that an ANDA’s formulation specifications are generally dispositive in infringement determinations unless contrary evidence proves otherwise. Lupin’s ANDA stated that its product contained a different IR-to-DR ratio than the claimed composition, and Galderma failed to provide convincing proof of deviation in real-world conditions.

3. The Role of In Vitro Dissolution Testing

A key evidentiary dispute involved in vitro dissolution tests showing some doxycycline release at pH 4.5. Galderma argued this indicated Lupin’s DR portion was behaving like an IR portion in vivo.

The court disagreed, finding that:

• The pH 4.5 test did not accurately reflect in vivo stomach conditions, where pH levels are typically between 1.0 and 2.0 in fasting conditions.
• Galderma’s evidence did not establish how many of Lupin’s coated pellets had weak enteric layers or how this would impact overall drug release.
• Even if some DR doxycycline released at pH 4.5, this did not prove Lupin’s formulation met the claimed 30 mg IR / 10 mg DR composition.

4. No Infringement Under the Doctrine of Equivalents

Galderma also argued that Lupin’s formulation was equivalent to the claimed invention under the doctrine of equivalents. The doctrine applies when a product does not literally infringe a patent but performs the same function, in the same way, to achieve the same result.

The court rejected this argument, stating:

• The function-way-result test was not met because Galderma failed to show Lupin’s ANDA product functioned identically to Oracea®.
• The differences between Lupin’s 22 mg IR / 18 mg DR formulation and the claimed 30 mg IR / 10 mg DR formulation were substantial, particularly given the FDA’s strict labeling and bioequivalence standards.

5. No Indirect or Induced Infringement

Because there was no direct infringement, the court also ruled out contributory and induced infringement claims against Lupin.

Final Decision and Impact

The Federal Circuit affirmed the district court’s ruling, holding that Lupin’s ANDA product does not infringe Galderma’s patents. The decision underscores the importance of ANDA specifications in Hatch-Waxman litigation, the limitations of in vitro testing for proving infringement, and the high bar for applying the doctrine of equivalents in pharmaceutical patent cases.

This case serves as a reminder that branded pharmaceutical companies must provide clear and convincing evidence when challenging ANDA products—particularly when alleging that small formulation differences amount to patent infringement.

Post by Charles Gideon Korrell