Technology & Information Law Blog by Charles Gideon Korrell

Tag: pharmaceuticals

  • Galderma v. Lupin: CAFC Weighs In on ANDA Infringement and the Doctrine of Equivalents

    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

  • Federal Circuit Vacates District Court’s Surprise Patent Ineligibility Ruling in Astellas v. Sandoz

    In a major rebuke to a district court’s handling of patent eligibility, the Federal Circuit has vacated a decision that invalidated Astellas’s pharmaceutical patent under 35 U.S.C. § 101—a ruling the lower court made on its own initiative, without either party raising the issue. The court’s strong reaffirmation of the “party presentation principle” signals a warning against judicial overreach in patent litigation.

    Background: The Overactive Bladder Treatment and the Patent Dispute

    Astellas Pharma, the manufacturer of Myrbetriq®, an extended-release formulation of mirabegron for overactive bladder (OAB), sued multiple generic drugmakers, including Sandoz, Lupin, and Zydus, for patent infringement under the Hatch-Waxman Act. The key patent at issue, U.S. Patent No. 10,842,780 (the ’780 patent), covered a sustained-release formulation of mirabegron that overcame the “food effect”—an issue where drug absorption varies significantly depending on whether the patient has eaten.

    During the litigation:

    • The generic manufacturers challenged the patent’s validity only under 35 U.S.C. § 112, arguing that the claims were not enabled, lacked written description, or were indefinite.
    • Sandoz explicitly waived arguments under §§ 102 (anticipation) and 103 (obviousness) before trial.
    • Neither side raised a challenge under 35 U.S.C. § 101 (patent eligibility).

    However, after a five-day bench trial, the district court unexpectedly ruled that the patent claims were invalid under § 101—a legal theory that had never been argued by the defendants. This ruling blindsided Astellas, prompting their appeal.

    Key Patent Law Issues Addressed

    1. Can a Court Invalidate a Patent on Grounds Not Raised by Either Party?

    The Federal Circuit’s resounding answer: No.

    The appeals court held that the district court violated the “party presentation principle”—a fundamental rule in U.S. litigation that courts must decide only the issues framed by the parties.

    The Supreme Court has repeatedly reinforced this principle, stating that courts should not act as “issue spotters” on behalf of litigants. The Federal Circuit echoed this, emphasizing:

    “It is for the parties—not the court—to chart the course of the litigation.”

    By introducing a new ground of invalidity sua sponte, the district court abused its discretion, undermining due process, and depriving Astellas of an opportunity to defend its patent.

    2. Is Patent Eligibility a Special Case Where a Court Can Rule on Its Own?

    No. The district court seemed to treat § 101 eligibility like a jurisdictional question, which courts must assess even if not raised. However, the Federal Circuit flatly rejected this view, clarifying that patent eligibility is subject to the same statutory presumption of validity under 35 U.S.C. § 282 as other validity defenses.

    The court noted:

    • The Supreme Court has never held that § 101 must be evaluated independently by courts.
    • Patent challengers bear the burden of proving invalidity—courts cannot assume this burden for them.

    3. Was the ’780 Patent’s “Food Effect” Solution Merely a Natural Law?

    The district court held that Astellas’s discovery of a sustained-release profile that eliminated the food effect was merely an application of a natural law, making it patent-ineligible under Mayo Collaborative Services v. Prometheus Labs (2012).

    The Federal Circuit avoided ruling on the merits of this issue, focusing instead on the procedural error. However, it hinted that the district court likely misunderstood the scope of § 101, as formulation patents like Astellas’s typically claim a non-naturally occurring composition—not a law of nature.

    Outcome and Key Takeaways

    IssueFederal Circuit Decision
    Court raising § 101 issue sua sponteAbuse of discretion—violates party presentation principle
    Treatment of § 101 as jurisdictionalError—validity challenges must be raised by parties
    Presumption of validity under § 282Applies equally to § 101 challenges
    Future of Astellas’s patentRemanded for ruling on infringement and § 112 validity defenses

    The Federal Circuit vacated the district court’s judgment and remanded the case for a proper adjudication—one limited to the issues actually raised by the parties (i.e., enablement, written description, and indefiniteness under § 112).

    What This Means for Future Patent Cases

    1. District Courts Must Stick to the Issues Raised

    This ruling strongly discourages judges from introducing new invalidity arguments. It reinforces that § 101 is not a jurisdictional test and that courts cannot invalidate patents sua sponte.

    2. Patent Defendants Cannot Rely on Courts to Raise Additional Defenses

    Generic manufacturers (and other patent challengers) must affirmatively raise § 101 defenses during litigation. A court cannot do their work for them.

    3. Clarifies That Formulation Patents Are Not Automatically “Natural Laws”

    While the Federal Circuit did not directly decide whether Astellas’s patent was ineligible under § 101, its reluctance to uphold the district court’s reasoning suggests that such pharmaceutical formulation patents remain patentable under existing law.

    Next Steps for Astellas

    On remand, Astellas’s patent infringement claims will continue—but the case will focus only on the § 112 defenses (enablement, written description, and indefiniteness). The generics will have to prove these defenses—which are often harder to establish than obviousness or anticipation.

    See also:

    Article relating to patent office interim guidance on subject matter elegibility.

    By Charles Gideon Korrell