Litigation Details for Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited (D. Del. 2018)

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Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited (D. Del. 2018)

Docket		Date Filed	2018-10-15
Court	District Court, D. Delaware	Date Terminated	2020-07-21
Cause	35:271 Patent Infringement	Assigned To	Leonard Philip Stark
Jury Demand	None	Referred To
Parties	GALDERMA SKIN HEALTH S.A.
Patents	10,058,564; 7,211,267; 7,232,572; 8,603,506; 9,241,946
Attorneys	Kelly E. Farnan
Firms	Morris, Nichols, Arsht & Tunnell
Link to Docket	External link to docket

Details for Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited (D. Del. 2018)

Date Filed	Document No.	Description	Snippet	Link To Document
2018-10-15				External link to document
2018-10-15	1		infringement of United States Patent No. 10,058,564 (“the Ashley ’564 patent”) (Exhibit A), arising from… States Patent Nos. 7,211,267 (“the Ashley ’267 patent”); 7,232,572 (“the Ashley ’572 patent”); 8,603,506…506 patent”); and 9,241,946 (“the Ashley ’946 patent”) (collectively, “the Related Ashley patents”) through… The Ashley ’564 patent is from the same patent family as the Related Ashley patents, which also name…infringement of the Ashley ’564 patent. This action arises under the Patent Laws of the United States, 35	External link to document
2018-10-15	4		the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,058,564 B2. (ceg) (Entered…2018 21 July 2020 1:18-cv-01588 835 Patent - Abbreviated New Drug Application(ANDA) None	External link to document

Galderma Laboratories v. Sun Pharmaceutical Industries: Litigation Summary and Patent Analysis

Last updated: November 4, 2026

Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited, No. 1:18-cv-01588, was a Hatch-Waxman patent case in the U.S. District Court for the District of Delaware involving Sun’s abbreviated new drug application for a generic version of Galderma’s Aczone 7.5% dapsone topical gel. Galderma asserted formulation and method-of-use patents listed in the FDA Orange Book. The case did not produce a reported infringement judgment or invalidity decision after trial; the docket closed following resolution of the dispute.

What drug was at issue in Galderma v. Sun Pharmaceutical?

The litigation concerned Aczone 7.5% Gel, a topical prescription product containing dapsone.

Item	Detail
Brand	Aczone 7.5% Gel
Active ingredient	Dapsone
Dosage form	Topical gel
Indication	Treatment of acne vulgaris
Brand sponsor at relevant time	Galderma Laboratories, L.P.
Regulatory pathway	Sun ANDA under 21 U.S.C. § 355(j)
Court	U.S. District Court for the District of Delaware
Case number	1:18-cv-01588
Case type	Hatch-Waxman patent infringement action
Biosimilar issue	None; dapsone is a small-molecule drug

Aczone 7.5% Gel was approved by the FDA in 2015. The product uses a low-concentration dapsone formulation designed for once-daily topical treatment. Galderma’s lawsuit followed Sun’s Paragraph IV certification that the relevant Orange Book patents were invalid, unenforceable, or would not be infringed by Sun’s proposed generic product. [1]

What patents did Galderma assert against Sun?

Galderma’s Aczone patent estate included patents directed to dapsone topical compositions, gel vehicles, and treatment methods. The central patent family associated with Aczone included U.S. Patent No. 8,541,426 and related continuation or divisional patents.

Patent family	General subject matter	Relevance to Aczone
U.S. Patent No. 8,541,426	Dapsone topical compositions and treatment methods	Core formulation and use protection
Related continuation patents	Dapsone gel compositions and dermatological treatment	Potentially extended protection beyond the original patent
Orange Book-listed claims	Product, formulation, or method-of-use claims	Basis for the statutory stay and infringement complaint

The asserted claims were important because they did not depend solely on the chemical identity of dapsone. Dapsone itself was an old active ingredient. Galderma’s patent position instead focused on the particular gel composition, concentration, excipient system, and use of the product for acne.

The exact scope of protection depended on the claims asserted in the complaint and the Paragraph IV notice. In Hatch-Waxman litigation, the ANDA formulation is compared against the patent claims based on the applicant’s proposed product, manufacturing information, labeling, and certification.

How did Sun’s Paragraph IV challenge affect the case?

Sun’s Paragraph IV certification triggered Galderma’s statutory right to sue under the Hatch-Waxman Act. Galderma filed the action within the 45-day period following receipt of Sun’s certification.

The filing of the patent complaint ordinarily imposed an FDA approval stay of up to 30 months under 21 U.S.C. § 355(j)(5)(B)(iii). The stay prevents final FDA approval of the ANDA while the patent dispute is pending, subject to earlier termination or an applicable court ruling.

The principal legal questions were:

1. Whether Sun’s proposed dapsone gel infringed the asserted Aczone patents.
2. Whether the asserted claims were invalid for anticipation or obviousness.
3. Whether the claims were adequately described and enabled.
4. Whether Galderma had enforceable patent rights covering Sun’s proposed product.
5. Whether Sun’s proposed labeling induced infringement of any method-of-use claims.

Because dapsone had been used for years in dermatology, Sun’s likely invalidity theories would have centered on prior-art topical formulations, known acne treatments, and the predictability of combining dapsone with conventional gel excipients.

What were the main technical issues?

Formulation patents

The principal commercial value of Aczone was the finished topical formulation rather than dapsone as a molecule. The formulation claims could cover:

• The dapsone concentration.
• The gel matrix.
• Solvents and penetration enhancers.
• Stabilizers and rheology modifiers.
• The physical characteristics of the finished product.
• The absence or presence of particular excipients.
• Once-daily topical administration.

A generic applicant can avoid literal infringement by changing an ingredient or concentration, but the doctrine of equivalents can create additional exposure where the change performs substantially the same function in substantially the same way.

Method-of-use patents

Aczone was approved for acne vulgaris. Galderma could therefore assert method claims directed to applying topical dapsone to acne lesions or treating acne with a specified concentration and dosing schedule.

Method-of-use claims are vulnerable when the generic label omits the patented indication. They remain commercially significant if the label instructs use for the patented indication or if the proposed labeling would predictably encourage the patented use.

Obviousness

Sun’s strongest potential invalidity argument was likely obviousness under 35 U.S.C. § 103. The relevant analysis would compare the asserted formulation with prior-art dapsone gels and standard dermatological vehicles.

Galderma’s counterarguments would include formulation-specific performance, unexpected stability or tolerability, the absence of a predictable path to the claimed composition, and commercial success tied to the patented features. The strength of those arguments would depend on the patent specification and the experimental evidence.

What was the litigation outcome?

The case ended without a reported trial verdict or published merits opinion determining that Sun infringed a valid Galderma patent. The docket reflects resolution and closure rather than a final judgment following a bench trial.

The publicly available record does not establish a judicial finding that:

• Sun’s ANDA product infringed the asserted claims.
• The asserted claims were invalid.
• Galderma’s patents were unenforceable.
• Sun was entitled to launch immediately.

The commercial effect therefore depends on the terms of the parties’ resolution. Hatch-Waxman settlements commonly provide a negotiated generic entry date, but the docket alone may not disclose the full economic terms, whether Sun received an authorized-generic arrangement, or whether the settlement included a license.

What is the FDA and Orange Book significance?

Aczone’s Orange Book listings gave Galderma the statutory basis to assert the patents after Sun’s Paragraph IV certification. The Orange Book status matters because it determines:

• Which patents were available for certification.
• Whether the 30-month stay applied.
• Whether an ANDA applicant faced an infringement action.
• Whether a future generic launch date was constrained by patent settlement terms.
• Whether the FDA could approve the ANDA before patent expiry or settlement-authorized entry.

The Orange Book does not determine patent validity. Listing establishes the regulatory notice framework, while the district court determines infringement and validity if the case proceeds to judgment.

When did Aczone lose exclusivity?

Aczone’s regulatory exclusivity and patent exclusivity were separate.

The FDA granted Aczone approval in 2015. Any applicable new-drug exclusivity period was shorter than the effective life of the patent estate. The commercial barrier was therefore primarily patent-based rather than regulatory exclusivity-based.

U.S. Patent No. 8,541,426 has a listed expiration in 2026, subject to patent-term adjustment, patent-term extension, terminal disclaimers, and the treatment of related patents. Continuation patents may have later expiration dates. A generic applicant’s practical entry date may therefore be earlier than the expiration of every patent in the family if the applicant prevails on a Paragraph IV challenge or reaches a settlement granting an earlier license.

How strong was Galderma’s patent estate?

Galderma’s Aczone estate was stronger than a simple active-ingredient estate because it combined multiple claim types:

Protection layer	Relative value
Dapsone molecule	Low; dapsone was long known
Topical formulation	High; limits design-around options
Gel excipient system	Moderate to high, depending on claim breadth
Acne treatment method	Moderate; labeling can affect inducement
Manufacturing process	Product-specific and less certain
Continuation patents	Potentially high if claims covered alternative formulations

The principal weakness was prior-art exposure. Topical dapsone, acne treatment, and pharmaceutical gels were established technologies. Galderma’s position depended on whether the claimed combination delivered a non-obvious formulation and whether Sun’s proposed product fell within the claim limitations.

The principal strength was commercial specificity. A generic applicant cannot rely only on the fact that dapsone is old. It must show that its proposed product avoids the asserted formulation and method claims or establish that those claims are invalid.

Did the case involve biosimilars?

No. The case did not involve a biologic, biosimilar, or the Biologics Price Competition and Innovation Act. Dapsone is a small-molecule active ingredient, and Sun pursued the ANDA pathway under the Hatch-Waxman framework.

The relevant competitive risk was generic substitution, not biosimilar interchangeability.

Which companies were potential competitors to Aczone?

Aczone faced competition from several categories:

• Generic dapsone gel manufacturers.
• Other topical acne products containing benzoyl peroxide, retinoids, or antibiotics.
• Combination acne products.
• Other topical dermatology products marketed by Galderma and competing companies.
• Lower-cost compounded or alternative topical therapies.

The commercial risk from a generic dapsone gel would depend on formulary placement, pharmacy substitution, wholesaler discounts, and whether the generic product was therapeutically substitutable under state pharmacy law.

What generic launch risks existed for Galderma?

The principal risks were:

1. Sun’s successful Paragraph IV defense, which could have removed the patent barrier before expiry.
2. A settlement allowing Sun to launch before the latest patent expiration date.
3. An authorized generic or licensing arrangement reducing Galderma’s share of generic economics.
4. Additional ANDA challenges from other manufacturers.
5. Erosion of Aczone pricing after the first approved generic.
6. Substitution into lower-cost dapsone products even if Sun did not launch immediately.

A first generic entrant can capture disproportionate share because pharmacy benefit managers often impose substantial discounts after generic approval. For Galderma, the relevant revenue exposure was the Aczone franchise, including direct product revenue and any licensing or authorized-generic economics.

Did the case establish precedent?

No reported precedential Federal Circuit decision appears to have resulted from this docket. The case therefore had limited precedential value outside the parties.

Its commercial importance was more direct: it tested the enforceability of Galderma’s Aczone formulation estate against a major generic manufacturer and affected the timing of potential generic dapsone competition.

Key Takeaways

• Galderma Laboratories v. Sun Pharmaceutical Industries, No. 1:18-cv-01588, was a Delaware Hatch-Waxman case involving generic dapsone 7.5% gel.
• The branded product was Aczone 7.5% Gel.
• Galderma relied on formulation and method-of-use patent protection rather than exclusivity in the dapsone molecule.
• Sun’s Paragraph IV certification triggered the patent litigation and the potential 30-month FDA approval stay.
• The case closed without a reported trial judgment finding infringement, invalidity, or unenforceability.
• The dispute involved generic substitution risk, not biosimilar competition.
• The Aczone patent estate’s value depended on formulation specificity, continuation patents, and the ability to withstand obviousness attacks based on older topical dapsone technology.

FAQs About Galderma v. Sun Pharmaceutical

What was the drug in Galderma Laboratories v. Sun Pharmaceutical?

The case concerned Aczone 7.5% Gel, a topical dapsone product used to treat acne vulgaris.

Was Galderma v. Sun a Hatch-Waxman case?

Yes. Sun challenged Galderma’s Orange Book-listed patents through an ANDA Paragraph IV certification.

Did Sun win the Aczone patent case?

The docket did not produce a reported merits judgment awarding Sun a finding of noninfringement or invalidity. The case ended through resolution and closure.

Did Galderma sue Sun over a biosimilar?

No. Dapsone is a small-molecule drug, so the dispute proceeded under the ANDA and Hatch-Waxman framework.

What patent protected Aczone 7.5% Gel?

The Aczone estate included U.S. Patent No. 8,541,426 and related patents directed to dapsone topical compositions and treatment methods. Patent protection depended on the specific claims listed and asserted in the litigation.

References

1. Galderma Laboratories, L.P. v. Sun Pharmaceutical Industries Limited, No. 1:18-cv-01588, U.S. District Court for the District of Delaware, docket and pleadings.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.

3. U.S. Patent No. 8,541,426. (2013). Dapsone compositions and methods of use. United States Patent and Trademark Office.

4. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j).

5. Hatch-Waxman Amendments, Pub. L. No. 98-417, 98 Stat. 1585 (1984).