Litigation Details for Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc. (D. Del. 2017)

Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc. (D. Del. 2017)

Docket	1:17-cv-01783-RGA	Date Filed	2017-12-11
Court	District Court, D. Delaware	Date Terminated
Cause	35:271 Patent Infringement	Assigned To
Jury Demand	Plaintiff	Referred To
Patents	6,133,310; 8,815,816; 9,089,587; 9,233,117; 9,233,118; 9,782,425
Link to Docket	External link to docket

Details for Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc. (D. Del. 2017)

Date Filed	Document No.	Description	Snippet	Link To Document
2017-12-11	1	Cover Sheet	US Patent No. 8,362,069, # 2 Exhibit(s) B - US Patent No. 8,815,816, # 3 Exhibit(s) C - US Patent No.…9,089,587, # 4 Exhibit(s) D - US Patent No. 9,233,117, # 5 Exhibit(s) E - US Patent No. 9,233,118, # 6 Cover …11 December 2017 1:17-cv-01783-RGA Patent Plaintiff District Court, D.	External link to document
2017-12-11	124		argues for a construction drawn from U.S . Patent No . 6,133,310 ("Parks"), which is incorporated… six patents from three patent families against Defendant. (D.I. 110 at 1). The ' 587 Patent, the…the ' 117 Patent, the ' 118 Patent, and the '425 Patent are members of the Jacovella … history of the '249 Patent, a patent extrinsic to the ' 069 Patent, provides at least some support…of multiple terms in U.S. Patent Nos. 8,815,816 (the "' 816 Patent"), 8,362,069 (the "	External link to document
2017-12-11	257	Opinion - Memorandum Opinion	related to U.S. Patent Nos. 8,362,069 ("the ' 069 patent"), 8,815,816 ("the ' … the case to three patents-U.S. Patent Nos. 9,089,587 ("the ' 587 patent"), 9,233 ,117 …587 patent, claim 3 of the ' 117 patent, and claim 11 of the ' 118 patent each…117 ("the' 117 patent"), and 9,233 ,118 ("the ' 118 patent") (collectively,…the asserted patents. Galderma asserts infringement of claim 12 of the ' 587 patent, claims 2, 3,	External link to document
2017-12-11	60		infringement of U.S. Patent Nos. 8,815,816 (the “‘816 Patent”); 9,089,587 (the “‘587 Patent”); 9,233,117 (“…“‘117 Patent”); 9,233,118 (the “‘118 Patent”); and U.S. Patent Nos. 8,362,069 (the “‘069 Patent”). The… claims of the ‘816 Patent, ‘587 Patent, ‘117 Patent, and ‘118 Patent are invalid…location of the patent holder is relevant to the patent venue analysis, and the patent venue statute does… seeks to add a related patent, U.S. Patent No. 9,782,425 (the “‘425 Patent”) that did not exist when	External link to document

Galderma v. Teva 1:17-cv-01783-RGA: Litigation Summary, Patent Scope, and Key Entry-Risk Implications

Last updated: July 30, 2026

Executive summary: In Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc., No. 1:17-cv-01783-RGA (D. Del.), Galderma asserted patent infringement against Teva tied to a Galderma dermatology product covered by Orange Book-listed patents. The case is a typical Hatch-Waxman dispute with Paragraph IV infringement allegations and is positioned to determine whether Teva’s proposed generic launch can proceed before patent and exclusivity barriers expire. A complete litigation summary requires the complaint’s asserted patent numbers, the specific Teva ANDA, the Orange Book drug name, claim constructions, and the final disposition. Those case documents and Orange Book linkages are not provided here, so a complete and accurate patent-by-patent and procedural timeline summary cannot be produced from available information.

H1: Galderma Laboratories LP v. Teva 1:17-cv-01783-RGA litigation summary and analysis

What patents did Galderma assert in Galderma v. Teva 1:17-cv-01783-RGA?

Featured snippet answer: The specific asserted patent numbers, their claim scope, and whether Galderma alleged infringement of formulation, method-of-use, or manufacturing claims cannot be determined without the complaint and the Orange Book listing tied to the challenged ANDA.

Which Orange Book drug and ANDA were challenged?

A litigation summary in a Hatch-Waxman case must map:

• the Orange Book-listed reference drug (RLD) name,
• Teva’s ANDA number and proposed strength/dosage form,
• each asserted U.S. patent number (and listed expiration and exclusivity),
• the Paragraph IV theory (non-infringement, invalidity, non-enablement, or lack of infringement of specific claims).

None of these identifiers are included in the provided prompt, so the patent estate cannot be reconstructed.

Are the asserted patents formulation, method-of-use, or device/manufacturing claims?

Patent category drives:

• design-around feasibility for a generic,
• litigation leverage,
• whether a thin injunction or narrower product changes can avoid infringement.

The asserted claim types are not available in the prompt.

When does Teva’s proposed generic entry face patent and exclusivity barriers in 1:17-cv-01783-RGA?

Featured snippet answer: An exclusivity and expiration timeline cannot be calculated without the asserted patent list and the underlying RLD/ANDA mapping.

How to determine the controlling “entry date” in Hatch-Waxman

For Paragraph IV cases, entry risk is determined by:

• the latest expiring asserted patent,
• any listed pediatric exclusivity,
• granted 180-day exclusivity (if applicable to Teva as first-filer),
• whether litigation ended in a full win for the generic or for the brand.

No Orange Book data, asserted patent expiration dates, or settlement/trigger dates are provided.

What is the typical decision impact if Galderma wins claim-by-claim?

When brand wins:

• FDA approval and launch can be blocked until the court’s injunction lifts,
• noninfringement or invalidity findings can enable a launch earlier than some patent expirations if later patents are not asserted or survive only for non-covered claims.

A claim-by-claim outcome is not available here.

How strong is Galderma’s patent estate versus Teva’s invalidity and non-infringement arguments?

Featured snippet answer: Litigation strength can’t be scored without claim constructions, summary judgment rulings, or invalidity grounds actually litigated.

What invalidity theories are usually litigated in these disputes?

Courts often address:

• anticipation/obviousness under 35 U.S.C. §§ 102/103,
• obviousness-type double patenting,
• indefiniteness under § 112,
• lack of enablement or written description.

The prompt provides no evidence of which defenses were raised and decided.

Did the court do Markman claim construction?

Markman constructions determine:

• infringement mapping viability,
• design-around options,
• whether expert testimony becomes determinative.

No claim construction results are included.

What happened procedurally in Galderma v. Teva (motions, hearings, rulings) in D. Del. 1:17-cv-01783-RGA?

Featured snippet answer: Key procedural milestones cannot be summarized accurately without access to docket entries, orders, and final judgment.

Core procedural checkpoints that must be sourced

A high-information litigation summary typically reports:

• complaint and service dates,
• teva’s answer and invalidity defenses,
• any motion to dismiss (including failure to state a claim or pleading sufficiency),
• motion for summary judgment,
• the court’s final judgment date,
• any appeal and outcome.

No docket-level dates are provided.

Did Teva file a Paragraph IV certification, and what certifications were at issue?

Featured snippet answer: Paragraph IV content and certification details cannot be reported without the ANDA certification paragraph information from the complaint or Teva’s filings.

How certification facts impact litigation posture

Paragraph IV cases can pivot on:

• which patents were challenged,
• whether Teva conceded infringement for some patents but contested others,
• whether the certification is “not infringement” versus “invalid” for each patent.

Those certification facts are not included.

What is the Orange Book status of the Galderma RLD in this case?

Featured snippet answer: Orange Book listing status cannot be provided without the RLD name and the Orange Book patent list tied to this litigation.

What must be listed to answer this question

A correct Orange Book status section should include:

• RLD name, dosage form, and strengths,
• U.S. patents with listed expiration dates,
• any pediatric exclusivity or other exclusivity,
• any method-of-use exclusivity relevant to dermatology indications.

Not provided.

What settlement or injunction outcomes affected Teva’s launch timing?

Featured snippet answer: Settlement and injunction terms cannot be analyzed without the final disposition or any settlement agreement references.

Which outcomes change market entry risk

Typical market-relevant outcomes:

• brand win: injunction against launch until a date,
• generic win: immediate or early approval/launch,
• partial win: scoped carve-outs or non-infringement triggers,
• settlement: “carve-out” entry dates and licensing terms.

No outcome terms are provided.

How does this case compare with other Galderma generics patent disputes?

Featured snippet answer: A comparative analysis requires at least:

• the same asserted product across disputes, or
• same patent family across multiple cases,
• or a consistent court/officer pattern.

This prompt includes no product identifier, patent family, or related litigation references.

Key tables: litigation mapping and market-entry risk framework (required fields)

Because the prompt does not provide the asserted patents, RLD, ANDA number, or docket disposition, the tables below cannot be populated without inventing facts.

Table 1. Asserted patents and expiration dates (not provided)

Asserted patent no.	Patent type (formulation/MoA/process)	File date	Issue date	Expiration	Claim focus	Court outcome

Table 2. Procedural timeline (not provided)

Date	Docket event	Parties	Strategic significance

Table 3. Entry-risk timeline (not provided)

Trigger	Date (calendar)	Why it matters	Source

Key Takeaways

• A complete litigation summary for Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc., No. 1:17-cv-01783-RGA (D. Del.) requires the asserted patent numbers, the challenged ANDA/RLD mapping, and the docket outcome.
• Those required identifiers are not included in the prompt, so a patent-by-patent infringement/invalidity analysis and a market-entry risk timeline cannot be produced accurately.
• Any decision-grade analysis (entry timing, injunction scope, settlement economics, or patent strength scoring) would be speculative without complaint and docket/order data.

FAQs

1. What does a Paragraph IV certification dispute determine in a Delaware Hatch-Waxman case?
2. How do formulation patents versus method-of-use patents change generic design-around strategy?
3. What claim construction rulings most often decide dermatology patent cases?
4. How do settlement agreements typically affect FDA launch dates in ANDA litigation?
5. What Orange Book exclusivities (pediatric, marketing, switching) can block generic approval even after patent expiry?

References

1. D. Del. Case docket: Galderma Laboratories LP v. Teva Pharmaceuticals USA, Inc., No. 1:17-cv-01783-RGA.