Last Updated: August 3, 2026

Litigation Details for LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)


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Small Molecule Drugs cited in LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc.
The small molecule drug covered by the patents cited in this case is ⤷  Start Trial .

Details for LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc. (D. Del. 2018)

Date Filed Document No. Description Snippet Link To Document
2018-01-03 External link to document
2018-01-02 1 of U.S. Patent No. 7,700,076 (“the ’076 patent”), U.S. Patent No. 8,435,498 (“the ’498 patent”), U.S.… COUNT I – INFRINGEMENT OF U.S. PATENT NO. 7,700,076 24. Plaintiffs fully incorporate…076 patent, the ’498 patent, the ’021 patent, the ’554 patent, the ’259 patent, or the ’725 patent, respectively…076 patent, the ’498 patent, the ’021 patent, the ’554 patent, the ’259 patent, or the ’725 patent, prior… of the ’076 patent, the ’498 patent, the ’021 patent, the ’554 patent, the ’259 patent, and the ’725 External link to document
2018-01-02 137 Patent/Trademark Report to Commissioner of Patents B2 ;8,900,554 B2 ;9,211,259 B2 ;9,265,725 B2 ;10,117,812 B2. (Attachments: # 1 Dismissal Order)(nmf) (… Report to the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,700,076 B2 ;…2018 17 October 2019 1:18-cv-00013 835 Patent - Abbreviated New Drug Application(ANDA) None External link to document
2018-01-02 4 the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 7,700,076 B2; 8,435,498 B2; 8,722,021…2018 17 October 2019 1:18-cv-00013 835 Patent - Abbreviated New Drug Application(ANDA) None External link to document
2018-01-02 67 infringement of United States Patent No. 10,117,812 (“the ’812 patent”) (Exhibit A), arising from the…infringed U.S. Patent No. 7,700,076 (“the ’076 patent”), U.S. Patent No. 8,435,498 (“the ’498 patent”), U.S.…U.S. Patent No. 8,722,021 (“the ’021 patent”), U.S. Patent No. 8,900,554 (“the ’554 patent”), U.S. Patent… The ’812 patent is from the same patent family as the Related Patents. The ’812 patent and the Related…9,211,259 (“the ’259 patent”), and U.S. Patent No. 9,265,725 (“the ’725 patent”) (collectively, “the External link to document
2018-01-02 68 the Commissioner of Patents and Trademarks for Patent/Trademark Number(s) 10,117,812 B2 . (Smith, Rodger…2018 17 October 2019 1:18-cv-00013 835 Patent - Abbreviated New Drug Application(ANDA) None External link to document
2018-01-02 71 Initial Invalidity Contentions Regarding U.S. Patent No. 10,117,812 filed by Perrigo UK FINCO Limited Partnership…2018 17 October 2019 1:18-cv-00013 835 Patent - Abbreviated New Drug Application(ANDA) None External link to document
>Date Filed >Document No. >Description >Snippet >Link To Document

Last updated: July 27, 2026

ecutive summary The U.S. litigation LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-00013 concerns patent infringement claims asserted by LEO Pharma against Teva. The record supporting a litigation summary with case posture, asserted patents, key filings, claim constructions, validity/infringement holdings, and current status is not provided here, so a complete, accurate litigation-and-patent analysis cannot be produced.

LEO Pharma v. Teva Pharmaceuticals USA, Inc. 1:18-cv-00013: What is the litigation summary and case status?

A litigation summary requires, at minimum, the complaint’s asserted patents and claims, the answer and defenses, the PTAB or FDA-related context (if invoked), the operative scheduling order, and the dispositive rulings or settlement docket entries. Those details are not included in the available information for 1:18-cv-00013, so no accurate case status can be stated.

What did LEO Pharma accuse Teva of infringing?

To summarize infringement allegations, the asserted patent numbers, product(s)/ANDA(s), and specific claim limitations mapped to the accused formulation/device must be identified from the complaint and any claim charts.

What defenses did Teva raise (noninfringement, invalidity, or unenforceability)?

A defensible analysis depends on whether Teva’s invalidity theories included anticipation/obviousness grounds, written description/enablement, indefiniteness, or inequitable conduct, plus any procedural defenses (no jurisdiction, failure to state a claim, or patent-specific defenses).

What has the court decided (motions to dismiss, summary judgment, or claim construction)?

A “litigation analysis” requires the outcome of:

  • claim construction decisions (Markman)
  • motions to dismiss or transfer
  • summary judgment on infringement/validity
  • preliminary injunction proceedings (if any)
  • trial verdicts or Rule 50/59 motions (if any)

Those rulings are not included.


Which patents are at issue in LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc., 1:18-cv-00013?

A correct patent list requires the asserted patent numbers from the complaint and any later amended complaint.

How many patents were asserted, and what is each patent’s expiration?

Patent-by-patent expiration analysis needs the patent numbers and prosecution history context for terminal disclaimers and any PTA adjustments.

Are the patents product, method-of-use, or formulation patents?

Patent category mapping requires reading the claims asserted (formulation composition, method-of-use instructions, device claims, or process/manufacturing steps).


What paragraph IV or ANDA timing drove LEO Pharma’s suit against Teva?

For ANDA-driven cases, the litigation summary usually hinges on:

  • Orange Book-listed patents for the reference product
  • the generic applicant and ANDA filing date
  • the Paragraph IV notice date
  • the statutory 30-month stay timeline
  • whether TEVA or its affiliate entered through an exclusivity or carveout

Those regulatory dates and Orange Book listings are not provided.


What is the Orange Book status of LEO Pharma’s reference product in the Teva case?

An Orange Book status summary must cite:

  • listed patents and their expiration
  • regulatory exclusivities (if any)
  • whether the suit targeted formulation or method-of-use listings

No Orange Book listing content is available for 1:18-cv-00013 here.


How does Teva’s accused product relate to the claimed LEO Pharma formulation or method-of-use?

Technical comparison needs the accused labeling/formulation details (e.g., strength, vehicle, dosing regimen) and the patent claim language.

Without access to the complaint and claim charts, a mapping is not possible.


What claim construction did the court adopt in LEO Pharma v. Teva, 1:18-cv-00013?

Claim construction analysis requires the specific adopted constructions, rejected constructions, and any “plain and ordinary meaning” determinations.

Those inputs are not present.


Did the court address patent validity (obviousness, anticipation, written description, enablement)?

A validity analysis depends on the exact invalidity grounds pleaded and the court’s analysis in any order.

No validity decision details are provided.


Did the case end in a settlement, dismissal, or final judgment?

A precise litigation outcome summary needs the docket’s final disposition, including any consent judgment, stipulation of dismissal (with or without prejudice), or settlement-related entries.

No disposition information is provided.


Key litigation timeline for LEO Pharma v. Teva (1:18-cv-00013)

A timeline must include filing and procedural milestones, such as:

  • complaint filing date
  • service and answer dates
  • amended complaint dates
  • Markman dates and claim construction order date
  • summary judgment or Daubert dates
  • trial dates or dispositive hearing dates
  • dismissal/judgment date

No milestone dates are supplied.


How strong is LEO Pharma’s patent estate versus Teva’s generic entry risk in this case?

Strength analysis requires, at minimum:

  • which patents were asserted
  • how the court treated them (if any decision exists)
  • whether validity was conceded or adjudicated
  • enforceability findings or prior art strength

Without asserted patents and rulings, the analysis would be nonfactual.


Key Takeaways

  • A litigation summary and patent litigation analysis for LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc., No. 1:18-cv-00013 requires docket-specific inputs (asserted patents, procedural posture, and dispositive rulings). Those details are not available in the provided information.
  • A complete, accurate summary cannot be produced without the complaint and the operative orders or docket disposition.

FAQs

  1. What information is needed to summarize infringement allegations in a Hatch-Waxman case like 1:18-cv-00013?
  2. How do Orange Book “listed patents” typically drive the scope of a Paragraph IV infringement suit?
  3. What procedural events most affect litigation leverage in a generic patent case (Markman, summary judgment, Daubert)?
  4. How are method-of-use versus formulation patents handled differently at claim construction?
  5. What docket signals usually distinguish a settlement from a merits-based dismissal in patent infringement suits?

References

  1. (No source content provided for LEO Pharma A/S v. Teva Pharmaceuticals USA, Inc., 1:18-cv-00013 beyond the case caption.)

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