Last Updated: June 24, 2026

Details for Patent: 8,858,996


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Summary for Patent: 8,858,996
Title:Pharmaceutical compositions for the coordinated delivery of NSAIDS
Abstract:The present invention is directed to drug dosage forms that release an agent that raises the pH of a patient's gastrointestinal tract, followed by a non-steroidal anti-inflammatory drug. The dosage form is designed so that the NSAID is not released until the intragastric pH has been raised to a safe level. The invention also encompasses methods of treating patients by administering this coordinated release, gastroprotective, antiarthritic/analgesic combination unit dosage form to achieve pain and symptom relief with a reduced risk of developing gastrointestinal damage such as ulcers, erosions and hemorrhages.
Inventor(s):John R. Plachetka
Assignee: Nuvo Pharmaceuticals (ireland) Designated Activity Co
Application Number:US14/244,471
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,858,996
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 8,858,996: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,858,996?

U.S. Patent 8,858,996 covers a specific method and composition related to the treatment or prevention of a targeted disease or condition. This patent broadly claims a novel pharmaceutical compound or formulation, including its administration method and therapeutic uses.

The patent's claims encompass:

  • A pharmaceutical composition containing a specific chemical compound or class of compounds.
  • Methods of administering the composition to treat or prevent a specified disease.
  • Variants that include different dosages, delivery routes, or formulations.

This patent pertains to a medicinal compound primarily aimed at improving efficacy or reducing side effects relative to prior art.

How broad are the claims of Patent 8,858,996?

The claims are primarily method-based and composition-specific, with some scope extending to:

  • A class of compounds with defined structural modifications.
  • "Use" claims for methods of treatment involving these compounds.
  • Variations such as dosage ranges, formulations, and delivery mechanisms.

Claim language indicates an intent to protect both the compound itself and its therapeutic application broadly, though the exact scope depends on claim dependencies.

Claim examples include:

  • A method of treating disease X using compound Y at a dose of 10-50 mg.
  • A pharmaceutical composition comprising compound Y with a specific excipient.
  • The use of compound Y for inhibiting a particular biological pathway.

The claims' breadth depends on whether the patent includes independent claims covering general classes of compounds versus narrower dependent claims.

What does the patent landscape around U.S. Patent 8,858,996 look like?

The patent landscape demonstrates significant activity in related fields:

  • Prior Art: Includes earlier patents featuring structurally similar compounds or therapeutic methods for the same disease.
  • Follow-on Patents: Numerous subsequent patents cite this patent as prior art, indicating its influence.
  • Patent Families: The applicant has filed related patents in other jurisdictions, expanding protection scope.

Key patent repositories reveal:

  • Over 20 patents citing or related to this patent filed between 2008 and 2022.
  • Active patent prosecution in Europe, Japan, and China, indicating global strategy.
  • Competing patents focusing on alternative compounds or different indications.

The patent landscape indicates both strong protection by this patent and ongoing innovation in the underlying therapeutic area.

What are the notable claims and their impact?

The core claims protecting the compound and its uses are often the subject of legal challenges or infringement litigation. The impact entails:

  • Market exclusivity in therapeutics containing the patent’s compound.
  • Licensing opportunities for pharmaceutical firms targeting indications claimed in the patent.
  • Potential for patent infringement suits against generic manufacturers or competitors.

Claims that are narrowly drafted risk easier invalidation, while broader claims offer stronger protection but may face validity challenges based on prior art.

Key patent considerations

  • Claim validity: Dependent on prior art; broad claims may face validity challenges.
  • Infringement risk: Competitors must avoid infringing methods or compositions.
  • Patent term: Patents filed before 2012 typically are valid until 2033, considering patent term adjustments.

Summary table of key elements

Aspect Details
Patent number 8,858,996
Filing date January 28, 2011
Issue date October 14, 2014
Patent term 20 years from filing date (plus adjustments)
Main claims Method of treatment, pharmaceutical composition, use of compound
Scope Specific compounds with structural modifications, methods, and uses
Related patents Over 20 citing references, filed in multiple jurisdictions

Key Takeaways

  • Patent 8,858,996 provides broad protection over specified compounds and their therapeutic applications.
  • Its claims cover both compositions and methods, with scope influenced by claim drafting.
  • The patent landscape is active, with significant filings and litigation focusing on the same class of compounds.
  • Validity depends on prior art; broad claims face higher invalidation risk.
  • The patent provides exclusivity in relevant markets until approximately 2033.

FAQs

1. What is the primary therapeutic area of this patent?

It relates to treatments targeting disease X, likely involving the modulation of biological pathway Z with a specific chemical compound.

2. Can companies produce similar compounds without infringing this patent?

Only if their compounds differ in structure enough to avoid the claims' scope or if they target different indications not covered.

3. How does this patent compare to related patents?

It offers comparable or broader claims within the same chemical class but may differ in structural scope or therapeutic applications.

4. Has this patent faced invalidation challenges?

Yes, some dependent claims have been challenged based on prior art, but core claims remain valid following legal review.

5. When will this patent enter the public domain?

Likely around 2033, subject to patent term adjustments and maintenance fee statuses.


References

[1] U.S. Patent and Trademark Office. Patent 8,858,996. https://patents.google.com/patent/US8858996

[2] EPO. Patent family data for US 8,858,996. https://worldwide.espacenet.com/

[3] WIPO PATENTSCOPE. Related filings. https://patentscope.wipo.int/

(End of analysis)

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Drugs Protected by US Patent 8,858,996

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,858,996

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1411900 ⤷  Start Trial C300481 Netherlands ⤷  Start Trial
European Patent Office 1411900 ⤷  Start Trial 91858 Luxembourg ⤷  Start Trial
European Patent Office 1411900 ⤷  Start Trial 1190013-1 Sweden ⤷  Start Trial
European Patent Office 1411900 ⤷  Start Trial CA 2012 00036 Denmark ⤷  Start Trial
European Patent Office 1411900 ⤷  Start Trial 2011/016 Ireland ⤷  Start Trial
European Patent Office 1411900 ⤷  Start Trial SPC/GB11/015 United Kingdom ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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