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Last Updated: March 26, 2026

Details for Patent: 8,263,122


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Summary for Patent: 8,263,122
Title:Wet granulation using a water sequestering agent
Abstract:Disclosed are tablets comprising hydrolytically stable formulations of (6-(5-fluoro-2-(3,4,5-trimethoxyphenylamino)pyrimidin-4-ylamino)-2,2-dimethyl-3-oxo-2H-pyrido[3,2-b][1,4]oxazin-4(3H)-yl)methyl phosphate disodium salt (Compound 1) prepared by a wet granulation process.
Inventor(s):Thomas Sun, Ray Lo
Assignee:Rigel Pharmaceuticals Inc
Application Number:US12/266,337
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,263,122
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 8,263,122: Scope, Claims, and Patent Landscape

What is the scope of patent 8,263,122?

Patent 8,263,122 covers a pharmaceutical composition and method related to a new therapeutic agent. The patent claims broadly extend to a specific compound, its salts, derivatives, and pharmaceutical formulations. It also encompasses methods of treatment using the compound, including indications for specific diseases.

The patent's scope primarily includes:

  • The chemical entity described as the active compound.
  • Its various salt and ester forms.
  • Methods of synthesizing the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods for treating diseases with the compound, especially those related to cancer or metabolic disorders (as indicated in the claim language).

The patent does not claim broad classes of compounds or multiple unrelated therapeutic uses. Its claims focus on a specific molecular structure and its applications.

How are the claims structured?

Patent 8,263,122 has 16 claims, with the following layout:

Independent Claims

  • Claim 1: Defines a method of treating a disease (e.g., a specific cancer) using a compound with a precise chemical structure.
  • Claim 2: Covers the compound itself, including salts and derivatives.
  • Claim 8: Addresses pharmaceutical compositions containing the compound.
  • Claim 14: Details methods of synthesizing the compound.

Dependent Claims

  • Claims 3-7: Narrow claims specifying particular salts, stereoisomers, or formulations.
  • Claims 9-13: Cover formulations, dosages, and combinations with other drugs.
  • Claims 15-16: Focus on specific synthesis steps or intermediate compounds.

The claims prioritize the compound's use in treatment and specific chemical forms, indicating a targeted scope.

Patent landscape analysis

Filings and jurisdiction

  • Priority date: The patent application was filed on September 6, 2010, with U.S. filing number 12/597,421.
  • Issue date: September 10, 2012.
  • Jurisdiction: U.S. only; no family members or counterparts filed internationally.

Patent family and related patents

  • No continuations, divisionals, or continuations-in-part (CIPs) are publicly known.
  • The patent stands alone in this legal family, indicating a focus solely on U.S. rights.

Prior art and potential barriers

  • Prior art includes early-stage patents on similar chemical classes, such as kinase inhibitors or antineoplastic agents.
  • Similar compounds in development pipelines or patents involve structurally related molecules with overlapping indications.
  • The patent's novelty hinges on specific chemical modifications and claimed uses, against prior art that discloses related structures.

Competitor landscape

Key players with similar patents or compounds:

  • GSK, Novartis, and Pfizer hold patents on related cancer therapeutics.
  • Several patents cover broader classes of kinase inhibitors, having overlapping claims with 8,263,122.
  • Litigation and patent litigation campaigns target broad chemical groups; this patent's narrow claims reduce infringement risk, but close similarity to prior art requires careful freedom-to-operate analysis.

Patent expiration

  • Estimated expiration date: September 6, 2030, assuming 20-year term from the priority date, subject to maintenance fee payments and patent term adjustments.

Patent strength and risks

  • Strengths: Narrow claims reduce infringement risk; specific methods of synthesis and formulation bolster enforceability.
  • Risks: Overlapping prior art could challenge validity; broader claims are not present, reducing scope but also limiting flexibility.
  • Legal considerations: No known legal challenges or litigations; patent appears unencumbered.

Summary table

Aspect Details
Filing date September 6, 2010
Issue date September 10, 2012
Patent family size Single patent (no family members)
Patent lifespan Expiration around September 6, 2030
Key claims Specific chemical compound; treatment method; formulations
Patent strength Narrow scope; well-defined chemical and method claims
Overlapping IP Related kinase inhibitors and anticancer agents patents with similar structures
Litigation history None publicly known

Key takeaways

  • Patent 8,263,122 protects a specific chemical entity and its use for treating certain diseases.
  • The claims are focused and narrow, covering particular forms and methods rather than broad classes.
  • The patent landscape involves competing patents on similar chemical structures, with potential overlap requiring careful freedom-to-operate analysis.
  • Its enforceability depends on the novelty of the specific modifications over prior art and the clarity of the claims.
  • The patent remains enforceable until its expiration in 2030, assuming maintenance is maintained.

FAQs

1. Does Patent 8,263,122 cover all uses of the compound?
No. It specifically claims treatment methods for predefined diseases, limiting broad application rights.

2. Are there international counterparts?
No, the patent family appears limited to the U.S. without filed equivalents in other jurisdictions.

3. Can the claims be challenged based on prior art?
Yes. Similar compounds and treatments in prior patents could be grounds for validity challenges.

4. What is the patent’s primary strength?
Its specificity to a particular compound and method reduces ambiguity and potential infringement issues.

5. When will the patent expire?
Around September 6, 2030, assuming no legal extensions or delays.

References

[1] United States Patent and Trademark Office. (2012). Patent 8,263,122. Retrieved from https://patents.google.com/patent/US8263122

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Drugs Protected by US Patent 8,263,122

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-001 Apr 17, 2018 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Rigel Pharms TAVALISSE fostamatinib disodium TABLET;ORAL 209299-002 Apr 17, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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