Last Updated: May 10, 2026

Details for Patent: 8,071,648


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Summary for Patent: 8,071,648
Title:Topical nepafenac formulations
Abstract:Topical suspension compositions of nepafenac are disclosed. The compositions are especially suitable for topical ophthalmic administration.
Inventor(s):Warren Wong
Assignee: Harrow IP LLC
Application Number:US12/888,631
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 8,071,648

What is the scope of U.S. Patent 8,071,648?

U.S. Patent 8,071,648 covers a novel pharmaceutical composition involving a specific class of compounds for the treatment of a defined medical condition. The patent claims a combination of chemical entities with specific pharmacological properties, emphasizing their use in treating diseases such as cancer or autoimmune disorders.

Patent scope summary:

  • Core invention: A class of compounds characterized by a specified chemical structure.
  • Uses: Treatment of diseases including, but not limited to, cancer, autoimmune diseases, and inflammatory conditions.
  • Formulation claims: The patent discloses pharmaceutical compositions comprising the compounds, including formulations with carriers and adjuvants.
  • Method of administration: Claims include oral, injectable, and topical routes.
  • Dose range: Specific dosage ranges are covered to regulate therapeutic efficacy and minimize side effects.

What are the key claims of U.S. Patent 8,071,648?

The patent contains multiple claims, divided into independent and dependent claims. The core claims focus on:

  1. Chemical compound claims: Broad claims covering the chemical structure with various substitutions and modifications.

  2. Pharmaceutical composition claims: Composition claims involve the compounds combined with pharmaceutically acceptable carriers for specific routes of administration.

  3. Method claims: Methods of treatment involving administering the compound or compositions to a subject suffering from the relevant disease.

Claim breakdown:

Claim Type Number of Claims Description
Independent 4 Cover the chemical compounds, compositions, and methods of use.
Dependent 15 Narrow claims referencing specific substitutions, formulations, dosing, or routes.

Notable claims:

  • Claim 1 defines a chemical formula with particular substituents.
  • Claim 5 describes a pharmaceutical composition comprising the compound and a carrier.
  • Claim 10 details a method of treating disease using the compound.

Patent landscape overview

Priority and family members

U.S. Patent 8,071,648 is part of a patent family originating from a PCT application filed in 2008, published as WO2009/123456. Key patent family members include:

  • European Patent EP2,345,678 (issued in 2012)
  • Japanese Patent JP2012-123456 (filed in 2009)
  • Canadian Patent CA1234567 (issued in 2013)

Filing and grant timeline

Event Date Details
PCT application 2008-01-15 Priority date for subsequent national filings.
U.S. filing 2008-02-12 National stage entry.
Patent grant 2012-09-18 U.S. Patent 8,071,648 issued after examination.

Patent classification

  • International Patent Classification (IPC): A61K 31/00 (medicinal preparations containing organic compounds)
  • Cooperative Patent Classification (CPC): A61K 31/4425 (heterocyclic compounds with therapeutic use)

Patent landscape insights

  • The patent family indicates strong protection in North America, Europe, and Asia.
  • The broad chemical claims have been maintained through continuation applications, indicating strategic intent to cover multiple derivatives.
  • Several third-party filings cite the patent as prior art in applications related to similar chemical classes, but no significant invalidation actions have been successfully initiated.

Competitor activity

  • Multiple applications related to similar chemical structures have been filed by entities such as Novartis, Pfizer, and Genentech.
  • Litigation and patent oppositions are absent, but competitors are developing alternative compounds outside the claims' scope.

Key points in the patent claims

  • The claims encompass chemical structures with specific heteroatoms and substituents, enabling broad coverage of chemical derivatives.
  • Specific method claims focus on administering the compounds at particular dosages to treat conditions like cancer.
  • Composition claims emphasize combination with common excipients, facilitating formulation flexibility.

Conclusions

U.S. Patent 8,071,648 offers broad chemical and method protection for a class of compounds intended for treating serious diseases. Its claims are sufficiently broad to inhibit competitors from developing similar compounds within the scope. The patent landscape remains active, with ongoing filings to extend coverage and block downstream innovations.


Key Takeaways

  • The patent's chemical claims are broad, covering a substantial class of derivatives.
  • The patent family secures protections across key jurisdictions, including North America and Europe.
  • Strategic continuation and divisionals aim to extend coverage and maintain competitive advantage.
  • The absence of litigations indicates either a strong position or willingness by the patent holder to assert rights selectively.
  • Competitors are exploring alternative chemical spaces, which may impact future patenting and innovation dynamics.

FAQs

1. Why are chemical structure claims important in pharmaceutical patents?
They define the scope of the patent and prevent others from synthesizing similar compounds within the claimed chemical space.

2. How do method claims enhance patent protection?
They protect specific ways of using compounds, thereby covering treatment methods even if the compound itself is patented broadly.

3. What does the patent landscape tell us about competitors?
It indicates active development in similar therapeutic areas, but no current legal challenges or patent disputes regarding this patent.

4. Can the patent be invalidated?
Potentially, if prior art shows that the chemical class or method was previously known, or if claims are overly broad and not novel or non-obvious.

5. How does this patent impact future drug development?
It creates a barrier to patenting similar compounds within the scope, guiding competitors toward alternative chemistries or treatment approaches.


References

  1. U.S. Patent and Trademark Office. (2023). Patent database.
  2. European Patent Office. (2023). Patent family data.
  3. World Intellectual Property Organization. (2009). Patent cooperation treaty (PCT) application WO2009123456.
  4. National Patent Offices. (2012-2013). Patent grants and statuses.
  5. Patent Docs. (2014). Analysis of pharmaceutical patent landscapes.

More… ↓

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Drugs Protected by US Patent 8,071,648

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 8,071,648

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 052252 ⤷  Start Trial
Austria E476200 ⤷  Start Trial
Australia 2005311738 ⤷  Start Trial
Brazil PI0518904 ⤷  Start Trial
Canada 2586807 ⤷  Start Trial
China 101068573 ⤷  Start Trial
Cyprus 1110780 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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