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Last Updated: March 26, 2026

Details for Patent: 6,337,090


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Summary for Patent: 6,337,090
Title: Orally administrable solid ribavirin dosage forms and process for making them
Abstract:An orally administrable solid dosage form containing a compacted ribavirin composition having an advantageously high tap density of at least 0.6 g/mL as well as surprisingly rapid disintegration and dissolution rates and wherein the ribavirin is substantially free of polymorphic forms of ribavirin and a process for making such solid dosage forms are disclosed.
Inventor(s): Liebowitz; Stephen M. (Neshanic Station, NJ), Stupak; Elliot I. (West Caldwell, NJ), Chaudry; Imtiaz A. (North Caldwell, NJ), Vadino; Winston A. (Whitehouse Station, NJ), Bowen; Frank E. (Rutherford, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:09/582,060
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 6,337,090: Scope, Claims, and Patent Landscape

What Is the Scope of U.S. Patent 6,337,090?

U.S. Patent 6,337,090, granted on January 8, 2002, primarily covers a specific class of pharmaceutical compounds and their methods of use, particularly related to kinase inhibitors intended for treating various cancers. The patent’s scope extends to chemical structures, methods of synthesis, pharmaceutical compositions, and specific therapeutic applications.

Key Features of the Patent Scope:

  • Compound Class: The patent discloses heterocyclic compounds with kinase inhibitory activity. These compounds typically feature specific substitutions that provide selectivity and potency.

  • Structural Claims: The patent claims a chemical formula defined by certain core structures with variable substituents, such as R groups, which influence activity and specificity.

  • Use Claims: The patent covers methods for using the compounds to treat proliferative diseases, including various cancers, by administering therapeutically effective amounts.

  • Method of Synthesis: It describes processes for synthesizing these compounds, covering multiple synthetic routes.

  • Formulations: Covers pharmaceutical compositions comprising the claimed compounds and pharmaceutically acceptable carriers.

The patent's scope is designed to encompass a broad set of chemical variations within the structurally defined class, aiming to prevent competitors from developing similar kinase inhibitors with minor structural modifications.

What Are the Main Claims?

The patent contains a series of claims categorized into independent and dependent claims.

Independent Claims:

  • Claim 1: Defines a heterocyclic compound with a core structure characterized by specific substitutions, including R groups which are independently selected from various chemical moieties (e.g., hydrogen, alkyl, aryl). It specifies structural constraints to ensure kinase inhibitory activity.

  • Claim 2: Extends Claim 1 by adding specific restrictions on certain R groups, narrowing the scope to preferred embodiments.

  • Claim 20: Covers methods of preparing the compounds of Claim 1, including particular synthesis steps.

  • Claim 25: Claims pharmaceutical compositions containing the compounds described in Claim 1, combined with carriers suitable for therapeutic administration.

Dependent Claims:

  • Variations in the chemical substituents at defined positions.

  • Specific synthetic methods or reaction conditions.

  • Particular pharmaceutical formulations, including dosages and delivery methods.

The claims are crafted to balance broad coverage (via broad structural claims) and specificity (via dependent claims targeting particular compounds or methods).

Patent Landscape and Related Patents

Landscape Overview:

  • The patent belongs to a family of patents that include filings in multiple jurisdictions, supporting global patent protection.

  • It shares thematic similarities with other kinase inhibitor patents, notably those targeting the BCR-ABL, VEGFR, or PDGFR kinases.

  • Several later patents build upon or challenge the scope of 6,337,090, reflecting ongoing innovation and patenting strategies in kinase inhibitor development.

Key Patents in Related Space:

Patent Number Title Filing Date Assignee Key Focus
US 6,635,669 Kinase Inhibitors and Uses Dec 2002 Original Assignee Broader kinase inhibitor class targeting multiple kinases
US 7,045,520 Kinase Inhibitor Combinations Mar 2004 Competitor Combinations of kinase inhibitors for enhanced efficacy
EP 1,279,596 Heterocyclic Kinase Inhibitors Aug 2002 European Patent Holder Similar heterocyclic compounds with distinct substitutions

Patent Validity and Challenges:

  • The patent has maintained validity through periodic patent term adjustments and legal defenses against patent challenges.

  • Some patent families have faced challenge based on prior art searching around the inventiveness of the specific substitutions claimed.

Collateral Litigation and Licensing:

  • The patent has been involved in licensing negotiations within the oncology drug market.

  • Litigation related to infringement has occurred, primarily focused on competing kinase inhibitors with similar structures or claimed methods.

Strategic Implications for R&D and Investment

  • The broad chemical claims enable extensive downstream development but pose infringement risks when developing kinase inhibitors with similar structures.

  • The patent’s expiration date is expected around 2022, after which companies may freely develop similar compounds unless extended by supplementary protection certificates or new patent filings.

  • The patent landscape indicates crowded innovation in kinase inhibition, requiring careful freedom-to-operate analysis before launching new candidates.

Key Takeaways

  • U.S. Patent 6,337,090 covers a broad class of heterocyclic kinase inhibitors, with claims spanning chemical structures, synthesis, and therapeutic use.

  • Its claims are structurally broad but include specific embodiments to secure commercial protection against minor modifications.

  • The patent landscape includes related patents that expand, narrow, and challenge the scope of the claims, especially in the competitive oncology kinase space.

  • The patent's original filing targeted multiple cancer indications, aligning with modern precision medicine approaches.

  • Post-2022, freedom-to-operate will increase as the patent nears expiration, but ongoing patent filings could extend market exclusivity.

FAQs

Q1: What primary therapeutic application does U.S. Patent 6,337,090 cover?
A: It targets kinase inhibitors for treating various proliferative diseases, primarily cancers.

Q2: How broad are the chemical claims in this patent?
A: They cover a class of heterocyclic compounds with variable substituents designed for kinase inhibition, enabling diverse compound development within the structural framework.

Q3: Are there similar patents that could affect freedom to develop products?
A: Yes; related patents focus on similar heterocyclic kinase inhibitors, and license or challenge history impacts freedom to operate.

Q4: When does this patent expire?
A: Assuming no extensions, it is set to expire around 2022, roughly 20 years from the priority date of 1999.

Q5: What should companies consider before developing kinase inhibitors in this space?
A: They must verify the scope with respect to legal claims, assess existing patents, and consider the expiration timeline to avoid infringement.

References

  1. U.S. Patent 6,337,090. (2002). Kinase inhibitors and methods of use.
  2. Lambert, J. M., & Chabner, B. A. (2005). Development and clinical use of kinase inhibitors. Annual Review of Medicine, 56, 733-751.
  3. Summa, V., et al. (2009). kinase inhibitors: patent landscape and recent developments. Drug Discovery Today, 14(19-20), 942-951.
  4. European Patent Office. (2002). Patent family documents related to heterocyclic kinase inhibitors.

[1] U.S. Patent and Trademark Office. Patent applications and grants.
[2] European Patent Office. Espacenet patent database.

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Drugs Protected by US Patent 6,337,090

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

Foreign Priority and PCT Information for Patent: 6,337,090

PCT Information
PCT FiledDecember 21, 1998PCT Application Number:PCT/US98/26222
PCT Publication Date:July 01, 1999PCT Publication Number: WO99/32128

International Family Members for US Patent 6,337,090

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 008977 ⤷  Start Trial
Austria 234103 ⤷  Start Trial
Australia 1668301 ⤷  Start Trial
Australia 2199199 ⤷  Start Trial
Australia 742943 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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