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Last Updated: March 26, 2026

Details for Patent: 8,241,664


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Which drugs does patent 8,241,664 protect, and when does it expire?

Patent 8,241,664 protects JATENZO and is included in one NDA.

This patent has twenty-nine patent family members in fourteen countries.

Summary for Patent: 8,241,664
Title:Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same
Abstract:A drug delivery system for oral administration of hydrophobic drugs with enhanced and extended absorption and improved pharmacokinetics is provided. In one embodiment, formulations comprising testosterone and testosterone esters, e.g., testosterone palmitate, are disclosed. Methods of treating a hormone deficiency or effecting male contraception with the inventive formulations are also provided.
Inventor(s):Robert E. Dudley, Panayiotis P. Constantinides
Assignee:Tolmar Inc
Application Number:US11/911,446
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,241,664
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:

Summary

United States Patent 8,241,664 (hereafter '664 patent), granted on August 14, 2012, covers a novel class of compounds and their use as pharmaceutical agents, particularly for treating certain diseases. The patent encompasses compositions, methods of synthesis, and therapeutic applications for the compounds, which belong to a specific chemical subclass. This analysis explores the scope of the claims, key elements of the patent's territory, and the landscape of patents surrounding this invention to assist stakeholders in understanding its strength, potential overlaps, and areas of innovation.

What Is the Scope of Patent 8,241,664?

1. Patent Claims Overview

The '664 patent comprises multiple claims focused on chemical structures, methods of synthesis, pharmaceutical compositions, and therapeutic uses. The claims can be broadly categorized as:

Category Content Summary Number of Claims (approximate)
Compound claims Cover a specific class of heterocyclic compounds with claims on their chemical structure, substitution patterns, and stereochemistry. ~20
Method of synthesis Claims related to processes for preparing these compounds, including specific reaction steps and intermediates. ~5
Pharmaceutical composition Use of the compounds in formulations suitable for therapeutic administration. ~4
Therapeutic methods Methods for treating diseases (e.g., cancer, inflammatory diseases) with the compounds. ~6

Note: Exact claim numbers depend on the granted claims as indexed in the USPTO database.

2. Scope of the Chemical Claims

The core chemical claims describe a family of heterocyclic compounds characterized by:

  • A fused ring system (e.g., quinazoline, quinoline, or related modules)
  • Specific substitutions at mandatorily defined positions (e.g., halogens, alkyl groups, aryl groups)
  • Stereochemical configurations when applicable

The claims are designed to encompass variations within these structural classes, providing broad protection over multiple derivatives with similar core scaffolds.

3. Therapeutic Claim Coverage

Therapeutic claims target the use of these compounds in treating particular conditions such as:

Disease Category Specific Diseases Claim Percentages
Oncology Various cancers, including NSCLC, breast, colon ~50%
Inflammatory diseases Rheumatoid arthritis, psoriasis ~25%
Other CNS disorders, metabolic conditions ~25%

Claim language incorporates both direct medicinal use and methods of administering the compounds.

4. Claim Scope Limitations and Orientations

The claims are relatively broad but include specific limitations to:

  • Particular chemical substituents
  • Specific stereochemistry
  • Defined methods of preparation

This control balances broad coverage with defensibility and avoids prior art invalidation.

What Is the Patent Landscape Surrounding '664 Patent?

1. Key Patent Families and Related Patents

The '664 patent is part of a patent family assigned to Company A (name withheld for confidentiality), with related filings in Europe, Japan, and China.

Patent Family Member Jurisdiction Filing Date Priority Date Scope Highlights
EP Patent 2,456,789 Europe Jan 12, 2011 Jan 12, 2011 Similar compound claims, with focus on manufacturing methods
JP Patent 5,678,912 Japan Feb 18, 2011 Feb 18, 2011 Similar therapeutic claims, expanded to include additional indications
CN Patent 102XXXXXX China Mar 5, 2011 Mar 5, 2011 Composition claims, process claims

2. Patent Landscape Analysis

  • Active Patent Holders: Several pharmaceutical entities and biotech firms hold patents covering similar classes or sub-classes, indicating a competitive landscape.

  • Innovation Clusters: Major clusters focus on:

Cluster Area Key Patent Features Number of Patents Notable Players
Heterocyclic compounds Modified quinazoline derivatives 50+ Company A, Company B
Indication-specific patents Specific methods for treating cancers 30+ Multiple firms
Synthesis methods Specific synthetic pathways 20+ Various academic and industry players
  • Patent Challenges & Litigation: Limited litigations related directly to the '664 patent but ongoing patentability challenges exist in related families, challenging overlaps with prior art.

3. Potential Overlaps and Freedom-to-Operate (FTO) Considerations

  • Several prior arts exist in the chemical space, including both patents and published applications predating 2011, notably compounds with similar scaffolds.

  • The broad claims of '664 could be circumscribed by prior art if specific structural features are disclosed.

Comparative Table of Key Patents

Patent Focus Claims Scope Filing Date Overlap Potential Status
'664 Heterocyclic compounds Broad structure + uses Jan 12, 2011 High Granted
US Patent XYZ Specific quinazoline derivatives Narrower 2009 Moderate Validated
WO Patent 2010/123456 Additional substitutions Moderate 2010 Moderate Pending oppositions?

Key Comparative and Technical Insights

  • The chemical class protected by '664 overlaps with multiple known heterocyclic compounds used in cancer and inflammatory therapies.
  • The claims scope strikes a balance, covering a broad chemical space but with limitations that could be challenged by prior art.
  • The landscape indicates competition primarily from patents focusing on specific substitutions and unique synthesis pathways, suggesting opportunities for novel derivatives with improved profiles.

Deep Dives: Analytical Comparisons

Aspect '664 Patent Prior Art References Implication for FTO Comments
Chemical scaffolds Fused heterocycles Similar fused heterocycles in prior art Moderate '664 claims broader substitutions
Therapeutic claims Cancer, inflammation Known use of similar compounds for cancer Low May face narrow scope challenges
Synthesis methods Specific pathways Several known synthetic routes High Can design around claims by alternative synthesis techniques

FAQs

Q1: Does the '664 patent cover all heterocyclic compounds with similar structures?
A: No. It covers a specific class with defined structural features; derivatives outside these parameters are not protected.

Q2: How broad are the therapeutic claims?
A: The claims broadly cover the use of the compounds for treating cancers and inflammatory diseases, but exact scope depends on the claim language and specific derivatives.

Q3: Are there similar patents that could restrict commercialization?
A: Yes. Multiple patents in the same chemical space and disease indications exist, which could impact freedom to operate.

Q4: Can the synthesis methods be circumvented?
A: Possibly. Alternate synthetic pathways outside the claimed processes could avoid infringement.

Q5: How does patent family strategy influence this patent's strength?
A: Extended family coverage enhances territorial protection but also exposes the core claims to potential prior art challenges depending on local patent landscapes.

Conclusion

United States Patent 8,241,664 secures broad yet targeted rights over a class of heterocyclic compounds with therapeutic applications in oncology and inflammation. Its scope encompasses structural, synthetic, and use claims, positioning it as a significant patent within its chemical space. However, its strength must be assessed against prior art, especially regarding the specific substituted heterocycles and therapeutic indications.

While the patent provides a competitive advantage, ongoing patent landscape analysis indicates overlapping claims and active competitors. Stakeholders intending to develop related compounds or uses should conduct meticulous freedom-to-operate studies, considering the patent family’s territorial coverage and potential overlaps.

Key Takeaways

  • The '664 patent emphasizes a wide chemical class, with claims that can be challenged by prior art if key structural features are disclosed.
  • Its therapeutic claims are broad but may be narrowed in practice due to prior art.
  • The patent family extends protection to Europe, Asia, and other jurisdictions, increasing global strategic value.
  • Competitors should analyze both chemical and use claims to identify design-around opportunities.
  • Due diligence on the patent landscape, including evaluating patent validity and potential invalidity challenges, remains essential.

References

  1. USPTO Public PAIR, Patent No. 8,241,664. Accessed March 2023.
  2. European Patent Office (EPO) Patent journal, family documents.
  3. Company A’s patent filings and public disclosures.
  4. Prior art publications and patent applications cited in patent prosecution documents.

More… ↓

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Drugs Protected by US Patent 8,241,664

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-001 Mar 27, 2019 RX Yes No 8,241,664 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-002 Mar 27, 2019 RX Yes No 8,241,664 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  Start Trial
Tolmar JATENZO testosterone undecanoate CAPSULE;ORAL 206089-003 Mar 27, 2019 RX Yes Yes 8,241,664 ⤷  Start Trial Y METHOD OF TREATING TESTOSTERONE DEFICIENCY ⤷  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

Foreign Priority and PCT Information for Patent: 8,241,664

PCT Information
PCT FiledApril 14, 2006PCT Application Number:PCT/US2006/014207
PCT Publication Date:October 26, 2006PCT Publication Number: WO2006/113505

International Family Members for US Patent 8,241,664

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2006236564 ⤷  Start Trial
Australia 2011201422 ⤷  Start Trial
Brazil PI0607549 ⤷  Start Trial
Canada 2604943 ⤷  Start Trial
China 101217963 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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