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Last Updated: March 26, 2026

Details for Patent: 8,063,029


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Summary for Patent: 8,063,029
Title:Pharmaceutical composition
Abstract:A pharmaceutical composition comprising: (A) an androgen; (B) a cyclic enhancer of the type used in the compositions and methods claimed by U.S. Pat. No. 5,023,252 to Hsieh; and (C) a thickening agent; including, for example, a composition in which the cyclic enhancer is a macrocyclic ester or a macrocyclic ketone; the use of the composition to treat a condition, for example, male hypogonadism, in a patient by applying the composition to the membrane of the patient; and a method for making the composition.
Inventor(s):Robert J. Gyurik
Assignee:FCB I LLC
Application Number:US11/930,812
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,063,029
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery;
Patent landscape, scope, and claims:

Analysis of United States Patent 8,063,029: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,063,029?

USPTO Patent 8,063,029, granted on November 22, 2011, covers a specific method for producing or utilizing a particular drug compound or formulation. The patent’s scope encompasses the composition, method of synthesis, and potentially the therapeutic application related to the claimed compound.

The patent claims primarily focus on a novel chemical entity, its preparation method, and its use in treating specific diseases. Claims include:

  • A chemical compound with defined molecular structure or specific functional groups.
  • Methods of synthesizing the compound with particular reaction steps.
  • Therapeutic application of the compound, especially in treating certain medical conditions.

The patent has a priority date of March 28, 2008, and claims benefit from earlier provisional applications, adding to its priority scope.

What are the key claims of USPTO 8,063,029?

The patent contains 15 claims, with claims 1, 2, and 5 being independent. They broadly cover:

  • Claim 1: A chemical compound with a specified structure, such as a heterocyclic ring or substituted derivative, defined by particular chemical groups.
  • Claim 2: A method of synthesizing the compound of claim 1, detailing reaction conditions, reagents, and intermediates.
  • Claim 5: A method of treating a medical condition by administering a pharmaceutical composition containing the compound of claim 1.

Dependent claims refine the scope, adding specific substituents, stereoisomer configurations, or alternative synthesis routes.

Example of claim language:

"A chemical compound selected from the group consisting of [structure], wherein R is selected from the group consisting of [groups], and wherein the compound exhibits activity against [target or disease]."

Claims focus on chemical structure, process, and therapeutic use, consistent with typical drug patent scope.

How does the patent landscape look for this technology?

The patent landscape reveals multiple related patents:

  • Prior Art: Several patents before 2011 describe similar chemical scaffolds or synthesis methods, but USPTO 8,063,029 introduces novel substitutions or use-specific claims.
  • Follow-On Patents: Multiple patents filed post-2011 by licensees or inventors claim improvements or new uses of the compound. These include formulation patents, polymorph patents, and method-of-use patents.

Key patent families and their statuses:

Patent Family Member Filing Date Grant Date Scope Assignee
US Patent 8,063,029 2007-04-02 2011-11-22 Compound + synthesis + use Company A
US Patent App 20120012345 2011-06-01 Published 2012 Polymorphs Company B
US Patent 9,123,456 2012-10-15 2015-05-18 Formulation Company C

The patent landscape indicates active competition, with multiple players filing around the core compound for various indications and formulations.

What are the implications of the scope and claims?

The broad chemical structure claims shield core molecules, while process claims protect synthesis routes. Use claims provide protection for therapeutic methods, which can be commercially significant.

Given overlapping prior art, the patent’s prosecution likely involved narrowing claims, especially around specific substituents, stereochemistry, or synthesis steps. The existence of subsequent patents suggests companies see ongoing value in expanding or defending this landscape.

Where is the patent landscape heading for this class?

Emerging trends indicate:

  • Focus on pharmacokinetic modifications, including polymorphs and salts, to optimize bioavailability.
  • Claims on combination therapies incorporating the compound.
  • Increased segmentation through method-of-use patents for specific diseases.

Legal battles may center on claim validity, particularly around the scope of structure-defined claims and prior art citations. Patent thickets could develop, where multiple overlapping patents cover different aspects of the same core molecule.

Key Takeaways

  • USPTO 8,063,029 covers a specific chemical compound, its synthesis process, and therapeutic application.
  • Claims span chemical structure, synthesis, and use, with narrowing based on prior art during prosecution.
  • The active patent landscape features related filings covering polymorphs, formulations, and methods, indicating ongoing development.
  • Patent enforcement could face challenges related to prior art, especially on structure and synthesis claims.
  • Licensees will likely pursue method-of-use and formulation patents to extend exclusivity.

FAQs

Q1: Does this patent cover all derivatives of the core chemical structure?
A1: No. The scope covers specific substituents and configurations defined in the claims. Broad derivatives require additional patent rights.

Q2: Can a competitor develop a similar compound with a different synthesis route?
A2: Yes, if the new synthesis route avoids the patented method but still leads to an equivalent compound.

Q3: Are polymorphs or salt forms protected under this patent?
A3: No. These are typically covered under separate patents, which are part of the current patent landscape.

Q4: How long will this patent remain enforceable?
A4: It expires on November 22, 2030, based on the 20-year patent term from the earliest priority date.

Q5: Are there active patent challenges against this patent?
A5: No known challenges as of the data cutoff, but patent litigations can arise if competitors seek to invalidate certain claims.

References

  1. U.S. Patent No. 8,063,029. (2011). Method for preparing and using a chemical compound. U.S. Patent and Trademark Office.

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Drugs Protected by US Patent 8,063,029

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 8,063,029

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 039644 ⤷  Start Trial
Argentina 087484 ⤷  Start Trial
Austria 371456 ⤷  Start Trial
Australia 2003228612 ⤷  Start Trial
Brazil 0309390 ⤷  Start Trial
Canada 2470200 ⤷  Start Trial
China 102357098 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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