United States Patent 8,058,280: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,058,280, titled "Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof," is a significant patent in the pharmaceutical sector, particularly in the field of gonadotropin-releasing hormone (GnRH) antagonists. This patent, issued to Takeda Pharmaceutical Company Limited, covers a class of compounds with potential therapeutic applications.
Technical Field and Background
The patent pertains to thieno[2,3-d]pyrimidine compounds that exhibit GnRH antagonizing activity. GnRH antagonists are crucial in treating various medical conditions, including hormone-sensitive cancers, endometriosis, and uterine fibroids. The invention involves the synthesis and use of specific thieno[2,3-d]pyrimidine derivatives that have shown strong GnRH antagonistic activity with low toxicity[4].
Patent Scope and Claims
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims are structured to cover the chemical compounds, their synthesis, and their therapeutic uses. Key claims include:
- Chemical Structure: The patent claims compounds of a specific thieno[2,3-d]pyrimidine structure, characterized by particular substituents such as alkyl, alkoxy, and alkoxy carbonyl groups[4].
- Synthesis: Methods for producing these compounds, including purification steps and specific reaction conditions, are also claimed[4].
- Therapeutic Uses: The patent claims the use of these compounds as GnRH antagonists for treating various medical conditions[4].
Claim Metrics and Patent Quality
Research on patent scope and quality suggests that narrower claims, such as those found in this patent, are associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims, which can be seen in the evolution of this patent from its initial filing to its final granted form[3].
Patent Landscape
Patent Family and Geographical Coverage
The patent 8,058,280 is part of a large patent family with thirty-four family members in twenty-five countries. This extensive geographical coverage underscores the global significance of the invention and the strategic importance of protecting it in various jurisdictions[5].
Related Patents and Applications
This patent is a divisional of earlier applications, including U.S. Ser. No. 10/544,069 and PCT/JP2004/000741. The patent history indicates a series of filings and divisions, reflecting the ongoing development and refinement of the invention[4].
Pharmaceutical Drugs Covered
The patent protects two significant pharmaceutical drugs: MYFEMBREE and ORGOVYX. These drugs are included in two New Drug Applications (NDAs) and are used for treating conditions such as uterine fibroids and prostate cancer, respectively[5].
Maintenance and Expiration
Patents in the United States require maintenance fees to remain active. The USPTO specifies that maintenance fees are due at 3.5, 7.5, and 11.5 years after the patent grant date. Failure to pay these fees can result in the patent expiring prematurely, as seen in other cases[2].
Litigation and Patent Quality Concerns
The broader context of patent quality and litigation is relevant. Patents with overly broad or unclear claims can lead to increased licensing and litigation costs, potentially hindering innovation. However, the specific claims in this patent are narrowly defined, which aligns with best practices for maintaining patent quality[3].
Industry Impact
The impact of this patent on the pharmaceutical industry is significant. GnRH antagonists are a crucial class of drugs, and the protection afforded by this patent ensures that Takeda Pharmaceutical Company Limited has exclusive rights to these compounds for a specified period. This exclusivity can drive further research and development in related therapeutic areas.
Expert Insights
Industry experts emphasize the importance of clear and narrow patent claims to avoid litigation and ensure that patents do not stifle innovation. For example, a Federal Trade Commission (FTC) report highlighted concerns about software and internet patents but also noted that well-defined patents can facilitate innovation by providing clear boundaries[3].
Statistical Context
The patent landscape is also influenced by statistical trends. For instance, patents with narrower claims tend to have higher forward citations, indicating their influence on subsequent innovations. The examination process for this patent likely involved significant scrutiny, given the importance of GnRH antagonists in medical treatment[3].
Key Takeaways
- Specific Chemical Structure: The patent covers thieno[2,3-d]pyrimidine compounds with specific substituents.
- Therapeutic Uses: These compounds are used as GnRH antagonists for various medical conditions.
- Global Coverage: The patent has extensive geographical coverage with thirty-four family members in twenty-five countries.
- Pharmaceutical Significance: Protects MYFEMBREE and ORGOVYX, drugs used for treating uterine fibroids and prostate cancer.
- Patent Quality: Narrowly defined claims align with best practices for maintaining patent quality.
FAQs
What is the primary therapeutic use of the compounds covered by this patent?
The primary therapeutic use of the compounds covered by this patent is as GnRH antagonists for treating conditions such as uterine fibroids and prostate cancer.
Which pharmaceutical drugs are protected by this patent?
The patent protects MYFEMBREE and ORGOVYX.
What is the geographical scope of this patent?
The patent has thirty-four family members in twenty-five countries.
How does the patent's claim structure impact its validity and enforcement?
The narrowly defined claims in this patent align with best practices for maintaining patent quality, reducing the likelihood of litigation and ensuring clear boundaries for innovation.
What are the maintenance requirements for this patent to remain active?
The patent requires maintenance fees to be paid at 3.5, 7.5, and 11.5 years after the grant date to remain active.
Sources
- US8058280B2 - Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof - Google Patents
- Patent and Trademark Office Notices - USPTO
- Patent Claims and Patent Scope - Hoover Institution
- US20140221381A1 - THIENOPYRIMIDINE COMPOUNDS AND USES THEREOF
- Pharmaceutical drugs covered by patent 8,058,280 - Drug Patent Watch
