United States Patent 7,332,481: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,332,481, titled "Thrombopoietin mimetics," is a significant patent in the field of pharmaceuticals, particularly in the area of hematopoietic disorders. This patent, granted on February 19, 2008, covers non-peptide thrombopoietin (TPO) mimetics, which are crucial for treating conditions related to thrombocytopenia.
Background of the Invention
Thrombopoietin is a hormone that stimulates the production of platelets in the blood. Thrombocytopenia, a condition characterized by low platelet counts, can be caused by various factors including chemotherapy, bone marrow disorders, and certain infections. The invention of non-peptide TPO mimetics addresses the need for effective treatments that can stimulate platelet production without the limitations associated with peptide-based therapies[4].
Scope of the Invention
The patent covers a broad range of non-peptide compounds that mimic the activity of thrombopoietin. These compounds are designed to interact with the TPO receptor, thereby stimulating platelet production. The scope includes:
Chemical Structure
The patent describes specific chemical structures of the non-peptide TPO mimetics, including oxo, hydrazino, ylidene, and dihydropyrazol derivatives, among others. These structures are critical for the biological activity of the compounds[4].
Synthesis Methods
The invention also encompasses novel processes and intermediates used in the preparation of these compounds. This includes detailed descriptions of the synthetic routes and the intermediates involved, which are essential for the manufacturing process[4].
Pharmacological Applications
The patent highlights the pharmacological applications of these TPO mimetics, including their use in treating thrombocytopenia and other hematopoietic disorders. The compounds are designed to be administered orally or via other routes to stimulate platelet production effectively[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
Compound Claims
Claims 1-10 describe the specific chemical compounds that are covered by the patent. These claims detail the structural features of the non-peptide TPO mimetics, including the presence of certain functional groups and molecular structures[4].
Method Claims
Claims 11-15 cover the methods of preparing these compounds. These claims outline the synthetic steps and intermediates involved in the production process[4].
Use Claims
Claims 16-20 relate to the use of these compounds in treating various medical conditions, including thrombocytopenia. These claims specify the therapeutic applications and the modes of administration[4].
Patent Landscape
Understanding the patent landscape around US 7,332,481 is crucial for assessing its impact and potential challenges.
Related Patents
Several other patents are related to this invention, including US 7,160,870 and US 7,956,048, which also cover aspects of TPO mimetics and their preparation. These patents collectively form a robust portfolio in the field of thrombopoietin mimetics[1][4].
Competitors and Licensing
The patent landscape also includes competitors who may be developing similar technologies. Companies like Pliva Hrvatska D.O.O., the assignee of this patent, play a significant role in licensing and commercializing these inventions. Licensing agreements can impact the availability and accessibility of these treatments[1].
Expiry and Maintenance
The patent has expired, which means that the protected technology is now in the public domain. However, during its active period, maintaining the patent involved periodic fees and ensuring that the claims remained valid through various legal and administrative processes[4].
Impact on the Pharmaceutical Industry
The invention covered by US 7,332,481 has had a significant impact on the pharmaceutical industry.
Treatment Options
The development of non-peptide TPO mimetics has expanded treatment options for patients with thrombocytopenia. These compounds offer an alternative to traditional peptide-based therapies, which may have limitations in terms of stability, administration, and patient compliance[4].
Research and Development
This patent has also driven further research and development in the field of hematopoietic disorders. The novel compounds and synthesis methods described have inspired new avenues of research into other hematopoietic agents[4].
Legal and Regulatory Considerations
The legal and regulatory environment surrounding this patent is complex.
Patent Litigation
Patent litigation is a common issue in the pharmaceutical industry. The validity and enforceability of the claims in US 7,332,481 would have been subject to legal challenges during its active period. Companies must navigate these legal complexities to protect their intellectual property[2].
Regulatory Approvals
Before these compounds could be marketed, they would need to undergo rigorous regulatory approvals. This includes clinical trials and submissions to regulatory bodies such as the FDA to ensure safety and efficacy[4].
Patent Analytics and Claim Coverage
To fully understand the protection offered by US 7,332,481, patent analytics tools are essential.
Claim Coverage Matrix
A Claim Coverage Matrix can help identify which patents and claims are actively protecting the intellectual property related to TPO mimetics. This tool categorizes patents by claims and scope concepts, providing a clear picture of the patent landscape[3].
Claim Charts
Interactive claim charts generated by tools like ClaimScape® can help technical experts review patent coverage. These charts facilitate the identification of gaps in current coverage and highlight future design opportunities[3].
Key Takeaways
- Non-Peptide TPO Mimetics: The patent covers a range of non-peptide compounds that mimic thrombopoietin activity.
- Synthesis Methods: Novel processes and intermediates are described for the preparation of these compounds.
- Therapeutic Applications: The compounds are used to treat thrombocytopenia and other hematopoietic disorders.
- Patent Landscape: The patent is part of a broader portfolio related to TPO mimetics, with implications for licensing and competition.
- Legal and Regulatory: The patent's validity and enforceability would have been subject to legal challenges, and regulatory approvals are necessary for market entry.
Frequently Asked Questions
Q: What is the main subject of United States Patent 7,332,481?
A: The main subject is non-peptide thrombopoietin (TPO) mimetics used to treat thrombocytopenia.
Q: Who is the assignee of this patent?
A: The assignee is Pliva Hrvatska D.O.O.
Q: What are the key claims of this patent?
A: The claims cover the specific chemical compounds, methods of preparation, and therapeutic uses of the TPO mimetics.
Q: Is the patent still active?
A: No, the patent has expired.
Q: How does this patent impact the pharmaceutical industry?
A: It provides new treatment options for thrombocytopenia and drives further research in hematopoietic disorders.
Cited Sources
- United States Patent and Trademark Office, "POLYMORPHS OF ELTROMBOPAG AND ELTROMBOPAG ETHANOLAMINE SALT, PREPARATION OF THESE POLYMORPHS AND PHARMACEUTICAL COMPOSITIONS COMPRISING THEM," US 8,217,021 B2.
- Administrative Conference of the United States, "U.S. Patent Small Claims Court."
- Schwegman Lundberg & Woessner, P.A., "Patent Analytics | Intellectual Property Law."
- Google Patents, "Thrombopoietin mimetics," US7332481B2.