Detailed Analysis of the Scope and Claims of United States Patent 8,338,489
Introduction
United States Patent 8,338,489, titled "Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas," marks a significant milestone in the treatment of hemangiomas, particularly infantile hemangiomas. This patent, issued on December 25, 2012, to inventors Christine Léauté-Labrèze, Éric Dumas De La Roque, Alain Taieb, and Jean-Benoît Thambo, and assigned to Université Victor Segalen—Bordeaux 2, introduces the use of beta blockers as a novel therapeutic approach.
Background
Hemangiomas, especially infantile hemangiomas, are benign vascular tumors that can cause significant morbidity and cosmetic concerns. Traditional treatments have included corticosteroids, interferon, and vincristine, each with its own set of side effects and limitations[2].
Scope of the Patent
The patent primarily focuses on the use of beta blockers, specifically non-selective beta blockers like propranolol, for the treatment of hemangiomas. Here are the key aspects of the patent's scope:
Beta Blockers as Therapeutic Agents
The patent highlights propranolol as a non-selective beta adrenergic antagonist that can be used to treat hemangiomas. Propranolol, known for its use in hypertension, angina, and other cardiovascular conditions, is shown to be effective in reducing the size and severity of hemangiomas[1][4].
Formulations and Administration
The patent describes various formulations of propranolol that can be used, including oral solutions, syrups, lotions, creams, ointments, and even injectable solutions. This versatility in formulation allows for tailored treatment approaches depending on the patient's needs and the specific characteristics of the hemangioma[1].
Treatment Methods
The patent outlines different methods of administration, such as oral, topical, and parenteral administration. This flexibility is crucial for treating hemangiomas in various locations and of different sizes and types[1].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Primary Claims
- The use of a beta blocker, specifically a non-selective beta blocker like propranolol, for the manufacture of a medicament to treat hemangiomas.
- The medicament can be in various forms, including oral solutions, syrups, and topical formulations[1].
Specific Formulations
- Claims include specific concentrations of propranolol, such as the 4.28 mg/mL solution approved by the FDA under the brand name Hemangeol[2].
Administration Methods
- Claims cover different methods of administration, ensuring that the treatment can be adapted to various clinical scenarios[1].
Patent Landscape
The patent landscape surrounding US 8,338,489 is complex and influenced by several factors:
Related Patents
- There are related patents, such as US 8,987,262, which also pertain to the use of beta blockers for treating hemangiomas. These patents have similar expiration dates, October 16, 2028, indicating a coordinated approach to protecting the intellectual property related to this therapeutic use[2].
Generic Availability
- As of the latest updates, there is no therapeutically equivalent generic version of Hemangeol available in the United States. This lack of generic competition is due to the patent protection and the specific formulation approved by the FDA[2].
Regulatory and Legal Aspects
- The patent is part of a broader regulatory framework that includes FDA approvals and exclusivity periods. The FDA approval of Hemangeol in 2014 and the lack of generic equivalents highlight the importance of patent protection in maintaining market exclusivity[2].
Impact on Treatment
The approval and use of beta blockers like propranolol for hemangiomas have significantly impacted treatment protocols:
Clinical Efficacy
- Studies and clinical trials have shown that propranolol is highly effective in reducing the size and severity of hemangiomas, offering a safer alternative to traditional treatments[4].
Side Effects and Safety
- While propranolol has its own side effects, the overall safety profile, especially in pediatric patients, has been favorable compared to other treatments like corticosteroids and interferon[1].
Industry and Market Implications
The use of beta blockers for hemangiomas has broader implications for the pharmaceutical industry:
Innovation and Patent Protection
- The patent highlights the importance of robust and predictable patent protection for innovators in the pharmaceutical industry. The ability to secure patents for new therapeutic uses of existing drugs can drive innovation and investment in drug development[3].
Market Expansion
- The market for therapeutic treatments, including those for rare conditions like infantile hemangiomas, is expanding. Patents like US 8,338,489 play a crucial role in protecting intellectual property and ensuring that innovators can recoup their investment in research and development[3].
Key Takeaways
- Beta Blockers as Therapeutic Agents: Propranolol, a non-selective beta blocker, is effective in treating hemangiomas.
- Versatile Formulations: The patent covers various formulations and administration methods.
- Patent Protection: The patent ensures market exclusivity until its expiration in 2028.
- Clinical Impact: The treatment has shown significant efficacy and safety in clinical trials.
- Industry Implications: The patent underscores the importance of intellectual property protection in driving innovation in the pharmaceutical industry.
FAQs
Q: What is the primary focus of United States Patent 8,338,489?
A: The patent focuses on the use of beta blockers, specifically propranolol, for the treatment of hemangiomas.
Q: What are the different formulations of propranolol mentioned in the patent?
A: The patent includes oral solutions, syrups, lotions, creams, ointments, and injectable solutions.
Q: Is there a generic version of Hemangeol available in the United States?
A: No, there is currently no therapeutically equivalent generic version of Hemangeol available in the United States.
Q: What is the expiration date of the patent?
A: The patent expires on October 16, 2028.
Q: How has the use of beta blockers impacted the treatment of hemangiomas?
A: The use of beta blockers like propranolol has provided a safer and more effective alternative to traditional treatments, significantly improving treatment outcomes.
Cited Sources
- US8338489B2 - Use of a beta blocker for the manufacture of a medicament for the treatment of hemangiomas - Google Patents
- Generic Hemangeol Availability - Drugs.com
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Propranolol: Uses, Interactions, Mechanism of Action - DrugBank
