United States Patent 8,323,677: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,323,677, titled "Therapeutic Foam," is a significant patent in the medical field, particularly in the treatment of vascular conditions. This patent, now expired, was part of a broader portfolio protecting the drug Varithena. Here, we will delve into the scope, claims, and the patent landscape surrounding this invention.
Background
The patent was filed by BTG International Ltd. and granted on December 4, 2012. It pertains to the generation of foam comprising a sclerosing material, specifically a sclerosing solution, used in medical treatments such as sclerotherapy for varicose veins and spider veins[1][2].
Scope of the Patent
The scope of US Patent 8,323,677 encompasses the preparation and use of therapeutic foam. Here are the key aspects:
Therapeutic Foam Composition
The patent describes a method for generating foam that includes a sclerosing agent, typically polidocanol, which is used to treat vascular malformations. The foam is created by mixing the sclerosing solution with a gas, such as carbon dioxide or air, in a specific ratio to achieve the desired consistency and efficacy[1].
Method of Preparation
The method involves using a canister or syringe to mix the sclerosing solution with the gas. This process ensures the uniform distribution of the gas within the liquid, resulting in a stable and effective foam[1].
Medical Applications
The therapeutic foam is primarily used in sclerotherapy to treat uncomplicated spider veins and reticular veins in the lower extremities. The foam helps in delivering the sclerosing agent directly to the targeted area, enhancing the treatment's effectiveness[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1: A method for generating foam comprising a sclerosing material, involving the mixing of a sclerosing solution with a gas.
- Claim 5: A foam composition comprising a sclerosing agent and a gas, where the gas is uniformly distributed within the liquid[1].
Dependent Claims
- Claims 2-4: Variations of the method involving different ratios of sclerosing solution to gas and different types of gases.
- Claims 6-10: Specific embodiments of the foam composition, including different concentrations of the sclerosing agent and various methods of administration[1].
Patent Landscape
The patent landscape surrounding US Patent 8,323,677 is complex, with multiple patents protecting various aspects of the therapeutic foam and its application.
Related Patents
Several other patents are associated with the same technology and drug:
- US Patent 7,812,914: Apparatus and method for dispensing foam.
- US Patent 7,942,283: Generation of therapeutic microfoam.
- US Patent 9,480,652: Aerosol valve, which is still active and protects the aerosol delivery system[2][4].
Patent Expiration and Generic Launch
US Patent 8,323,677 expired in May 2020. The expiration of this and other related patents has paved the way for potential generic versions of the drug. However, the generic launch date for Varithena, the drug protected by these patents, is estimated to be May 12, 2032, due to the presence of other active patents[2].
Legal Activities and Extensions
Recent legal activities, such as maintenance fee payments and interim patent term extensions, have affected the patent landscape. For example, the patent term extension granted for US Patent 7,357,336 extended its life, but it eventually expired in July 2022[2].
Impact on the Medical Field
The therapeutic foam described in US Patent 8,323,677 has significantly impacted the treatment of vascular conditions. It offers a more targeted and effective method for delivering sclerosing agents, reducing the risk of complications and improving patient outcomes.
Clinical Use
Polidocanol, the sclerosing agent used in this foam, is widely recognized for its efficacy in treating spider veins and reticular veins. The foam formulation enhances the delivery of this agent, making the treatment more efficient and less invasive[4].
Future Developments
The expiration of this patent and others in the same family opens up opportunities for innovation and the development of new sclerosing agents and delivery methods. Companies can now explore new formulations and technologies without infringing on the expired patents.
Key Takeaways
- Therapeutic Foam: The patent describes a method for generating foam with a sclerosing agent for treating vascular conditions.
- Scope and Claims: The patent covers the composition, preparation, and medical applications of the therapeutic foam.
- Patent Landscape: The patent is part of a broader portfolio protecting Varithena, with several related patents still active.
- Expiration and Generic Launch: The patent expired in May 2020, but the generic launch of Varithena is delayed due to other active patents.
- Impact on Medical Field: The therapeutic foam has improved the treatment of vascular conditions, offering a more targeted and effective delivery method.
FAQs
Q: What is the primary use of the therapeutic foam described in US Patent 8,323,677?
A: The primary use is in sclerotherapy to treat uncomplicated spider veins and reticular veins in the lower extremities.
Q: What is the active ingredient in the therapeutic foam?
A: The active ingredient is typically polidocanol, a sclerosing agent.
Q: When did US Patent 8,323,677 expire?
A: The patent expired in May 2020.
Q: What is the estimated generic launch date for Varithena?
A: The estimated generic launch date for Varithena is May 12, 2032.
Q: How does the therapeutic foam improve the treatment of vascular conditions?
A: The foam enhances the delivery of the sclerosing agent, making the treatment more targeted, efficient, and less invasive.
Cited Sources
- US8323677B2 - Therapeutic foam - Google Patents
- Varithena patent expiration - Pharsight - GreyB
- Patent Analytics | Intellectual Property Law
- Polidocanol: Uses, Interactions, Mechanism of Action - DrugBank
