United States Patent 7,256,310: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 7,256,310, titled "Levalbuterol salt," is a significant patent in the pharmaceutical industry, particularly in the context of respiratory medications. Here is a comprehensive analysis of its scope, claims, and the surrounding patent landscape.
Patent Title and Abstract
The patent is titled "Levalbuterol salt" and focuses on levalbuterol L-tartrate, which is a crystalline form of levalbuterol. The abstract highlights that this crystalline form possesses desirable properties for use in a metered dose inhaler, making it crucial for the treatment of bronchospasm and asthmatic symptoms[1].
Inventors and Assignee
The inventors listed for this patent are Paul McGlynn, Roger Bakale, and Craig Sturge, all associated with Sepracor Inc., which is the assignee of the patent. Sepracor Inc. is a pharmaceutical company based in Marlborough, Massachusetts[1].
Patent Claims
The patent includes various types of claims, such as composition, formulation, delivery, device, process, and use claims. These claims are designed to protect the specific crystalline form of levalbuterol L-tartrate and its application in medical devices, particularly metered dose inhalers[1].
Composition Claims
These claims cover the specific chemical composition of levalbuterol L-tartrate, ensuring that the patented form is distinct from other forms of levalbuterol.
Formulation Claims
The formulation claims pertain to the preparation and mixture of levalbuterol L-tartrate with other ingredients to create a stable and effective formulation for inhalation.
Delivery and Device Claims
These claims protect the method of delivering the drug through a metered dose inhaler and the design of the inhaler device itself.
Process Claims
The process claims cover the manufacturing steps involved in producing the crystalline form of levalbuterol L-tartrate.
Use Claims
The use claims specify the therapeutic applications of levalbuterol L-tartrate, primarily for the treatment or prevention of bronchospasm and asthmatic symptoms[1].
Patent Expiration and Generic Entry
The patent 7,256,310 has recently expired, with its expiration date in October 2024. This expiration allows for the potential entry of generic versions of the drug into the market. The drug, XOPENEX HFA, which is protected by this patent, is now open to generic competition[2].
International Patent Landscape
This patent has a significant international presence, with thirty-six patent family members in eighteen countries. This global coverage ensures that the protection of levalbuterol L-tartrate extends beyond the United States, safeguarding the intellectual property rights of Sepracor Inc. and its successors in multiple jurisdictions[1].
Litigation and PTAB Cases
The patent has been involved in several litigation and PTAB (Patent Trial and Appeal Board) cases, which are indicative of its importance and the disputes surrounding its claims. These legal actions often involve challenges to the patent's validity and scope[1].
Impact on the Pharmaceutical Industry
The expiration of this patent has significant implications for the pharmaceutical industry. It opens up the market for generic versions of XOPENEX HFA, potentially increasing competition and reducing costs for patients. This can also lead to increased innovation as other companies may develop new formulations or delivery methods for levalbuterol.
Market Competition
With the patent's expiration, other pharmaceutical companies can now develop and market their own versions of levalbuterol L-tartrate, leading to increased market competition. This competition can drive down prices and improve access to the medication for patients.
Innovation
The expiration of the patent can also spur innovation as companies may focus on developing new and improved formulations or delivery systems for levalbuterol, which could offer better efficacy or patient compliance.
Metrics for Measuring Patent Scope
The scope of a patent like 7,256,310 can be measured using various metrics, such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Research has shown that narrower claims tend to have a higher probability of grant and a shorter examination process, indicating a more focused and valid patent[3].
Conclusion
United States Patent 7,256,310 is a critical patent in the pharmaceutical industry, particularly for respiratory medications. Its recent expiration marks a significant shift in the market landscape, allowing for generic competition and potentially driving innovation. Understanding the scope, claims, and international landscape of this patent is essential for pharmaceutical companies and researchers looking to navigate the complex world of intellectual property in the healthcare sector.
Key Takeaways
- Patent Title and Abstract: The patent is titled "Levalbuterol salt" and focuses on the crystalline form of levalbuterol L-tartrate.
- Inventors and Assignee: The inventors are Paul McGlynn, Roger Bakale, and Craig Sturge, with Sepracor Inc. as the assignee.
- Patent Claims: The patent includes composition, formulation, delivery, device, process, and use claims.
- Patent Expiration: The patent expired in October 2024, allowing for generic entry.
- International Presence: The patent has thirty-six family members in eighteen countries.
- Impact on Industry: The expiration opens up the market to generic competition and potential innovation.
FAQs
What is the main subject of United States Patent 7,256,310?
The main subject of the patent is the crystalline form of levalbuterol L-tartrate, specifically its use in metered dose inhalers for treating bronchospasm and asthmatic symptoms.
Who are the inventors of this patent?
The inventors are Paul McGlynn, Roger Bakale, and Craig Sturge.
What company is the assignee of this patent?
The assignee is Sepracor Inc., a pharmaceutical company based in Marlborough, Massachusetts.
What types of claims are included in this patent?
The patent includes composition, formulation, delivery, device, process, and use claims.
When did the patent expire?
The patent expired in October 2024.
What is the impact of the patent's expiration on the pharmaceutical industry?
The expiration allows for generic versions of XOPENEX HFA to enter the market, increasing competition and potentially driving innovation.
Sources
- Drug Patent Watch: "Patent 7,256,310: Levalbuterol salt"
- Pharsight: "Xopenex Hfa patent expiration"
- SSRN: "Patent Claims and Patent Scope"
