United States Patent 5,225,183: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 5,225,183, titled "Levalbuterol Salt," is a significant patent in the pharmaceutical industry, particularly in the field of respiratory medications. This patent, granted on July 6, 1993, covers a specific salt form of levalbuterol, a compound used in the treatment of asthma and other respiratory conditions.
Background
Levalbuterol is the R-enantiomer of the bronchodilator albuterol, known for its efficacy in treating bronchospasm associated with asthma and chronic obstructive pulmonary disease (COPD). The patent for levalbuterol salt was filed by Sepracor Inc., a company that later became part of Sunovion Pharmaceuticals Inc.[4].
Scope of the Patent
The scope of U.S. Patent 5,225,183 is defined by its claims, which specify the particular salt forms of levalbuterol and their methods of preparation. Here are the key aspects:
Claims
- The patent includes claims for the levalbuterol salt itself, as well as methods for its preparation and use.
- Specific claims cover the salt forms, including tartrate, sulfate, and other acid salts.
- The claims also include the process for synthesizing these salts and their pharmaceutical compositions[4].
Salt Forms
- The preferred salt form mentioned in the patent is oleic acid, which is highlighted for its stability and efficacy.
- Other salt forms, such as tartrate and sulfate, are also covered, each with their own set of characteristics and uses[4].
Claims Analysis
Independent Claims
- The independent claims define the broadest scope of the invention, including the levalbuterol salt and its pharmaceutical compositions.
- These claims are crucial as they set the boundaries of what is considered novel and non-obvious under patent law.
Dependent Claims
- Dependent claims narrow down the scope by specifying particular aspects of the invention, such as the method of preparation or specific salt forms.
- These claims provide additional protection by covering various embodiments of the invention[4].
Patent Landscape
Prior Art
- The patent landscape for levalbuterol salts involves a thorough review of prior art to ensure the novelty and non-obviousness of the invention.
- The USPTO and other international patent offices provide tools like the Patent Public Search and Global Dossier to facilitate this review[1].
Related Patents
- Other patents related to levalbuterol and its salts are part of the broader patent landscape.
- For example, patents covering different enantiomers or other salt forms of albuterol are relevant and must be considered to avoid infringement[4].
International Filings
- The patent was filed under the Patent Cooperation Treaty (PCT), allowing for international protection.
- National phase entries in various countries, such as Canada, are part of the international patent landscape for this invention[4].
Economic and Market Impact
Market Dominance
- The patent for levalbuterol salt has contributed significantly to the market dominance of Sepracor Inc. (now Sunovion Pharmaceuticals Inc.) in the respiratory medication sector.
- The exclusivity provided by the patent allowed the company to capture a substantial market share and generate significant revenue.
Generic Competition
- The expiration of the patent in 2010 opened the door for generic competition, which has since impacted the market dynamics.
- Generic versions of levalbuterol salts have been introduced, reducing the market share of the original patent holder but increasing accessibility and affordability for patients[4].
Legal and Regulatory Aspects
Patent Term
- The patent term for U.S. Patent 5,225,183 has expired, which means that the invention is now in the public domain.
- This expiration allows other companies to manufacture and market generic versions of levalbuterol salts without infringing on the original patent.
Litigation
- Patent litigation is a common aspect of the pharmaceutical industry, and U.S. Patent 5,225,183 has likely been involved in various legal disputes over its lifetime.
- These disputes often revolve around issues of infringement, validity, and the scope of the claims[5].
Conclusion
U.S. Patent 5,225,183 represents a significant milestone in the development of respiratory medications, particularly in the treatment of asthma and COPD. The patent's scope, claims, and impact on the market landscape are critical for understanding its importance and the broader context of pharmaceutical patent law.
Key Takeaways
- Patent Scope: The patent covers specific salt forms of levalbuterol and their methods of preparation.
- Claims Analysis: Independent and dependent claims define the scope and embodiments of the invention.
- Patent Landscape: The patent is part of a broader landscape involving prior art, related patents, and international filings.
- Economic Impact: The patent contributed to market dominance and revenue for the patent holder before its expiration.
- Legal Aspects: The patent term has expired, allowing for generic competition, and the patent has likely been involved in litigation.
FAQs
Q: What is the main subject of U.S. Patent 5,225,183?
A: The main subject is the levalbuterol salt, specifically its various salt forms and methods of preparation.
Q: Who was the original patent holder for U.S. Patent 5,225,183?
A: The original patent holder was Sepracor Inc., which later became part of Sunovion Pharmaceuticals Inc.
Q: What is the significance of the patent's expiration?
A: The expiration of the patent allows for generic competition, increasing accessibility and affordability of levalbuterol salts.
Q: How does the patent fit into the broader patent landscape?
A: The patent is part of a broader landscape involving prior art, related patents, and international filings under the PCT.
Q: What are some potential legal issues related to this patent?
A: Potential legal issues include infringement disputes, validity challenges, and scope of claims disputes.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- USA.gov - U.S. Patent and Trademark Office (USPTO): https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Canadian Patents Database - Patent 2507572 Summary: https://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2507572/summary.html
- Casetext - Ashurst et al. V. Britto et al.: https://casetext.com/admin-law/ashurst-et-al-v-britto-et-al-v-ashurst-et-al-v-ashurst-et-al-v-brugger-et-al-2
