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Patent landscape, scope, and claims: |
United States Patent 6,040,344: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,040,344, issued in March 2000, is a significant patent in the pharmaceutical industry, particularly in the formulation and delivery of certain drugs. This patent, owned by Sunovion Pharmaceuticals (formerly known as Sepracor Inc.), pertains to specific formulations of formoterol, a long-acting beta-2 adrenergic receptor agonist used in the treatment of respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD).
Background and Invention
The patent describes formulations of formoterol that address the stability issues associated with this drug in aqueous solutions. Formoterol is known to be unstable in aqueous environments, which can lead to degradation and loss of potency. The inventors of this patent developed formulations that stabilize formoterol, ensuring its efficacy and shelf life[4][5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific embodiments of the invention. Here are some key aspects:
Claims
- The patent includes claims for pharmaceutical compositions containing formoterol and a stabilizing agent. These compositions are designed to maintain the stability of formoterol in aqueous solutions[5].
- Specific claims cover the use of certain excipients and the methods of preparing these formulations.
- The patent also claims methods for treating respiratory diseases using these stabilized formoterol compositions.
Embodiments
- The patent details various embodiments of the pharmaceutical compositions, including solutions, suspensions, and inhalation formulations.
- It specifies the types and amounts of stabilizing agents that can be used, such as antioxidants and chelating agents[5].
Patent Landscape Analysis
Technological Context
The patent landscape analysis for this technology involves examining the broader context of respiratory drug formulations and the specific area of formoterol stabilization.
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Competitive Intelligence: The analysis reveals that several companies, including Sunovion Pharmaceuticals, Dey, L.P., and Teva Pharmaceuticals, have been actively involved in developing and patenting various formulations of respiratory drugs. This competition highlights the importance of intellectual property in this field[3][4].
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Geographical Distribution: Patents related to formoterol and other respiratory drugs are filed globally, with a significant concentration in the United States, Europe, and Japan. This geographical distribution indicates the global nature of research and development in this area[3].
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Trends and Insights: The patent landscape shows a trend of increasing research and development in the stabilization of formoterol and other respiratory drugs. This trend is reflected in the number of patents filed and the focus on improving drug delivery systems[3].
Legal and Regulatory Aspects
The patent has been involved in several legal disputes, which provide insights into its validity and scope.
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Dey, L.P. v. Sunovion Pharmaceuticals, Inc.: This case highlights the issue of public use and the patentability bar under 35 U.S.C. § 102(b). The Federal Circuit's decision in this case underscores the complexities of patent law, particularly in the context of clinical trials and public use[2].
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Dey, L.P. v. Teva Parenteral Medicines, Inc.: In this case, the court upheld the validity of Dey's patents, including those related to formoterol formulations, against Teva's invalidity defenses. This ruling reinforces the importance of these patents in the pharmaceutical industry[4].
Competitive Landscape
The competitive landscape for respiratory drug formulations is highly dynamic, with several key players.
- Sunovion Pharmaceuticals: As the owner of the patent, Sunovion has a significant stake in the market for formoterol formulations.
- Dey, L.P.: Dey has also developed and patented various respiratory drug formulations, including those related to formoterol.
- Teva Pharmaceuticals: Teva, a major generic drug manufacturer, has been involved in litigation related to these patents, highlighting the competitive nature of the industry[4].
Geographical and Temporal Analysis
Geographical Analysis
- The geographical distribution of patents related to formoterol and other respiratory drugs shows a strong presence in the United States, Europe, and Japan. This indicates the regions where research and development are most active[3].
Temporal Analysis
- The patent landscape analysis reveals that the research and development in this area have been extensive over the past few decades, with a peak in the late 1990s and early 2000s. This period saw significant advancements in the stabilization of formoterol and other respiratory drugs[3].
Key Takeaways
- Stability of Formoterol: The patent addresses critical stability issues associated with formoterol in aqueous solutions, ensuring its efficacy and shelf life.
- Legal Significance: The patent has been central to several legal disputes, highlighting the complexities of patent law and the importance of intellectual property in the pharmaceutical industry.
- Competitive Landscape: The competitive landscape is highly dynamic, with several key players actively involved in developing and patenting respiratory drug formulations.
- Geographical and Temporal Trends: The analysis shows a global distribution of patents with a significant focus on the United States, Europe, and Japan, and a temporal peak in research and development in the late 1990s and early 2000s.
FAQs
What is the main invention described in United States Patent 6,040,344?
The main invention is the stabilization of formoterol in aqueous solutions through the use of specific stabilizing agents and formulations.
Which companies are involved in the patent landscape related to this invention?
Key companies include Sunovion Pharmaceuticals, Dey, L.P., and Teva Pharmaceuticals.
What are the legal implications of this patent?
The patent has been involved in several legal disputes, including issues related to public use and patent validity, highlighting the complexities of patent law.
How does the geographical distribution of patents reflect the global nature of this technology?
The patents are filed globally, with a significant concentration in the United States, Europe, and Japan, indicating the global nature of research and development.
What trends are observed in the temporal analysis of patent filings?
The analysis shows a peak in research and development in the late 1990s and early 2000s, reflecting significant advancements in the stabilization of formoterol and other respiratory drugs.
Sources
- United States Patent and Trademark Office, "Compositions, methods and systems are provided for pulmonary delivery of long-acting muscarinic antagonists and," US10716753, October 10, 2019.
- JD Supra, "Dey, L.P. v. Sunovion Pharmaceuticals, Inc. (Fed. Cir. 2013)," May 24, 2013.
- Signicent, "Patent Landscape Analysis," Accessed January 2, 2025.
- Casetext, "Dey, L.P. v. Teva Parenteral Medicines, Inc.," March 21, 2014.
- United States Patent and Trademark Office, "Pharmaceutical composition," US9463161, October 11, 2016.
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