| Inventor(s): | Ortyl; Thomas T. (Overland Park, KS), Skultety; Paul F. (Leawood, KS), Mitchell; Kristen C. (Lee's Summit, MO), Phadke; Deepak S. (Olathe, KS), Attarchi; Faraneh (Kansas City, MO), Pierce; Marguerite L. (Fairway, KS), Schoeneman; Aaron W. (Lee's Summit, MO), Schnitz; Joseph M. (Kansas City, MO) |
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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 5,932,247
Introduction
The United States Patent 5,932,247, titled "Pharmaceutical composition for piperidinoalkanol compounds," is a significant patent in the pharmaceutical industry. This patent, issued to Aventis Pharmaceuticals Inc., pertains to a specific formulation of pharmaceutical compositions, particularly those involving piperidinoalkanol compounds. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
The patent 5,932,247 describes a pharmaceutical composition in solid unit dosage form, which includes a therapeutically effective amount of a piperidinoalkanol compound. This compound is often used in antihistamine medications, such as fexofenadine, which is a common active ingredient in allergy treatments[4].
Claims Analysis
Claim Structure
The patent claims are crucial as they define the boundaries of the invention and the rights of the patentee. The claims in this patent are structured to cover specific formulations and methods of preparation. Here are some key aspects of the claims:
- Active Ingredients: The claims specify the use of piperidinoalkanol compounds, which are the active therapeutic agents.
- Inert Ingredients: The patent details the use of specific inert ingredients such as powdered cellulose, mannitol, crospovidone, and povidone. However, the prosecution history and court decisions have clarified that some of these ingredients, although disclosed, were not claimed and thus dedicated to the public[1].
- Formulation: The claims describe the solid unit dosage form, which could be tablets, capsules, or other solid forms.
Prosecution History
The prosecution history of the patent is significant in understanding the scope of the claims. The patent went through several amendments during the application process, which narrowed down the claims to specific formulations. This history is crucial in determining the equivalents that can be claimed under the doctrine of equivalents. For instance, the court has held that narrowing amendments made during the prosecution process can lead to the presumption of surrender of equivalents, which the patentee must rebut[1].
Patent Landscape Analysis
Technological Domain
Patent landscape analysis is essential in understanding the technological domain and competitive landscape. For the pharmaceutical industry, particularly in the area of piperidinoalkanol compounds, this analysis reveals several key points:
- Competitors and Market Trends: The analysis shows the presence of other pharmaceutical companies working on similar formulations. This includes trends in mergers and acquisitions, licensing agreements, and litigation activities[3].
- Innovation Hotspots: The patent landscape highlights areas of intense innovation, such as new formulations, delivery systems, and combinations of active and inert ingredients.
- Regulatory Environment: The analysis also considers the regulatory environment, including FDA approvals, clinical trials, and compliance with patent laws.
Market Developments
The patent landscape analysis provides insights into market developments such as:
- Litigation and Opposition: The patent has been involved in several litigation cases, particularly regarding the scope of claims and the doctrine of equivalents. These cases have set precedents that affect the broader patent landscape[1].
- Licensing and Collaborations: The analysis may reveal licensing agreements or collaborations between pharmaceutical companies, which can impact the market dynamics and competition.
Legal Considerations
Claim Indefiniteness
The claims of the patent must meet the definiteness requirement under 35 U.S.C. § 112. This means the claims must be precise enough to afford clear notice of what is claimed, thereby informing the public of what is still open to them. The court has emphasized that claims must be viewed in the context of the specification and prosecution history to ensure reasonable certainty[5].
Doctrine of Equivalents
The doctrine of equivalents is crucial in determining whether a product infringes on the patent claims. However, as seen in the prosecution history of this patent, narrowing amendments can lead to the presumption of surrender of equivalents. The patentee must provide strong arguments to rebut this presumption[1].
Industry Impact
The patent 5,932,247 has significant implications for the pharmaceutical industry:
- Competition: The patent's claims and the broader patent landscape influence competition among pharmaceutical companies. Companies must navigate these patents carefully to avoid infringement.
- Innovation: The patent encourages innovation by protecting specific formulations and methods, thereby incentivizing further research and development in the field.
- Regulatory Compliance: The patent's validity and scope affect regulatory compliance, as companies must ensure their products do not infringe on existing patents.
Key Takeaways
- Specific Claims: The patent claims are narrowly defined to cover specific formulations of piperidinoalkanol compounds.
- Prosecution History: The prosecution history is critical in understanding the scope of claims and the doctrine of equivalents.
- Patent Landscape: The patent landscape analysis provides valuable insights into market trends, competitors, and regulatory environments.
- Legal Considerations: The claims must meet the definiteness requirement, and the doctrine of equivalents is subject to the presumption of surrender due to narrowing amendments.
FAQs
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What is the main subject matter of United States Patent 5,932,247?
- The patent pertains to pharmaceutical compositions in solid unit dosage form, specifically involving piperidinoalkanol compounds.
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What are the key inert ingredients mentioned in the patent?
- The patent mentions powdered cellulose, mannitol, crospovidone, and povidone as inert ingredients.
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How does the prosecution history affect the scope of claims?
- The prosecution history, including narrowing amendments, can lead to the presumption of surrender of equivalents, which the patentee must rebut.
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What is the significance of patent landscape analysis in this context?
- Patent landscape analysis helps in understanding the competitive landscape, market trends, and regulatory environment, which is crucial for business and legal strategies.
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What is the legal standard for claim definiteness?
- Claims must provide reasonable certainty in defining what is patented, as per 35 U.S.C. § 112, and must be viewed in the context of the specification and prosecution history[5].
Sources
- Aventis Pharmaceuticals Inc. et al v. Barr Laboratories Inc. - Law.com
- Determining Inventorship for US Patent Applications - Oregon State University
- Navigating Technological Domains with Patent Landscape Analysis - Sagacious Research
- Pharmaceutical composition for piperidinoalkanol compounds - Google Patents
- UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT - CAFC.uscourts.gov
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