Understanding the Scope and Claims of United States Patent 6,699,833
Introduction
United States Patent 6,699,833, titled "Pharmaceutical formulations for sustained drug delivery," is a significant patent in the field of pharmaceuticals, particularly focusing on sustained drug delivery systems. This patent, issued to Praecis Pharmaceuticals, Inc., addresses a critical need in the treatment of various diseases by providing innovative formulations for drug delivery.
Background of the Invention
The patent is a continuation of an earlier application (Ser. No. 08/762,747) and builds upon the development of pharmaceutical formulations that enable the efficient delivery of high concentrations of peptides in a small volume. This is particularly important for treating diseases such as prostate cancer, which can be managed through the administration of pharmaceutically active peptides like luteinizing hormone-releasing hormone (LHRH) analogues[5].
Key Claims and Inventions
The patent includes several key claims that define the scope of the invention:
Pharmaceutical Formulations
The primary claim revolves around the development of pharmaceutical formulations designed for sustained drug delivery. These formulations allow for the loading of high concentrations of peptides in a small volume, ensuring efficient and prolonged release of the active pharmaceutical ingredient (API)[5].
Composition and Structure
The patent describes the composition and structure of these formulations, which typically include a combination of the peptide, a carrier, and other excipients. The formulation is designed to maintain the stability and bioavailability of the peptide over an extended period[5].
Method of Delivery
The method of delivery is another crucial aspect of the patent. The formulations are designed to be administered in a way that ensures sustained release of the peptide, which can be through various routes such as subcutaneous or intramuscular injection[5].
Patentability Requirements
To understand the patentability of this invention, it is essential to consider the requirements outlined by the U.S. Patent and Trademark Office (USPTO).
Novelty Requirement
The claimed invention must be novel, meaning it must not have been previously disclosed in the prior art. The patent application must demonstrate that every element of the claimed invention was not already available to the public before the effective filing date of the patent application[1].
Nonobviousness Requirement
The invention must also meet the nonobviousness requirement, which means that the claimed invention must be significantly different from existing knowledge in the field. It should not be obvious to a person of ordinary skill in the relevant field that the combination of elements in the claimed invention would produce the disclosed result[1].
Subject Matter Eligibility
For pharmaceutical inventions, subject matter eligibility is a critical consideration. The invention must not be directed to ineligible subject matter such as laws of nature, natural phenomena, or abstract ideas unless it includes an "inventive concept" that transforms the nature of the claim into a patent-eligible application[1][4].
Practical Application and Real-World Benefits
The patent highlights the practical application of the pharmaceutical formulations in real-world scenarios. For instance, the use of LHRH analogues in treating prostate cancer demonstrates how the invention provides concrete benefits by improving the treatment outcomes for patients. This aligns with the USPTO's guidance on ensuring that patent claims integrate judicial exceptions into practical applications, thereby making the claims patent-eligible[4].
Impact on the Patent Landscape
The issuance of this patent has several implications for the patent landscape in pharmaceuticals:
Innovation in Drug Delivery
The patent encourages innovation in drug delivery systems by providing a framework for developing sustained release formulations. This can lead to better treatment options and improved patient outcomes.
Competitive Landscape
The patent grants Praecis Pharmaceuticals, Inc. exclusive rights to the invention, which can influence the competitive landscape in the pharmaceutical industry. Other companies may need to develop alternative formulations or seek licenses to use the patented technology.
Future Research and Development
The patent can also serve as a foundation for future research and development in pharmaceutical formulations. It provides a basis for further innovation and improvement in drug delivery systems.
Conclusion and Key Takeaways
- Innovative Formulations: The patent introduces innovative pharmaceutical formulations for sustained drug delivery, particularly for peptides.
- Practical Application: The invention is practically applied in treating diseases like prostate cancer, demonstrating real-world benefits.
- Patentability Requirements: The patent meets the requirements of novelty, nonobviousness, and subject matter eligibility.
- Impact on Patent Landscape: The patent influences innovation, competition, and future research in pharmaceutical drug delivery systems.
FAQs
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What is the main focus of United States Patent 6,699,833?
- The main focus is on pharmaceutical formulations designed for sustained drug delivery, particularly for peptides.
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How does the patent address the treatment of prostate cancer?
- The patent describes the use of LHRH analogues in treating prostate cancer through sustained release formulations.
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What are the key requirements for the patentability of this invention?
- The invention must be novel, nonobvious, and meet the subject matter eligibility criteria.
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How does the patent impact the competitive landscape in the pharmaceutical industry?
- The patent grants exclusive rights to Praecis Pharmaceuticals, Inc., influencing competition and potentially requiring other companies to develop alternative formulations or seek licenses.
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What is the significance of the practical application of the invention?
- The practical application ensures that the invention integrates judicial exceptions into real-world applications, making the claims patent-eligible and providing tangible benefits.
Sources
- Congressional Research Service - The Patent Trial and Appeal Board and Inter Partes Review.
- U.S. Patent and Trademark Office - U.S. Patent and Trademark Office (USPTO).
- USPTO - Patent Claims Research Dataset.
- Mintz - Understanding the 2024 USPTO Guidance Update on AI Patent.
- Justia Patents - US Patent for Pharmaceutical formulations for sustained drug delivery.
