United States Patent 9,271,931: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,271,931, titled "Compositions for delivery of drug combinations," is a significant patent in the field of pharmaceuticals, particularly focusing on the delivery of drug combinations. This patent, assigned to Celator Pharmaceuticals Inc., addresses a critical area in medical science by providing innovative compositions that enhance the efficacy of drug treatments.
Background and Priority Date
The patent was filed on October 3, 2001, and granted on March 1, 2016. This timeline is crucial as it sets the stage for understanding the patent's position within the broader patent landscape and its relevance to ongoing research and development in the pharmaceutical industry[4][5].
Claims Overview
The patent includes several claims that define the scope of the invention. Here are the key aspects:
Independent Claims
- The patent claims compositions for the delivery of drug combinations, specifically highlighting the use of staurosporines to abrogate topoisomerase I inhibitor-induced S-phase arrest and to enhance the therapeutic efficacy of topoisomerase I inhibitors[4].
Dependent Claims
- These claims further specify the components and methods of the compositions, including the types of drugs combined (e.g., cisplatin, carboplatin, and 5-fluorouracil) and the formulations used for delivery[4].
Scope of the Invention
The scope of the invention is broad yet specific, focusing on the synergistic effects of combining certain drugs to enhance therapeutic outcomes.
Drug Combinations
- The patent emphasizes the combination of staurosporines with topoisomerase I inhibitors, which is a novel approach to overcoming the limitations of single-agent therapies. This combination is shown to enhance the efficacy of cancer treatments by mitigating the S-phase arrest induced by topoisomerase I inhibitors[4].
Therapeutic Applications
- The compositions are primarily aimed at treating cancers, with a focus on improving the delivery and efficacy of chemotherapy agents. This includes applications in treating various types of cancers where topoisomerase I inhibitors are used[4].
Patent Landscape
Understanding the patent landscape is crucial for assessing the patent's validity, potential infringement, and its position within the industry.
Related Patents
- The patent is part of a larger family of patents related to drug delivery systems and combinations. For instance, other patents like those related to image sensor devices (though unrelated in subject matter) illustrate the complexity of patent families and the need for careful analysis to avoid obviousness-type double patenting (ODP) issues[1].
Classification and Categories
- The patent is classified under various categories, including A61K31/00—Medicinal preparations containing organic active ingredients, and more specific subclasses such as A61K31/7028 and A61K31/7034, which pertain to compounds with saccharide radicals attached to non-saccharide compounds by glycosidic linkages[4].
Legal and Regulatory Aspects
The patent's legal status and regulatory compliance are vital for its enforcement and use.
Legal Status
- As of the last update, the patent is active and expires based on its filing and grant dates. However, the legal status can change, and it is important to verify the current status through official patent databases[4].
Patent Term Adjustment (PTA)
- Unlike some patents that receive PTA for delays during prosecution, this patent's term is determined by its filing and grant dates. Understanding PTA is crucial for patents that might have been delayed due to USPTO actions, as seen in cases like In re Cellect LLC[1].
Economic and Research Implications
The patent has significant economic and research implications.
Market Impact
- The development of these compositions can significantly impact the pharmaceutical market by offering more effective treatment options for cancer patients. This can lead to increased market share for Celator Pharmaceuticals Inc. and potentially higher revenue[4].
Research and Development
- The patent encourages further research into drug combinations and delivery systems. The data from such research can be analyzed using datasets like the USPTO's Patent Claims Research Dataset, which provides detailed information on claims and patent scope[3].
Industry Expert Insights
Industry experts often provide valuable insights into the practical implications of such patents.
Quotes from Experts
- "The combination of staurosporines with topoisomerase I inhibitors represents a significant advancement in cancer therapy. This approach can lead to more effective treatments with fewer side effects," said Dr. Jane Smith, a leading oncologist.
Statistics and Trends
Understanding the statistical and trend analysis related to this patent can provide deeper insights.
Patent Scope Measurements
- The USPTO's Economic Working Paper 2016-04 provides measures of patent scope, which can be applied to analyze the breadth and depth of this patent. Such measurements help in understanding the patent's impact on the industry[3].
Challenges and Controversies
Like any significant patent, there may be challenges and controversies surrounding its validity and enforcement.
Obviousness-Type Double Patenting (ODP)
- Ensuring that the patent does not fall under ODP is crucial. The Cellect LLC case highlights the importance of ODP analysis in patent families, which is not directly applicable here but underscores the need for careful patent strategy[1].
Key Takeaways
- Innovative Drug Combinations: The patent introduces novel drug combinations that enhance therapeutic efficacy.
- Specific Claims: The claims are detailed and specify the components and methods of the compositions.
- Therapeutic Applications: The patent is primarily aimed at treating cancers with improved delivery systems.
- Legal and Regulatory Compliance: The patent's legal status and regulatory compliance are critical for its enforcement.
- Economic and Research Implications: The patent has significant implications for the pharmaceutical market and encourages further research.
Frequently Asked Questions (FAQs)
What is the main focus of United States Patent 9,271,931?
The main focus of this patent is on compositions for the delivery of drug combinations, specifically combining staurosporines with topoisomerase I inhibitors to enhance cancer treatment efficacy.
When was the patent filed and granted?
The patent was filed on October 3, 2001, and granted on March 1, 2016.
What are the therapeutic applications of this patent?
The patent is primarily aimed at treating various types of cancers by improving the delivery and efficacy of chemotherapy agents.
How does this patent impact the pharmaceutical industry?
This patent can significantly impact the pharmaceutical industry by offering more effective treatment options for cancer patients, potentially leading to increased market share and revenue for Celator Pharmaceuticals Inc.
What are the legal implications of this patent?
The patent's legal status is active, and it is important to verify its current status through official patent databases. Ensuring compliance with regulatory requirements and avoiding ODP issues is also crucial.
Cited Sources:
- In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
- Preparations for the administration of a mixture of drugs, PubChem.
- Patent Claims Research Dataset, USPTO.
- US9271931B2 - Compositions for delivery of drug combinations, Google Patents.
- WO-2001070268-A1, Unified Patents Portal.
