United States Patent 11,020,363: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,020,363, titled "Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same," is a significant development in the field of pharmaceuticals, particularly in the area of cancer treatment. This patent, issued to address the formulation and delivery of nitrogen mustard compounds, is crucial for understanding the current state of patent protection and innovation in this domain.
Background
Nitrogen mustard compounds, such as melphalan and mechlorethamine, are well-known chemotherapeutic agents used in the treatment of various cancers. However, their use is often limited by their solubility, stability, and toxicity profiles. The incorporation of cyclodextrin derivatives aims to enhance these properties, making the drugs more effective and safer for patients.
Scope of the Patent
Pharmaceutical Compositions
The patent primarily focuses on pharmaceutical compositions that include a nitrogen mustard compound and a cyclodextrin derivative. These compositions are designed to improve the solubility, stability, and bioavailability of the nitrogen mustard compounds, thereby enhancing their therapeutic efficacy and reducing side effects[1].
Cyclodextrin Derivatives
Cyclodextrins, particularly sulfobutylether-beta-cyclodextrin, play a critical role in forming inclusion complexes with the nitrogen mustard compounds. This complexation helps in solubilizing the drug, protecting it from degradation, and facilitating its delivery to the target site[1].
Methods of Preparation
The patent describes various methods for preparing these pharmaceutical compositions. These methods involve the formation of inclusion complexes between the nitrogen mustard compound and the cyclodextrin derivative, often in an aqueous solution. The process ensures the stability and homogeneity of the final product[1].
Claims of the Patent
Composition Claims
The patent includes claims related to the specific compositions of the nitrogen mustard compounds and cyclodextrin derivatives. For example, Claim 1 describes a pharmaceutical composition comprising melphalan and a sulfobutylether-beta-cyclodextrin, highlighting the specific ratios and concentrations of the components[1].
Method Claims
In addition to composition claims, the patent also includes method claims. These cover the processes for preparing the pharmaceutical compositions, including the steps involved in forming the inclusion complexes and the conditions under which these processes are carried out[1].
Use Claims
The patent further includes claims related to the use of these compositions in medical treatments. For instance, Claim 10 describes the use of the composition for treating cancer, specifying the administration routes and dosages[1].
Patent Landscape
Prior Art
The patent landscape in this area is rich with prior art related to the use of cyclodextrins in pharmaceutical formulations. However, the specific combination of nitrogen mustard compounds with cyclodextrin derivatives as described in this patent is novel and addresses specific challenges associated with these chemotherapeutic agents[1].
Competing Patents
Other patents in the field may cover similar aspects, such as the use of cyclodextrins for drug delivery, but the unique combination and method of preparation described in US 11,020,363 distinguish it from existing patents. For example, the patent US 6,576,261-B1 discusses the potentiation of inclusion complex formation of cyclodextrin with different compounds but does not specifically address nitrogen mustard compounds[5].
Future Directions
The patent analytics tools, such as those described by Schwegman, can help in tracking patents by claims and scope concepts, identifying gaps or opportunities in the current patent landscape. This can guide future research and development in optimizing drug delivery systems using cyclodextrin derivatives[3].
Technological and Market Impact
Enhanced Efficacy and Safety
The compositions described in this patent have the potential to significantly enhance the efficacy and safety of nitrogen mustard compounds. By improving solubility and stability, these formulations can reduce the side effects associated with traditional chemotherapeutic agents.
Market Opportunities
The market for cancer treatments is vast and growing, driven by the increasing incidence of cancer and the need for more effective and safer treatments. This patent positions the holder to capitalize on this market by offering a novel and improved formulation of nitrogen mustard compounds.
Legal and Regulatory Considerations
Patent Eligibility
The patentability of pharmaceutical compositions and methods is subject to strict scrutiny under the Alice test, which ensures that the claims are not directed to abstract ideas or natural phenomena. The specific technological improvements described in this patent, such as the formation of inclusion complexes and the enhanced delivery of nitrogen mustard compounds, are likely to meet the criteria for patent eligibility[2].
Regulatory Approval
To bring these compositions to market, the patent holder must obtain regulatory approval from agencies such as the FDA. This involves demonstrating the safety, efficacy, and quality of the formulations through clinical trials and other regulatory processes.
Key Takeaways
- Novel Compositions: The patent introduces novel pharmaceutical compositions combining nitrogen mustard compounds with cyclodextrin derivatives.
- Improved Solubility and Stability: These compositions enhance the solubility and stability of the drugs, leading to better therapeutic outcomes.
- Specific Methods: The patent details specific methods for preparing these compositions, ensuring their stability and homogeneity.
- Market Potential: The market for these formulations is significant, given the growing need for effective and safe cancer treatments.
- Regulatory and Legal Considerations: The patent holder must navigate regulatory approval and ensure patent eligibility under relevant legal frameworks.
FAQs
Q: What is the primary focus of United States Patent 11,020,363?
A: The primary focus is on pharmaceutical compositions comprising nitrogen mustard compounds and cyclodextrin derivatives, along with methods for their preparation and use.
Q: How do cyclodextrin derivatives improve the properties of nitrogen mustard compounds?
A: Cyclodextrin derivatives form inclusion complexes with the nitrogen mustard compounds, enhancing their solubility, stability, and bioavailability.
Q: What are the key claims of this patent?
A: The patent includes claims related to the specific compositions, methods of preparation, and medical uses of the nitrogen mustard compounds with cyclodextrin derivatives.
Q: How does this patent differ from prior art in the field?
A: The specific combination of nitrogen mustard compounds with cyclodextrin derivatives and the detailed methods of preparation distinguish this patent from existing prior art.
Q: What are the potential market opportunities for this patent?
A: The patent positions the holder to capitalize on the growing market for cancer treatments by offering improved and safer formulations of nitrogen mustard compounds.
Sources
- US11020363B2 - Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same.
- CONTOUR IP HOLDING LLC v. GOPRO, INC..
- Patent Analytics | Intellectual Property Law.
- Search for patents - USPTO.
- Potentiation of inclusion complex formation of cyclodextrin.
