United States Patent 11,141,457: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,141,457, titled "Oral Octreotide Therapy and Contraceptive Methods," was issued on October 12, 2021, to Amryt Endo, Inc. on assignment from inventors Asi Haviv, Ruth Stevens, and Jennings Dawkins. This patent is part of a broader portfolio of patents related to pharmaceutical compositions and delivery methods, particularly focusing on oral octreotide therapy.
Background and Context
Octreotide is a synthetic somatostatin analogue used in the treatment of various conditions, including acromegaly, carcinoid syndrome, and certain types of tumors. The development of oral formulations of octreotide represents a significant advancement, as it offers a more patient-friendly alternative to traditional injectable forms.
Scope of the Patent
Claims Overview
The patent 11,141,457 includes several claims that define the scope of the invention. Here are some key aspects:
- Method of Administration: The patent claims methods for administering oral octreotide to female subjects, particularly in the context of avoiding combined oral contraceptives. This is crucial because oral contraceptives can interact with octreotide, affecting its efficacy or safety[4].
- Pharmaceutical Compositions: The claims cover specific pharmaceutical compositions that include octreotide and other components designed to enhance its oral bioavailability and stability.
- Contraceptive Methods: The patent also includes claims related to contraceptive methods that can be used in conjunction with oral octreotide therapy to avoid interactions and ensure the efficacy of both treatments.
Detailed Claims Analysis
Independent Claims
The independent claims of the patent are pivotal as they define the core invention. For example:
- Claim 1 might describe a method of administering oral octreotide to a female subject, specifying the dosage, timing, and any necessary precautions to avoid interactions with contraceptives.
- Claim 2 could detail the pharmaceutical composition, including the active ingredient octreotide, excipients, and other formulation components that facilitate oral delivery.
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations or features to the independent claims. These might include specific dosing regimens, patient populations, or additional therapeutic agents that can be co-administered.
Patent Landscape Analysis
Why Conduct a Patent Landscape Analysis?
A patent landscape analysis is essential for understanding the competitive environment, identifying potential risks, and uncovering opportunities for innovation. For the patent 11,141,457, such an analysis would help in:
- Risk Assessment: Identifying prior art and potential infringement risks.
- Freedom to Operate: Ensuring that the patented methods and compositions do not infringe on existing patents.
- Mergers and Acquisitions: Evaluating the patent portfolio for potential mergers or acquisitions involving Amryt Endo, Inc.[3].
Geographical Boundaries and Jurisdiction
The analysis would include patents filed in various jurisdictions, particularly in countries where Amryt Endo, Inc. operates or plans to expand. This involves identifying the geographical boundaries, patent families, and their legal status.
Key Players and Market Trends
Identifying top players in the field of oral octreotide therapy and contraceptive methods is crucial. This includes analyzing patents held by competitors, new entrants in the market, and trends in patent filings and grants. For instance, other companies like Teva, which has filed ANDAs for generic versions of similar drugs, could be significant players in this landscape[5].
Technological Status and Relevance
The analysis would assess the current technological status of oral octreotide therapy and its relevance in the market. This involves evaluating whether the scope of the technology is already explored or if it is a nascent area with room for further innovation.
Country-Based Trends and Regulations
Understanding country-specific trends, regulations, and approvals is vital. For example:
- Licensing and Partnerships: Identifying opportunities for licensing and partnerships that could enhance the market presence of the patented technology.
- Regulatory Approvals: Ensuring compliance with FDA regulations and other international standards for pharmaceutical products.
Monitoring Technology Trends
Continuous monitoring of the technology landscape helps in understanding trends in filing, prosecution, and the scope of patent grants. This involves tracking legal status, grants, and any changes in the regulatory environment that could impact the patent.
Examples and Case Studies
Amryt Endo, Inc.'s Patent Portfolio
Amryt Endo, Inc. has a robust portfolio of patents related to pharmaceutical compositions and delivery methods. The '457 patent is part of this portfolio, which includes other patents like the '812, '246, '709, and '397 patents, all focused on various aspects of disease treatment and drug delivery[2][5].
Competitor Analysis
Competitors like Teva, which are involved in filing ANDAs for generic versions of drugs, pose a significant challenge. Analyzing their patent strategies and litigation history can provide insights into potential risks and opportunities.
Industry Expert Insights
Industry experts emphasize the importance of a thorough patent landscape analysis in navigating the complex intellectual property landscape. For instance:
"A patent landscape search and analysis is like creating a story about a specific technology which can be shared with the people related to the work," according to the World Intellectual Property Organization (WIPO)[3].
Illustrative Statistics
- The number of patent filings in the pharmaceutical sector has seen a significant increase in recent years, with a focus on innovative delivery methods and formulations.
- The market for oral octreotide therapy is expected to grow substantially, driven by patient preference for oral medications over injectables.
Key Takeaways
- The patent 11,141,457 covers critical methods and compositions related to oral octreotide therapy and contraceptive methods.
- A thorough patent landscape analysis is essential for understanding the competitive environment and identifying opportunities for innovation.
- Continuous monitoring of technology trends and regulatory changes is vital for maintaining a strong patent portfolio.
Frequently Asked Questions (FAQs)
What is the main focus of the United States Patent 11,141,457?
The main focus of the patent is on methods for administering oral octreotide therapy to female subjects, particularly in the context of avoiding interactions with combined oral contraceptives.
Who are the inventors of the patent 11,141,457?
The inventors of the patent are Asi Haviv, Ruth Stevens, and Jennings Dawkins.
What is the significance of a patent landscape analysis for this patent?
A patent landscape analysis helps in understanding the competitive environment, identifying potential risks, and uncovering opportunities for innovation, ensuring freedom to operate, and assessing market trends.
How does this patent fit into Amryt Endo, Inc.'s broader patent portfolio?
The patent is part of a robust portfolio of patents related to pharmaceutical compositions and delivery methods, including other patents like the '812, '246, '709, and '397 patents.
What are the potential market trends and growth areas for oral octreotide therapy?
The market for oral octreotide therapy is expected to grow substantially, driven by patient preference for oral medications over injectables and the increasing need for innovative delivery methods.
Cited Sources:
- USITC Document: Certain Semiconductor Integrated Circuits and Products Containing Same, USITC.
- RPX Insight: In the United States District Court, RPX Insight.
- Prometheus IP: Patent Landscape Search, Analysis and Report: An Overview, Prometheus IP.
- Google Patents: US11141457B1 - Oral octreotide therapy and contraceptive methods, Google Patents.
- RPX Insight: In the United States District Court, RPX Insight.
