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Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 9,861,644
Introduction
Patents are a crucial component of intellectual property, providing exclusive rights to inventors and innovators. The United States Patent 9,861,644, assigned to EIRGEN PHARMA LTD. and OPKO RENAL, LLC, is a significant patent in the pharmaceutical sector, particularly related to vitamin D formulations. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape.
Patent Overview
United States Patent 9,861,644 is titled "Stabilized modified release vitamin D formulation and method of manufacturing the same." This patent pertains to a specific formulation of vitamin D that exhibits stable dissolution profiles and improved pharmacokinetic parameters, which are critical for therapeutic efficacy and patient safety[4].
Patent Claims
The claims of a patent define the scope of the invention and what is protected under the patent. Here are some key aspects of the claims in Patent 9,861,644:
Independent Claims
- The patent includes several independent claims that describe the composition of the stabilized vitamin D formulation. These claims specify the ingredients, their proportions, and the manufacturing process to achieve the desired stability and release characteristics[4].
Dependent Claims
- Dependent claims further detail specific embodiments of the invention, such as particular types of excipients, stabilizers, and release mechanisms. These claims build upon the independent claims and provide additional specificity to the invention[4].
Scope of the Patent
The scope of a patent is determined by the language of its claims. Here are some key points regarding the scope of Patent 9,861,644:
Claim Language and Scope
- The claims in this patent are designed to be specific enough to protect the unique aspects of the invention while being broad enough to cover variations that do not stray from the core concept. For instance, the claims might specify a range of concentrations for certain ingredients, allowing for some flexibility in the formulation[3].
Patent Scope Metrics
- Metrics such as independent claim length and independent claim count can be used to measure patent scope. Generally, narrower claims (shorter length and fewer claims) are associated with a higher probability of grant and a shorter examination process. However, the scope of Patent 9,861,644 would need to be evaluated based on its specific claim language and the context of the pharmaceutical industry[3].
Patent Landscape
Understanding the broader patent landscape is crucial for navigating the intellectual property environment surrounding a particular invention.
Related Patents and Applications
- The patent landscape for vitamin D formulations includes numerous other patents and applications. For example, the list of prior art cited in Patent 9,861,644 includes a wide range of patents related to vitamin D formulations, manufacturing processes, and therapeutic applications. This indicates a complex and densely populated patent landscape[5].
Global Protection
- Patents are territorial, meaning they provide protection only within the jurisdiction where they are granted. However, many pharmaceutical companies, including EIRGEN PHARMA LTD. and OPKO RENAL, LLC, often seek protection in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and competition[2].
Opposition and Litigation
- Patents can be subject to opposition and litigation, which can affect their validity and scope. For instance, if a patent is challenged, the claims may be narrowed or the patent could be invalidated. Monitoring legal activities such as opposition proceedings and litigation is vital for maintaining and enforcing patent rights[2].
Impact on Innovation and Competition
The patent system is designed to incentivize innovation by providing exclusive rights to inventors. However, the balance between innovation and competition is delicate.
Patent Thickets
- The concept of "patent thickets" refers to large numbers of patents that cover minor variations of a single invention, potentially stifling competition. Critics argue that such practices can lead to higher costs for competitors attempting to enter the market. However, the pharmaceutical industry, where Patent 9,861,644 resides, often relies on a complex web of patents to protect innovative formulations and manufacturing processes[1].
Criticisms and Controversies
- There are ongoing debates about the quality and scope of patents, particularly in the pharmaceutical sector. Some argue that overly broad patents can diminish innovation by increasing licensing and litigation costs. The methodology used to count and analyze patents, as seen in the criticisms of I-MAK's data, can also be flawed, leading to misleading narratives about the patent landscape[1][3].
Maintenance and Expiry
Patents have a limited lifespan and require maintenance to remain in force.
Maintenance Fees
- Patents in the United States require the payment of maintenance fees at various intervals to keep the patent in force. For Patent 9,861,644, these fees would need to be paid to maintain the exclusive rights granted by the patent[2].
Expiry Date
- The expiry date of a patent can be affected by various factors, including legal activities such as term extensions or amendments to the claims. Understanding the expiry date is crucial for planning generic entry into the market[2].
Key Takeaways
- Specific Claims: The claims in Patent 9,861,644 are detailed and specific, protecting the unique aspects of the stabilized vitamin D formulation.
- Scope and Metrics: The scope of the patent is defined by its claims, and metrics like claim length and count can help evaluate its breadth.
- Global Landscape: The patent landscape for vitamin D formulations is complex and global, requiring careful navigation.
- Innovation and Competition: The patent system aims to balance innovation with competition, though criticisms about patent thickets and overly broad patents persist.
- Maintenance and Expiry: Regular maintenance fees and monitoring of legal activities are essential to maintain and understand the patent's lifespan.
FAQs
Q: What is the main subject of United States Patent 9,861,644?
A: The main subject is a stabilized modified release vitamin D formulation and the method of manufacturing it.
Q: How are the claims in Patent 9,861,644 structured?
A: The patent includes independent claims that define the core invention and dependent claims that provide additional specificity.
Q: What metrics can be used to measure the scope of a patent?
A: Metrics such as independent claim length and independent claim count can be used to measure patent scope.
Q: Why is understanding the global patent landscape important?
A: It helps in strategizing market entry and competition by identifying areas with weaker patent protection.
Q: How can the expiry date of a patent be affected?
A: The expiry date can be affected by legal activities such as term extensions, amendments to the claims, or abandonment of the patent.
Sources
- Comments of the Pharmaceutical Research and Manufacturers of America to the USPTO on Terminal Disclaimers. PhRMA.
- Rayaldee Patent Expiration. Pharsight.
- Patent Claims and Patent Scope. Hoover Institution.
- Stabilized Modified Release Vitamin D Formulation and Method of Manufacturing the Same. United States Patent 9,861,644.
- United States Patent 9,861,644. Google Patents.
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