Understanding the Scope and Claims of United States Patent 11,160,804
Introduction
United States Patent 11,160,804, titled "Pharmaceutical dosage forms," is a patent that delves into the realm of solid pharmaceutical dosage forms. To comprehend the full implications and protections offered by this patent, it is crucial to analyze its scope, claims, and the broader patent landscape.
Background of the Patent
The patent in question pertains to pharmaceutical dosage forms, specifically focusing on solid formulations. This area is critical in the pharmaceutical industry, as it involves the development of effective and stable drug delivery systems.
Description of the Invention
The patent provides a detailed description of the invention, including the composition and preparation of the solid pharmaceutical dosage forms. This description is essential for enabling others to reproduce the invention, a key requirement for patent applications[2].
- Technical Field: The patent falls within the technical field of pharmaceuticals, specifically solid dosage forms.
- Background Art: The patent likely discusses existing technologies and challenges in the field of solid pharmaceutical dosage forms.
- Summary of Invention: This section summarizes the core of the invention, highlighting the novel aspects and improvements over existing technologies.
- Technical Problem and Solution: The patent addresses a specific technical problem, such as the stability or efficacy of solid dosage forms, and provides a solution through its inventive concept.
Claims
The claims section is pivotal in defining the scope of protection for the patent.
Types of Claims
- Independent Claims: These claims define the essential features of the invention without referencing other claims. They are critical in establishing the broadest scope of protection[2].
- Dependent Claims: These claims build upon the independent claims, adding additional features that are desirable or optional. They provide a safeguard against potential invalidation of the independent claims and can be valuable in licensing negotiations[2].
Claim Structure
Each claim must be clear, concise, and written in plain English. They must clearly define the invention, distinguish it from other inventions, and focus on the essential technical features[2].
Scope of the Patent
The scope of the patent is determined by the language and breadth of its claims.
Independent Claim Length and Count
Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as indicated by shorter lengths and fewer counts, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The patent examination process can significantly narrow the scope of patent claims. This is evident from studies showing that the examination process tends to reduce claim length and count, making the claims more specific and less broad[3].
Industrial Applicability
The patent must demonstrate industrial applicability, meaning it must be capable of being made and used in industry. This includes examples of how the solid pharmaceutical dosage forms can be manufactured and used in clinical settings[2].
Reference to Deposited Biological Material
If the patent involves biological material, there must be a reference to the deposited biological material, ensuring that the invention can be reproduced by others[2].
Terminal Disclaimers
In cases where there are concerns about nonstatutory double patenting (NSDP), the patentee may file a terminal disclaimer. This disclaimer ensures that the patent term of the challenged patent expires at the same time as the reference patent, preventing unjust extensions of patent terms[4].
Patent Term and Exclusivity
The patent term for this invention, like most patents in the United States, is generally 20 years from the date of filing the patent application. However, various factors such as terminal disclaimers, patent term adjustments, and exclusivity periods can affect the actual duration of the patent's exclusivity[5].
FDA Regulations and Exclusivity
For pharmaceutical patents, the FDA plays a crucial role in regulating the submission and approval of patent information. The FDA requires patent information to be submitted with new drug applications (NDAs) and publishes this information in the Orange Book. Exclusivity periods, such as the 180-day exclusivity for generic drugs, can also impact the market dynamics of the patented drug[5].
Key Takeaways
- Detailed Description: The patent provides a detailed description of the solid pharmaceutical dosage forms, enabling others to reproduce the invention.
- Claims Structure: The patent includes independent and dependent claims that define the scope of protection.
- Scope Metrics: The scope of the patent can be measured by the length and count of independent claims.
- Examination Process: The patent examination process can narrow the scope of claims.
- Industrial Applicability: The patent demonstrates industrial applicability through examples of manufacture and use.
- Terminal Disclaimers: Terminal disclaimers may be used to address NSDP concerns.
- Patent Term and Exclusivity: The patent term is generally 20 years, with potential adjustments and exclusivity periods.
FAQs
Q: What is the primary focus of United States Patent 11,160,804?
A: The primary focus is on solid pharmaceutical dosage forms, specifically the composition and preparation of these forms.
Q: How are the claims structured in this patent?
A: The claims include independent claims that define the essential features and dependent claims that add additional features.
Q: What is the significance of terminal disclaimers in this context?
A: Terminal disclaimers are used to overcome nonstatutory double patenting concerns by ensuring that the patent term of the challenged patent expires at the same time as the reference patent.
Q: How does the FDA regulate patent information for pharmaceuticals?
A: The FDA requires patent information to be submitted with NDAs and publishes this information in the Orange Book. It also oversees exclusivity periods.
Q: What metrics can be used to measure the scope of a patent?
A: Metrics such as independent claim length and count can be used to measure the scope of a patent.
Cited Sources
- US11160804B2 - Pharmaceutical dosage forms - Google Patents
- How To Write A Specification | IP Australia
- Patent Claims and Patent Scope - SSRN
- Comments of the Pharmaceutical Research and Manufacturers of America - PhRMA
- Patents and Exclusivity | FDA
