United States Patent 8,618,142: A Detailed Analysis of Scope, Claims, and Patent Landscape
Overview of the Patent
United States Patent 8,618,142, hereafter referred to as the '142 Patent, is a significant intellectual property asset that protects the drug DALIRESP (roflumilast), a medication used for the treatment of certain respiratory conditions. Here is a comprehensive analysis of its scope, claims, and the broader patent landscape.
Patent Details
- Document Number and Type: The patent number is 8,618,142, with the prefix "US" indicating it is a U.S. patent. The "B2" code signifies that this patent has a previously published application[1].
- Application and Grant Dates: The application was filed on March 10, 2003, and the patent was granted on January 23, 2011[2].
- Title and Description: The title of the invention is related to roflumilast, and the specification includes a detailed description of the drug, its composition, and its use in treating respiratory diseases[1][2].
Claims
Definition and Importance
The claims section of a patent is crucial as it defines the scope of protection for the invention. The '142 Patent includes multiple claims that outline the legal boundaries of the invention.
Number and Scope
The '142 Patent has several claims, although the exact number is not specified in the available sources. Generally, patents can have anywhere from one to hundreds of claims. These claims are divided into independent and dependent claims, with independent claims standing alone and dependent claims referring back to one or more of the independent claims[1][3].
Legal Boundaries
The claims in the '142 Patent define what is protected under the patent, including the specific composition of roflumilast, its method of use, and any other aspects that distinguish it from prior art. These claims are critical in determining infringement and the patent's validity[1].
Patent Landscape
International Protection
The '142 Patent is part of a larger patent family with thirty-seven patent family members in twenty-nine countries. This extensive international protection ensures that the invention is safeguarded globally, preventing unauthorized use and manufacture of roflumilast in multiple jurisdictions[2].
Foreign Priority and PCT Information
The patent has foreign priority data, indicating that it was filed under the Patent Cooperation Treaty (PCT) and subsequently nationalized in various countries. For example, it has corresponding patents in the European Patent Office with estimated expiration dates and supplementary protection certificates in several European countries[2].
Patent Scope and Quality
Metrics for Measuring Scope
The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in assessing the breadth and clarity of the patent claims. Narrower claims are often associated with a higher probability of grant and shorter examination processes, while broader claims may face more scrutiny and potential litigation[3].
Impact on Innovation
The quality and scope of patents like the '142 Patent can influence innovation in the pharmaceutical industry. Overly broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for further innovation. However, well-defined and narrowly scoped patents like the '142 Patent can provide clear boundaries, encouraging further research and development[3].
Approval and Regulatory Context
FDA Approval
The drug protected by the '142 Patent, roflumilast (DALIRESP), has been approved by the U.S. Food and Drug Administration (FDA). This approval is crucial for marketing the drug in the United States and is referenced in the patent documentation[2].
Litigation and Jurisdiction
The '142 Patent has been involved in legal actions, such as those related to generic drug manufacturers seeking to market similar products. These cases highlight the importance of patent protection in the pharmaceutical industry and the jurisdictional aspects of patent litigation[5].
Probability of Receiving a U.S. Patent
General Trends
The probability of receiving a U.S. patent varies by field and over time. For the pharmaceutical field, the allowance rate has decreased substantially, particularly for applications filed in recent years. This trend suggests that the USPTO has become more stringent in granting patents, which could impact the landscape for future pharmaceutical patents[4].
Key Takeaways
- Patent Scope and Claims: The '142 Patent has multiple claims that define the legal boundaries of the invention, protecting the drug roflumilast.
- International Protection: The patent is part of a large patent family with protection in twenty-nine countries.
- Regulatory Approval: The drug has been approved by the FDA, which is essential for its marketing.
- Patent Quality and Innovation: The scope and quality of the patent can influence innovation in the pharmaceutical industry.
- Litigation and Jurisdiction: The patent has been involved in legal actions, highlighting its importance in protecting intellectual property.
FAQs
Q: What is the main subject of United States Patent 8,618,142?
A: The main subject of the '142 Patent is the drug roflumilast, marketed as DALIRESP, used for treating certain respiratory conditions.
Q: How many patent family members does the '142 Patent have internationally?
A: The '142 Patent has thirty-seven patent family members in twenty-nine countries.
Q: What are the key components of the claims section in a patent?
A: The claims section includes independent and dependent claims that define the scope of protection for the invention.
Q: How does the scope of a patent impact innovation?
A: The scope of a patent can influence innovation by affecting licensing and litigation costs. Narrower claims often encourage more innovation.
Q: What is the significance of FDA approval for the drug protected by the '142 Patent?
A: FDA approval is crucial for marketing the drug in the United States and is a key regulatory milestone referenced in the patent documentation.
