United States Patent 8,623,922: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,623,922, titled "Bronchodilating Beta-agonist Compositions and Methods," was granted on January 7, 2014. This patent is significant in the pharmaceutical industry, particularly in the development and use of bronchodilating beta-agonists. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Inventors and Assignee
The patent was invented by Partha S. Banerjee, Wynnewood, PA; Imtiaz A. Chaudry, American Canyon, CA; and Stephen Pham, Sacramento, CA. The assignee of this patent is Dey Pharma, L.P., based in Basking Ridge, NJ[1].
Background and Prior Art
The patent builds upon a series of earlier applications and patents, including those filed in 2004, 2008, and 2010. These prior applications and patents laid the groundwork for the development of bronchodilating beta-agonist compositions and methods[1].
Scope of the Patent
The scope of the patent revolves around the formulation and use of bronchodilating beta-agonists, which are crucial in treating respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). The patent describes specific compositions and methods for delivering these beta-agonists, enhancing their efficacy and stability[5].
Key Components
- Compositions: The patent details various formulations of bronchodilating beta-agonists, including combinations with other therapeutic agents to enhance bronchodilation.
- Methods: It outlines methods for administering these compositions, including inhalation routes, which are common for treating respiratory diseases[5].
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
Independent Claims
- The patent includes independent claims that describe the specific compositions of bronchodilating beta-agonists and their methods of use. These claims are critical in defining the novelty and non-obviousness of the invention[1].
Dependent Claims
- Dependent claims further specify the details of the compositions and methods, including the types of beta-agonists, excipients, and delivery systems used. These claims provide a narrower scope within the broader independent claims[1].
Patent Landscape
Expiration and Generic Competition
The patent was granted in 2014, and its term is subject to the standard 20-year period from the earliest filing date of the application from which it claims priority. This means the patent would expire around 2028, assuming no extensions or adjustments. Once the patent expires, generic versions of the drug can enter the market, potentially increasing competition and reducing costs for consumers[4].
Related Patents and Litigation
The patent is part of a larger family of patents related to bronchodilating beta-agonists. The history of these patents includes multiple continuations and divisions, indicating a complex and evolving landscape. Litigation and office actions related to these patents can provide insights into the challenges and validations faced during the patent examination process[1].
Metrics for Measuring Patent Scope
The scope of a patent can be measured using various metrics, such as independent claim length and independent claim count. Research has shown that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process often narrows the scope of patent claims, which can be significant when the duration of examination is longer[3].
Impact on Innovation
The patent's scope and claims can influence innovation in the pharmaceutical industry. Broad or overly broad claims can lead to increased licensing and litigation costs, potentially discouraging innovation. However, well-defined and narrow claims can provide clear boundaries, encouraging further research and development in related areas[3].
Industry Expert Insights
Industry experts often emphasize the importance of patent clarity and scope. For example, the Federal Trade Commission (FTC) has noted that unclear or overly broad patent claims, particularly in software and biotechnology, can impede innovation by creating legal uncertainties and barriers to entry[3].
Statistics and Economic Impact
The economic impact of pharmaceutical patents is significant. For instance, the expiration of drug patents can lead to substantial savings for healthcare systems. Between 2020 and 2022, the expiration of 91 drug patents was expected to save billions of dollars in healthcare costs[4].
Key Takeaways
- Scope and Claims: The patent covers specific compositions and methods for bronchodilating beta-agonists, with a focus on enhancing efficacy and stability.
- Patent Landscape: The patent is part of a complex family of related patents, with implications for generic competition and litigation.
- Metrics for Scope: Narrower claims are associated with a higher probability of grant and shorter examination processes.
- Impact on Innovation: Clear and narrow claims can encourage innovation, while broad or unclear claims can impede it.
- Economic Impact: The expiration of pharmaceutical patents can lead to significant cost savings in healthcare.
FAQs
What is the main subject of United States Patent 8,623,922?
The main subject of this patent is the formulation and use of bronchodilating beta-agonist compositions and methods.
Who are the inventors of this patent?
The inventors are Partha S. Banerjee, Imtiaz A. Chaudry, and Stephen Pham.
What is the assignee of this patent?
The assignee is Dey Pharma, L.P., based in Basking Ridge, NJ.
When is the patent expected to expire?
Assuming no extensions, the patent is expected to expire around 2028.
How does the patent's scope impact innovation?
The patent's scope can influence innovation by providing clear boundaries for further research and development, but overly broad claims can impede innovation.
What are the economic implications of pharmaceutical patent expirations?
The expiration of pharmaceutical patents can lead to significant cost savings in healthcare by allowing generic versions of the drugs to enter the market.
Sources
- United States Patent and Trademark Office: "Bronchodilating Beta-agonist Compositions and Methods" - US Patent 8,623,922 B2.
- Drug Patent Watch: "Pharmaceutical drugs covered by patent 8,623,922".
- Hoover Institution: "Patent Claims and Patent Scope".
- GreyB: "List - 91 Drug Patents that are Expiring between 2020 to 2022".
- PubChem: "Bronchodilating Beta-agonist compositions and methods - Patent US-8623922-B2".
