United States Patent 9,808,442: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,808,442, titled "Enalapril Formulations," is a significant patent in the pharmaceutical industry, particularly in the context of hypertension and heart failure treatments. This patent is part of a series of patents held by companies like Azurity Pharms., Inc. and Silvergate Pharmaceuticals, Inc., which have been involved in various patent infringement disputes.
Background of the Patent
The patent 9,808,442 was granted to Azurity Pharms., Inc. and is related to enalapril formulations, specifically oral liquid formulations of enalapril, which are used for treating hypertension and symptomatic congestive heart failure[4].
Scope of the Patent
Claims Overview
The patent includes multiple claims that define the scope of the invention. These claims typically cover the composition of the enalapril formulation, the method of preparation, and the specific characteristics of the formulation, such as stability and bioavailability. For instance, the claims might specify the presence of a buffer, the concentration of enalapril, and other excipients that ensure the stability and efficacy of the formulation[4].
Key Claim Elements
- Buffer Requirement: One of the critical elements in the claims is the presence of a buffer, which is essential for maintaining the stability of the enalapril formulation. This was a pivotal point in the patent infringement case against Bionpharma, where the court ruled that Bionpharma's ANDA product did not infringe because it did not contain the buffer required by the patent claims[2].
- Stability and Bioavailability: The claims also emphasize the stability and bioavailability of the enalapril formulation, ensuring that the drug remains effective over its shelf life and is absorbed properly by the body.
Patent Landscape
Related Patents
The patent 9,808,442 is part of a family of patents related to enalapril formulations. Other patents in this family include U.S. Patents Nos. 9,669,008, 10,039,745, and 10,154,987. These patents collectively cover various aspects of enalapril formulations, including different compositions and methods of preparation[2][5].
Global Dossier and Patent Family
Using the Global Dossier service provided by the USPTO, users can access the file histories of related applications from participating IP Offices, including the IP5 Offices. This service helps in understanding the patent family and the global landscape of similar patents, facilitating a more comprehensive analysis of the patent's scope and claims[1].
Patent Infringement Disputes
Azurity Pharms., Inc. v. Bionpharma Inc.
This patent was at the center of a significant patent infringement dispute between Azurity Pharms., Inc. and Bionpharma Inc. Azurity alleged that Bionpharma's ANDA seeking to market a generic enalapril product would infringe on their patents, including 9,808,442. However, the court ruled in favor of Bionpharma, finding that the ANDA product did not contain the buffer required by the patent claims[2].
Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc.
In another related case, Silvergate Pharmaceuticals, Inc. sued Bionpharma for infringement of U.S. Patents Nos. 9,669,008, 9,808,442, and 10,039,745. This case highlights the ongoing legal battles in the pharmaceutical industry over patent rights and the importance of precise claim language in determining infringement[5].
Claim Preclusion and Obviousness-Type Double Patenting
The dispute between Azurity and Bionpharma also involved the interpretation of claim preclusion and obviousness-type double patenting. The court clarified that the test for claim preclusion differs from the test for obviousness-type double patenting, emphasizing that claims which are "essentially the same" are critical for determining claim preclusion[2].
Economic and Research Implications
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset provides detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. This dataset can be used to analyze trends in patent scope and claims, including those related to pharmaceutical patents like 9,808,442[3].
Impact on Pharmaceutical Industry
The patent landscape around enalapril formulations has significant implications for the pharmaceutical industry. It influences the development of generic drugs, the pricing of medications, and the overall accessibility of treatments for hypertension and heart failure.
Public Access and Search Resources
USPTO Public Search Facility
The USPTO Public Search Facility and Patent and Trademark Resource Centers (PTRCs) provide public access to patent and trademark information, including the ability to search and analyze patents like 9,808,442. These resources are crucial for researchers, inventors, and legal professionals[1].
Common Citation Document (CCD)
The Common Citation Document (CCD) application consolidates prior art cited by participating IP Offices, allowing users to visualize search results for the same invention on a single page. This tool is particularly useful for understanding the prior art landscape relevant to patent 9,808,442[1].
Key Takeaways
- Patent Scope and Claims: The patent 9,808,442 covers specific enalapril formulations, including the presence of a buffer, stability, and bioavailability.
- Patent Infringement Disputes: The patent has been involved in significant legal battles, highlighting the importance of precise claim language and the distinction between claim preclusion and obviousness-type double patenting.
- Global Patent Landscape: The Global Dossier and CCD tools are essential for understanding the global patent family and prior art related to this patent.
- Economic Implications: The patent affects the development and pricing of generic drugs, impacting the pharmaceutical industry and patient access to treatments.
FAQs
What is the main subject of United States Patent 9,808,442?
The main subject of United States Patent 9,808,442 is enalapril formulations, specifically oral liquid formulations used for treating hypertension and symptomatic congestive heart failure.
Why was the buffer requirement crucial in the patent infringement case against Bionpharma?
The buffer requirement was crucial because the court ruled that Bionpharma's ANDA product did not infringe on Azurity's patents since it did not contain the buffer specified in the patent claims.
How does the Global Dossier service help in analyzing patent 9,808,442?
The Global Dossier service provides access to the file histories of related applications from participating IP Offices, allowing users to see the patent family and understand the global landscape of similar patents.
What is the significance of the Patent Claims Research Dataset in analyzing pharmaceutical patents?
The Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, enabling the analysis of trends in patent scope and claims, which is crucial for understanding the landscape of pharmaceutical patents.
How does patent 9,808,442 impact the development of generic drugs?
The patent impacts the development of generic drugs by defining the specific characteristics of enalapril formulations that generic manufacturers must avoid to prevent infringement, influencing the timing and cost of bringing generic versions to market.
Sources
- USPTO - Search for patents: https://www.uspto.gov/patents/search
- Robins Kaplan - Azurity Pharms., Inc. v. Bionpharma Inc.: https://www.robinskaplan.com/newsroom/insights/azurity-pharms-v-bionpharma
- USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - US9808442B2 - Enalapril formulations: https://patents.google.com/patent/US9808442B2/en
- Insight.RPXCorp - Silvergate Pharmaceuticals, Inc. v. Bionpharma Inc.: https://insight.rpxcorp.com/litigation_documents/13377870
