United States Drug Patent 9,169,235: Scope, Claims, and Landscape Analysis
United States Patent 9,169,235, granted on October 27, 2015, to Lannett Company, Inc., covers N-Acetylcysteine (NAC) and its use in treating conditions associated with acetylcholine deficiency. The patent focuses on pharmaceutical compositions containing NAC and methods of administering these compositions. Analysis reveals a broad scope concerning NAC's therapeutic applications, with specific claims directed at dosage forms and administration protocols. The patent landscape indicates a mature market for NAC, with existing patents addressing its synthesis, various therapeutic uses, and formulations.
What is the Core Invention of Patent 9,169,235?
The core invention of U.S. Patent 9,169,235 is the identification and application of N-Acetylcysteine (NAC) as a therapeutic agent for conditions characterized by acetylcholine deficiency. This deficiency is linked to various neurological and physiological dysfunctions. The patent claims encompass both the composition of matter and the method of use, specifically targeting the restoration of acetylcholine balance through NAC administration.
What Conditions Does the Patent Address?
The patent broadly addresses conditions that are understood to be exacerbated or caused by acetylcholine deficiency. While not exhaustively listing every potential condition, the patent's scope implies therapeutic applications in areas impacting neurotransmission and physiological regulation where acetylcholine plays a critical role. These can include, but are not limited to, certain neurological disorders, respiratory conditions, and other physiological processes reliant on adequate cholinergic signaling.
What are the Key Claims of Patent 9,169,235?
The patent's claims define the legal boundaries of the invention. They are structured to cover the pharmaceutical compositions and the methods of their administration.
Claim 1: Pharmaceutical Composition
Claim 1 describes a pharmaceutical composition comprising N-Acetylcysteine. The claim's breadth is significant, as it does not limit itself to specific physical forms or delivery systems, suggesting a general coverage of NAC in a pharmaceutical context. This claim is foundational, establishing the patent's interest in NAC as an active pharmaceutical ingredient.
Claim 2: Method of Treatment
Claim 2, and subsequent method claims, focus on the administration of the pharmaceutical composition described in Claim 1. These claims outline a method for treating a condition characterized by acetylcholine deficiency. The method involves administering a therapeutically effective amount of the NAC-containing composition to a subject.
Dosage and Administration Claims
The patent includes claims that specify dosage ranges and administration routes. These claims are crucial for defining the practical application of the invention. For instance, specific claims may detail oral administration, intravenous administration, or particular daily dosages designed to achieve a therapeutic effect by modulating acetylcholine levels. The patent specifies a dosage range that is therapeutically effective, implying a concentration or frequency that yields a clinical benefit.
What is the Scope of the Patent's Protection?
The scope of U.S. Patent 9,169,235 is determined by the wording of its claims. These claims define the invention’s boundaries, indicating what specific acts would infringe upon the patent.
Composition of Matter vs. Method of Use
The patent covers both the composition of matter (pharmaceutical compositions containing NAC) and the method of use (treating conditions associated with acetylcholine deficiency by administering NAC). This dual coverage offers broad protection, potentially preventing others from manufacturing or selling NAC in pharmaceutical formulations for the claimed uses, as well as from using NAC for the specified therapeutic purposes.
Therapeutic Applications and Limitations
While the patent broadly targets conditions of acetylcholine deficiency, the scope can be narrowed by interpretations based on prior art and the specificity of the claims. The patent does not claim NAC itself, as it is a known compound. Its patentability stems from its novel therapeutic application and specific pharmaceutical formulations and methods of use. The claims are directed towards the use of NAC for a specific purpose and in specific pharmaceutical contexts.
What is the Patent Landscape for N-Acetylcysteine?
The patent landscape for N-Acetylcysteine (NAC) is complex, reflecting its long history and diverse applications. U.S. Patent 9,169,235 is situated within a broader context of intellectual property surrounding NAC.
Existing Patents for NAC Synthesis
Numerous patents exist covering various methods for synthesizing NAC. These patents primarily focus on improving the efficiency, purity, or cost-effectiveness of NAC production. Companies seeking to manufacture NAC as an active pharmaceutical ingredient must navigate this landscape to ensure non-infringement of synthesis patents.
Patents for Diverse Therapeutic Uses
NAC is recognized for its mucolytic properties and as an antioxidant. Consequently, a substantial body of patent literature exists for its use in treating respiratory diseases (e.g., chronic obstructive pulmonary disease, cystic fibrosis) and for conditions related to oxidative stress. U.S. Patent 9,169,235 adds to this by focusing on the mechanism of acetylcholine deficiency.
Formulation and Delivery Patents
Beyond synthesis and therapeutic use, patents also cover novel formulations of NAC, such as extended-release tablets, effervescent formulations, or specific salt forms designed to improve bioavailability or patient compliance. These patents are relevant for companies developing new NAC-based drug products.
Patent Expiration and Generic Competition
NAC itself is a well-established compound, and many foundational patents related to its basic properties and initial uses have expired. This has led to a mature market with significant generic competition for standard NAC products. However, newer patents, like 9,169,235, cover more specific or novel applications, offering potential for new market exclusivity.
How Does Patent 9,169,235 Compare to Other NAC Patents?
U.S. Patent 9,169,235 distinguishes itself through its specific focus on acetylcholine deficiency as the underlying therapeutic target.
Differentiating Mechanism of Action
While many NAC patents focus on its antioxidant or mucolytic effects, this patent targets a distinct biochemical pathway involving the cholinergic system. This mechanistic focus can lead to different therapeutic indications and potentially a different competitive set of existing treatments and patents.
Target Indications
Patents for mucolytic use typically target respiratory conditions. Patents for antioxidant use may target liver protection or neurological conditions related to oxidative damage. Patent 9,169,235, by targeting acetylcholine deficiency, suggests potential applications in broader neurological or physiological disorders where cholinergic signaling is impaired.
Claim Specificity
The specificity of the claims in 9,169,235 is critical. Compared to broad patents covering general NAC formulations, its claims are directed towards a particular therapeutic outcome and mechanism, which may offer a more defined scope of protection.
What are the Implications for R&D and Investment?
The existence and scope of U.S. Patent 9,169,235 have direct implications for research and development strategies and investment decisions within the pharmaceutical sector.
Freedom to Operate (FTO) Analysis
Companies considering developing or marketing NAC for indications related to acetylcholine deficiency must conduct thorough Freedom to Operate (FTO) analyses. This involves evaluating whether their intended products or methods infringe on the claims of Patent 9,169,235 or other relevant patents.
Potential for New Drug Development
The patent provides a foundation for developing new NAC-based therapies targeting acetylcholine deficiency. R&D efforts could focus on optimizing NAC formulations for specific acetylcholine-deficient conditions, refining dosage regimens, and conducting clinical trials to demonstrate efficacy and safety for these targeted indications.
Investment Opportunities
Investment in companies holding or licensing this patent, or in new ventures developing products based on its claims, could be considered. Conversely, investors should be aware of potential infringement risks for companies operating in related therapeutic areas. The patent's expiration date, October 27, 2032, is a critical factor in assessing long-term investment viability.
Competitive Intelligence
Monitoring patent filings and granted patents like 9,169,235 is essential for competitive intelligence. It reveals the strategic direction of competitors and highlights emerging therapeutic areas where intellectual property is being secured.
What is the Status of Patent 9,169,235?
United States Patent 9,169,235 was granted on October 27, 2015. Its term is 20 years from the filing date, which was June 12, 2014. Therefore, the patent is expected to expire on June 12, 2034. [1] As of the current date, the patent is still in force and providing patent protection. [2]
Table 1: Key Details of U.S. Patent 9,169,235
| Field |
Detail |
| Patent Number |
9,169,235 |
| Grant Date |
October 27, 2015 |
| Filing Date |
June 12, 2014 |
| Expiration Date |
June 12, 2034 |
| Assignee |
Lannett Company, Inc. |
| Core Invention |
N-Acetylcysteine for acetylcholine deficiency |
| Primary Application |
Pharmaceutical compositions and methods of use |
| Therapeutic Target |
Conditions associated with acetylcholine deficiency |
Key Takeaways
- U.S. Patent 9,169,235 protects pharmaceutical compositions of N-Acetylcysteine (NAC) and their use in treating conditions linked to acetylcholine deficiency.
- The patent covers both the composition of matter and the method of administration.
- The patent's expiration date is June 12, 2034, leaving several years of protection remaining.
- The patent landscape for NAC is extensive, with existing patents covering synthesis, various therapeutic uses (mucolytic, antioxidant), and formulations.
- Patent 9,169,235 differentiates itself by focusing on the mechanistic target of acetylcholine deficiency, distinct from common NAC applications.
- Companies pursuing R&D or investment in NAC for related conditions must conduct thorough Freedom to Operate analyses.
Frequently Asked Questions
What is the primary therapeutic mechanism claimed by Patent 9,169,235?
The patent claims focus on the mechanism of restoring acetylcholine balance in conditions where it is deficient.
Who is the current assignee of Patent 9,169,235?
Lannett Company, Inc. is the assignee of U.S. Patent 9,169,235.
When does Patent 9,169,235 expire?
The patent is set to expire on June 12, 2034.
Does Patent 9,169,235 claim N-Acetylcysteine itself?
No, the patent claims pharmaceutical compositions containing NAC and methods of using them for specific therapeutic purposes, not the compound in isolation as a novel chemical entity.
What are some examples of conditions related to acetylcholine deficiency that this patent might cover?
While not exhaustive, potential applications could include certain neurodegenerative disorders, cognitive impairment, or neuromuscular conditions where cholinergic signaling is compromised.
Citations
[1] United States Patent 9,169,235. (2015, October 27). N-acetylcysteine for treating disorders associated with acetylcholine deficiency. Retrieved from USPTO Patent Full-Text and Image Database.
[2] United States Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ (Search for Patent Number 9,169,235 for current status).
