United States Patent 9,687,506: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,687,506, titled "Sodium nitrite-containing pharmaceutical compositions," is a significant patent in the pharmaceutical sector, particularly in the area of emergency medical treatments. This patent is associated with the drug Nithiodote, which is used for treating cyanide poisoning and other conditions. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
Inventors and Assignees
The patent was granted to inventors associated with Hope Pharmaceuticals, the company that markets Nithiodote. Understanding the inventors and assignees is crucial as it highlights the ownership and control over the intellectual property.
Publication and Grant Dates
The patent was published and granted on various dates, with the most recent activities indicating ongoing maintenance and updates. For instance, recent records show patent grant notifications and maintenance fee payments, ensuring the patent remains active[5].
Scope of the Patent
Pharmaceutical Compositions
The patent focuses on pharmaceutical compositions containing sodium nitrite, often used in conjunction with sodium thiosulfate. These compositions are critical for reducing the risk of hospital-acquired infections and treating conditions such as cyanide poisoning[4].
Therapeutic Uses
The scope extends to various therapeutic uses, including the treatment of cyanide poisoning, which is a life-threatening condition. The patent also touches on the prevention of nosocomial infections, highlighting its broad applicability in medical emergencies[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims typically describe the composition, method of preparation, and specific uses of the sodium nitrite-containing pharmaceuticals. For example, Claim 1 might describe a pharmaceutical composition comprising a specific concentration of sodium nitrite and sodium thiosulfate[4].
Dependent Claims
Dependent claims further specify the invention by adding additional limitations or features to the independent claims. These could include specific dosages, administration methods, or additional ingredients that enhance the efficacy or stability of the composition.
Patent Landscape
Patent Family and International Protection
The patent is part of a larger patent family with protections in multiple countries. For Nithiodote, there are fifty-six patent family members in fifteen countries, indicating a robust global intellectual property strategy[1].
US Patents and Regulatory Protections
In the United States, Nithiodote is protected by seven patents, with the earliest generic entry date estimated to be December 24, 2031, subject to patent challenges or licensing agreements[1][5].
Patent Litigation and Challenges
There have been patent litigation cases involving the patents protecting Nithiodote, reflecting strong interest in generic versions. Recent data suggest that a significant percentage of patent challenges are decided in favor of generic challengers, who often promptly launch generic drugs following a successful challenge[1].
Nonobviousness and Novelty Requirements
Nonobviousness
The patent must meet the nonobviousness requirement, meaning the invention must be significantly different from existing knowledge in the field. The Patent Trial and Appeal Board (PTAB) and judicial reviews ensure that the claimed invention is not obvious to a person of ordinary skill in the art[3].
Novelty
The novelty requirement ensures that the claimed invention is new and not previously disclosed in the prior art. This is a fundamental requirement for patentability, and any failure to meet this criterion can result in the patent being invalidated[3].
Eligible Subject Matter
The patent claims must be directed to eligible subject matter, excluding laws of nature, natural phenomena, and abstract ideas. The Alice/Mayo test is often applied to determine if the patent claims have an "inventive concept" that transforms the nature of the claim into a patent-eligible application[3].
Impact on the Pharmaceutical Industry
Market Position and Competition
The unique market position of Nithiodote, coupled with its critical therapeutic uses, makes it a significant player in the pharmaceutical industry. The patent protections ensure that Hope Pharmaceuticals maintains market exclusivity, influencing the financial trajectory of the drug[1].
Generic Entry and Competition
The estimated generic entry date and potential challenges to the patent can significantly impact the market dynamics. Generic entry can lead to increased competition, potentially reducing the market share and revenue of the branded drug[1].
Conclusion
The United States Patent 9,687,506 is a critical intellectual property asset for Hope Pharmaceuticals, protecting the drug Nithiodote. The scope of the patent encompasses specific pharmaceutical compositions and therapeutic uses, with a robust patent landscape that includes international protections and ongoing litigation.
Key Takeaways
- Patent Scope: The patent covers sodium nitrite-containing pharmaceutical compositions, particularly for treating cyanide poisoning and preventing nosocomial infections.
- Claims: Independent and dependent claims define the invention, including composition, preparation, and specific uses.
- Patent Landscape: Protected by seven US patents and fifty-six international patent family members, with an estimated generic entry date of December 24, 2031.
- Regulatory Protections: Meets nonobviousness, novelty, and eligible subject matter requirements.
- Market Impact: Significant market exclusivity for Hope Pharmaceuticals, with potential competition from generic entries.
FAQs
1. What is the primary use of the drug protected by United States Patent 9,687,506?
The primary use of the drug protected by this patent is the treatment of cyanide poisoning and the prevention of nosocomial infections.
2. How many US patents protect Nithiodote?
Nithiodote is protected by seven US patents.
3. What is the estimated generic entry date for Nithiodote?
The estimated generic entry date for Nithiodote is December 24, 2031, subject to patent challenges or licensing agreements.
4. What are the key components of the pharmaceutical composition described in the patent?
The key components are sodium nitrite and sodium thiosulfate.
5. Why is the patent landscape important for Nithiodote?
The patent landscape is crucial as it ensures market exclusivity for Hope Pharmaceuticals, influencing the financial trajectory and competitive position of the drug.
Cited Sources:
- Drug Patent Watch - Nithiodote Drug Patent Profile
- CAFC - INTEL CORPORATION v. PACT XPP SCHWEIZ AG
- Congressional Research Service - The Patent Trial and Appeal Board and Inter Partes Review
- Google Patents - Sodium nitrite-containing pharmaceutical compositions
- Pharsight - Nithiodote patent expiration