United States Patent 8,653,061: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,653,061, commonly referred to as the "061 Acetadote Patent," is a significant intellectual property asset owned by Cumberland Pharmaceuticals. This patent is crucial for the company's Acetadote product, which is used to treat acetaminophen overdose. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Issuance
The USPTO issued the 061 Acetadote Patent on February 18, 2014. This patent is part of a series of patents associated with Cumberland Pharmaceuticals' Acetadote product, which has been a cornerstone in the treatment of acetaminophen overdose[2][4].
Scope of the Patent
The 061 Acetadote Patent specifically encompasses the use of a 200 mg/ml Acetadote formulation for treating patients with acetaminophen overdose. This formulation is notable for being EDTA-free, which distinguishes it from earlier versions of the drug that contained EDTA (ethylenediaminetetraacetic acid), a metal chelating agent[2][4].
Claims of the Patent
The claims of the 061 Acetadote Patent are focused on the method of using the specified formulation to treat acetaminophen overdose. These claims are detailed and specific, ensuring that the patent protection covers the exact method and formulation developed by Cumberland Pharmaceuticals. The patent's claims were designed to be robust enough to withstand challenges from generic manufacturers while ensuring the continued market exclusivity of Acetadote[2].
Patent Protection and Exclusivity
Following its issuance, the 061 Acetadote Patent was listed in the FDA Orange Book, which is a critical step in maintaining market exclusivity for pharmaceutical products. This listing helps to prevent generic versions of the drug from entering the market until the patent expires. The patent is scheduled to expire in August 2025[2][4].
Challenges and Litigation
The 061 Acetadote Patent has faced several challenges from generic pharmaceutical companies. Companies such as Perrigo, Sagent Pharmaceuticals, Mylan, Akorn, Aurobindo Pharma Limited, and Zydus Pharmaceuticals (USA) Inc. have filed Paragraph IV certification notices challenging the patent on grounds of non-infringement, unenforceability, and/or invalidity. Cumberland Pharmaceuticals has vigorously defended its patent, resulting in favorable court rulings, including a permanent injunction preventing the marketing of generic versions of Acetadote until the patent's expiration[2][4].
Court Rulings and Validation
In 2015, an Illinois judge issued a final ruling in favor of Cumberland Pharmaceuticals, upholding the validity of the patent and granting a permanent injunction against generic challengers. This ruling was later affirmed by an Appeals Court in 2017, further solidifying the patent's validity and Cumberland's market exclusivity for Acetadote[4].
Broader Patent Landscape
Cumberland Pharmaceuticals has a robust patent portfolio related to Acetadote and other products. In addition to the 061 Acetadote Patent, the company holds other patents such as the 738 Acetadote Patent, which covers administration methods of acetylcysteine injection without specifying the presence or absence of EDTA. These patents collectively protect various aspects of the Acetadote product and its use, ensuring comprehensive intellectual property protection[2].
Impact on Market and Patients
The 061 Acetadote Patent has significant implications for both the market and patient care. By maintaining exclusivity, Cumberland Pharmaceuticals can continue to invest in research and development, ensuring high-quality medicines are available for critical conditions like acetaminophen overdose. This exclusivity also allows the company to control the distribution and pricing of Acetadote, which can impact patient access and healthcare costs[4].
Future Considerations
As the patent approaches its expiration date in August 2025, Cumberland Pharmaceuticals will need to strategize for the post-patent landscape. This could involve developing new formulations, seeking additional patent protections, or exploring other market opportunities to maintain their competitive edge.
Conclusion and Key Takeaways
- Patent Scope: The 061 Acetadote Patent covers the use of a 200 mg/ml EDTA-free Acetadote formulation for treating acetaminophen overdose.
- Claims: The patent's claims are specific to the method of using this formulation.
- Exclusivity: Listed in the FDA Orange Book, the patent ensures market exclusivity until August 2025.
- Challenges: The patent has faced several challenges from generic manufacturers but has been upheld in court.
- Broader Landscape: Part of a robust patent portfolio protecting various aspects of Acetadote.
- Impact: Significant for market control, patient care, and future strategic planning.
FAQs
Q: What is the primary use of the 061 Acetadote Patent?
A: The primary use of the 061 Acetadote Patent is for the treatment of acetaminophen overdose using a 200 mg/ml EDTA-free formulation.
Q: When was the 061 Acetadote Patent issued?
A: The 061 Acetadote Patent was issued on February 18, 2014.
Q: What is the significance of the patent being listed in the FDA Orange Book?
A: Listing in the FDA Orange Book ensures that the patent is recognized by regulatory authorities, helping to maintain market exclusivity until the patent expires.
Q: Have there been any legal challenges to the 061 Acetadote Patent?
A: Yes, several generic pharmaceutical companies have challenged the patent, but Cumberland Pharmaceuticals has successfully defended it in court.
Q: When is the 061 Acetadote Patent scheduled to expire?
A: The 061 Acetadote Patent is scheduled to expire in August 2025.
Cited Sources
- US8653061B2 - Acetylcysteine composition and uses thereof - Google Patents
- September 14, 2015 Via EDGAR United States Securities and ... - Cumberland Pharmaceuticals
- Patent Claims Research Dataset - USPTO
- Annual Reports - Cumberland Pharmaceuticals
- US-5124351-A | Unified Patents - Unified Patents
