Detailed Analysis of the Scope and Claims of United States Patent 8,344,006
Introduction
The United States Patent 8,344,006, issued on January 1, 2013, pertains to stable liquid formulations of bendamustine, a chemotherapeutic agent used in the treatment of various neoplastic diseases. This patent is crucial for understanding the intellectual property landscape surrounding bendamustine formulations.
Inventors and Assignees
The patent was invented by Drager Anthony S., Labell Rachel Y., and Patel Piyush R., and is assigned to Cephalon, Inc., a pharmaceutical company now part of Teva Pharmaceutical Industries[2].
Scope of the Patent
Liquid Formulations of Bendamustine
The patent describes stable liquid formulations of bendamustine and its pharmaceutically acceptable salts. These formulations utilize polar aprotic solvents, which are essential for maintaining the stability of bendamustine in liquid form. This is significant because bendamustine is typically unstable in aqueous solutions, making the development of stable liquid formulations a critical advancement[2].
Pharmaceutical Use
The liquid formulations covered by this patent are intended for pharmaceutical use, particularly in the treatment of neoplastic diseases such as chronic lymphocytic leukemia and non-Hodgkin's lymphoma. The stability of these formulations ensures consistent and effective delivery of the drug, which is vital for patient treatment outcomes[2].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Composition Claims
- The patent claims cover the composition of the liquid formulations, including bendamustine and its pharmaceutically acceptable salts, along with polar aprotic solvents.
- Specific solvents mentioned include dimethyl sulfoxide (DMSO), N,N-dimethylformamide (DMF), and N,N-dimethylacetamide (DMA)[2].
Method Claims
- The patent also includes method claims related to the preparation and use of these liquid formulations. This encompasses the steps involved in mixing the components and ensuring the stability of the final product[2].
Patent Expiration Dates
The patent is set to expire on September 23, 2029, although there are variations in expiration dates depending on the specific claims and any potential extensions or adjustments under U.S.C. 154(b)[2].
Related Patents and Intellectual Property Landscape
Other Bendamustine Patents
There are several other patents related to bendamustine formulations, including patents for lyophilized bendamustine (Patent 8,436,190), novel solid forms of bendamustine hydrochloride (Patent 8,669,279), and additional pharmaceutical compositions (Patent 8,791,270)[2].
Patent Analytics and Claim Coverage
To fully understand the patent landscape, it is essential to conduct patent analytics. This involves analyzing the claims and scope concepts of all relevant patents to identify gaps or opportunities in intellectual property protection. Tools like ClaimScape® software can help in categorizing and analyzing large numbers of patent claims to determine their applicability and value[3].
Impact on Generic and Competitor Products
The expiration of this patent will have significant implications for the availability of generic versions of bendamustine. Once the patent expires, other pharmaceutical companies can develop and market generic versions of the liquid formulations, potentially increasing competition and reducing costs for patients.
Regulatory Considerations
For any generic or competitor product, regulatory compliance is crucial. This includes addressing all unexpired patents listed in the Orange Book and ensuring that the application does not infringe on existing patents. The FDA requires applicants to certify to all relevant patents and to notify the patent holders if a Paragraph IV certification is submitted[1].
Conclusion
United States Patent 8,344,006 is a pivotal patent in the field of bendamustine formulations, providing exclusive rights to Cephalon, Inc. for the development and marketing of stable liquid formulations. Understanding the scope, claims, and expiration dates of this patent is essential for navigating the intellectual property landscape and for any company considering the development of generic or competitor products.
Key Takeaways
- The patent covers stable liquid formulations of bendamustine and its pharmaceutically acceptable salts.
- The formulations use polar aprotic solvents to ensure stability.
- The patent expires on September 23, 2029.
- Related patents cover other forms of bendamustine, such as lyophilized and solid forms.
- Patent analytics is crucial for understanding the broader intellectual property landscape.
- The expiration of the patent will impact the availability of generic versions of bendamustine.
Frequently Asked Questions (FAQs)
What is the main subject of United States Patent 8,344,006?
The main subject of this patent is the stable liquid formulations of bendamustine, a chemotherapeutic agent.
Who are the inventors and assignees of this patent?
The inventors are Drager Anthony S., Labell Rachel Y., and Patel Piyush R., and the assignee is Cephalon, Inc.
What are the key components of the liquid formulations described in this patent?
The key components include bendamustine and its pharmaceutically acceptable salts, along with polar aprotic solvents such as DMSO, DMF, and DMA.
When is the patent set to expire?
The patent is set to expire on September 23, 2029.
How does this patent impact the development of generic versions of bendamustine?
The expiration of this patent will allow other pharmaceutical companies to develop and market generic versions of the liquid formulations, increasing competition and potentially reducing costs for patients.
Cited Sources:
- FDA Document: 208194Orig1s000OtherR.pdf - FDA.
- Drugs.com: Generic Treanda Availability - Drugs.com.
- Schwegman: Patent Analytics | Intellectual Property Law - Schwegman.
- Google Patents: United States Patent - googleapis.com.
- Unified Patents Portal: WO-2020035806-A1 - Unified Patents Portal.
