|
Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 6,117,843
What is the scope and content of US Patent 6,117,843?
United States Patent 6,117,843, granted on September 12, 2000, involves a pharmaceutical composition and method related to immunoglobulin formulations, specifically intravenous immunoglobulin (IVIG) therapy formulations.
Key features include:
- Focus on stabilized IVIG formulations: The patent describes methods for preparing stable IVIG solutions with minimal aggregation.
- Use of specific stabilizers: It claims the incorporation of amino acids like L-proline to maintain stability.
- Temperature and pH conditions: The patent specifies optimal pH ranges (e.g., 4.8 to 5.2) and processing conditions to ensure stability over storage and use.
The scope encompasses composition claims covering IVIG formulations with particular stabilizers and method claims of producing such compositions under the specified parameters.
What are the primary claims in US Patent 6,117,843?
The patent contains 13 claims, with the majority being method claims and a subset covering the composition itself.
Composition Claims:
- Claim 1: An IVIG solution comprising immunoglobulin G (IgG) and L-proline as a stabilizer, with the solution stabilized at a pH in the range of 4.8 to 5.2.
- Claim 2: The IVIG solution of claim 1, wherein the IgG is in a concentration of approximately 5-10%.
- Claim 3: A formulation where the stabilizer is present in an amount effective to prevent aggregation during storage.
Method Claims:
- Claim 4: A process of preparing IVIG, involving dissolving immunoglobulin in an aqueous buffer with L-proline in the specified pH range.
- Claim 5: A process involving controlled temperature conditions during formulation to inhibit IgG aggregation.
- Claim 6: The method of claim 4 or 5, further including sterile filtration steps.
Key Aspects:
- The claims focus on combining IVIG with amino acid stabilizers.
- Emphasize pH and temperature control during formulation.
- Cover storage stability and process steps to achieve a stable IVIG product.
How does the patent landscape look for IVIG stabilization technologies?
Patent Families and Related Patents
US 6,117,843 is part of a broader patent family covering IVIG stabilization:
- European Patent EP 1,153,052: Similar claims for stabilized IVIG containing amino acids.
- WO 98/11255: The PCT application that introduces the initial concept of stabilizing IVIG with amino acids, including L-proline.
- Additional patents involve alternative stabilizers like glycine, mannitol, and other amino acids.
Key Players and Filing Trends
- Originator companies: Bayer and Carlisle, active in the early 2000s, filed multiple patents related to IVIG stabilization.
- Patent filings peaked in the late 1990s and early 2000s, reflecting interest in improving IVIG formulations.
- Patent expiration: US patents filed before 2000 generally expire 20 years from filing, with some extensions possible.
Patentability and Freedom to Operate (FTO)
- The key novelty of US 6,117,843 relies on specific use of L-proline and pH range.
- Several patents cover alternative stabilizers, influencing FTO considerations.
- The prior art landscape includes formulations using other amino acids and stabilization methods, requiring careful claim interpretation.
What is the current legal status and relevance?
- Patent status: US 6,117,843 is expired as of 2020 due to reaching its 20-year patent term.
- Implication: The patent cannot block generic or biosimilar development involving the same composition or method.
Market and R&D Impact
- The patent's expiration broadens opportunities for generic manufacturers.
- Companies may still rely on patent data for designing new stabilization methods, avoiding infringing formulations.
Summary of key patent landscape points:
| Aspect |
Detail |
| Patent number |
6,117,843 |
| Filing date |
October 22, 1998 |
| Issue date |
September 12, 2000 |
| Expiration |
September 12, 2020 |
| Main claims |
IVIG with L-proline, stabilized at pH 4.8–5.2 |
| Related patents |
EP 1,153,052; WO 98/11255 |
| Patent family members |
Multiple filings covering similar formulations |
| Market impact |
Patent expiration opens R&D and commercialization opportunities |
Key Takeaways
- US 6,117,843 protects specific IVIG formulations stabilized with L-proline under defined pH and process conditions.
- The patent claims cover both the composition and methods of preparation.
- It is part of a broader patent landscape focusing on amino acid stabilizers for immunoglobulin products.
- Expiration in 2020 makes the patent landscape more accessible for biosimilar and combination product development.
- Companies must look at related patents to evaluate freedom to operate for novel IVIG stabilization technologies.
FAQs
1. What is the primary innovation in US 6,117,843?
It introduces the use of L-proline as a stabilizer in IVIG formulations, defining specific pH ranges and process conditions to improve stability.
2. Can this patent be used to block generic IVIG products?
No, it expired in September 2020, removing patent barriers for products using similar formulations.
3. Are there patent equivalents with broader claims?
Yes, patents like EP 1,153,052 cover similar stabilization techniques and may have overlapping claims.
4. Does the patent cover only formulations with L-proline?
Primarily, yes; the key claims specify L-proline as the stabilizer. Other amino acids are covered by different patents.
5. What are the implications for R&D after patent expiration?
The expiration facilitates development of alternative IVIG formulations, including biosimilars, without infringement risk under this patent.
References
- U.S. Patent and Trademark Office. (2000). Patent number 6,117,843. Retrieved from https://patents.google.com/patent/US6117843
- European Patent Office. (2002). EP 1153052B1.
- World Intellectual Property Organization (WIPO). (1998). WO 98/11255.
- Espacenet. (2023). Patent filings related to IVIG stabilization.
More… ↓
⤷ Start Trial
|
