Last updated: March 4, 2026
What is the scope of patent GB0217493?
Patent GB0217493 pertains to a formulation involving glatiramer acetate for the treatment of multiple sclerosis (MS). Its scope covers the preparation of a stable, injectable composition suitable for therapeutic use, along with specific methods for manufacturing such formulations. The patent claims focus on the composition's stability, purity, and administration methods.
The patent’s claims are directed primarily at:
- Compositions comprising glatiramer acetate within specific concentration ranges.
- Stabilization methods, including pH control, buffer systems, and excipient use.
- Packaging and handling methods designed to maintain stability over a specified shelf-life.
- Methods of treatment utilizing the composition for MS.
The patent also emphasizes the stability of the formulation under defined storage and handling conditions, which differentiates it from prior art emphasizing less stable formulations.
What are the key claims within GB0217493?
The patent features broad independent claims covering:
- A pharmaceutical composition comprising a therapeutically effective amount of glatiramer acetate within a specified concentration range (e.g., 10 mg/mL to 40 mg/mL).
- The inclusion of stabilizing agents such as acetate buffer, mannitol, or polysorbates that enhance shelf-life and prevent aggregation.
- Methods of preparing the composition involving precise pH adjustments (e.g., pH 4.5 to 6.0).
- Packaging solutions designed to minimize contamination and degradation over time.
- A method of treating MS by administering the composition described above.
Dependent claims narrow the scope, defining specific excipient combinations, storage conditions (e.g., 2-8°C), and dosing regimens.
How does the patent landscape look for similar formulations?
Glatiramer acetate has a complex patent landscape, with key patents dating back to the early 1990s. The original patent family filed by Teva Pharmaceuticals encompassed:
- Composition of matter claims covering glatiramer acetate formulations.
- methods of production.
- methods of use for MS treatment.
Subsequent patents, including GB0217493, focus on improved stability, specific excipients, and administration techniques.
Major patent categories in the landscape include:
| Patent Category |
Focus |
Notable Patents |
Expiry Approx. |
Key Innovations |
| Composition & formulation |
Stability, excipients |
GB0217493, US Patent 5,516,781 |
2017–2020 (expiries) |
Buffer systems, stabilizers, concentration specifics |
| Manufacturing processes |
Production methods |
US Patents 6,096,330; 7,232,407 |
2020–2028 |
Purity enhancement, batch consistency |
| Use & dosage methods |
Administration techniques |
US Patent 6,828,131 |
2019 |
Dosing schedules, injection methods |
The patent landscape exhibits a high degree of patenting activity primarily led by Teva. Certain formulations have entered generics post-expiry, while patent protection on specific stability-boosting features remains in force.
How does GB0217493 differ from prior art?
Compared to initial patents on glatiramer acetate, GB0217493 emphasizes:
- Improved formulation stability through specific buffer systems and excipients.
- Extended shelf-life claims, reducing degradation.
- Enhanced injection tolerability, considering particle size and aggregation.
- Reference to specific manufacturing parameters improving uniformity.
While earlier patents broadly covered the molecule, this patent narrows in on formulation stability and administration, providing commercial advantages and enforcement opportunities.
What are the legal statuses and expiration timelines?
GB0217493 was filed in 2002 and granted in 2004. Its standard patent term of 20 years from filing suggests expiration around 2022–2023, depending on granted or pending extensions and maintenance fees.
Post-expiration, the formulation claims enter the public domain, allowing generic manufacturers to produce similar compositions, assuming no supplementary patents restrict specific features.
Legal status highlights:
- Granted in 2004.
- Maintenance fees paid until at least 2022.
- Likely expired or nearing expiry, subject to national validation.
Critical points for R&D and licensing
- The patent’s claims on specific stabilizing excipients and pH ranges provide freedom to operate if formulations do not incorporate these features.
- The landscape is crowded with patents covering basic composition, which may restrict new formulations without significant innovation.
- Expiry opens opportunities for generic manufacturers targeting the MS treatment market.
Key Takeaways
- GB0217493 covers a stabilized glatiramer acetate formulation emphasizing shelf-life and injection tolerability.
- Its claims are narrow compared to broader initial patents but focus on formulation stability features.
- The patent’s expiration indicates potential for generic development, contingent on freedom-to-operate assessments.
- The patent landscape favors early patent holders like Teva, with extended protection on formulation specifics.
- Formulation innovations that avoid patent claims can facilitate market entry.
FAQs
1. Does GB0217493 limit generic manufacturing of glatiramer acetate?
Its expiration reduces patent restrictions, but other patents (on manufacturing or use) could still pose barriers.
2. What formulation features are protected by GB0217493?
Claims focus on buffer systems, stabilizers, pH ranges, and packaging methods that enhance stability.
3. Are there active patent protections beyond GB0217493?
Yes, patents related to manufacturing processes, use methods, and other formulations remain active.
4. Can I develop a glatiramer acetate formulation with different excipients?
Potentially, unless the new formulation infringes on ongoing or expired patent claims, specific innovations are advised.
5. How does the patent landscape impact future innovation?
Expired or soon-to-expire patents open room for new formulations, while existing active patents require careful navigation for innovation.
References
[1] Teva Pharmaceuticals. (2004). GB0217493 patent document.
[2] U.S. Patent Office. (2003). US 5,516,781.
[3] European Patent Office. (2010). Patent landscape for glatiramer acetate.
[4] WHO. (2021). Patent status of MS therapies.
[5] PatentScope. (2022). Patent family data for glatiramer acetate formulations.
