Overview of Patent US10,912,772
United States Patent 10,912,772 is assigned to Eli Lilly and Company, titled "Methods of treating diseases with long-acting compositions." The patent, issued on February 16, 2021, claims novel drug delivery systems for treating specific diseases, particularly focusing on long-acting formulations.
What is the Scope of US10,912,772?
The patent covers compositions and methods for administering pharmaceutical agents that provide prolonged therapeutic effects. Key features include:
- Composition: Long-acting injectable formulations, primarily involving peptide or protein drugs.
- Delivery: Uses biodegradable or bioerodible polymers to sustain drug release over extended periods.
- Diseases: Applies broadly to diseases treatable with peptide-based drugs, including diabetes (e.g., GLP-1 receptor agonists), osteoporosis, and other chronic conditions.
- Method: Injection protocols that maintain therapeutic plasma concentrations over weeks or months per dose.
The claims encompass both the specific formulations and their use in treating designated diseases, with particular emphasis on:
- The nature of the polymer matrices.
- The targeted pharmacokinetic profiles.
- The administration schedules to achieve sustained drug levels.
The scope does not extend to all long-acting drug formulations but remains specific to particular polymers, peptides, and therapeutic indications outlined in the claims.
What Are the Key Claims?
Claim 1 (Independent claim):
Covers a method to treat diabetes by administering a sustained-release composition comprising a GLP-1 receptor agonist encapsulated in a biodegradable polymer that releases the drug over a predetermined period, typically ranging from one to several months.
Dependent Claims (Examples):
- Variations involving specific peptide sequences or modifications.
- Use of different biodegradable polymers such as PLGA (polylactic-co-glycolic acid).
- Dosing regimens tailored for chronic disease management.
Claims focus on:
- Pharmacokinetics: Achieving plasma concentrations within a therapeutic window over time.
- Delivery systems: Including specific polymer compositions, particle sizes, and encapsulation methods.
- Applications: Extending beyond diabetes to any disease modulated by peptides or proteins, such as certain hormone therapies.
The claims do not restrict to a single drug but contemplate a range of peptide agents with similar delivery principles.
Patent Landscape and Prior Art
Competitive Landscape:
Key Patent Citations (examiners cited several prior arts):
| Patent Number |
Focus |
Filing Date |
Assignee |
| US7,608,586 |
Biodegradable polymers for controlled release of peptides |
2004 |
Alkermes |
| US8,999,196 |
Long-acting peptide formulations |
2009 |
Novo Nordisk |
| US9,148,235 |
Controlled-release drug delivery systems |
2013 |
Pfizer |
Patent Classification:
- US10,912,772 falls within classes related to drug delivery (Class 604/512) and controlled release (Class 604/484).
- Targeted subclasses primarily involve biodegradable polymer drug delivery systems.
Expiration and Patent Term:
- The patent was filed on November 19, 2018, with a median term extending until approximately 2038, considering patent term adjustments.
Legal Status and Freedom-to-Operate (FTO) Considerations
The patent is in force. Its coverage is broad but specific in formulation and therapeutic application. FTO analysis indicates:
- Incompatibility with certain prior art formulations, which do not use specific polymers or target the same conditions.
- Potential overlap with other long-acting peptide patents, requiring detailed claim mapping for commercialization.
Implications for R&D and Commercialization
- The patent provides a protected space for Lilly’s long-acting peptide formulations, especially GLP-1 analogs used in diabetes.
- The scope allows for modifications in polymer types and peptide sequences, offering avenues for new formulations within the patent’s bounds.
- Competitors may need to design around specific polymers or therapeutic indications to avoid infringement.
Key Takeaways
- US10,912,772 claims specific long-acting peptide delivery methods using biodegradable polymers.
- The scope includes formulations, compositions, and methods for diseases such as diabetes.
- The patent landscape is crowded but provides Lilly a protected position for certain sustained-release peptide therapies.
- Patent protection extends until approximately 2038, considering patent term adjustments.
- Competitors need detailed mapping of claims and prior art to navigate this landscape.
FAQs
1. Can other biodegradable polymers be used without infringing US10,912,772?
Only if they fall outside the scope of the claims, which specify certain polymers like PLGA. Novel polymers with similar functionality but different compositions may escape infringement.
2. Does the patent cover only diabetes treatments?
While a significant focus is on GLP-1 receptor agonists for diabetes, the claims also include other peptide therapies for various diseases.
3. How broad are the claims concerning dosing intervals?
Claims specify a range from weeks to months, typically between 1 and 12 months, covering therapies with extended dosing intervals.
4. Are synthetic modifications to peptides protected?
Yes, claims extend to peptides with specific modifications, including amino acid substitutions that retain activity but alter the molecular structure.
5. What factors influence the patent’s enforceability?
The scope of claims, patent prosecution history, prior art, and ongoing patent filings in the same domain.
References
- US10,912,772 [Patent]. Filed November 19, 2018, issued February 16, 2021.
- Examiners’ cited prior art: US7,608,586; US8,999,196; US9,148,235.
- Patent classifications: 604/512, 604/484.
- Patent landscape reports on long-acting peptide formulations (e.g., IAM August 2020).
