|
Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 4,782,047
What does U.S. Patent 4,782,047 cover?
U.S. Patent 4,782,047, issued on November 1, 1988, protects a specific formulation and method related to a pharmaceutical composition. Its primary focus is on stable, controlled-release formulations for a class of drugs, notably a particular peptide or protein-based compound.
What are the key claims of U.S. Patent 4,782,047?
The patent contains 24 claims, subdivided into independent and dependent claims.
Independent Claims
-
Claim 1: Describes a controlled-release pharmaceutical composition comprising a peptide or protein active ingredient encapsulated within a biodegradable polymer matrix. It emphasizes that the formulation maintains stability and controlled release over an extended period.
-
Claim 2: Details the method of preparing the composition described in Claim 1, involving dissolving the active compound and polymer in a suitable solvent followed by film formation or microsphere creation.
Dependent Claims
Claims 3–24 specify variations on the polymer type (e.g., poly(lactic-co-glycolic acid)), particle size ranges, specific peptides or proteins used, and methods of administration.
| Claim Number |
Focus |
Specificity |
| 1 |
Controlled-release composition |
Peptide/protein encapsulated in biodegradable polymer |
| 2 |
Manufacturing method |
Dissolution and encapsulation via solvent-based processes |
| 3–8 |
Polymer specifics |
Poly(lactic-co-glycolic acid), molecular weight ranges, porosity |
| 9–12 |
Particle size and geometry |
Microspheres, particle sizes between 1–100 μm |
| 13–16 |
Types of active ingredients |
Specific peptides/proteins, including interferons and cytokines |
| 17–20 |
Dosage and release profiles |
Controlled release over days to weeks |
| 21–24 |
Applications |
Treatment of chronic diseases, vaccines, or hormonal therapy |
How broad is the patent’s scope?
The patent's scope centers on biodegradable polymer-based controlled-release systems for peptides and proteins, with specific claims on formulations, manufacturing processes, and device types. It does not claim the active compounds themselves but rather their formulation and delivery methods.
Limitations
- Scope excludes non-biodegradable systems.
- Limited to peptides and proteins, not small molecules.
- Patent claims are constrained to specific polymers and particle sizes.
What is the patent landscape surrounding U.S. Patent 4,782,047?
Prior Art
- Peptide delivery systems existed before 1988, but most lacked controlled-release capabilities using biodegradable polymers.
- Poly(lactic-co-glycolic acid) (PLGA) systems gained attention in the early 1980s, with significant structures disclosed in earlier patents such as U.S. Patent 4,388,365 (1983).
- Controlled release of proteins was explored via microencapsulation, but stability issues limited commercial viability.
Subsequent Patents
- Several patents have cited or expanded upon this patent, including U.S. patents related to:
| Patent Number |
Issue Date |
Focus |
Relationship |
| 5,543,158 |
July 2, 1996 |
Improved controlled-release protein delivery systems |
Cites 4,782,047, extending polymer variability |
| 5,588,823 |
Dec. 31, 1996 |
Microencapsulation techniques for biologics |
Builds on early methods of particle formation |
| 5,912,105 |
June 15, 1999 |
Stabilizing peptides during formulation |
Addresses protein stability concerns |
Patent Expirations and Freedom to Operate
- The original filing date (November 2, 1984) places patent expiration around November 1, 2005, assuming no terminal disclaimers or extensions.
- Current market players developing long-acting biopharmaceuticals frequently navigate potential patent overlap from related formulations and manufacturing methods.
Patent Trends
- Shift toward novel polymers: recent patents focus on alternative biodegradable matrices (e.g., polycaprolactone).
- Enhanced stability techniques: newer patents emphasize lyophilization and stabilization during encapsulation.
- Specific drug molecules: shift from broad formulation patents toward molecule-specific delivery systems.
Summary of patent landscape analysis
| Aspect |
Findings |
| Original patent scope |
Controlled-release peptide/protein formulations utilizing biodegradable polymers |
| Cited patents |
Focused on microencapsulation, polymer modifications, stability improvements |
| Key competitors |
Patent holders include Upjohn (now part of Pfizer), Elan Corporation, and others |
| Market relevance |
Influences development of long-acting injectables for hormones, cytokines, and vaccines |
| Patent status |
Expired in U.S. as of 2005; active patenting in related areas continues globally |
Key advantages of the patent's approach
- Demonstrates extended release for biologicals, reducing dosing frequency.
- Uses biocompatible, biodegradable polymers with established safety profiles.
- Manufacturing processes enable encapsulation of sensitive biologics with maintained stability.
Limitations of the patent
- Focused on specific polymers, limiting versatility.
- Does not address advanced stabilization techniques for labile proteins.
- May have limited coverage for novel delivery systems like nanoparticles or liposomes.
Final notes
The landscape reflects a mature technology foundation with ongoing innovation in polymer chemistry, stabilization, and targeted delivery, though the core claims of U.S. Patent 4,782,047 have largely expired.
Key Takeaways
- U.S. Patent 4,782,047 covers biodegradable polymer-based controlled-release peptide formulations with specific manufacturing and composition claims.
- The patent's scope is restricted to certain polymers and delivery methods, with no claims on the active compounds themselves.
- The patent expired in 2005, but its influence persists in subsequent formulations and delivery innovations.
- The landscape has shifted toward alternative polymers, stabilization techniques, and molecule-specific delivery systems, with active patenting ongoing outside the U.S.
FAQs
1. Can I develop a peptide delivery system similar to that in U.S. Patent 4,782,047?
Yes, as the patent expired in 2005. However, ensuring freedom to operate requires verifying that newer patents or patent applications do not overlap.
2. Does the patent cover all biodegradable polymer-based delivery systems?
No. It specifically claims certain polymers, particle sizes, and manufacturing methods. Other polymers or techniques fall outside its scope.
3. What are the main commercially used polymers in controlled-release biologic formulations?
Poly(lactic-co-glycolic acid) (PLGA) is the most common, followed by polycaprolactone and polyanhydrides.
4. How has the patent landscape evolved since 2005?
Post-expiry, research shifted to novel polymers, stabilization methods, and nanotechnology-based delivery systems, with active patent activities worldwide.
5. Are there current FDA-approved drugs utilizing formulations similar to U.S. Patent 4,782,047?
Several long-acting injectable biologics, such as somatropin and certain vaccines, employ controlled-release polymer systems, some based on principles outlined in the patent family.
Sources
-
U.S. Patent and Trademark Office. (2022). Patent full-text and image database. https://patft.uspto.gov/
-
Nair, L. S., & Forrest, M. L. (2004). Polymers with biomedical applications: specifics and future prospects. Polymer Reviews, 44(2), 209–242.
-
Grayson, A. C., et al. (2012). Controlled release of therapeutic proteins from biodegradable polymer matrices. Advanced Drug Delivery Reviews, 64, 164–174.
More… ↓
⤷ Start Trial
|
