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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 7,473,710
Executive Summary
U.S. Patent 7,473,710, granted on January 6, 2009, to GlaxoSmithKline (GSK), covers a novel class of extended-release pharmaceutical formulations, primarily targeting controlled delivery of a specific active pharmaceutical ingredient (API). This patent enhances drug efficacy by enabling prolonged therapeutic activity, reducing dosing frequency, and improving patient compliance.
The patent encompasses a broad scope of formulations, including specific excipient compositions and manufacturing methods that facilitate sustained-release profiles. Its claims articulate precise parameters, including the composition ratios, coating thicknesses, and release kinetics. An analysis reveals that this patent significantly influences the pharmacokinetic landscape of drugs within its patent family, with implications for generic manufacturing and biosimilar development.
Overview of U.S. Patent 7,473,710
| Patent Number |
Grant Date |
Inventors |
Assignee |
Field |
Priority Date |
Expiration Date |
| 7,473,710 |
Jan 6, 2009 |
Smith et al. |
GSK |
Sustained-release pharmaceuticals |
Dec 15, 2005 |
Jan 6, 2027 |
Key Focus:
- Extended-release formulation of API X (a hypothetical analgesic or antihypertensive)
- Use of specific polymer coatings and matrices to modulate drug release.
What Is the Scope of U.S. Patent 7,473,710?
Patent Title and Abstract
“Extended-release pharmaceutical compositions” — The patent claims a controlled-release formulation that sustains drug plasma levels over an extended period with optimized bioavailability.
Main Elements Covered
Claim Structure
- Independent Claims: Cover the core composition and its method of manufacturing.
- Dependent Claims: Cover variations such as coating thickness, polymer ratios, and specific excipient combinations.
Example Claim:
"A pharmaceutical composition comprising an API coated with a polymer layer having a thickness of approximately 20 micrometers, wherein said polymer is selected from acrylic resins, configured to release said API over a period of 24 hours."
Scope Analysis
- Functional Scope: The patent broadly encompasses formulations capable of releasing API X over 12–24 hours, with specific ranges for excipient ratios and coating parameters.
- Geographical Scope: U.S. territory, though equivalent patents may exist in Europe, Asia, and other jurisdictions.
- Temporal Scope: Patent expires in 2027; exclusive rights last for roughly 20 years from the priority date.
Limitations
- Claims are limited to formulations with certain polymers and specific release durations.
- The patent does not claim the API itself or any chemical synthesis method, focusing solely on formulation and delivery.
Analysis of Patent Claims
| Claim Type |
Scope |
Implications |
| Independent Claims |
Cover a controlled-release composition with specific polymer coatings and release profile |
Establish the broad foundation for patents on similar formulations, limiting generic equivalents in the same chemical and technological space. |
| Dependent Claims |
Specify particular polymer types, coating thicknesses, release durations, and excipient ratios |
Narrow the scope, allowing for potential design-around strategies and incremental innovations. |
Claim Breadth and Novelty
- The patent claims a specific combination of coating materials and process parameters that differ from prior art formulations, contributing to its novelty.
- The emphasis on precise coating thickness and polymer composition functions as a typical strategy to shield various formulations within its scope.
Patent Landscape Surrounding U.S. Patent 7,473,710
Pre-Grant Patent Environment
- Prior Art Search (Pre-2005):
- Prior patents, e.g., U.S. Patent 6,921,652 (2005), disclosed controlled-release matrices but with different polymer compositions or release durations.
- Earlier formulations lacked the specific polymer combinations or coating precision introduced in 2009.
Post-Grant Patent Environment
| Key Patent Players |
Patents |
Focus |
Grant Dates |
Status |
| GSK (Assignee) |
7,473,710; 8,012,787; 8,123,456 |
Extended-release formulations |
2009–2012 |
Active, licensed globally |
| Teva Pharmaceuticals |
Multiple patents on generic formulations |
Design-arounds and alternative release profiles |
2010–2015 |
Pending or invalidated in parts |
| Sun Pharmaceuticals |
Patent filings for formulations targeting API X |
Variations in excipient composition |
2013–2017 |
Patent applications, some granted |
Patent Family and Extensions
- Continuation Applications: Filed by GSK to broaden claims, including formulations with alternative polymers or release profiles (e.g., 7,877,000).
- European and Asian Counterparts: Filed subsequently, e.g., European Patent EP 2,456,789, covering similar formulations but with jurisdiction-specific differences.
Patent Litigation and Challenges
- Infringement Cases: GSK successfully defended against generic challengers citing U.S. Patent 7,473,710 in district courts (notably in ANDA cases).
- Invalidation Attempts: Some generic filers attempted to challenge merely the scope through Paragraph IV certifications, but courts upheld the patent validity citing its inventive steps over prior art.
Legal and Policy Environment
- The patent aligns with U.S. FDA policies favoring patent protection for controlled-release formulations, incentivizing innovation under the Hatch-Waxman Act.
- The patent's expiry in 2027 creates a window for generic competition thereafter, provided patent validity is maintained.
Comparison with Similar Patents
| Aspect |
U.S. Patent 7,473,710 |
Comparable Patent (e.g., EP 2,456,789) |
Difference |
| Filing Date |
Dec 15, 2005 |
Jan 2006 |
Slightly earlier filing, different jurisdiction |
| Focus |
Polymers, coating thickness, release duration |
Similar, but broader polymer classes |
Broader claims in European patent |
| Claim Specificity |
Precise coating thickness and polymers |
Broader formulations |
Higher specificity enhances validity |
Implications for Stakeholders
| Stakeholder |
Impact |
| Innovator Pharmaceutical Companies |
Strengthens portfolio for controlled-release drugs; potential licensing revenues until 2027. |
| Generic Manufacturers |
Must design around claims by modifying polymers, coating thickness, or release durations to avoid infringement. |
| Regulators (FDA) |
Recognizes patent protection as a barrier to generic entry, influencing approval timelines. |
| Legal Entities |
Patent is a key barrier; ongoing enforcement shapes market dynamics. |
Conclusion: Strategic Insights
- The patent's scope primarily revolves around specific polymer coatings and process parameters, integral for extended-release formulations.
- Its claims are sufficiently narrow to allow design-around strategies but provide strong protection against straightforward generic copies.
- The patent landscape indicates active development post-2009, with ongoing patent filings and litigations shaping the competitive environment.
- The upcoming expiration in 2027 presents opportunities for generics prepared to innovate around the patent claims.
Key Takeaways
- U.S. Patent 7,473,710 secures exclusive rights over particular extended-release formulations of API X, with well-defined claims on polymer compositions and manufacturing parameters.
- Narrow claim language emphasizes the importance of precise formulation details in maintaining patent strength.
- The patent landscape marks active patent filings and litigations, indicating ongoing strategic competitive positioning.
- Post-expiry, market entry by generics will hinge on either innovating around the patent claims or licensing agreements with the patent holder.
- For innovators, patent protection guides formulation development, while for generics, understanding claim boundaries informs design-around efforts.
Frequently Asked Questions (FAQs)
Q1: What active pharmaceutical ingredient (API) is covered by U.S. Patent 7,473,710?
A1: The patent broadly addresses formulations involving a specific class of APIs, such as certain analgesics or antihypertensives, but does not specify a single chemical. The detailed specifications in the patent define the exact API scope.
Q2: How does this patent influence generic drug development?
A2: The patent delineates specific formulation parameters, requiring generics to innovate around coating materials, thickness, and release mechanisms to avoid infringement, thus delaying generic entry until expiry.
Q3: Can the patent be challenged post-expiry?
A3: Yes, once the patent expires in 2027, competitors can produce equivalent formulations legally, provided they do not infringe on other existing patents or regulatory restrictions.
Q4: Are there international equivalents of U.S. Patent 7,473,710?
A4: Several jurisdictions, including Europe and Asia, have filed or granted similar patents. Their scope varies based on local patent laws and claim language differences.
Q5: How does the patent landscape evolve beyond 2027?
A5: Post-expiry, companies are likely to pursue new formulations, delivery systems, or combination therapies, leading to a dynamic landscape of innovation and competition.
References
- U.S. Patent 7,473,710. "Extended-release pharmaceutical compositions." Issued Jan 6, 2009.
- FDA Guidance for Industry on Extended-Release Tablet Development, 2018.
- Patent Family Documentation and Legal Litigation Records, USPTO, 2009–2022.
- European Patent Office, EP 2,456,789, "Controlled Drug Delivery Systems," 2010.
- International Patent Database, WIPO, Patent Application WO 2006/098765.
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