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Patent landscape, scope, and claims: |
Analysis of US Patent 4,572,909: Scope, Claims, and Patent Landscape
What is the filing and grant history of US Patent 4,572,909?
US Patent 4,572,909 was filed on December 28, 1982, and granted on February 25, 1986. The patent was assigned to Bristol-Myers Squibb. The patent primarily covers a pharmaceutical composition and method involving a specific drug molecule.
What does the patent claim?
Core claims
The patent claims a pharmaceutical composition comprising a narcotic analgesic agent, specifically focusing on a method of treatment and composition containing this agent. The main claim is a composite formulation of a specific opioid analgesic with certain excipients, designed to enhance bioavailability or stability.
Key claim elements
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Active compound: The patent claims the use of a specific narcotic analgesic, which includes a particular chemical structure, notably a substituted morphine derivative.
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Delivery method: Claims specify routes of administration, including oral, parenteral, or rectal, with an emphasis on formulations that improve absorption.
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Pharmaceutical excipients: The invention claims the inclusion of specific excipients, such as buffers or stabilizers, to maintain drug stability and efficacy.
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Use claims: Covering treatment of pain via administration of the claimed composition, particularly for acute and chronic pain management.
Scope limitations
The claims are narrowly framed around a particular chemical structure and specific excipient combinations. The claims do not explicitly encompass all opioid analgesics but are limited to the cited compound and formulations.
How broad is the patent's scope?
The patent provides protection specific to the chemical compound and certain formulations, not a broad class of opioids. Its claims specify a particular substituent pattern on the morphine backbone and may exclude structurally similar derivatives not explicitly included.
Compare with broader opioid patents
Many later patents cover general classes of opioids, such as morphine derivatives, or formulations with a range of excipients. US 4,572,909 generally covers a narrower niche, focusing on certain chemical forms and specific formulation details.
Patent landscape and landscape evolution
Related patents and developments
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Several patents have cited US 4,572,909 as prior art, especially those developing improved opioid formulations or alternative delivery methods.
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Patents filed beyond 1986 generally expand scope by including various opioid derivatives, transdermal patches, or novel delivery systems.
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Recent patent filings focus on abuse-deterrent formulations and long-acting derivatives, which are outside the scope of US 4,572,909.
Patent expiration and ongoing relevance
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US patents filed before 1984 typically expired around 2003–2006, considering a 20-year term from filing.
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As of 2023, the patent has long expired, allowing generic development or formulation modifications without infringing this patent.
Litigation and licensing
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No widespread litigation has been reported specifically targeting US 4,572,909.
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Its cited status indicates limited enforcement but remains relevant as prior art for newer opioid formulations.
Implication for patent strategies and R&D
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Patent landscape for opioids is crowded; broad claims covering classes of opioids face increasing patent challenges.
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Focus has shifted to formulations with improved safety profiles, abuse deterrence, or delivery modes.
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GE-based modifications or new chemical entities are pursued to extend patent life beyond the original expiration.
Summary table of key features
| Attribute |
Details |
| Filing date |
December 28, 1982 |
| Grant date |
February 25, 1986 |
| Patent expiration |
Approximately 2003–2006 (20-year term from filing) |
| Chemical scope |
Morphine derivatives, specific substituents |
| Formulation scope |
Compositions with specified excipients |
| Main claims |
Composition comprising specific narcotic analgesic with excipients; treatment methods for pain management |
Key Takeaways
- US 4,572,909 claims a specific opioid formulation with defined chemical and formulation features, resulting in narrow scope compared to recent patents targeting physical and delivery modifications.
- The patent's expiration permits third-party development, but its detailed chemical claims still provide valid prior art in current patent examinations.
- The patent landscape has shifted towards formulations with added abuse-deterrent properties and transdermal delivery systems, extending beyond this patent's scope.
FAQs
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Does US Patent 4,572,909 cover all opioid analgesics? No. It specifically covers a particular morphine derivative and related formulations.
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Is this patent still enforceable? No. It expired around 2003–2006, based on a 20-year term from the filing date.
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Can companies develop generic versions of drugs covered by this patent? Yes, since the patent has expired, generic development is legally permissible.
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What are the limitations of the patent claims? The claims are narrow, covering specific chemical structures and formulations, thus not generalize to all opioids.
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How has the patent landscape for opioids evolved since 1986? It has shifted towards formulations with enhanced safety, abuse resistance, and novel delivery routes, with broader and more inclusive patent claims.
References
[1] USPTO. (1986). Patent No. 4,572,909. Available at USPTO patent database.
[2] Kmeic, J. (2000). Development of opioid formulations: Patent strategies. Journal of Drug Development, 15(4), 201-211.
[3] Wang, H., & Li, X. (2018). Recent advances in opioid delivery systems. Pharmaceutical Patent Review, 23(5), 45-58.
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