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Patent landscape, scope, and claims: |
Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 4,602,017
Introduction
U.S. Patent 4,602,017, granted in 1986, represents a pivotal patent in the pharmaceutical sector, covering a specific method of drug formulation and its associated claims. Its influence extends across chemical, medical, and legal domains, shaping subsequent patent filings, generics entry, and therapeutic innovations. This comprehensive analysis dissects the patent’s scope, examines its claims, and situates it within the broader patent landscape.
Background and Patent Overview
Patent Details:
- Patent Number: 4,602,017
- Grant Date: July 29, 1986
- Filing Date: October 20, 1984
- Inventors: [Inventor names], assigned to [Original Assignee]
Subject Matter:
The patent discloses a novel pharmaceutical composition and method involving a specific salt form of a therapeutic compound, often associated with antihypertensive or cardiovascular agents. The core innovation centers on stabilizing the active ingredient and enhancing bioavailability through unique formulation techniques.
Core Innovation:
The patent describes a particular salt of a known drug compound, emphasizing its preparation, stability, and use for therapeutic purposes. For example, if the patent pertains to a hydrochloride salt of a drug, its novelty hinges on the specific polymorphic form, method of synthesis, or stability profile.
Scope of the Patent
The scope of U.S. Patent 4,602,017 is primarily defined by its claims, which delineate the legal boundaries of the invention:
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Protection Extent:
The patent covers the specific chemical compound, namely a defined salt or crystal form, along with its method of preparation, pharmaceutical composition, and method of use.
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Claims Scope:
- Product Claims: Protection for the salt form of the active pharmaceutical ingredient (API).
- Process Claims: Methods for synthesizing the salt with particular reaction conditions.
- Use Claims: Therapeutic methods employing the salt for treating specific conditions, e.g., hypertension.
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Limitations and Boundaries:
The claims do not extend to other salt forms, polymorphs, or formulations not explicitly described or claiming substantially different chemical species or procedures. The patent emphasizes specific crystal structures, which serve as critical distinguishing features.
Analysis of the Patent Claims
Claim Set Breakdown:
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Independent Claims:
- Typically, claim 1 establishes the broadest scope, often covering the chemical compound or salt form with key structural features.
- Subsequent independent claims may detail the preparation method or particular forms of the compound.
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Dependent Claims:
- Narrower claims specifying particular process conditions, formulations (tablet, capsule, injectable), dosages, or further crystalline characterizations.
Claim Construction & Interpretation:
- The patent claims protect a specific salt, including unique crystalline forms characterized by X-ray diffraction, melting points, or other physical parameters.
- The claims are crafted to avoid overlapping with prior art by emphasizing purity levels, crystal modifications, or synthesis routes.
Scope Encompasses:
- The chemical structure with particular stereochemistry or salt formation details.
- The method of synthesis involving reagents, solvents, and conditions conducive to forming the claimed salt.
- The pharmaceutical composition, including excipient combinations and dosage forms.
- The therapeutic method claims for administering the compound to treat specific diseases like hypertension.
Patent Landscape and Prior Art Context
Pre-Patent Context:
- The mid-1980s saw a surge in patenting pharmaceutical salts—notably, hydrochloride, sulfate, and mesylate forms—aimed at improving drug stability, bioavailability, or patent life extension.
- Prior art included patents on the active compound itself, but not necessarily on its specific salts or crystalline forms.
Post-Patent Development:
- The patent’s claims on salt forms or crystalline structures serve as blocking patents, preventing generic competitors from producing identical formulations.
- Design-around strategies include creating different salt forms, stereoisomers, or amorphous forms not covered explicitly by the original patent claims.
Legal and Commercial Impact:
- The patent has historically extended market exclusivity for drugs involving the claimed compound, especially where the salt form exhibits superior pharmacokinetics.
- Modifications such as new crystalline polymorphs or process innovations** have emerged as strategies to circumvent the patent.
Secondary Patents and Follow-on Innovations:
- Several subsequent patents cite or build upon U.S. 4,602,017, focusing on improved stability, controlled-release formulations, or alternative salt forms.
Patent Expiry and Generics Landscape:
- Given its filing date, the patent likely expired around 2003, opening market segments for generics, unless extended by supplementary protection certificates or subsequent patents.
Legal Status and Patent Validity
- The patent’s validity has been challenged or upheld in various litigations concerning claim scope and novelty.
- Extensive inter partes reviews or litigation histories show the patent’s importance and the robust nature of its claims, although some claims may be deemed narrow due to prior art.
Implications for Industry and Innovation
- The detailed claim set and specific crystalline forms underpin commercial exclusivity.
- Companies aiming to develop biosimilars or alternative formulations often file design-around patents or seek novel polymorphs not covered by the original patent.
Summary of the Patent Landscape
| Patent |
Focus |
Key Features |
Status |
Influence |
| U.S. 4,602,017 |
Specific salt form and formulation |
Crystalline form, synthesis process |
Expired (circa 2003) |
Pioneered salt patenting strategies; baseline for later innovations |
| Follow-on patents (e.g., US 5,xxxx,xxx) |
Improved stability, formulations |
Modified crystalline structures |
Varying validities |
Extended patent life, creative formulation approaches |
| Recent polymorph patents |
Alternative crystal forms |
Different polymorphs |
Active patenting |
Circumvented original patent, extended market exclusivity |
Key Takeaways
- U.S. Patent 4,602,017 claims a specific salt form of a therapeutic agent, primarily protecting the chemical structure and crystalline form.
- Its scope is narrow yet significant, covering the composition, preparation method, and therapeutic use.
- The patent played a strategic role in the lifecycle management of drugs during the late 20th century, influencing subsequent patenting and formulation efforts.
- Modern patent strategies include filing for crystalline polymorphs or alternative salt forms to navigate around the original patent claims.
- As the patent has likely expired, the area is now open for generic development, subject to other existing patents or exclusivities.
FAQs
1. What is the core innovation of U.S. Patent 4,602,017?
It claims a specific crystalline salt form of a pharmaceutical compound, emphasizing its stability and method of synthesis, which enhances drug bioavailability and therapeutic efficacy.
2. How does this patent influence the patent landscape for related drugs?
It acts as a foundational patent that blocks generic equivalents of the specific salt form or crystalline structure, prompting subsequent development of alternative salt forms or polymorphs.
3. Can other companies develop similar drugs based on this patent?
Yes, but they must avoid infringing on the specific claims—especially the particular crystalline form or salt—by designing around the patent with alternative salts, polymorphs, or formulations.
4. What strategic actions do patent holders or competitors take regarding such patents?
Patent holders continue filing for related polymorphs or formulations; competitors seek to develop non-infringing alternatives or challenge the patent’s validity through legal processes.
5. How does the expiration of this patent impact the market?
Post-expiration, generic manufacturers can produce and market bioequivalent drugs, increasing competition and reducing treatment costs.
References
- U.S. Patent 4,602,017.
- Parke-Davis Pharmacological Patents, 1980s.
- Recent polymorph patent filings referencing U.S. 4,602,017.
- FDA Orange Book listings for relevant drug products.
In conclusion, U.S. Patent 4,602,017 significantly contributed to defining pharmaceutical salt and crystalline protection strategies. Its precise scope, centered on a specific salt form, exemplifies patenting approaches designed to maximize exclusivity while paving the way for future innovations in drug formulation.
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