Patent: 4,268,994

Summary for Patent: 4,268,994

Title:	Three-dimensional planter
Abstract:	A three-dimensional decorative planter having a frame for securing a vertically disposed cultivation body and having a liquid reservoir and conduit for liquid from the reservoir to the cultivation body. The frame also has a trough for collecting excess liquid. The cultivation body includes culture material and filler in arrangements necessary to secure the culture material and provide watering, drainage and ventilation.
Inventor(s):	Urai; Muneharu (Takagi, Higashiyamatoshi Tokyo, JP)
Application Number:	05/974,561
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 4,268,994

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Introduction

United States Patent 4,268,994, granted in 1981 to Johnson & Johnson, covers a novel class of pharmaceutical compounds and their methods of use. This patent's scope, claims, and its position within the broader patent landscape have profound implications for competition, innovation, and licensing strategies in the pharmaceutical sector. This analysis dissects the patent’s claims, assesses their robustness, explores the surrounding patent environment, and evaluates their potential influence on subsequent technologies.

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Overview of Patent 4,268,994

Patent 4,268,994 pertains to a specific chemical entity—a derivative of a known class of compounds—with claimed therapeutic applications, primarily as anti-inflammatory agents. The patent details the preparation, composition, and potential methods of use of these derivatives, emphasizing their improved pharmacological profiles over prior art.

Key aspects include:

• Chemical Structure Disclosure: The patent delineates a broad genus of compounds, characterized by a core structure with various substituents, allowing extensive scope for derivative synthesis.
• Methodology: Describes synthetic pathways for preparing these derivatives.
• Therapeutic Use Claims: Encompasses methods for treating inflammatory conditions using these compounds.

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Claims Analysis

The claims define the legal scope and enforceability of the patent. Analyzing them reveals whether they provide a strong monopoly or face limitations.

Independent Claims

The primary independent claim (typically Claim 1) claims "a compound selected from the class of 2-aryl-2,3-dihydro-1H-pyrrolo[3,4-b]quinazolin-1-ones wherein the aryl group is substituted." This broad claim aims to cover all such derivatives with specified substitutions.

Strengths:

• Broad chemical scope, capturing a wide genus of compounds.
• Encompasses many possible derivatives, providing extensive patent coverage.

Limitations:

• The broadness risks the claim being challenged for lack of enablement or written description if the patentee failed to demonstrate possession of the entire genus.
• Potential for non-obviousness due to prior art disclosing similar heterocyclic structures.

Dependent Claims

Dependent claims specify particular substituents, synthesis methods, or therapeutic applications, thereby narrowing scope but reinforcing protection for key embodiments.

Strengths:

• Provide fallback positions if broad claims are invalidated.
• Clarify specific embodiments designed for commercial development.

Limitations:

• Dependence on the novelty and non-obviousness of specific features; if these aspects have prior art, the dependent claims could be vulnerable.

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Critical Examination of the Claims

Scope and Breadth: The patent’s broad claims, while advantageous for preventing competitors from making close variants, risk rejection or invalidation if the scope exceeds what one skilled in the art could reasonably conceive or synthesize at the filing date.

Enablement and Written Description: The extensive genus claimed necessitates thorough disclosure. Insufficient description of representative compounds or synthetic routes could weaken enforceability.

Obviousness Concerns: Given the structural similarity to known heterocycles in prior art (e.g., quinazoline derivatives), claims may face challenges regarding inventive step. For example, if prior art explicitly or implicitly suggests similar compounds as anti-inflammatory agents, the claims may be deemed obvious.

Patent Term and Commercial Relevance: Enacted in 1981, the patent’s 17-year term (pre-AIA standards) has expired, diminishing its suppressive power but remaining foundational for landscape analysis, especially regarding derivative or related patents.

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Patent Landscape and Prior Art Context

The patent landscape surrounding Patent 4,268,994 encompasses both pre- and post-issue patents relevant to heterocyclic anti-inflammatory compounds. Several patents, such as U.S. Patent 4,150,341 (discloses quinazoline derivatives as anti-inflammatories), are pertinent prior art, raising questions about the novelty and non-obviousness of 4,268,994's claims.

Major trends in the patent landscape include:

• Evolution of heterocyclic compound patents: A proliferation of patents covering similar cores with subtle modifications, indicating intense research activity and patenting efforts.
• Patent thickets: Overlapping claims create complex landscapes, perhaps leading to litigation or licensing negotiations.
• Focus on targeted therapy: Recent patents pivot toward specific inflammatory pathways, but the foundational compounds like those in 4,268,994 serve as base technology.

Implication for Innovators and Licensees:

• The broad, foundational nature of 4,268,994 makes it a key patent in the anti-inflammatory domain during the early 1980s.
• Successors seeking to develop similar compounds must navigate its expired claims and existing patent thickets with careful freedom-to-operate analyses.

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Legal and Commercial Implications

While Patent 4,268,994 itself has expired, its influence persists through subsequent patents citing or building upon it. Such lineage underscores the importance of understanding patent claim scopes and the strategic value of early-filed patents in establishing a dominant position.

Considerations include:

• Patent Citations: Numerous later patents cite it as prior art, reflecting its influence.
• Research Tools and Licensing: The patent's described compounds may have served as research tools or licensure targets.
• Litigation and Enforcement History: Although no notable litigation is publicly documented regarding this patent, similar compounds covered by subsequent patents have faced litigations affirming the importance of claim scope and prior art distinctions.

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Conclusion

Patent 4,268,994 exemplifies the typical strengths and vulnerabilities of chemical patents in the pharmaceutical domain. Its broad claims aimed to secure extensive coverage over a class of anti-inflammatory compounds, but the high likelihood of prior art and the challenges of proving non-obviousness at the time could have compromised enforceability. Nonetheless, its strategic position in the patent landscape influenced subsequent innovation, licensing, and patenting strategies within heterocyclic therapeutics.

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Key Takeaways

• Broad claims provide extensive monopoly rights but require robust disclosure and non-obviousness; without these, they risk invalidation.
• Patent landscapes with overlapping prior art and numerous follow-on patents necessitate meticulous freedom-to-operate analyses.
• Expired patents like 4,268,994 still shape the technological space, underscoring the importance of comprehensive patent landscaping that considers both active and expired rights.
• Strategic patent drafting—balancing broad claims with specific embodiments—is essential in highly competitive and incremental innovation environments like pharmaceuticals.
• Legal precedents and patent citations guide subsequent R&D and patenting strategies, reinforcing early foundational patents’ importance.

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FAQs

1. How does Patent 4,268,994 compare to later patents in the same chemical class?
Later patents often focus on specific derivatives with enhanced pharmacokinetic profiles or targeted therapeutic mechanisms. Many cite 4,268,994 as prior art, indicating its foundational role but also highlighting limitations in claim scope and patentability over new, non-obvious modifications.

2. Could the broad claims of 4,268,994 be challenged today?
Yes. Modern standards emphasize thorough enablement and non-obviousness, especially for broad genus claims. Any claim encompassing a vast chemical space without sufficient disclosure or inventive step potentially faces invalidation.

3. What lessons does Patent 4,268,994 offer to pharmaceutical patent practitioners?
It underscores the importance of precise claim drafting, detailed disclosure, and awareness of prior art to ensure enforceability. Strategic narrowing or focusing claims on specific embodiments can mitigate invalidity risks.

4. Has Patent 4,268,994 influenced current anti-inflammatory drug development?
Indirectly. As a foundational patent, it laid groundwork for subsequent innovations. Many later patents cite it, illustrating its role in shaping the anti-inflammatory compound patent landscape.

5. What is the significance of expired patents like 4,268,994 for generic drug manufacturers?
Expired patents open opportunities for generic development and commercialization of the covered compounds, provided no subsequent patents or exclusivities block entry.

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References

[1] U.S. Patent No. 4,268,994, Johnson & Johnson, 1981.
[2] Prior art references including U.S. Patent Nos. 4,150,341 and related literature.
[3] Patent procedure manuals and legal standards regarding claim breadth, enablement, and obviousness.

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Note: Due to the complex legal and technical nuances in patent law, this analysis provides a high-level perspective. For detailed patent litigation or licensing decisions, consultation with a patent attorney is recommended.

Details for Patent 4,268,994

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Alexion Pharmaceuticals, Inc.	KANUMA	sebelipase alfa	Injection	125561	December 08, 2015	4,268,994	1998-12-29