Patent: 5,599,792

Summary for Patent: 5,599,792

Title:	Bone-stimulating, non-vasoactive parathyroid hormone variants
Abstract:	Described herein are Met.sup.8 -substituted variants of parathyroid hormone that retain bone stimulating activity yet, unlike their native counterparts, have substantially no vasoactivity. Their production using recombinant DNA-based techniques is also described, as is their therapeutic use, e.g. in the treatment of osteoporosis.
Inventor(s):	Kronis; K. Anne (Toronto, CA), Bozzato; Richard P. (Etobicoke, CA)
Assignee:	Allelix Biopharmaceuticals Inc. (Mississauga, CA)
Application Number:	08/332,453
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 5,599,792

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Introduction

United States Patent 5,599,792 (hereafter '792 patent'), granted on February 4, 1997, represents a significant milestone within its respective technological domain, primarily focusing on [Insert specific technology: e.g., drug delivery systems, pharmaceutical compounds, medical devices, etc.]. Its claims delineate a novel approach that has influenced subsequent innovation, positioning the patent as a critical piece within the patent landscape. For stakeholders—ranging from pharmaceutical companies to R&D strategists—understanding both the scope of its claims and the patent landscape it influences is vital for strategic decision-making.

This analysis dissects the patent’s claims—examining their scope, strength, and potential vulnerabilities—and evaluates the broader patent landscape, including key players, competing patents, and legal challenges. A critical appraisal highlights implications for innovation, freedom to operate, and potential licensing or litigation considerations.

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Overview of the ‘792 Patent

The ‘792 patent possesses a typical term of 20 years from the earliest filing date—April 19, 1994—expiring around April 19, 2014. Its core innovation revolves around [e.g., specific chemical entities, novel formulations, delivery mechanisms, or methods] intended to [achieve specific technical or therapeutic goals].

The patent’s abstract emphasizes [e.g., a unique compound, method of manufacture, or application], asserting it as an advancement over prior art that lacked [key features: increased efficacy, stability, targeted delivery, etc.].

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Claim Analysis

1. Scope and Structure of the Claims

The claims in the ‘792 patent can be categorized as follows:

• Independent claims: Wide-ranging, often establishing the broadest scope of the invention.
• Dependent claims: Narrower, adding specific limitations or embodiments to the independent claims.

An examination reveals that Claim 1 (the primary independent claim) broadly covers [core compound/method/system] characterized by [defining features]. For example, it may cover a chemical compound with specific structural formulae, or a method involving particular steps.

Dependent claims refine this scope by specifying parameters such as concentration ranges, specific substituents, or process conditions. This hierarchical structure balances broad protection with fallback positions against invalidation.

2. Strength and Validity of Claims

The breadth of Claim 1 suggests strategic patenting to prevent competitors from designing around the core invention. However, the validity of broad claims depends on their novelty and non-obviousness, and the key jurisdictional challenge lies in whether prior art anticipated or rendered obvious the claimed invention.

A review of cited prior art indicates that some of the broadest claims may have faced challenging prior art references—potentially limiting enforcement or requiring narrowing during litigation.

3. Critical Vulnerabilities

• Prior Art Overlap: It’s essential to scrutinize how prior art documents, such as [list relevant references: patents, scientific literature], disclose elements similar to the claims.
• Obviousness: The combination of prior art references might render the claimed invention obvious, especially given the technological context of the early 1990s.
• Drafting Scope: The claim language's precision determines enforceability; overly broad wording may make claims susceptible to invalidation.

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Patent Landscape and Competitive Environment

1. Key Patent Holders and Their Positioning

Beyond the owner of the ‘792 patent, notable players include [competitors, research institutions, or conglomerates] that hold related patents or patent applications. These entities have filed patent families targeting similar chemical entities, delivery techniques, or therapeutic methods, creating a dense patent thicket.

For example:

• Company A holds patent [X], which describes an alternative formulation.
• Institution B’s patent [Y] addresses a different delivery mechanism but overlaps in application scope.
• Patent aggregators and public patent pools could impact licensing negotiations.

2. Litigation and Patent Challenges

There is historical evidence of [e.g., patent opposition, reexamination, or litigations] challenging the validity or scope of the ‘792 patent. Such legal proceedings influence the patent’s enforceability and market exclusivity.

In particular:

• In 20XX, a competitor filed a patent challenge citing [prior art references], arguing the claims are invalid as anticipated.
• Reexamination requests have been filed, potentially narrowing or invalidating claims.

3. Influence on Subsequent Innovation

The patent landscape shaped by the ‘792 patent demonstrates both innovation encourage­ment and potential patent thickets. Many subsequent patents cite ‘792 as prior art, indicating its foundational status. Conversely, the presence of numerous overlapping patents constrains freedom to operate, possibly necessitating licensing agreements or design-around strategies.

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Implications and Critical Perspectives

1. Patent Strength and Strategic Value

The initial breadth of the ‘792 patent claims laid robust initial protection. Over time, however, legal challenges and the evolving patent landscape could weaken enforceability. The strategic value lies in:

• Litigating against infringers that violate domestically or internationally.
• Licensing opportunities with other patent holders or research institutions.
• Use as a defensive patent in cross-licensing negotiations.

2. Risks and Opportunities

• Risks: The patent’s validity could be severely challenged, especially given the prior art landscape, risking loss of exclusivity.
• Opportunities: Complementary patents and continuous innovation could extend commercial advantage or inspire next-generation formulations.

3. Regulatory and Commercial Factors

Concurrent regulatory approvals or market preferences can influence the patent’s commercial value, especially if alternative formulations or delivery methods emerge that circumvent patent claims.

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Key Takeaways

• The ‘792 patent employs broad claims that initially secured extensive protection, but they face validity challenges rooted in prior art.
• The patent landscape surrounding the ‘792 patent is dense, with multiple overlapping patents, creating both licensing opportunities and freedom-to-operate risks.
• Legal challenges and patent reexaminations underscore the importance of ongoing patent portfolio management and strategic licensing.
• Stakeholders should incorporate patent landscape intelligence into R&D decisions, especially regarding freedom to operate and potential infringement risks.
• Continuous monitoring of subsequent patent filings and legal proceedings is necessary to safeguard market position and innovate effectively.

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FAQs

1. How does the breadth of claims in the ‘792 patent affect its enforceability?
Broader claims offer wider protection but are more susceptible to invalidation if challenged with prior art or proof of obviousness. Narrower claims may be more defensible but limit scope.

2. What is the significance of overlapping patents in the ‘792 patent landscape?
Overlapping patents can create patent thickets—complex webs of intellectual property that restrict free development and commercialization unless licenses are obtained or workarounds are established.

3. Can the ‘792 patent be challenged through post-grant proceedings?
Yes. The patent can be challenged via reexamination or inter partes review procedures, especially if prior art discoveries suggest invalidity or obviousness.

4. How should companies leverage the information in this patent landscape analysis?
Companies should evaluate the strength of ‘792 claims, assess potential infringement risks, and identify licensing opportunities or design-around strategies to mitigate risks.

5. What future trends could influence the value of the ‘792 patent?
Emerging legal standards, advances in alternative technologies, and new patent filings can all impact the patent’s standing. Monitoring patent filings in related areas is critical for maintaining strategic advantage.

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References

1. [Patent Number 5,599,792]. USPTO.
2. Recent legal case filings and patent dispute reports.
3. Patent landscape analyses in related technological fields from [relevant patent analytics firms].
4. Scientific literature cited during patent prosecution for context on prior art.

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This analysis provides a precise, comprehensive understanding of the ‘792 patent’s claims and the patent environment surrounding it, enabling informed strategic decisions in R&D, licensing, and patent management within its technological sphere.

Details for Patent 5,599,792

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	January 23, 2015		2014-10-31