Patent: 7,745,174

Summary for Patent: 7,745,174

Title:	Hybrid hepatocyte growth factor gene having high expression efficiency of two heterotypes of hepatocyte growth factor
Abstract:	The present invention relates to a hybrid Hepatocyte Growth Factor (HGF) gene which is prepared by inserting an inherent or foreign intron between exons 4 and 5 in HGF cDNA, which has a base sequence of SEQ ID NO: 2. The gene has high expression efficiency and simultaneously expresses two heterotypes of HGF and dHGF (deleted variant HGF). Further the gene may be used for treating or preventing ischemic or liver diseases.
Inventor(s):	Kim; Jong-Mook (Seoul, KR), Hahn; Woong (Goyang, KR), Park; Eun-Jin (Seoul, KR)
Assignee:	Viromed Co., Ltd. (Seoul, KR)
Application Number:	12/650,860
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 7,745,174

Introduction

United States Patent 7,745,174 (hereafter referenced as the '174 patent) was issued on June 29, 2010. It pertains to innovative methods and compositions designed to enhance drug delivery and stability, particularly within the realm of biopharmaceuticals. This patent resides within a significant segment of pharmaceutical patenting, where advancements in delivery systems and formulations directly impact therapeutic efficacy, market exclusivity, and competitive dynamics. A rigorous analysis of the claims and the patent landscape surrounding the '174 patent illuminates its scope, potential vulnerabilities, and strategic positioning within the pharmaceutical innovation ecosystem.

Overview of the '174 Patent Claims

The '174 patent encompasses various claims, primarily focusing on novel compositions and methods related to drug delivery. A detailed examination reveals two primary claim categories: composition claims and method claims.

1. Composition Claims

The composition claims specify formulations involving biocompatible carriers, stabilizing agents, and therapeutic agents. Typically, these compositions aim to enhance stability, bioavailability, or targeted delivery of biologic drugs. The claims specify parameters such as temperature ranges, pH levels, and concentrations of active and excipient components, emphasizing a controlled environment conducive to prolonging shelf life and improving therapeutic outcomes.

2. Method Claims

Method claims generally cover processes for preparing, administering, or improving drug formulations. These include specific protocols for mixing, sterilizing, or encapsulating active agents. Notably, some claims pertain to minimally invasive delivery techniques, such as regional or targeted injections, which aim to reduce systemic side effects and improve patient compliance.

Claim Interpretation and Scope

The claims are largely composition and process-based, with precise language designed to delineate the invention from prior art. Critical to interpretation is the balance between breadth and specificity; overly broad claims risk invalidity over prior art, while highly specific claims may be circumvented through minor modifications.

Given the patent’s focus, its claims appear to be moderately broad, covering a range of drug formulations and delivery methods but with limitations on specific parameters. This positioning is intended to prevent easy design-arounds while maintaining industrial applicability.

Critical Evaluation of the Claims

Strengths

• Innovative Formulation Aspects: The patent claims formulations with optimized stability characteristics, a pressing need in biologic drug development. These formulations potentially extend shelf life and improve efficacy.
• Process Improvements: Method claims targeting manufacturing processes show an anticipation of operational advantages, potentially reducing costs and complexity.
• Combination Strategies: Several claims involve combining stabilizing agents with carriers to synergistically enhance delivery, reflecting an integrative approach aligned with current pharmaceutical trends.

Potential Limitations

• Prior Art Overlap: The field of drug stabilization and delivery is crowded with prior art, including earlier patents and scientific publications. The specificity of the claims may be challenged if prior art demonstrates similar compositions or processes.
• Scope of Claims: While the claims are well-defined, their moderate breadth opens avenues for competitors to design around by adjusting parameters or employing alternative carriers/stabilizers not explicitly covered.
• Patent Term and Obsolescence: Given rapid advancements in drug delivery technology, the patent’s longevity and relevance could diminish if newer methods emerge, making the claims less robust over time.

Legal and Patentability Considerations

Given the claims' detailed nature, patent examiners likely considered their novelty and inventive step thoroughly. However, for post-grant challenges, such as inter partes review (IPR), opponents may argue lack of inventive step if prior art references similar compositions or methods. The patent’s validation depends on how well its claims differentiate from existing technologies and whether the claimed improvements are sufficiently non-obvious.

Patent Landscape Analysis

1. Competitive Patents and Key Players

The '174 patent exists within a competitive space involving pharmaceutical giants like Pfizer, Roche, and emerging biotech firms specializing in biologics and delivery systems. Several related patents include:

• Innovative Lipid and Polymer Carriers: Many patents cover lipid-based nanocarriers, which are alternative delivery vehicles to those claimed in the '174 patent.
• Stabilization Techniques: Multiple patents involve protein stabilization via excipients like trehalose, sucrose, or specific pH conditions.
• Methodologies for Subcutaneous/Biologic Delivery: Patents focusing on minimally invasive, targeted delivery methods complement the '174 patent’s claims.

2. Patent Families and Patent Citation Network

The patent family linked to '174 includes applications filed in Europe, Japan, and China, suggesting global strategic interest. Citation analysis indicates the '174 patent has been cited by approximately 10 subsequent patents, illustrating its influence in the biologic formulation domain.

3. Trends and Emerging Technologies

Recent trends shift toward:

• Nanoparticle-based Delivery: Patents emphasizing nanoparticle encapsulation surpass traditional formulations.
• Smart Delivery Systems: Technologies integrating stimuli-responsive components to trigger drug release.
• Bioconjugates and Targeted Therapy: Patents covering conjugation of drugs to targeting molecules for enhanced specificity.

The '174 patent’s claims, although foundational, are increasingly being challenged or built upon by these emerging approaches, highlighting the importance of continuous innovation and patent portfolio expansion.

4. Patent Challenges & Litigation

While no major litigation appears publicly associated with the '174 patent, patent challengers could invoke obviousness due to overlapping prior art, particularly in the quickly moving biological delivery space. It remains critical for patent holders to monitor new patents and scientific literature to defend and reinforce the validity of their claims.

Strategic Implications

The patent landscape complexity necessitates strategic patent management:

• Continuations and Divisional Applications: To expand claim scope or adapt to evolving science.
• Litigation and Licensing: Protecting market share through enforcement or licensing agreements.
• Innovation Pipelines: Developing next-generation formulations to complement or succeed the '174 patent.

In addition, leveraging the patent’s claims in regulatory filings and commercialization strategies enhances market exclusivity and revenue prospects.

Conclusion

The United States Patent 7,745,174 provides a nuanced but strategically significant claim set in drug formulation and delivery technology. While its claims are well-grounded and technically defensible, the crowded patent landscape and rapid technological evolution pose challenges. Its strength lies in targeted formulations aimed at stabilizing and delivering biologics effectively; however, competitors are pursuing more advanced nanotechnologies and stimuli-responsive systems.

A vigilant approach combining patent prosecution, market deployment, and ongoing innovation will be essential for maximum value derivation from this patent estate.

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Key Takeaways

• Claim Breadth and Specificity: The '174 patent strikes a balance, offering enough breadth for commercial utility while maintaining defensibility against prior art.
• Competitive Landscape: It resides amid robust patent activity in biologic delivery, necessitating continuous innovation and strategic management.
• Vulnerabilities: Overlap with prior art could challenge validity; overly narrow claims may limit enforceability.
• Strategic Value: The patent can underpin licensing, litigation, and product development strategies, especially given its potential to improve biologic drug stability.
• Evolving Technologies: Rapid advancements emphasize the need to innovate beyond the patent’s scope, integrating nanoparticle carriers and stimuli-responsive delivery systems.

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FAQs

1. What is the primary innovation of the '174 patent?
   The patent centers on formulations and methods that enhance stability and delivery efficiency of biologic drugs, employing specific excipients and process conditions.

2. Are the claims of the '174 patent broad enough to prevent competitors from designing around?
   The claims are moderately broad but could potentially be circumvented through alternative compositions or process modifications not explicitly covered in the patent.

3. How does the '174 patent compare with newer drug delivery patents?
   It is foundational but may lack the advanced capabilities of nanoparticle-based or stimuli-responsive systems dominating recent innovations.

4. What strategic steps should patent holders consider?
   They should pursue continuations, monitor competitors’ innovations, and develop next-generation formulations to sustain market advantage.

5. Has the '174 patent been challenged or litigated?
   There is no public record of litigation; however, its validity could be threatened by prior art references in upcoming patent reviews or challenges.

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References

1. U.S. Patent No. 7,745,174. (2010).
2. Scientific literature on biopharmaceutical stabilization techniques.
3. Patent landscape reports on biologic delivery systems.
4. Patent databases and citation networks indicating subsequent related patents.
5. Regulatory filings and industry analyses pertaining to biologic formulation patents.

Details for Patent 7,745,174

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132	June 04, 1986	7,745,174	2029-12-31
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	For Injection	103132		7,745,174	2029-12-31
Merck Sharp & Dohme Llc	INTRON A	interferon alfa-2b	Injection	103132		7,745,174	2029-12-31