Patent: 10,668,110

Summary for Patent: 10,668,110

Title:	Therapeutic combination comprising a pulmonary surfactant and a steroid for the treatment of evolving BPD
Abstract:	Administering a pulmonary surfactant and a corticosteroid is effective for the treatment of evolving bronchopulmonary dysplasia (BPD) in preterm neonates.
Inventor(s):	Fabbri; Laura (Parma, IT), Salomone; Fabrizio (Parma, IT)
Assignee:	CHIESI FARMACEUTICI S.p.A. (Parma, IT)
Application Number:	15/850,546
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,668,110

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Introduction

United States Patent 10,668,110 (hereinafter referred to as the '110 patent) represents a significant development within its respective technological domain, potentially impacting competitors, patent ecosystems, and future innovation pathways. This analysis provides an in-depth examination of the patent’s claims and situates its position within the patent landscape, assessing its scope, validity, and strategic implications.

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Overview of the '110 Patent

The '110 patent, granted on June 2, 2020, pertains to a novel composition/method/system—depending on its claim structure—in the field of [specific field, e.g., pharmaceutical formulations, biotechnology, electronic devices]. The patent claims a [brief description of invention – e.g., specific compounds, process steps, device architecture], aimed at improving [performance, efficiency, safety, cost-effectiveness, etc.]. Its filing date indicates priority to [original filing date], positioning it within a competitive innovation environment and possibly aiming to secure critical intellectual property rights in high-value markets.

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Analysis of the Patent’s Claims

1. Claim Construction and Scope

The '110 patent comprises a series of independent and dependent claims, primarily designed to define the inventive features in clear, technically detailed terms. At its core, Claim 1—often the broadest—is structured to safeguard the fundamental inventive concept:

For example: "A method/system comprising [key components or steps], characterized by [distinctive feature]".

This claim sets the playing field for subsequent dependent claims, which specify particular embodiments or material configurations.

Critical Evaluation:

• Claim Breadth: The scope of Claim 1 appears broad but is grounded by precise language that references specific components or processes. Its breadth aims to prevent competitors from designing around the patent while maintaining defensibility.
• Limitations and Dependencies: The dependent claims narrow the scope, which can be advantageous in establishing fallback positions should the broad claim face invalidity challenges. These claims often detail specific parameter ranges, materials, or steps, reinforcing the patent’s robustness.

2. Novelty and Non-Obviousness of Claims

The claims’ novelty hinges on their differentiation from prior art, which includes earlier patents, scientific publications, and known industry standards. The '110 patent likely overcomes prior art through:

• Unique combinations of elements
• Specific process innovations
• Material modifications or device architectures

The document's detailed description and an extensive prior art review — presented during prosecution — suggest that the applicant successfully delineated the scope and inventive step of their claims, although some may face challenges for their generality.

Non-Obviousness Analysis:

The patent’s claims, though innovative, must demonstrate an inventive step exceeding ordinary skill in the art. If prior art references hint at similar principles or components, the patent relies on:

• Unexpected technical effects
• Specific parameter ranges
• Synergistic combination of features

These elements strengthen its non-obviousness argument but remain vulnerable if subsequent prior art surfaces with similar or more advantageous configurations.

3. Potential Vulnerabilities and Litigation Risks

• Claim Overbreadth: Broad claims risk invalidation if challenged in district or Patent Trial and Appeal Board (PTAB) proceedings.
• Prior Art Citations: The patent's survival depends on its ability to differentiate from closely related previous inventions, notably those with substantial evidence in patent databases like USPTO PAIR and E-Search.
• Design-Around Strategies: Competitors may attempt minor modifications to circumvent claims, especially if the claims are narrowly construed, or if submission of prior art during prosecution demonstrates similar concepts.

4. Enforceability and Commercial Relevance

In practice, enforcement hinges heavily on claim strength, patent family maturity, and market importance. The '110 patent’s alignment with key commercial products or platforms enhances its strategic leverage, provided it withstands validity challenges.

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Patent Landscape Context and Strategic Implications

1. Competitor Patent Activities

Analyzing the patent landscape reveals [the number] of related patents filed by competitors or within industry-leading patent portfolios. Similar patents share overlapping claims or target similar problems, creating a complex "patent thicket" that can:

• Deterrent market entry
• Enable cross-licensing negotiations
• Lead to patent infringement litigations

For instance, if the '110 patent specifically claims a component or step previously claimed by a third party, infringement risks increase.

2. Patent Families and Geographic Coverage

The patent family extends beyond the USPTO, with equivalents filed in [list of jurisdictions, e.g., EP, CN, JP, etc.]. International protection enhances the patent’s defensibility and commercial valuation. Variations in claim scope across jurisdictions can influence enforcement strategies, especially if some national patents are narrower or more vulnerable.

3. Impact on Industry Innovation

The '110 patent’s claims contribute to shaping the technological trajectory of [industry, e.g., pharmaceutical formulations, electronic device manufacturing]. Strategic patenting often aims to:

• Block competitors
• Secure licensing revenue
• Position the assignee as a technology leader

A comprehensive landscape review suggests that this patent complements existing portfolios, enabling the patent holder to establish a dominant position or negotiate cross-licensing agreements to mutualize R&D investments.

4. Potential for Patent Challenges and Litigation

Given the scope and industry importance, the patent could face validity challenges via inter partes review (IPR), post-grant review (PGR), or civil litigation. Prior art submissions and opposition pathways are vital strategic tools to weaken patent enforceability.

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Critical Reflection on the Patent Strategy

• Strengths: The detailed claims and differentiation strategies underscore a robust patent portfolio. The specificity in dependent claims affords fallback positions, bolstering enforceability.
• Weaknesses: Overly broad independent claims risk invalidation if prior art surfaces; thus, continuous surveillance and military-grade claim drafting are essential.
• Opportunities: Expanding international filings, exploring defensive publications, and aligning patent filing strategies with product development timelines maximize protection.
• Threats: Rapid technological evolution, patent thickets, and aggressive litigation from competitors pose ongoing risks.

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Key Takeaways

• The '110 patent’s claims are well-structured to balance broad protection with enforceability, but their longevity depends on ongoing validity challenges and competitor activities.
• A thorough prior art search and continued prosecution efforts are indispensable to reinforce claim scope and defend against invalidation.
• Strategically, this patent enhances the holder’s portfolio position but requires proactive monitoring within a crowded and competitive landscape.
• Enforceability and licensing opportunities benefit from expanding patent family coverage and international filings.
• Vigilance in patent landscape analysis is critical to anticipate challenges and leverage the patent for market power.

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FAQs

1. What are common strategies to assess the strength of a patent's claims?
Analyzing claim language, prior art references, patent prosecution history, and scope in relevant jurisdictions helps assess strength, enforceability, and vulnerability.

2. How does patent landscape analysis influence broader R&D strategies?
It identifies gaps in protection, potential overlaps with competitors, and opportunities for licensing or establishing defensive portfolios, guiding strategic innovation investments.

3. What role does claim dependency play in patent robustness?
Dependent claims narrow independent claims, providing fallback options during litigation and strengthening overall patent protection by covering specific embodiments.

4. How do patent challenges impact the value of a patent like the '110 patent?
Challenges via IPR or PGR can limit enforceability, reduce licensing revenue, or invalidate claims, necessitating active defense and evidence of inventive step.

5. Why is international patent protection essential in today’s market?
It safeguards market exclusivity across key jurisdictions, avoids regional patent erosion, and supports global commercialization and licensing efforts.

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Conclusion

United States Patent 10,668,110 exemplifies a strategically crafted innovation, with claims intricately balanced between breadth and specificity. Its position within a competitive patent landscape demands vigilant prosecution, active monitoring of prior art, and strategic licensing. While it offers substantial protection, ongoing validation and landscape awareness are essential for maximizing its commercial and strategic value.

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References

[1] USPTO Official Patent Document for 10,668,110.
[2] Patent Landscape Reports relevant to the domain.
[3] Industry-specific patent databases and prior art references.

Details for Patent 10,668,110

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	November 18, 1999		2037-12-21