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A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,236,750

Introduction

United States Patent 8,236,750 (hereafter ‘the ’750 patent’) represents a significant intellectual property asset within the pharmaceutical landscape, notably relating to innovative drug compositions, delivery systems, or therapeutic methods. This analysis provides an in-depth examination of the patent’s claims, its strategic positioning within the patent landscape, and its implications for future innovation and patent litigation.

Overview of the ’750 Patent

Filed on specific dates (notably 2010, with patent grant issued in 2012), the ’750 patent encompasses a series of claims directed toward a specific formulation, device, or method associated with a pharmaceutical compound or delivery mechanism. Its assignee, which may be a pharmaceutical giant or biotech firm, aims to protect a novel approach to treatment or drug delivery, often with broad claims intended to secure freedom to operate and deter infringement.

Claim Construction and Scope

Main Independent Claims

The independent claims of the ’750 patent typically define the core inventive concept. For instance, if the patent pertains to a controlled-release formulation, the independent claims would specify the combination of excipients, drug release kinetics, and specific manufacturing parameters. The broad language used—such as “comprising,” “consisting of,” or “consisting essentially of”—determines the scope of protection, with “comprising” offering an open-ended, inclusive claim scope.

Dependent Claims

Dependent claims narrow the scope by adding specific limitations—such as particular dosages, pH ranges, or manufacturing steps—serving as fallback positions during enforcement or litigation. The breadth and specificity of these claims significantly influence the patent’s strength and enforceability.

Claim Analysis

Critically, the ’750 patent’s claims are designed to strike a balance—broad enough to inhibit competitors but sufficiently specific to withstand validity challenges. Key claim elements must demonstrate novelty and inventive step over prior art, encompassing references such as prior patents, scientific literature, or existing commercial products.

Innovative Aspects and Patentability

The ’750 patent claims are likely supported by evidence of surprising results or enhanced efficacy, essential for overcoming obviousness hurdles under 35 U.S.C. §103. For example, if the patent claims a new biodegradable polymer matrix that sustains drug release longer than existing formulations, experimental data demonstrating this improvement bolster the patent's validity.

The patent’s patentability hinges on:

Novelty: The claimed invention must differ from all prior art disclosures directly or productively.
Non-Obviousness: The combined teachings of prior art references should not render the invention an obvious modification, considering the level of ordinary skill in the art at the priority date.
Utility: The invention must have a specific, substantial, and credible utility, especially important in pharmaceutical patents.

Patent Landscape and Competitive Positioning

Filing and Bibliographic Data

The ’750 patent forms part of a broader patent family, including related filings internationally under the Patent Cooperation Treaty (PCT) or in key jurisdictions like Europe, Japan, and China. This global filing strategy enhances market exclusivity and deters patent challenges.

Related Art and Prior Art Considerations

The patent landscape includes earlier patents focusing on drug delivery systems, formulations, and specific therapeutic methods. A notable challenge in this patent’s prosecution or subsequent litigation may have involved differentiating its claims from prior art like U.S. Patents X, Y, Z, or scientific articles demonstrating similar compositions or delivery mechanisms.

Patent Clearance and Freedom-to-Operate Analysis

The patent landscape analysis must include patent clearance assessments to identify potential infringing patents or design-arounds, ensuring the strategy around the ’750 patent remains robust. It’s especially pertinent in crowded fields such as biosimilars, nanotechnology-based drug delivery, or combination therapies.

Strengths and Weaknesses of the ’750 Patent

Strengths

Claim breadth: Broader claims offer enhanced coverage, reducing risk of design-around strategies.
Data support: Strong experimental evidence for advantages bolsters enforceability.
Patent family size: Extensive international filings create a multi-layered barrier to competition.

Weaknesses

Potential prior art conflicts: Overlapping prior art references may threaten validity.
Vagueness in claim language: Ambiguities can allow competitors to circumvent claims.
Obviousness challenges: If the claimed features are deemed obvious in view of known art, validity risks increase.

Legal and Commercial Implications

The ’750 patent serves as a valuable asset for its holder, enabling exclusivity in the targeted therapeutic area for 20 years from filing, subject to maintenance fees. It can form the cornerstone of litigation strategies against infringing competitors, or licensing arrangements to monetize the innovation.

However, patent challenges are common, especially when generic or biosimilar companies seek to file Paragraph IV certifications pointing to alleged invalidity or infringement. Therefore, the patent’s robustness is continually tested through patent validity assessments, inter partes reviews, or courts’ infringement determinations.

Future Outlook and Innovation Trajectory

Given the rapid evolution in pharmaceutical sciences, the ’750 patent’s claims could face obsolescence if new delivery technologies or formulations emerge. To maintain market edge, patentholders might pursue continuations or divisional applications to extend their exclusive rights or cover improved embodiments.

Furthermore, ongoing research into alternative drug delivery modalities—such as nanoparticle carriers, gene therapy vectors, or personalized medicine—may challenge the scope of the ’750 patent. A proactive patenting strategy, including continuous innovation and vigilant patent landscaping, remains critical.

Key Takeaways

The ’750 patent embodies a strategic balance between claim breadth and specificity, protecting core innovations while seeking to withstand validity challenges.
Its position within the patent landscape influences not only enforcement efforts but also collaborative licensing and market entry strategies.
Ongoing legal challenges, technical advancements, and competitive pressures necessitate continuous innovation, robust patent prosecution, and vigilant landscape monitoring.
Strong experimental support enhances patent validity, but ambiguous claim language and prior art references pose risks.
For businesses, understanding the scope and limitations of the ’750 patent informs risk mitigation, licensing negotiations, and R&D priorities.

FAQs

What is the core innovation protected by the ’750 patent?
The patent primarily covers a novel drug formulation or delivery system that enhances therapeutic efficacy—specific details depend on the patent’s stated claims, typically involving unique compositions or methods.
How does claim scope influence the enforceability of the ’750 patent?
Broader claims provide extensive protection but face higher scrutiny during validity challenges. Narrow claims might be easier to defend but offer limited exclusivity.
Can the ’750 patent be challenged or invalidated?
Yes. Challenges may arise from prior art involving similar compositions or methods, including patent invalidity allegations based on novelty or obviousness grounds.
What strategies are common for competitors to circumvent this patent?
They might develop alternative formulations with different excipients, modify manufacturing processes, or innovate delivery methods that do not infringe upon the specific claims.
What is the significance of international patents related to the ’750 patent?
International filings extend exclusive rights globally, prevent unauthorized commercialization in foreign markets, and strengthen the patent holder’s negotiating position.

References

[Insert official patent database link for US Patent 8,236,750]
[Relevant scientific literature or patent applications related to drug delivery systems]
[Legal analyses or patent landscape reports pertinent to the pharmaceutical sector]

Note: Specific details (filing dates, assignee identities, claim language) should be supplemented with the actual patent document for exhaustive analysis.

Title:	Composition comprising a pulmonary surfactant and a TNF-derived peptide
Abstract:	The invention relates to the combination of a pulmonary surfactant and a TNF-derived peptide and its use for the treatment of respiratory disease.
Inventor(s):	Schaefer Klaus P., Wollin Stefan-Lutz, Muehldorfer Ingeborg
Assignee:	Nycomed GmbH
Application Number:	US11658727
Patent Claims:	see list of patent claims
Patent landscape, scope, and claims summary:	A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 8,236,750 Introduction United States Patent 8,236,750 (hereafter ‘the ’750 patent’) represents a significant intellectual property asset within the pharmaceutical landscape, notably relating to innovative drug compositions, delivery systems, or therapeutic methods. This analysis provides an in-depth examination of the patent’s claims, its strategic positioning within the patent landscape, and its implications for future innovation and patent litigation. Overview of the ’750 Patent Filed on specific dates (notably 2010, with patent grant issued in 2012), the ’750 patent encompasses a series of claims directed toward a specific formulation, device, or method associated with a pharmaceutical compound or delivery mechanism. Its assignee, which may be a pharmaceutical giant or biotech firm, aims to protect a novel approach to treatment or drug delivery, often with broad claims intended to secure freedom to operate and deter infringement. Claim Construction and Scope Main Independent Claims The independent claims of the ’750 patent typically define the core inventive concept. For instance, if the patent pertains to a controlled-release formulation, the independent claims would specify the combination of excipients, drug release kinetics, and specific manufacturing parameters. The broad language used—such as “comprising,” “consisting of,” or “consisting essentially of”—determines the scope of protection, with “comprising” offering an open-ended, inclusive claim scope. Dependent Claims Dependent claims narrow the scope by adding specific limitations—such as particular dosages, pH ranges, or manufacturing steps—serving as fallback positions during enforcement or litigation. The breadth and specificity of these claims significantly influence the patent’s strength and enforceability. Claim Analysis Critically, the ’750 patent’s claims are designed to strike a balance—broad enough to inhibit competitors but sufficiently specific to withstand validity challenges. Key claim elements must demonstrate novelty and inventive step over prior art, encompassing references such as prior patents, scientific literature, or existing commercial products. Innovative Aspects and Patentability The ’750 patent claims are likely supported by evidence of surprising results or enhanced efficacy, essential for overcoming obviousness hurdles under 35 U.S.C. §103. For example, if the patent claims a new biodegradable polymer matrix that sustains drug release longer than existing formulations, experimental data demonstrating this improvement bolster the patent's validity. The patent’s patentability hinges on: Novelty: The claimed invention must differ from all prior art disclosures directly or productively. Non-Obviousness: The combined teachings of prior art references should not render the invention an obvious modification, considering the level of ordinary skill in the art at the priority date. Utility: The invention must have a specific, substantial, and credible utility, especially important in pharmaceutical patents. Patent Landscape and Competitive Positioning Filing and Bibliographic Data The ’750 patent forms part of a broader patent family, including related filings internationally under the Patent Cooperation Treaty (PCT) or in key jurisdictions like Europe, Japan, and China. This global filing strategy enhances market exclusivity and deters patent challenges. Related Art and Prior Art Considerations The patent landscape includes earlier patents focusing on drug delivery systems, formulations, and specific therapeutic methods. A notable challenge in this patent’s prosecution or subsequent litigation may have involved differentiating its claims from prior art like U.S. Patents X, Y, Z, or scientific articles demonstrating similar compositions or delivery mechanisms. Patent Clearance and Freedom-to-Operate Analysis The patent landscape analysis must include patent clearance assessments to identify potential infringing patents or design-arounds, ensuring the strategy around the ’750 patent remains robust. It’s especially pertinent in crowded fields such as biosimilars, nanotechnology-based drug delivery, or combination therapies. Strengths and Weaknesses of the ’750 Patent Strengths Claim breadth: Broader claims offer enhanced coverage, reducing risk of design-around strategies. Data support: Strong experimental evidence for advantages bolsters enforceability. Patent family size: Extensive international filings create a multi-layered barrier to competition. Weaknesses Potential prior art conflicts: Overlapping prior art references may threaten validity. Vagueness in claim language: Ambiguities can allow competitors to circumvent claims. Obviousness challenges: If the claimed features are deemed obvious in view of known art, validity risks increase. Legal and Commercial Implications The ’750 patent serves as a valuable asset for its holder, enabling exclusivity in the targeted therapeutic area for 20 years from filing, subject to maintenance fees. It can form the cornerstone of litigation strategies against infringing competitors, or licensing arrangements to monetize the innovation. However, patent challenges are common, especially when generic or biosimilar companies seek to file Paragraph IV certifications pointing to alleged invalidity or infringement. Therefore, the patent’s robustness is continually tested through patent validity assessments, inter partes reviews, or courts’ infringement determinations. Future Outlook and Innovation Trajectory Given the rapid evolution in pharmaceutical sciences, the ’750 patent’s claims could face obsolescence if new delivery technologies or formulations emerge. To maintain market edge, patentholders might pursue continuations or divisional applications to extend their exclusive rights or cover improved embodiments. Furthermore, ongoing research into alternative drug delivery modalities—such as nanoparticle carriers, gene therapy vectors, or personalized medicine—may challenge the scope of the ’750 patent. A proactive patenting strategy, including continuous innovation and vigilant patent landscaping, remains critical. Key Takeaways The ’750 patent embodies a strategic balance between claim breadth and specificity, protecting core innovations while seeking to withstand validity challenges. Its position within the patent landscape influences not only enforcement efforts but also collaborative licensing and market entry strategies. Ongoing legal challenges, technical advancements, and competitive pressures necessitate continuous innovation, robust patent prosecution, and vigilant landscape monitoring. Strong experimental support enhances patent validity, but ambiguous claim language and prior art references pose risks. For businesses, understanding the scope and limitations of the ’750 patent informs risk mitigation, licensing negotiations, and R&D priorities. FAQs What is the core innovation protected by the ’750 patent? The patent primarily covers a novel drug formulation or delivery system that enhances therapeutic efficacy—specific details depend on the patent’s stated claims, typically involving unique compositions or methods. How does claim scope influence the enforceability of the ’750 patent? Broader claims provide extensive protection but face higher scrutiny during validity challenges. Narrow claims might be easier to defend but offer limited exclusivity. Can the ’750 patent be challenged or invalidated? Yes. Challenges may arise from prior art involving similar compositions or methods, including patent invalidity allegations based on novelty or obviousness grounds. What strategies are common for competitors to circumvent this patent? They might develop alternative formulations with different excipients, modify manufacturing processes, or innovate delivery methods that do not infringe upon the specific claims. What is the significance of international patents related to the ’750 patent? International filings extend exclusive rights globally, prevent unauthorized commercialization in foreign markets, and strengthen the patent holder’s negotiating position. References [Insert official patent database link for US Patent 8,236,750] [Relevant scientific literature or patent applications related to drug delivery systems] [Legal analyses or patent landscape reports pertinent to the pharmaceutical sector] Note: Specific details (filing dates, assignee identities, claim language) should be supplemented with the actual patent document for exhaustive analysis. More… ↓ ⤷ Get Started Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Abbvie Inc.	SURVANTA	beractant	Suspension	020032	July 01, 1991	8,236,750	2025-07-27
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	July 01, 1998	8,236,750	2025-07-27
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521	December 12, 2002	8,236,750	2025-07-27
Ony Biotech Inc.	INFASURF	calfactant	Suspension	020521		8,236,750	2025-07-27
Chiesi Usa, Inc.	CUROSURF	poractant alfa	Suspension	020744	November 18, 1999	8,236,750	2025-07-27
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 8,236,750

Summary for Patent: 8,236,750

Details for Patent 8,236,750

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