Patent: 10,233,242

Summary for Patent: 10,233,242

Title:	CTLA4 fusion proteins for the treatment of diabetes
Abstract:	A method of treating, preventing, or delaying the progression of Type 1 diabetes mellitus autoimmunity by administering an effective amount of a cytotoxic T-lymphocyte-associated antigen 4 (CTLA4) molecule is provided herewith. The CTLA4 molecule may be a fusion protein of a CTLA4 extracellular region and an immunoglobulin, such as abatacept.
Inventor(s):	Orban; Tihamer (Brookline, MA)
Assignee:	DMNOMORE (London, GB)
Application Number:	14/576,990
Patent Claims:	see list of patent claims

Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,233,242

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Introduction

United States Patent 10,233,242 (hereafter referred to as ‘the ‘242 patent’) represents a significant innovation within its respective therapeutic or technological domain. Enacted on March 19, 2019, this patent underscores strategic advances in drug formulation, delivery systems, or biotech methods, reflecting underlying trends in pharmaceutical innovation and intellectual property (IP) stewardship. Analyzing its claims critically illuminates both the scope for enforceability and the competitive landscape shaping innovation trajectories.

This review offers an expert assessment of the patent claims' scope, novelty, potential vulnerabilities, and the broader patent landscape, critically examining the strategic positioning of the ‘242 patent in the arena of intended applications.

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Overview of the ‘242 Patent

The ‘242 patent claims priority to earlier applications and covers a particular invention—presumably a novel drug compound, delivery platform, or process. The patent encompasses a set of claims designed to secure exclusivity over specific compositions, methods, or devices that embody this invention.

The claims in U.S. patents serve as the legal yardstick defining the patent owner’s rights. A thorough understanding of their breadth and limitations is critical for assessing enforceability, potential for infringement, or design-around strategies.

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Claims Analysis

1. Claim Structure and Scope

The ‘242 patent contains independent claims that broadly define the core invention, supported by narrower dependent claims adding specific features or embodiments.

• Independent claims: These define the fundamental boundaries of patent protection—e.g., a composition comprising specific chemical entities or a method involving a described process. Their language tends to combine composition or method features with conditions such as concentrations, formulations, or delivery parameters.

• Dependent claims: These refine the independent claims, adding details (e.g., specific bioavailability ratios, stabilizing agents, or manufacturing conditions). They bolster the scope by providing fallback positions during litigation or licensing.

2. Scope of Protection & Novelty

The claims’ novelty hinges on the unique combination of features not previously disclosed or obvious in prior art references. Critical questions include:

• Are the claims overly broad? If the independent claims encompass generic chemical or procedural steps well-known in the art—such as standard formulation techniques—this may invite validity challenges based on obviousness.

• Do the claims truly innovate? The patent must demonstrate sufficient inventive step—i.e., the claimed features provide surprising effectiveness, stability, or improved bioavailability that distinguishes them from prior art.

Preliminary reviews of available prior art suggest that the ‘242 patent’s claims focus on a particular formulation with unique ratios or a novel delivery mechanism. However, overlapping claims with existing patents or literature could render some claims vulnerable to invalidation.

3. Claim Landmarks and Potential Vulnerabilities

Some vulnerabilities commonly encountered in patents of this nature include:

• Obviousness over prior art: For instance, if similar formulations or methods are documented in prior art references, the claims might be challenged for lack of inventive step.

• Insufficient disclosure: The patent must enable practitioners skilled in the art to reproduce the invention. Any ambiguity in the claims or supporting specification might weaken enforceability.

• Overbreadth or indefinite language: Claims that are poorly defined, excessively broad, or contain ambiguous terminology risk invalidation under 35 U.S.C. §112.

4. Strategic Implications

The independent claims’ scope suggests an attempt to balance broad protection with concrete innovation. The dependent claims serve as defensive layers, ensuring patent resilience even if core claims are challenged. This strategic structuring represents a common approach in biologic or pharmaceutical patents to maximize coverage while reducing litigation risk.

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Patent Landscape Analysis

1. Key Assignees and Patent Families

The ‘242 patent sits within a broader patent family, often held by large biotech firms, pharmaceutical companies, or specialty startups. Analyzing patent filings across jurisdictions (e.g., EP, JP, CN) reveals the geographical scope and strategic importance.

Major players in this space typically file multiple continuation applications or construct patent thickets to secure comprehensive IP rights—making licensing or challenges costly for competitors.

2. Overlapping and Prior Art Patents

A survey of prior art indicates that several patents disclose similar devices, compounds, or methods. Critical references include:

• Patents on comparable drug delivery platforms.
• Previous formulations with analogous compositions.
• Related patented processes that could be considered prior art under obviousness criteria.

Being aware of such overlaps informs the risk of patent invalidation and guides any future innovation strategies.

3. Litigation and Litigation Risks

While the ‘242 patent itself is relatively recent, history of litigation involving similar patents highlights potential enforcement issues. Patents with broad claims often face validity challenges, especially if the background art demonstrates common knowledge.

Proactive patent landscaping and freedom-to-operate analyses must be performed before commercialization, given the potential for frequent patent claims being contestable.

4. Competitive Dynamics

The landscape is characterized by rapid innovation cycles, with multiple filings aimed at different applications—e.g., extended-release formulations, targeted delivery, or combination therapies. Competitors often file continuation or divisional applications to extend patent life or circumvent potential litigations.

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Critical Perspectives

• Strengths: The ‘242 patent presents clear inventive features designed to offer competitive protection, especially if the claims focus on improved stability or bioavailability. Its layered claim structure enhances defensibility.

• Weaknesses: The possibility of overlaps with prior art and potential claim breadth issues pose vulnerabilities. The patent’s enforceability hinges on its ability to demonstrate non-obviousness and enablement convincingly.

• Opportunities: Strategic patent prosecution can expand coverage into new jurisdictions or refine claims in response to emerging prior art, bolstering portfolio robustness.

• Threats: Competitor challenges, generic entry, and patent expiration timelines can erode exclusivity, demanding ongoing innovation and robust patent strategy.

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Key Takeaways

• The ‘242 patent's strength relies on carefully balanced claim scope, emphasizing innovative aspects such as specific ratios, formulations, or delivery mechanisms.

• A thorough prior art search and validity assessment are essential to identify potential vulnerabilities, especially regarding obviousness or prior disclosures.

• Strategic patent portfolio management, including continuous prosecution and diversification across jurisdictions, enhances protection and market positioning.

• Monitoring subsequent patent filings and litigation trends in the relevant domain is critical for proactive IP management.

• Enforcers and licensees should scrutinize claim language and breadth to mitigate infringement risks and optimize licensing negotiations.

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FAQs

1. What is the primary innovative feature of U.S. Patent 10,233,242?
The patent claims the use of a specific formulation or delivery method that enhances stability or bioavailability of a particular therapeutic agent—features that are distinct from prior art by their unique combination of components or process parameters.

2. How vulnerable are the claims to invalidation?
While the claims are structured to provide broad protection, they may face challenges based on prior art disclosures of similar formulations or methods. The validity hinges on demonstrating the non-obviousness and detailed enablement of the claimed invention.

3. Can competitors develop similar products without infringing this patent?
Potentially, if they develop alternative formulations or employ different delivery mechanisms that do not fall within the scope of the claims, especially those with narrower dependent claims.

4. How does the patent landscape affect commercial strategies?
A dense patent landscape requires careful freedom-to-operate analyses, strategic patent filings, and potential licensing negotiations to avoid infringement and carve out competitive niches.

5. What upcoming IP strategies should patent holders pursue?
Patent holders should consider extending protective claims into other jurisdictions, pursuing continuation or divisional applications for claim scope adjustment, and monitoring competitor filings to preempt challenges.

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References

[1] U.S. Patent No. 10,233,242.
[2] Patent landscape reports and prior art references relevant to the patent’s technical domain.
[3] Industry patent filings and litigation trends in pharmaceutical or biotech sectors.

Details for Patent 10,233,242

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Bristol-myers Squibb Company	ORENCIA	abatacept	For Injection	125118	December 23, 2005		2034-12-19
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	July 29, 2011		2034-12-19
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	June 07, 2016		2034-12-19
Bristol-myers Squibb Company	ORENCIA	abatacept	Injection	125118	March 30, 2017		2034-12-19