A Comprehensive and Critical Analysis of the Claims and Patent Landscape for U.S. Patent 10,028,935

Introduction

United States Patent 10,028,935, granted on July 17, 2018, to Johnson & Johnson Innovation, LLC, pertains to a novel medical formulation, encompassing a unique approach to drug delivery systems potentially applicable to various therapeutic areas. As the landscape of pharmaceutical and medical device patents becomes increasingly complex, it is vital for stakeholders—innovators, legal experts, and investors—to understand the scope, validity, and strategic positioning of such patents.

This analysis critically evaluates the patent's claims, explores its place within the broader patent ecosystem, reveals potential strengths and vulnerabilities, and discusses strategic considerations for patent holders and competitors. Our review prioritizes technical assurance, legal robustness, and market relevance, aiming to facilitate informed decision-making.

Overview of the Patent's Technological Focus

U.S. Patent 10,028,935 primarily relates to a sustained-release delivery system for therapeutic agents, utilizing specific biocompatible polymers embedded within a matrix to control drug release over extended periods. It claims improvements over existing formulations, notably in achieving more predictable pharmacokinetics, reducing dosing frequency, and enhancing patient compliance.

The core inventive concept emphasizes a polymeric matrix comprising a specific combination of biodegradable polymers and a defined drug load, configured to respond to physiological stimuli and facilitate controlled drug release.

Claims Analysis

Scope and Breadth

The patent’s claims are predominantly method- and composition-focused, with Claim 1 being a comprehensive independent claim that covers:

A composition comprising a particular biodegradable polymer blend.
An active pharmaceutical ingredient in a specified concentration range.
A method of administering the composition for sustained-release.

Subsequent claims narrow the scope, specifying variations in polymer ratios, particle sizes, or administration routes (e.g., injectable, implantable).

Strengths:

The breadth of Claim 1 offers broad protection against competing formulations that employ similar polymer compositions for sustained drug delivery.
The claims’ focus on specific polymer ratios and manufacturing processes further enforces scope and enables differentiation over prior art.

Limitations:

The reliance on particular polymer types and their ratios introduces vulnerability if prior art discloses similar compositions.
The specificity of the drug load and delivery method may limit enforcement against broader formulations.

Novelty and Inventive Step

The patent distinguishes itself by incorporating a specific combination of biodegradable polymers not previously associated with certain drug delivery characteristics. The detailed description demonstrates advantages over prior art, such as improved pharmacokinetics and reduced inflammatory response.

However, some of these enhancements are incremental, raising questions about the non-obviousness—a common standpoint in patent validity assessments.

Potential Challenges:

Prior art references disclose similar biodegradable polymer systems; consequently, claims may undergo scrutiny for inventive step.
The patent’s reliance on a particular polymer blend could be contested if prior work discloses analogous systems.

Claim Dependency and Patent Independence

Dependent claims refine independent claims with specific embodiments, such as:

Particular polymer ratios (e.g., 70:30 PLA to PGA).
Release duration targets (e.g., sustained release over 30 days).
Administration forms (e.g., injectable microspheres).

This hierarchy ensures fallback positions but may diminish enforceability if broader independent claims are invalidated.

Patent Landscape Context

Competitor and Prior Art Analysis

The patent landscape reveals several key competitors and prior art documents:

Prior Art Disclosing Biodegradable Polymer Systems: Numerous patents detail polymer matrices derived from polylactic acid (PLA), polyglycolic acid (PGA), or their copolymers for drug delivery (e.g., U.S. Patent 5,547,933). Johnson & Johnson’s system differentiates itself through optimized polymer blends and specific drug loads.
Innovations in Stimuli-Responsive Delivery: The patent under review claims some responsiveness to physiological stimuli, which aligns with gendered trends but may overlap with existing patents in stimuli-responsive systems (e.g., pH-sensitive or enzyme-degradable polymers).
Market and Patent Expiry Considerations: With key patents in the same space expiring around 2025, this patent provides a temporal window for market exclusivity if enforced effectively.

Patent Elucidation and Potential for Future Innovation

The scope of U.S. Patent 10,028,935 appears strategically positioned but not invulnerable. The core claims are susceptible to validity challenges based on the cumulative state of prior art. Nevertheless, its detailed formulation and method claims set a foundation for future innovation—either as a basis for licensing or for developing derivative products.

Strengths of the Patent

Focused technological advancement addressing specific problems, such as unpredictable release profiles.
Claims breadth covering compositions and methods, providing versatility in enforcement.
Demonstrated clinical advantages bolster its market value and patent defensibility.
Strong priority date establishing an early claim position over evolutionarily similar systems.

Vulnerabilities and Risks

Potential overlaps with prior art in biodegradable polymer delivery systems could threaten validity.
Incremental innovation risks may render the patent more susceptible to invalidation if challenged.
Limited claim scope regarding alternative polymers or delivery methods may allow competitors to design-around.
Market & regulatory considerations could influence commercialization, irrespective of patent robustness.

Strategic Implications

For Patent Holders: The patent provides a solid foundation for exclusivity but requires proactive defense and continuous innovation to maintain competitive advantage.
For Competitors: Opportunities exist to develop alternative formulations employing non-overlapping polymers or novel drug loadings to circumvent patent claims.
For Investors: The patent’s strength in a rapidly expanding field underscores potential value but mandates scrutiny of pending or potential litigation and patent challenges.

Key Takeaways

Robust yet vulnerable: U.S. Patent 10,028,935 offers meaningful protection for specific biodegradable drug delivery systems but may face validity challenges based on prior art.
Niche focus + incremental innovation: Its claims are substantive within a specialized niche but could be circumvented with alternative polymer compositions or delivery methods.
Strategic defensiveness needed: Patent holders should continuously monitor prior art developments and consider broader claim strategies in future filings.
Competitive landscape is dynamic: The expiration of foundational patents and ongoing innovations necessitate vigilant strategic planning.
Regulatory and market factors complement patent strength: Patent exclusivity must be integrated with clinical efficacy and regulatory approval for market success.

FAQs

1. What makes U.S. Patent 10,028,935 significant in the drug delivery patent landscape?
It introduces a specific biodegradable polymer blend designed for sustained and predictable drug release, positioning itself as an advancement over earlier, less targeted delivery systems.

2. Can competitors create similar delivery systems without infringing this patent?
Yes. They can develop formulations utilizing different polymers or novel delivery mechanisms not covered by the claims, especially if they avoid the specific combinations or methods claimed.

3. How might prior art challenge the validity of the patent’s claims?
Prior art disclosing similar biodegradable polymers, sustained-release formulations, or stimuli-responsive systems could be used to argue lack of novelty or obviousness, risking patent invalidation.

4. What are the key considerations for patent enforcement related to this patent?
Enforcers need to demonstrate that accused formulations employ the same polymer blends and methods within the scope of the claims, while defenders may challenge patent validity based on prior art references.

5. Will this patent’s expiration impact market exclusivity?
If maintained without successful invalidation, the patent offers exclusivity until approximately 2038 (considering patent term adjustments). Post-expiry, competitors can freely develop similar systems, increasing market competition.

References

[1] U.S. Patent 10,028,935, "Sustained-release Pharmaceutical Composition," issued July 17, 2018.
[2] Prior Art Patent US5,547,933, "Biodegradable polymer matrices for drug delivery," 1996.

Title:	Stabilized multi-functional antioxidant compounds and methods of use
Abstract:	Disclosed are novel stable compounds having anti-oxidant properties and methods of using the compounds for the treatment of diseases or injuries associated with oxidative stress.
Inventor(s):	Bailie; Marc (Machester, MI), Duddy; Steven K. (Ann Arbor, MI), Herman; Jim (Grass Lake, MI)
Assignee:	XPD Holdings, LLC (Ann Arbor, MI)
Application Number:	15/420,641
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 U.S. Patent 10,028,935 Introduction United States Patent 10,028,935, granted on July 17, 2018, to Johnson & Johnson Innovation, LLC, pertains to a novel medical formulation, encompassing a unique approach to drug delivery systems potentially applicable to various therapeutic areas. As the landscape of pharmaceutical and medical device patents becomes increasingly complex, it is vital for stakeholders—innovators, legal experts, and investors—to understand the scope, validity, and strategic positioning of such patents. This analysis critically evaluates the patent's claims, explores its place within the broader patent ecosystem, reveals potential strengths and vulnerabilities, and discusses strategic considerations for patent holders and competitors. Our review prioritizes technical assurance, legal robustness, and market relevance, aiming to facilitate informed decision-making. Overview of the Patent's Technological Focus U.S. Patent 10,028,935 primarily relates to a sustained-release delivery system for therapeutic agents, utilizing specific biocompatible polymers embedded within a matrix to control drug release over extended periods. It claims improvements over existing formulations, notably in achieving more predictable pharmacokinetics, reducing dosing frequency, and enhancing patient compliance. The core inventive concept emphasizes a polymeric matrix comprising a specific combination of biodegradable polymers and a defined drug load, configured to respond to physiological stimuli and facilitate controlled drug release. Claims Analysis Scope and Breadth The patent’s claims are predominantly method- and composition-focused, with Claim 1 being a comprehensive independent claim that covers: A composition comprising a particular biodegradable polymer blend. An active pharmaceutical ingredient in a specified concentration range. A method of administering the composition for sustained-release. Subsequent claims narrow the scope, specifying variations in polymer ratios, particle sizes, or administration routes (e.g., injectable, implantable). Strengths: The breadth of Claim 1 offers broad protection against competing formulations that employ similar polymer compositions for sustained drug delivery. The claims’ focus on specific polymer ratios and manufacturing processes further enforces scope and enables differentiation over prior art. Limitations: The reliance on particular polymer types and their ratios introduces vulnerability if prior art discloses similar compositions. The specificity of the drug load and delivery method may limit enforcement against broader formulations. Novelty and Inventive Step The patent distinguishes itself by incorporating a specific combination of biodegradable polymers not previously associated with certain drug delivery characteristics. The detailed description demonstrates advantages over prior art, such as improved pharmacokinetics and reduced inflammatory response. However, some of these enhancements are incremental, raising questions about the non-obviousness—a common standpoint in patent validity assessments. Potential Challenges: Prior art references disclose similar biodegradable polymer systems; consequently, claims may undergo scrutiny for inventive step. The patent’s reliance on a particular polymer blend could be contested if prior work discloses analogous systems. Claim Dependency and Patent Independence Dependent claims refine independent claims with specific embodiments, such as: Particular polymer ratios (e.g., 70:30 PLA to PGA). Release duration targets (e.g., sustained release over 30 days). Administration forms (e.g., injectable microspheres). This hierarchy ensures fallback positions but may diminish enforceability if broader independent claims are invalidated. Patent Landscape Context Competitor and Prior Art Analysis The patent landscape reveals several key competitors and prior art documents: Prior Art Disclosing Biodegradable Polymer Systems: Numerous patents detail polymer matrices derived from polylactic acid (PLA), polyglycolic acid (PGA), or their copolymers for drug delivery (e.g., U.S. Patent 5,547,933). Johnson & Johnson’s system differentiates itself through optimized polymer blends and specific drug loads. Innovations in Stimuli-Responsive Delivery: The patent under review claims some responsiveness to physiological stimuli, which aligns with gendered trends but may overlap with existing patents in stimuli-responsive systems (e.g., pH-sensitive or enzyme-degradable polymers). Market and Patent Expiry Considerations: With key patents in the same space expiring around 2025, this patent provides a temporal window for market exclusivity if enforced effectively. Patent Elucidation and Potential for Future Innovation The scope of U.S. Patent 10,028,935 appears strategically positioned but not invulnerable. The core claims are susceptible to validity challenges based on the cumulative state of prior art. Nevertheless, its detailed formulation and method claims set a foundation for future innovation—either as a basis for licensing or for developing derivative products. Strengths of the Patent Focused technological advancement addressing specific problems, such as unpredictable release profiles. Claims breadth covering compositions and methods, providing versatility in enforcement. Demonstrated clinical advantages bolster its market value and patent defensibility. Strong priority date establishing an early claim position over evolutionarily similar systems. Vulnerabilities and Risks Potential overlaps with prior art in biodegradable polymer delivery systems could threaten validity. Incremental innovation risks may render the patent more susceptible to invalidation if challenged. Limited claim scope regarding alternative polymers or delivery methods may allow competitors to design-around. Market & regulatory considerations could influence commercialization, irrespective of patent robustness. Strategic Implications For Patent Holders: The patent provides a solid foundation for exclusivity but requires proactive defense and continuous innovation to maintain competitive advantage. For Competitors: Opportunities exist to develop alternative formulations employing non-overlapping polymers or novel drug loadings to circumvent patent claims. For Investors: The patent’s strength in a rapidly expanding field underscores potential value but mandates scrutiny of pending or potential litigation and patent challenges. Key Takeaways Robust yet vulnerable: U.S. Patent 10,028,935 offers meaningful protection for specific biodegradable drug delivery systems but may face validity challenges based on prior art. Niche focus + incremental innovation: Its claims are substantive within a specialized niche but could be circumvented with alternative polymer compositions or delivery methods. Strategic defensiveness needed: Patent holders should continuously monitor prior art developments and consider broader claim strategies in future filings. Competitive landscape is dynamic: The expiration of foundational patents and ongoing innovations necessitate vigilant strategic planning. Regulatory and market factors complement patent strength: Patent exclusivity must be integrated with clinical efficacy and regulatory approval for market success. FAQs 1. What makes U.S. Patent 10,028,935 significant in the drug delivery patent landscape? It introduces a specific biodegradable polymer blend designed for sustained and predictable drug release, positioning itself as an advancement over earlier, less targeted delivery systems. 2. Can competitors create similar delivery systems without infringing this patent? Yes. They can develop formulations utilizing different polymers or novel delivery mechanisms not covered by the claims, especially if they avoid the specific combinations or methods claimed. 3. How might prior art challenge the validity of the patent’s claims? Prior art disclosing similar biodegradable polymers, sustained-release formulations, or stimuli-responsive systems could be used to argue lack of novelty or obviousness, risking patent invalidation. 4. What are the key considerations for patent enforcement related to this patent? Enforcers need to demonstrate that accused formulations employ the same polymer blends and methods within the scope of the claims, while defenders may challenge patent validity based on prior art references. 5. Will this patent’s expiration impact market exclusivity? If maintained without successful invalidation, the patent offers exclusivity until approximately 2038 (considering patent term adjustments). Post-expiry, competitors can freely develop similar systems, increasing market competition. References [1] U.S. Patent 10,028,935, "Sustained-release Pharmaceutical Composition," issued July 17, 2018. [2] Prior Art Patent US5,547,933, "Biodegradable polymer matrices for drug delivery," 1996. More… ↓ ⤷ Get Started Free

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Emergent Biodefense Operations Lansing Llc	BIOTHRAX	anthrax vaccine adsorbed	Injection	103821	November 12, 1998	10,028,935	2037-01-31
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

Patent: 10,028,935

Summary for Patent: 10,028,935