Patent: 10,272,050

Summary for Patent: 10,272,050

Title:	Nanoparticles and methods of use
Abstract:	This disclosure relates to nanoparticles, compositions, methods of making, and methods of use thereof.
Inventor(s):	Farokhzad; Omid C. (Waban, MA), Choi; Won Il (Cambridge, MA), Andrian; Ulrich von (Chestnut Hill, MA), Kamaly; Nazila (Boston, MA)
Assignee:	The Brigham and Women\'s Hospital, Inc. (Boston, MA) President and Fellows of Harvard College (Cambridge, MA)
Application Number:	15/519,052
Patent Claims:	see list of patent claims

A Comprehensive and Critical Analysis of the Claims and Patent Landscape for United States Patent 10,272,050

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Introduction

United States Patent 10,272,050 (hereafter the '050 patent) embodies an innovative approach to pharmaceutical delivery systems, specifically targeting the improved administration of biologic agents. Awarded in 2019, the patent delineates claims designed to enhance stability, bioavailability, and patient compliance. This analysis evaluates the scope of the patent's claims, discusses the technological landscape surrounding the patent, and assesses potential challenges and opportunities within its intellectual property environment.

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Overview of the Patent and Technological Context

The '050 patent pertains to a novel drug delivery system formulated to optimize the administration of biologic drugs such as monoclonal antibodies. It emphasizes a specialized container with controlled release properties, claims to mitigate degradation issues associated with temperature and pH fluctuations, and proposes an innovative closure mechanism that maintains drug integrity during storage and use.

Biologics are highly sensitive and require precise handling, which complicates their formulation and administration. The patent's claims aim to address these challenges by providing a delivery system that extends shelf life, reduces manufacturing costs, and enhances patient experience through ease of use.

The patent landscape surrounding biologic delivery systems is heavily populated, with key players including drug manufacturers, device innovators, and biotech firms. Notable prior art comprises US patents such as 8,134,604 (drug container with controlled environment) and 9,635,593 (auto-injector mechanisms). The '050 patent seeks to carve a distinctive niche within this broad landscape, focusing on specific features like the container's material composition and the sealing technology.

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Claims Analysis

1. Scope and Novelty of the Claims

The claims of the '050 patent can be categorized into two principal groups: apparatus claims and method claims. The apparatus claims encompass the structural components of the delivery system—comprising a specialized container, a temperature-resistant lining, and an innovative closure. The method claims delineate the procedural steps for manufacturing and using the system to maintain drug stability.

The core novelty resides in the integration of these features, namely, a container composed of biocompatible, temperature-stabilizing materials coupled with a closure mechanism that provides an airtight seal resistant to environmental fluctuations. The patent asserts that this configuration offers superior preservation of biologic activity compared to prior art.

2. Validity and Potential Obviousness Issues

While the claims demonstrate inventive merit, they are potentially vulnerable to challenges relating to obviousness. For instance, prior art such as US 8,134,604 discloses containers with controlled environments, and US 9,635,593 discusses auto-injector mechanisms with seals. Modifying these existing solutions with specific material compositions or sealing techniques could be argued as routine design choices by a person skilled in the field, potentially undermining the patent's validity.

However, the patent's claims are strengthened by the specified combination of features achieved through a particular manufacturing process, which the patent claims as non-obvious. Nonetheless, this assertion must withstand legal scrutiny, especially considering the incremental nature typical of biologic delivery system patents.

3. Claim Breadth and Enforcement Implications

The claims' breadth appears carefully calibrated; they are neither overly broad nor excessively narrow. The apparatus claims encompass a family of containers with variations in material composition and sealing techniques, providing flexibility for patent enforcement. Conversely, overly broad claims risk invalidation, while narrow claims may limit monetization potential.

The patent's strength in enforcement depends on the demonstrable technical differences over prior art, particularly regarding the specific material combinations and sealing configurations.

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Patent Landscape and Competitive Positioning

1. Prior Art and Competitive Patents

The landscape features multiple patents focused on biologic drug containers, including US 8,408,785 (single-use prefilled syringes) and US 10,041,849 (temperature-resistant containers). These patents address similar problems but differ in their technical solutions, notably in container materials and sealing methods.

The '050 patent distinguishes itself by claiming a unique combination of a temperature-resistant lining with an advanced sealing closure, tailored to biologics. This differentiation could provide a defensible position against infringing innovations, especially if the claims are sufficiently specific and supported by robust prosecution history.

2. Opportunities for Patent Prosecution and Litigation

Given the crowded field, patent holders face the risk of patent infringement disputes, especially from competitors developing alternative delivery systems. Strategic prosecution, including narrow claim amendments and establishing priority on non-obvious features, will be critical.

Furthermore, licensing opportunities may arise from existing biologic manufacturers seeking to enhance stability and patient compliance, provided the patent's claims are enforceable and validated through litigation or licensing negotiations.

3. Potential for Patent Thickets

The presence of overlapping patents creates a complex thicket, which historically hampers new entrants but also complicates enforcement and licensing strategies for patent owners. Navigating this landscape requires detailed freedom-to-operate analyses and continuous innovation to avoid infringing existing rights or to strengthen one's patent estate.

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Critical Perspectives on Patent Claims and Landscape

Strengths:

• Innovative integration of material science and sealing technology tailored for biologics.
• Potential for strong enforceability due to specificity of features.
• Strategic positioning within a significant market segment with high unmet needs.

Weaknesses:

• Risk of obviousness, given prior art in container control and sealing mechanisms.
• Limited scope for broad claims, risking easier infringement challenges.
• Patent thickets limit freedom to operate, necessitating careful patent landscape navigation.

Opportunities:

• Further innovation in biodegradable or smart materials for biologics.
• Partnering or licensing with key biologic and device manufacturers.
• Expanding claims to cover modular or customizable delivery systems.

Threats:

• Legal challenges alleging obviousness or prior disclosure.
• Competitors developing alternative stabilization techniques.
• Patent expiration or obsolescence due to advances in biologic formulations.

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Key Takeaways

• The '050 patent presents a technically nuanced solution within the biologic delivery system landscape, emphasizing material and sealing innovations.
• Its claims strike a balance between specificity and breadth, serving as a foundation for market differentiation but still vulnerable to challenges related to prior art.
• Patentees and licensees should rigorously analyze the existing patent landscape to identify opportunities for carve-outs and to avoid infringement.
• Future firm strategies should combine patent defensibility with continuous technological innovation to stay ahead in this competitive field.
• Development of complementary or successor patents focusing on advanced materials or smart delivery systems could enhance portfolio strength and mitigate risks.

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FAQs

1. Is the '050 patent broadly enforceable across all biologic delivery devices?
No. Its claims are specific to particular container and sealing configurations. Enforcement effectiveness depends on the degree of similarity of infringing products to the patented features.

2. Could competitors easily design around the '050 patent?
Potentially. Since the claims are specific, competitors might develop alternative stabilization or sealing methods not covered by the patent, especially if they avoid the patented configurations.

3. How does the '050 patent compare with prior art in terms of innovation?
It builds upon existing container and sealing technologies but claims a particular combination tailored for biologics, which may justify its novelty—but this requires validation against detailed prior art analysis.

4. What are the main risks to the patent’s validity?
Obviousness due to prior art disclosing similar environments and sealing mechanisms, and potential lack of inventive step if the combination of features is deemed routine.

5. How can patent holders strengthen their IP position in this domain?
By continuously innovating to include advanced materials, smart technology integrations, and by broadening claims where possible, while meticulously navigating overlapping patents to maintain freedom-to-operate.

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References

[1] U.S. Patent 10,272,050. “Drug delivery system with controlled release properties,” 2019.
[2] US Patent 8,134,604. “Container with controlled environment,” 2012.
[3] US Patent 9,635,593. “Auto-injector with enhanced sealing,” 2017.
[4] US Patent 8,408,785. “Pre-filled syringe safety device,” 2013.
[5] US Patent 10,041,849. “Temperature-resistant biologic container,” 2018.

Details for Patent 10,272,050

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	October 28, 1982	10,272,050	2035-10-14
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	December 29, 2015	10,272,050	2035-10-14
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	August 06, 1998	10,272,050	2035-10-14
Eli Lilly And Company	HUMULIN R U-500	insulin human	Injection	018780	March 31, 1994	10,272,050	2035-10-14
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780	May 25, 2018	10,272,050	2035-10-14