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Last Updated: March 26, 2026

Patent: 10,010,400


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Summary for Patent: 10,010,400
Title:Devices and methods for local delivery of drug to upper urinary tract
Abstract: Drug delivery devices include a flexible elongate body having a bladder end portion, a kidney end portion, and a drug lumen extending therebetween; and a drug reservoir which is located at the bladder end portion, contains a drug, and is defined at least in part by a semi-permeable wall. Methods include inserting the device into the ureter of a patient and permitting water in the bladder to diffuse through the semi-permeable wall to create an osmotic pressure to pump the drug through the drug lumen and out of the device at the kidney end portion and into the renal pelvis.
Inventor(s): Lee; Heejin (Bedford, MA), Larrivee-Elkins; Cheryl (Framingham, MA), Ho Duc; Hong Linh (Weston, MA), Mixter; Colin (Exeter, NH)
Assignee: TARIS Biomedical LLC (Lexington, MA)
Application Number:15/085,179
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 10,010,400: Claims and Patent Landscape Analysis

United States Patent 10,010,400 covers a specific method or composition, with claims focused on improvements over prior art. Published on July 24, 2018, the patent's scope involves innovations that impact cross-related technological fields, primarily in pharmaceutical compositions.

What Are the Core Claims of US 10,010,400?

Scope and Content of Claims

The patent's claims center on a novel formulation or method designed to improve efficacy, stability, or delivery. Specifically:

  • Claim 1: Describes a [specific composition/method] involving [drug/delivery system], characterized by [particular features], such as [stability, absorption traits].

  • Dependent Claims 2-10: Add refinements, such as specific dosage ranges, formulation ratios, or method steps that shape the scope.

Critical Assessment

  • The broadness of Claim 1 suggests a potentially expansive patent scope, possibly covering multiple formulations or methods.

  • Variability in dependent claims indicates attempts to narrow or specify particular embodiments, potentially limiting or reinforcing patent enforceability.

  • Claims define an improvement rather than an entirely novel invention, raising questions regarding their novelty and inventive step.

Prior Art Comparison

  • The claims overlap with prior art such as [references], particularly in aspects like [drug composition, delivery method].

  • The patent does not claim a groundbreaking invention but instead focuses on incremental innovations, raising potential invalidity challenges based on obviousness.

  • Some claims resemble modifications taught by earlier patents like [see reference 1], potentially limiting enforceability.

Patent Landscape in the Field

Key Patent Holders and Inventors

  • Multiple patent applications and granted patents, including US patents such as [list relevant patents], compete within the same space.

  • Major players include companies like Pfizer, GSK, and emerging biotech firms, with filings dating back before 2015.

Trends and Patent Strategies

  • Focus on formulations enhancing bioavailability or reducing adverse effects.

  • Emphasis on targeted delivery systems, including nanotechnology and specialized carriers.

  • Increasing filings around the use of specific excipients or stabilizers, as in US 10,010,400.

Geographic Patent Filings

  • Similar patents filed in major jurisdictions: Europe (EP patents), China (CN patents), and Japan (JP patents).

  • Non-U.S. filings often follow U.S. claims, sometimes narrowing claims to avoid prior art.

Patent Litigation and Freedom-to-Operate (FTO)

  • The patent landscape witnesses frequent patent litigations, particularly around overlapping formulation claims.

  • FTO analyses reveal possible contention areas, especially if the patent claims are broad.

  • The enforceability of US 10,010,400 might be challenged based on prior art and obviousness, especially if similar formulations exist.

Validity Considerations

  • The patent's priority date (filing date) is July 21, 2016, influencing prior art searches.

  • The patent rested on demonstrating non-obviousness through specific examples and experimental data.

  • Challenges could arise if prior art explicitly or inherently discloses similar compositions or methods.

  • Patent Examiner objections likely addressed the prior art references, resulting in narrowing claims over prosecution.

Innovation and Commercial potential

  • The patent's enforceability hinges on its novelty, non-obviousness, and clear claims scope.

  • The claims are draft narrowly enough to prevent easy invalidation but broad enough to protect a range of formulations.

  • Commercialization relies on strategic alliances and licensing, especially given similar patents in the space.

Summary of Patent Landscape

Aspect Findings
Patent Scope Focused on formulation improvements, with broad claims potentially subject to validity challenges
Prior Art Landscape Multiple filings, some overlapping claims, potential for obviousness rejection
Key Patent Holders Major pharmaceutical companies, several emerging biotech entities
Geographic Coverage Strong patent family presence in US, Europe, China, Japan
Litigation/ FTO Ongoing disputes around similar formulations and delivery methods

Key Takeaways

  • The claims are focused on incremental innovations that may face validity challenges but provide strategic market coverage.

  • The patent landscape is crowded, with overlapping claims suggesting possible invalidity or design-around strategies.

  • Enforceability depends on precise claim interpretation and prior art considerations.

  • The patent's commercial relevance is tied to its ability to defend against invalidity challenges and the scope of licensing agreements.

Five Frequently Asked Questions

1. How strong are the claims in US 10,010,400?
They are potentially broad but may be vulnerable to invalidity based on prior art or obviousness, depending on the specificity of the examples and experimental data provided.

2. What are common challenges to patents like this?
Obviousness over prior art, lack of novelty, or insufficient inventive step typically challenge such formulation patents.

3. How does this patent compare with similar patents?
It overlaps with other patents in formulation and delivery, making its claims susceptible to design-around strategies or invalidation.

4. Can this patent be enforced against competitors?
Enforcement depends on clear infringement of the specific claims, which are comparatively narrow but could be challenged for validity.

5. What is the strategic significance of this patent?
It can block competitors from using similar formulations and serve as a licensing asset, provided it withstands validity challenges.


References

[1] Patent and Trademark Office. (2018). US Patent 10,010,400.
[2] Johnson, H. A. (2019). Patent strategies for pharmaceutical formulations. Journal of Patent Law, 41(2), 150-172.
[3] European Patent Office. (2020). Patent landscapes in drug delivery systems.
[4] World Intellectual Property Organization. (2022). Patent filing trends in pharmaceuticals.
[5] Smith, R. T., & Lee, P. M. (2021). Analyzing obviousness in formulation patents. Intellectual Property Quarterly, 36(4), 312-329.

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Details for Patent 10,010,400

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Merck Teknika Llc TICE BCG bcg live For Injection 102821 June 21, 1989 10,010,400 2036-03-30
Iovance Biotherapeutics Manufacturing Llc PROLEUKIN aldesleukin For Injection 103293 May 05, 1992 10,010,400 2036-03-30
Genentech, Inc. AVASTIN bevacizumab Injection 125085 February 26, 2004 10,010,400 2036-03-30
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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