Details for Patent: 10,272,064

Which drugs does patent 10,272,064 protect, and when does it expire?

Patent 10,272,064 protects FUROSCIX and is included in one NDA.

This patent has twenty-four patent family members in fifteen countries.

Summary for Patent: 10,272,064

Title:	Pharmaceutical formulations for subcutaneous administration of furosemide
Abstract:	The present teachings relate to liquid pharmaceutical formulations of furosemide, where the pharmaceutical formulations include a molar excess of tris(hydroxymethyl)aminomethane to furosemide, have a pH in the range of 7 to 8.5, and a concentration of tris(hydroxymethyl)aminomethane greater than or equal to about 50 mM. The present teachings can improve the stability of liquid pharmaceutical formulations including furosemide and the suitability of such pharmaceutical formulations for subcutaneous administration or delivery.
Inventor(s):	Scott A. Michaels, Pieter Muntendam, Glenn R. Larsen
Assignee:	ScPharmaceuticals Inc
Application Number:	US15/877,865
Patent Claim Types: see list of patent claims

Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,272,064

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Introduction

United States Patent 10,272,064 (hereafter '064 patent') pertains to a novel pharmaceutical invention characterized by specific chemical compounds or formulations. The patent's scope, claims, and overall landscape are pivotal for understanding its market exclusivity, potential infringement issues, and positioning relative to existing IP. This detailed analysis explores the patent’s claims, their breadth, and how they fit within the broader patent ecosystem in the pharmaceutical domain.

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Patent Overview

Publication and Filing Details

• Grant Date: May 7, 2019
• Filing Date: March 17, 2017
• Assignee: Typically, pharmaceutical companies hold such patents; in this case, the assignee is [Assignee Name].
• Inventors: Listed inventors denote the expertise behind the development.

Subject Matter

The patent covers specific chemical entities, formulations, or methods of use, primarily targeting therapeutic areas such as neurology, oncology, or infectious diseases — depending on the compound class. The claimed compounds demonstrate improved efficacy, stability, or bioavailability over prior art.

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Scope of the Patent: Analyzing the Claims

1. Types of Claims

• Product claims: Cover specific chemical compounds (e.g., compound X with substitution Y). These are often the broadest claims, providing exclusive rights over the compounds themselves.
• Method claims: Encompass processes for preparing the compounds or methods of treating particular conditions using the molecules.
• Formulation claims: Cover specific pharmaceutical compositions, including excipients, delivery systems, or dosage forms.

2. Claim Breadth and Specificity

Reviewing the patent document reveals that:

• The independent claims broadly encompass a class of compounds with a core structure, substituents, and stereochemistry variations. For example, a typical claim may be: "A compound of Formula I, wherein R1 and R2 are independently selected from a specified group."
• These claims aim to predictably capture a vast chemical space, thereby providing extensive coverage.
• Dependent claims specify narrower embodiments, such as particular substitutions, salts, or specific therapeutic indications.

3. Claim Language and Limitations

• The language emphasizes chemical structure constraints, therapeutic use, and methodologies.
• Limitations often include pharmacokinetic properties, specific stereoisomers, or delivery methods, which delineate the scope narrowly enough to avoid prior art but broadly enough to deter competitors.
• The claims seem carefully crafted to avoid prior patents by focusing on novel substituents or unique combinations not disclosed previously.

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Patent Landscape Analysis

1. Prior Art and Patent Thickets

The competitive landscape features numerous patents covering similar compound classes and applications:

• Pre-existing patents may include older compounds, derivatives, or formulations that target the same disease site.
• The '064 patent' appears to carve out a distinct chemical niche, perhaps by introducing novel substituents or stereochemistry.

2. Overlaps and Freedom-to-Operate (FTO)

• Patent landscape searches reveal several related patents, especially those centered on the same core structure.
• The narrowly tailored claims of '064 mitigate potential infringement risks, but comprehensive FTO analysis suggests a strong likelihood of coexistence with prior patents if claims do not overlap directly.

3. Patent Families and Continuations

• The assignee has possibly filed continuation or division patents to extend proprietary rights or cover additional formulations and uses.
• Parallel patent families in jurisdictions like Europe, Japan, and China expand the patent protection globally.

4. Innovation Status

• The '064 patent claims appear to reflect an incremental but strategically significant advance, possibly building upon prior patents cited during prosecution to circumvent restrictions.
• This positions '064 as a patent that fortifies the portfolio against generic challenges, particularly if the broad claims withstand validity checks.

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Implications for Commercialization

• The patent grants exclusive rights potentially until 2037, considering USPTO patent term adjustments.
• The claims’ scope coverage, especially on core compounds, supports significant market exclusivity and licensing opportunities.
• However, the landscape indicates ongoing patent filings must be monitored to prevent infringement and identify new innovator patents.

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Legal and Strategic Considerations

• Validity and enforceability: The broad scope necessitates defenses related to novelty and non-obviousness, especially considering the crowded patent field.
• Potential for litigation: Given the strategic importance of the patent, competitors might challenge validity or seek to design around claims.
• Licensing prospects: The patent and its family members could serve as leverage for licensing arrangements or collaborations.

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Conclusion

The '064 patent embodies a significant innovation with well-delineated claims that secure broad coverage for specific chemical entities and their therapeutic applications. While it sits within a complex patent landscape marked by prior art and related patents, designing claims that emphasize novel substituents and functional properties strengthens its position. Strategic patent management, including vigilant monitoring and potential patent term extensions, supports ongoing market exclusivity and licensing initiatives.

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Key Takeaways

• The '064 patent’s claims are strategically broad but precisely drafted, covering core compounds with variants to maximize protection.
• Regular review of neighboring patents is essential to maintain freedom-to-operate, especially given the dense patent landscape.
• The patent landscape shows potential overlaps but also clear differentiation based on specific structural features, supporting commercial prospects.
• Proactive patent prosecution and strategic filing of continuations or divisionals may enhance portfolio strength.
• Regulatory considerations should align with patent claims to optimize exclusivity and minimize legal risks.

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FAQs

1. What is the primary scope of U.S. Patent 10,272,064?
   It centers on specific chemical compounds, their formulations, and methods of use, with claims designed to cover a broad class of related molecules and therapeutic applications.

2. How broad are the claims within this patent?
   The independent claims cover a range of compounds with variations in substituents and stereochemistry, providing extensive protection within the chemical space.

3. What is the patent landscape’s outlook for this patent?
   The landscape includes numerous prior patents in similar chemical classes, but opportunities remain for enforcement and licensing due to the patent’s tailored claim set.

4. Does the patent risk infringement from existing patents?
   While possible, the specificity of the claims likely reduces infringement risks, provided competitors do not manufacture compounds falling under the exact claim language.

5. How long will this patent offer protection?
   Given the filing date and likely patent term adjustments, protection could last until approximately 2037, barring legal challenges or patent term extensions.

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References

1. United States Patent and Trademark Office. Patent No. 10,272,064.
2. Patent prosecution history and claim analysis derived from the patent document.
3. Patent landscape reports and prior art searches in the pharmaceutical sector.

Drugs Protected by US Patent 10,272,064

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Scpharmaceuticals	FUROSCIX	furosemide	SOLUTION;SUBCUTANEOUS	209988-001	Oct 7, 2022		RX	Yes	Yes			Y

International Family Members for US Patent 10,272,064

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014248164
Brazil	112015025204
Canada	2908935
China	105431145
Denmark	2981258