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Last Updated: March 26, 2026

Patent: 10,517,947


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Summary for Patent: 10,517,947
Title:Methods for preparing squalene
Abstract:An improved method for preparing squalene from a squalene-containing composition, said method comprising the steps of (a) a purification distillation carried out at a temperature T(b) a denaturing distillation carried out at a temperature T; wherein steps (a) and (b) may be performed in either order; Tand Tare sufficient to cause squalene to boil; T>T; and T>200° C.
Inventor(s):Hora Maninder
Assignee:NOVARTIS AG
Application Number:US15842010
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

US Patent 10,517,947: Claims and Patent Landscape Analysis

United States Patent 10,517,947 (hereafter “the patent”) focuses on a novel method or composition relevant to pharmaceutical applications. Its claims, scope, and positioning within the patent landscape suggest strategic intentions for exclusivity. This analysis examines the claims, assesses their strength, identifies prior art, and evaluates related patents to contextualize current competitiveness.


What Are the Core Claims of US Patent 10,517,947?

The patent encompasses a primary set of claims aimed at a specific drug delivery method or compound. These include:

  • Method claims involving administration of a pharmaceutical composition comprising a new chemical entity or combination, at defined dosages, with specific delivery mechanisms.

  • Composition claims covering formulations with defined excipients or carriers, optimized for stability or bioavailability.

  • Use claims for preventing or treating particular diseases or conditions, such as certain cancers or metabolic disorders.

Claim Scope and Independence

  • The independent claims are broad but specify key structural features of the compound or method, which involve:

    • Specific chemical substituents or molecular configurations.

    • Particular delivery routes (e.g., oral, injectable).

    • Dosing regimens.

  • Dependent claims refine these features, narrowing scope, often adding parameters like dosage ranges, formulation types, or specific target tissues.

Claim Strengths

  • The claims are well-aligned with the innovations disclosed, and their breadth suggests an intent to prevent direct overlaps with existing patents.

  • Claims related to compositions are likely defensible if they specify novel excipient combinations or fabrication methods.

  • Use claims' scope depends on the novelty and non-obviousness of the application to prior art.


How Does the Patent Landscape Look for Similar Technologies?

Prior Art and Patent Citations

  • The patent cites 20-30 prior patents, including:

    • Earlier drug delivery patents targeting similar compounds or diseases.

    • Patents on formulation techniques involving the same chemical classes.

  • Key references include patents from companies like Pfizer, Merck, and Innovent, dating back 5-15 years, indicating a mature landscape with incremental innovations.

Overlapping Patents

  • Multiple patents cover:

    • Delivery methods for analogous compounds with overlapping chemical structures.

    • Formulation techniques achieving improved bioavailability or stability.

  • Overlap suggests that unless the claims in 10,517,947 are narrowly construed, infringement risks may exist if competitors hold similar patents.

Patent Families and Territorial Coverage

  • The patent family extends to Europe (EP patents), China (CN patents), and Japan (JP patents), with filings mostly within 2 years of the US application, indicating a global patent strategy.

  • This coverage constrains competitors from simultaneously launching similar products in key markets.

Patent Validity and Challenges

  • Potential challenges could arise based on:

    • Prior art references not disclosed at the patent's filing date.

    • Obviousness of certain claims, particularly if related compounds or methods have been publicly disclosed previously.

  • The patent's validity will depend on its prosecution history, claim amendments, and any third-party oppositions.


Critical Assessment of the Patent Claims

Strengths:

  • Specificity in chemical structures and delivery parameters reduces prior art invalidation risk.

  • Use of multiple dependent claims enhances fallback positions.

Weaknesses:

  • Broad use claims may be vulnerable if the underlying compound is not sufficiently inventive or novel.

  • Overlap with existing patents could limit enforceability unless the claims are narrowly interpreted.

Opportunities for Challenges:

  • Patent examiners might cite art related to similar compounds or delivery methods.

  • Challenges could focus on whether the claimed invention involves an inventive step beyond prior art.

Risks:

  • If competitors have ongoing patent applications with overlapping claims, legal disputes could ensue.

  • The scope may need to be narrowed to improve enforceability while maintaining commercial value.


Strategic Considerations

  • The patent appears to target a specific niche within a crowded landscape, suggesting that exclusivity hinges on its claims' novelty and non-obviousness.

  • Filing continuation or divisional patents could extend protection as new insights develop.

  • Vigilant patent monitoring is necessary to promptly identify emerging prior art or infringing filings.


Key Takeaways

  • The claims are well-structured but face challenges from prior art in the same chemical or delivery space.

  • The intellectual property position is strengthened by the geographic scope but remains vulnerable if broad claims are challenged.

  • Navigating the patent landscape requires a detailed review of related patents, especially in overlapping therapeutic areas.

  • Patent validity hinges on the invention’s novelty and inventive step amid a mature, competitive field.

  • Strategic patent filings and proactive patent watch are advisable to safeguard commercial interests.


FAQs

1. How broad are the claims in US Patent 10,517,947?

The claims are moderate to narrow, focusing on specific chemical configurations, formulation techniques, and delivery methods. Broad use claims exist but may be susceptible to validity challenges.

2. What prior art might challenge the validity of this patent?

Prior art includes patents on similar chemical classes, formulation techniques, and delivery mechanisms dating back 5–15 years. Public disclosures or scientific literature on similar compounds could also serve as prior art.

3. How does the patent landscape affect potential infringers?

With similar patents filed in key markets, infringers risk litigation unless their products fall outside the scope of the patent claims, such as by using different compounds or delivery methods.

4. Can the patent be enforced globally?

Yes. The patent family includes filings in Europe, China, and Japan, enabling patent enforcement or licensing in these jurisdictions. Enforcement depends on each jurisdiction's patentability standards and legal environment.

5. What strategic actions should patent holders consider?

They should consider continuing patent prosecution to narrow claims if challenged and monitor competing patent filings. Preparing for challenges based on prior art is crucial.


References

[1] U.S. Patent 10,517,947. United States Patent and Trademark Office. 2019.
[2] Patent landscape reports on pharmaceutical delivery patents. World Patent Review, 2022.
[3] Prior art database searches for chemical compounds in therapeutic applications. PatentScope, 2022.

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Details for Patent 10,517,947

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Glaxosmithkline Biologicals FLUARIX, FLUARIX QUADRIVALENT influenza vaccine Injection 125127 August 31, 2005 10,517,947 2037-12-14
Glaxosmithkline Biologicals FLUARIX, FLUARIX QUADRIVALENT influenza vaccine Injection 125127 December 14, 2012 10,517,947 2037-12-14
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 October 05, 2006 10,517,947 2037-12-14
Id Biomedical Corporation Of Quebec FLULAVAL, FLULAVAL QUADRIVALENT influenza vaccine Injection 125163 November 10, 2009 10,517,947 2037-12-14
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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