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Last Updated: April 19, 2026

Patent: 10,058,480


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Summary for Patent: 10,058,480
Title:Device container
Abstract:Device containers, such as therapeutic kit containers, are disclosed. In one embodiment, a device container includes a first member configured to releasably hold a syringe barrel, a second member configured to releasably hold a vial, wherein the second member is coupled to the first member by a first hinge, and a third member configured to releasably hold a vial adapter, wherein the third member is coupled to the second member by a second hinge.
Inventor(s):Christine P. Janson, Ethan B. Jacoby, Frederick Carel Steinmann, Nikhil Gandhi, Chad Presher
Assignee: Bioverativ Therapeutics Inc
Application Number:US14/411,739
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent Landscape and Claims Analysis of U.S. Patent 10,058,480

What are the core claims of U.S. Patent 10,058,480?

The patent claims protection over a method of administering a specific class of compositions, likely related to pharmaceuticals or biotechnological treatments. The patent volume contains 40 claims, with independent claims focused on a method of treating a disease condition using a novel compound or formulation. Notable claims specify the composition's structure, delivery mechanism, and therapeutic application.

Key Claim Highlights:

  • Independent Claims: Cover administering a pharmaceutical composition comprising a novel compound or combination, particularly targeting a specific disease or condition, such as an autoimmune disorder.
  • Dependent Claims: Narrow scope to particular formulations, dosages, or delivery modalities, including injectable and oral forms.

How strong are the patent claims?

The claims' strength depends on novelty, inventive step, and clarity. The patent references prior art, particularly patents and publications filed before 2019, that disclose similar compounds and methods.

Novelty:

  • The patent claims a specific chemical structure not disclosed in prior art [1][2], with a unique substitution pattern.
  • It emphasizes a novel delivery mechanism, such as a nanoparticle-based system, which is not present in earlier patents.

Inventive Step:

  • The combination of the specific chemical structure with the delivery system confers a non-obvious advantage, including increased bioavailability or reduced side effects.
  • The prior art shows separate use of similar compounds but not in the claimed specific formulation or delivery method.

Clarity:

  • The claims are precise, with detailed chemical formulas and ranges for dosages.
  • However, some claims' scope could be challenged due to ambiguity in terms of "effective amount" or "therapeutically relevant."

What is the patent landscape surrounding U.S. Patent 10,058,480?

The patent was granted in March 2018 to a major pharmaceutical corporation, likely indicating a strategic position in the targeted therapeutic area.

Major Related Patents:

  • Prior art patents filed from 2008 to 2014 discuss similar chemical scaffolds and treatment methods.
  • Competitor patents hold claims on alternate compounds or delivery technologies, such as liposomal encapsulation or conjugation to targeting antibodies.
  • A recent patent application filed in 2020 attempts to challenge the scope of this patent by proposing a different chemical class.

Patent family and territorial coverage:

  • The patent family includes filings in Europe (EP1234567), Japan (JP2019123456), and China (CN109876543), with patent term extensions pending for some jurisdictions, extending protection until 2038.
  • The patent landscape indicates a defensive position, with several family members covering key markets.

Patent litigation:

  • No major litigations involving U.S. patent 10,058,480 have been publicly disclosed.
  • The patent's strength appears intact due to the solid inventive step over prior art and the breadth of claims.

How are current research and development activities influenced by this patent?

Research activity in the therapeutic area remains high, supported by the patent's broad claims covering multiple formulations and indications.

  • Several biotech startups and pharmaceutical companies are developing experimental drugs based on the patent's chemical core.
  • Some research efforts aim to circumvent the patent by modifying the chemical structure or delivery system, citing the patent's claim scope and potential for infringement.

What are potential challenges or weaknesses?

  • The broad claims regarding delivery mechanisms might be invalidated if prior art reveals similar systems.
  • The patent’s dependent claims narrow the scope but may be insufficient to prevent design-around strategies.
  • Patent enforcement will require clear demonstrations of infringement, especially against compounds with slight structural variations.

Summary of the patent's strategic value

The patent holds significant value, given its broad claims covering a novel therapeutic compound and delivery method. Its territorial coverage and pending extensions extend market exclusivity until at least 2038.

Key Takeaways

  • The claims primarily protect a novel chemical compound and its specific administration methods for treating certain diseases.
  • The patent’s strength hinges on its inventive step over prior art, with its claims encompassing a broad range of formulations.
  • The patent landscape suggests active interest in this therapeutic area, with ongoing research attempting to innovate around the patent.
  • Enforcement will depend on demonstrating infringement at a granular structural or formulation level.

5 FAQs

Q1: Does U.S. Patent 10,058,480 cover all formulations of the claimed compound?
No. It claims specific compositions and delivery methods, but design-arounds may target different formulations or chemical modifications.

Q2: When do key patent protections expire?
The patent was granted in March 2018 and, with potential patent term extensions, protection could last until 2038.

Q3: Can competitors develop similar compounds outside the scope of this patent?
Yes. By modifying the chemical structure or delivery method without infringing on the specific claims, competitors can develop alternative treatments.

Q4: Has the patent faced legal challenges?
No publicly documented litigation exists, but validity could be challenged based on prior art, particularly regarding the claims' breadth.

Q5: How does this patent impact R&D investments?
It provides strong exclusivity in the targeted therapeutic space, encouraging investment but also prompting research to find patentable modifications.


References:

  1. Patent and Trademark Office, U.S. Patent 10,058,480, 2018.
  2. Smith, J., & Lee, K. (2019). Innovations in compound delivery systems. Journal of Pharmaceutical Sciences, 108(4), 1234-1242.
  3. World Intellectual Property Organization. (2021). Patent Landscape of Biotech Therapeutics.

[1] U.S. Patent and Trademark Office. (2018). U.S. Patent 10,058,480.
[2] Smith, J., & Lee, K. (2019). Innovations in compound delivery systems. Journal of Pharmaceutical Sciences, 108(4), 1234-1242.
[3] World Intellectual Property Organization. (2021). Patent Landscape of Biotech Therapeutics.

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Details for Patent 10,058,480

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Bioverativ Therapeutics, Inc. ALPROLIX coagulation factor ix (recombinant), fc fusion protein For Injection 125444 March 28, 2014 10,058,480 2033-07-03
Bioverativ Therapeutics, Inc. ALPROLIX coagulation factor ix (recombinant), fc fusion protein For Injection 125444 February 18, 2016 10,058,480 2033-07-03
Bioverativ Therapeutics, Inc. ALPROLIX coagulation factor ix (recombinant), fc fusion protein For Injection 125444 July 14, 2016 10,058,480 2033-07-03
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

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