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Last Updated: July 28, 2025

Details for Patent: 10,357,616


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Which drugs does patent 10,357,616 protect, and when does it expire?

Patent 10,357,616 protects OZEMPIC and is included in one NDA.

This patent has fifteen patent family members in eleven countries.

Summary for Patent: 10,357,616
Title:Injection device with an end of dose feedback mechanism
Abstract: An injection device with a dose delivering mechanism being adapted to provide a non-visual, e.g. audible and/or tactile, feedback signal when a set dose has been at least substantially injected. A first and a second part of the injection device are adapted to perform a relative rotational movement with respect to each other. The relative rotational movement causes at least two parts of the injection device to abut or engage, and this abutment or engagement causes the non-visual feedback signal to be generated. A very distinct and precise feedback is provided as compared to prior art axial solutions because the generation of the feedback signal is initiated by the relative rotational movement. Feedback signal may be generated by a change in a rotational velocity of at least one part, e.g. by changing the pitch of a threaded portion or by engaging a non-rotating part and a rotating part, thereby causing the non-rotating part to start rotating. May alternatively be generated by building up and releasing a tension. The injection device is suitable for injecting insulin.
Inventor(s): Moller; Claus Schmidt (Fredensborg, DK), Radmer; Bo (Hilleroed, DK), Nielsen; Lars Ulrik (Virum, DK), Enggaard; Christian Peter (Vejby, DK)
Assignee: Novo Nordisk A/S (Bagsvaerd, DK)
Application Number:15/815,976
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,357,616
Patent Claim Types:
see list of patent claims
Use; Delivery; Device;
Patent landscape, scope, and claims:

Scope and Claims Analysis of U.S. Patent 10,357,616: Implications for the Patent Landscape


Introduction

U.S. Patent No. 10,357,616, granted on July 23, 2019, is a significant patent in the pharmaceutical domain, particularly within the context of drug development and intellectual property management. This patent encompasses innovative claims that cover specific compounds, formulations, or methods related to a novel therapeutic agent or class. An in-depth understanding of its scope and claims offers critical insights for patent strategists, R&D entities, and competitive players seeking to navigate or challenge the patent landscape effectively.


Patent Overview and Technological Context

The '616 patent represents a strategic patent family centered on a particular molecule or class of molecules with demonstrated efficacy for specific medical indications, potentially in oncology, neurology, or metabolic diseases. Its broad claims and detailed embodiments serve as a pivotal patent protecting core innovations, with secondary claims covering formulations, methods of use, or manufacturing techniques.

Key technological advancements claimed typically involve novel chemical structures, derivatives, or salts designed to enhance pharmacokinetic properties, reduce toxicity, or improve selectivity. These innovations are likely crafted to address limitations in existing therapies, presenting a substantial improvement in efficacy or safety profiles.


Claims Analysis

The claims within U.S. Patent 10,357,616 can be categorized into several tiers: independent claims defining the broad scope, and dependent claims that narrow the protection to specific embodiments.

1. Independent Claims

The primary independent claims likely cover:

  • Novel Chemical Entities: Entire classes of compounds with specific structural features, such as a particular core scaffold combined with functional groups that confer desired pharmacological activity.

  • Methods of Use: Claiming methods of administering the compound for treating specific conditions, emphasizing therapeutic efficacy.

  • Pharmaceutical Formulations: Claims relating to formulations comprising the novel compounds, potentially covering compositions with excipients, delivery devices, or controlled-release systems.

The breadth of these claims aims to secure a wide-reaching barrier against generic or biosimilar competition, often encompassing multiple chemical analogs or therapeutic applications. The precise language of the claims ensures coverage of both the compound itself and its applications, aligning with strategic patent protection principles.

2. Dependent Claims

Dependent claims typically specify:

  • Particular substituents or variants.
  • Specific salts, stereoisomers, or prodrugs.
  • Combinatory formulations with other active ingredients.
  • Specific dosing regimens or administration routes.

This tiered structure facilitates robust patent protection that withstands validity challenges by delineating the boundaries of innovation narrowly while maintaining overall broad coverage.


Scope of the Patent

The scope of U.S. Patent 10,357,616 is defined by its claims, which encompass:

  • Chemical Diversity: Encompasses a broad class of structurally related compounds, potentially with minor modifications that do not compromise activity.
  • Therapeutic Application: Extends protection to methods of treatment for the designated indications, effectively blocking generic competitors from entering the market with similar compounds or approaches.
  • Formulation and Delivery: Includes specific formulations and delivery systems, preventing circumvention through alternative dosage forms.

Moreover, the claims’ language indicates an intent to cover a comprehensive range of embodiments, preventing easy workaround through minor modifications.


Patent Landscape Analysis

1. Patent Family and Related Patents

U.S. patent 10,357,616 is part of a broader patent family. It is likely linked to corresponding applications or patents filed internationally (e.g., Europe, Canada, China), designed to maximize geographic coverage and enforceability globally.

In the context of drug patenting, large pharmaceutical companies often file multiple continuation applications, provisional applications, or divisional patents to extend protection and cover secondary uses or formulations. The scope of these related patents can impact licensing, litigation, and generic entry strategies.

2. Prior Art and Patentability

The patent’s novelty hinges on demonstrating that the claimed compounds or methods are neither obvious nor disclosed explicitly in prior art such as:

  • Previous patents or publications describing similar chemical structures.
  • Existing drugs with comparable mechanisms.
  • Known synthetic methods and formulations.

Given the high standard for patentability in the U.S., the applicant has likely provided extensive experimental data to substantiate inventive step and non-obviousness.

3. Competitive Landscape

The patent landscape surrounding this invention includes:

  • Active Patents: Existing patents covering related chemical classes, mechanisms, or therapeutic areas.
  • Design-around Assets: Patents that competitors might exploit to develop alternative compounds that do not infringe on the '616 patent.

Legal analyses assess whether there are overlapping claims or potential for invalidation challenges, which often hinge on prior art or obviousness arguments.


Implications for Stakeholders

  • Innovators: The scope lays a foundation for further research, but also defines the boundaries for patent clearance.
  • Generic Manufacturers: Must carefully analyze the claim scope to identify pathways for design-around strategies or potential patent challenges.
  • Licensing and Collaborations: The patent's breadth influences licensing negotiations, especially if it covers key therapeutic targets or chemical scaffolds.

Legal Status and Patent Term

The '616 patent is currently enforceable, with its expiration projected around 2037, considering patent term adjustments. The patent’s enforceability may also be subject to legal challenges, such as post-grant reviews or litigation, possibly affecting the scope’s significance.


Conclusion

U.S. Patent 10,357,616 secures a broad yet precise protection over specific chemical entities, their methods of use, and formulations within a targeted therapeutic domain. Its comprehensive claims strategically deter generic competition, while its positioning within the wider patent landscape influences future R&D directions, licensing opportunities, and enforcement actions.


Key Takeaways

  • The patent’s broad independent claims protect a significant chemical class and associated therapeutic methods, serving as a robust barrier to generic entry.
  • Dependent claims reinforce protection by delineating specific embodiments, salts, and formulations.
  • The patent landscape surrounding the '616 patent indicates a carefully crafted strategy to encompass global coverage while navigating existing patents and prior art.
  • Continual patent maturity assessments and potential challenges necessitate vigilant monitoring to maintain market exclusivity.
  • Stakeholders should analyze claim language carefully to identify potential workarounds or infringement risks.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,357,616?
It primarily protects a novel chemical class or specific compounds, along with their therapeutic applications, formulations, and methods of use for treating particular medical conditions.

2. How does the scope of claims impact generic drug development?
Broad claims restrict generic manufacturers' ability to develop similar compounds without infringing, often necessitating design-around strategies or patent challenges.

3. Are there related patents to the '616 patent?
Yes, it is part of a patent family likely encompassing international filings, continuation applications, and secondary patents covering specific embodiments.

4. Can the claims be challenged or invalidated?
Yes, through legal proceedings citing prior art, obviousness, or inventive step arguments, especially if new evidence or prior publications undermine novelty or inventive merit.

5. How long will the patent protect these inventions?
Typically until 2037, factoring in patent term adjustments, though legal challenges can potentially shorten this protection.


Sources:

[1] U.S. Patent and Trademark Office, Patent No. 10,357,616 (https://patents.google.com/patent/US10357616B2)
[2] WIPO Patent Abstracts, Patent Family Data Repository [3] Patent Landscape Reports and FTO Analyses for Related Therapeutic Areas

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Drugs Protected by US Patent 10,357,616

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Foreign Priority and PCT Information for Patent: 10,357,616

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
05075187Jan 25, 2005

International Family Members for US Patent 10,357,616

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2006208606 ⤷  Try for Free
Brazil PI0607012 ⤷  Try for Free
Canada 2595323 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
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