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Last Updated: March 19, 2025

Details for Patent: 11,253,478


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Which drugs does patent 11,253,478 protect, and when does it expire?

Patent 11,253,478 protects ANJESO and is included in one NDA.

This patent has sixteen patent family members in eight countries.

Summary for Patent: 11,253,478
Title:Reduction of flake-like aggregation in nanoparticulate active agent compositions
Abstract: This invention is directed to reduction of flake-like aggregation in nanoparticulate compositions. Also encompassed by the invention are compositions comprising a nanoparticulate active agent, at least one surface stabilizer and a flake-like aggregation reducing agent, such as a buffer and a sugar. The nanoparticulate active agent compositions comprise particles of the active agent having an effective average particle size of less than about 2000 nm.
Inventor(s): Ryde; Niels P. (Malvern, PA), Snyder; Peter (King of Prussia, PA), Liu; Wei (Exton, PA), Slifer; David M. (Downingtown, PA)
Assignee: Alkermes Pharma Ireland Limited (Dublin, IE)
Application Number:15/971,616
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,253,478

To delve into the details of the scope and claims of a specific patent, such as United States Patent 11,253,478, it is essential to analyze several key aspects, including the patent's claims, the scope of the invention, and the broader patent landscape.

Patent Claims: The Foundation of Patent Scope

Claim Structure and Types

Patent claims are the legal definitions of the invention and are crucial in determining the scope of the patent. They typically include independent claims and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Claim Language and Scope

The language used in the claims is vital. Independent claim length and count can be metrics to measure patent scope. Generally, narrower claims with fewer words and fewer dependent claims are associated with a higher probability of grant and a shorter examination process[3].

Scope of the Invention

Patent Claims Analysis

To understand the scope of United States Patent 11,253,478, one must carefully analyze the claims. This involves identifying the key elements of the invention, the relationships between these elements, and any limitations or exceptions.

Claim Interpretation

Claim interpretation is a critical step in determining the scope. This involves understanding the ordinary meaning of the claim terms, as well as any special definitions provided in the specification. The Federal Circuit has emphasized that claim interpretation should be based on the "ordinary and customary meaning" of the claim terms[5].

Patent Specification and Drawings

Detailed Description

The patent specification provides a detailed description of the invention, including how it is made and used. This section often includes examples, diagrams, and drawings that help in understanding the invention's scope.

Enablement and Written Description

The specification must meet the requirements of enablement and written description. Enablement ensures that the invention can be made and used by one of ordinary skill in the field, while the written description requirement ensures that the inventor has clearly described the invention[5].

Inventorship and Ownership

Determining Inventorship

Correctly determining who the true and only inventors are is crucial. Inventorship focuses on the conception of the idea, which is defined as the formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention[5].

Patent Assignment and Ownership

Understanding who owns the patent is important. Patents can be assigned, and changes in ownership must be recorded with the USPTO. The Patent Assignment Search website can be used to search for patent assignments and changes in ownership[4].

Obviousness-Type Double Patenting (ODP)

ODP Analysis

ODP is a doctrine that prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA). This analysis is crucial in ensuring that the patent does not extend beyond the terminal disclaimer date[1].

Terminal Disclaimers

Terminal disclaimers are often used to overcome ODP rejections. The Board has reasoned that ODP and terminal disclaimers should be considered after any PTA, ensuring that the patent term does not extend beyond the specified date[1].

Patent Term Adjustment (PTA) and Patent Term Extension (PTE)

PTA and PTE Differences

PTA extends the patent term to compensate for delays during the prosecution process, while PTE extends the term due to regulatory review. The Board has clarified that a grant of PTA does not extend the term of a patent past the date of a terminal disclaimer[1].

Global Patent Landscape

Global Dossier

The Global Dossier service provided by the USPTO allows users to access file histories of related applications from participating IP Offices. This helps in understanding the global patent family and any international implications of the patent[4].

Public Search Facilities

The USPTO Public Search Facility and other resources like the Main STIC Library provide access to patent and trademark information, helping in comprehensive searches and analyses of patents[4].

Litigation and Enforcement

Patent Validity and Enforceability

Ensuring the patent is valid and enforceable is critical. Errors in inventorship or deceptive intent can render a patent unenforceable. A thorough job of invention disclosure is essential to maintain the enforceability of the patent[5].

Court Decisions and Precedents

Court decisions, such as those from the Federal Circuit, provide precedents that can influence the interpretation and enforcement of patent claims. Understanding these precedents is vital in navigating the patent landscape[5].

Key Takeaways

  • Claims Analysis: Carefully analyze the claims to understand the scope of the patent.
  • Specification and Drawings: The specification and drawings provide detailed descriptions and visual aids to comprehend the invention.
  • Inventorship and Ownership: Correctly determine the inventors and track changes in ownership.
  • ODP and Terminal Disclaimers: Ensure compliance with ODP and use terminal disclaimers as necessary.
  • PTA and PTE: Understand the differences and implications of PTA and PTE on the patent term.
  • Global Landscape: Utilize resources like Global Dossier to understand the international patent family.
  • Litigation and Enforcement: Ensure the patent is valid and enforceable through thorough disclosure and compliance with legal requirements.

Frequently Asked Questions (FAQs)

1. What is the significance of independent claims in a patent?

Independent claims define the invention and stand alone, providing the broadest scope of protection.

2. How does the USPTO determine inventorship for a patent?

Inventorship is determined by identifying who conceived the idea of the patent claims, focusing on the formation of a definite and permanent idea of the complete and operative invention.

3. What is the difference between Patent Term Adjustment (PTA) and Patent Term Extension (PTE)?

PTA extends the patent term to compensate for delays during prosecution, while PTE extends the term due to regulatory review.

4. Why is it important to analyze the global patent landscape?

Analyzing the global patent landscape helps in understanding related applications and international implications, ensuring comprehensive protection and avoiding potential conflicts.

5. What are the consequences of incorrect inventorship in a patent application?

Incorrect inventorship, especially with deceptive intent, can render the patent unenforceable and invalid.

Cited Sources:

  1. In re Cellect, LLC, United States Court of Appeals for the Federal Circuit, August 28, 2023.
  2. U.S. Patent and Trademark Office (USPTO), USA.gov.
  3. Patent Claims and Patent Scope, SSRN, September 29, 2016.
  4. Search for patents - USPTO, USPTO.
  5. Determining Inventorship for US Patent Applications, Oregon State University.

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Drugs Protected by US Patent 11,253,478

Showing 1 to 1 of 1 entries

International Family Members for US Patent 11,253,478

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2010254180 ⤷  Try for Free
Canada 2763456 ⤷  Try for Free
European Patent Office 2435027 ⤷  Try for Free
European Patent Office 3167875 ⤷  Try for Free
Spain 2609415 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 5 of 5 entries

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