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Last Updated: December 28, 2024

Details for Patent: 11,154,552


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Summary for Patent: 11,154,552
Title:Aripiprazole prodrug composition
Abstract: Described is a composition comprising (a) a population of particles of an aripiprazole prodrug having a volume based particle size (Dv50) of less than 1000 nm and (b) at least one surface stabilizer comprising an adsorbed component which is adsorbed on the surface of the aripiprazole prodrug particles and a free component available for solubilisation of the aripiprazole prodrug. The surface stabilizer to prodrug ratio provides the optimal quantity of free surface stabilizer for the purposes of producing a lead-in formulation. Also described are methods of treatment using the aforementioned composition.
Inventor(s): Cresswell; Philip (Athlone, IE), Hickey; Magali (Westwood, MA), Perkin; Kristopher (Athlone, IE), Smith; Greg (Norton, MA), Liversidge; Elaine (Charlestown, MA), Steinberg; Brian (Arlington, MA), Manser; David (Keenagh, IE), Zeidan; Tarek (Waltham, MA)
Assignee: ALKERMES PHARMA IRELAND LIMITED (Dublin, IE)
Application Number:16/904,246
Patent Claim Types:
see list of patent claims
Composition; Compound;
Patent landscape, scope, and claims:

Analyzing the Scope and Claims of United States Patent 11,154,552: A Comprehensive Guide

Introduction

Understanding the scope and claims of a patent is crucial for inventors, patent holders, and those interested in the intellectual property landscape. This article delves into the specifics of United States Patent 11,154,552, focusing on its claims, scope, and the broader patent landscape.

Overview of the Patent

Publication Details

United States Patent 11,154,552, titled "Aripiprazole prodrug composition," was published and granted to its inventors. The patent is categorized under the United States Patent and Trademark Office (USPTO) and is currently active[4].

Subject Matter

The patent pertains to a composition comprising a population of particles of an aripiprazole prodrug. Aripiprazole is a medication used primarily in the treatment of schizophrenia and bipolar disorder. The prodrug composition is characterized by a specific volume-based particle size (Dv50) of less than 1000 micrometers.

Claims Analysis

Independent and Dependent Claims

The patent includes both independent and dependent claims. Independent claims define the invention broadly and are not dependent on other claims. Dependent claims, on the other hand, build upon the independent claims and provide additional specifics.

  • Independent Claims: These claims outline the core aspects of the invention, such as the composition of the aripiprazole prodrug and its particle size.
  • Dependent Claims: These claims specify additional features or limitations of the invention, such as the formulation and the method of preparation.

Claim Scope

The scope of the claims is critical in determining the patent's breadth and what is protected. Narrower claims are generally easier to defend but offer less protection, while broader claims can be more challenging to defend but provide wider protection.

  • Independent Claim Length and Count: Research suggests that the length and count of independent claims can be metrics for measuring patent scope. Shorter and fewer independent claims often indicate a narrower scope, which can be associated with a higher probability of grant and a shorter examination process[3].

Determining Inventorship

True and Only Inventors

The US patent law stipulates that only the true and only inventors are entitled to a patent. This involves identifying individuals who conceived the idea or subject matter of the patent claims.

  • Conception and Reduction to Practice: Inventorship is determined by the conception of the idea and the reduction of that idea to practice. Conception is complete when the idea is sufficiently definite and permanent to permit one with ordinary skill in the field to reduce it to practice without undue experimentation[2].

Joint Inventors

In cases where multiple individuals contribute to the invention, joint inventorship applies. Each joint inventor must contribute significantly to at least one claim in the patent.

  • Significant Contribution: The law does not specify a lower limit to the amount each individual must contribute, but the contribution must be significant and inventive[2].

Patent Landscape and Implications

Patent Quality and Scope

The quality and scope of patents are subjects of ongoing debate. Patents with broader claims can be more contentious due to increased licensing and litigation costs. However, narrower claims, as seen in this patent, may offer clearer boundaries and fewer legal challenges[3].

Global Dossier and Public Search Facilities

For patents like US 11,154,552, tools such as the Global Dossier and the USPTO Public Search Facility are invaluable. These resources provide access to the file histories of related applications, classification data, and citation information, helping to navigate the global patent landscape[1].

Legal and Practical Considerations

Small Claims Patent Court

There is ongoing discussion about the establishment of a small claims patent court to address issues related to patent litigation costs and accessibility. Such a court could simplify the process for smaller entities and individuals to enforce their patent rights[5].

Correcting Inventorship Errors

Errors in inventorship can have significant legal implications. Correcting these errors, even after a patent is issued, is crucial to maintaining the patent's enforceability. Deceptive intent in naming inventors can render a patent unenforceable[2].

Practical Applications and Benefits

Pharmaceutical Industry

The aripiprazole prodrug composition patented in US 11,154,552 has practical applications in the pharmaceutical industry. The specific particle size and formulation can enhance the drug's efficacy, stability, and patient compliance.

  • Formulation Advantages: The smaller particle size can improve the bioavailability and absorption of the drug, making it more effective for patients.

Challenges and Future Directions

Litigation and Licensing

Patents in the pharmaceutical sector often face litigation and licensing challenges. The clarity and specificity of the claims in US 11,154,552 can help mitigate some of these issues by providing a clear definition of what is protected.

  • Forward Citations: The number of forward citations a patent receives can indicate its impact and relevance. Narrower claims, as in this patent, may attract fewer but more relevant citations[3].

Key Takeaways

  • Clear Claims: The patent's claims are specific and narrow, which can simplify enforcement and reduce litigation risks.
  • Inventorship: Correct identification of inventors is crucial for maintaining the patent's validity.
  • Global Resources: Tools like the Global Dossier and USPTO Public Search Facility are essential for navigating the patent landscape.
  • Practical Applications: The aripiprazole prodrug composition has significant practical benefits in the pharmaceutical industry.
  • Legal Considerations: The potential for a small claims patent court and the importance of correcting inventorship errors are key legal considerations.

FAQs

What is the main subject matter of US Patent 11,154,552?

The main subject matter is a composition comprising a population of particles of an aripiprazole prodrug with a specific volume-based particle size.

How is inventorship determined in US patent law?

Inventorship is determined by identifying individuals who conceived the idea or subject matter of the patent claims and reduced it to practice.

What are the implications of broader versus narrower patent claims?

Broader claims can be more contentious and costly, while narrower claims offer clearer boundaries and fewer legal challenges.

What resources are available for searching and analyzing patents?

Resources include the Global Dossier, USPTO Public Search Facility, and Patent Assignment Search.

Why is correct inventorship important for a patent?

Correct inventorship is crucial for maintaining the patent's validity and enforceability, as errors or deceptive intent can render the patent unenforceable.

Sources

  1. USPTO: Search for patents - USPTO. Retrieved from https://www.uspto.gov/patents/search
  2. Oregon State University: Determining Inventorship for US Patent Applications. Retrieved from https://agsci.oregonstate.edu/sites/agsci/files/main/research/vrc_release_inventorship-gattari.pdf
  3. SSRN: Patent Claims and Patent Scope. Retrieved from https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2844964
  4. Google Patents: US11154552B2 - Aripiprazole prodrug composition. Retrieved from https://patents.google.com/patent/US11154552B2/en
  5. ACUS: U.S. Patent Small Claims Court. Retrieved from https://www.acus.gov/research-projects/us-patent-small-claims-court

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Drugs Protected by US Patent 11,154,552

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Alkermes Inc ARISTADA INITIO KIT aripiprazole lauroxil SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 209830-001 Jun 29, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,154,552

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2015306198 ⤷  Subscribe
Brazil 112017002926 ⤷  Subscribe
Canada 2957762 ⤷  Subscribe
China 106794251 ⤷  Subscribe
China 112494492 ⤷  Subscribe
China 112641785 ⤷  Subscribe
Cyprus 1121594 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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