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Last Updated: December 28, 2024

Details for Patent: 11,400,087


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Which drugs does patent 11,400,087 protect, and when does it expire?

Patent 11,400,087 protects ABILIFY MAINTENA KIT and is included in one NDA.

Summary for Patent: 11,400,087
Title:Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
Abstract: The disclosed embodiments relate to methods of initiating aripiprazole treatment in a patient who is a CYP2D6 poor metabolizer or a CYP3A4 poor metabolizer, or both.
Inventor(s): Raoufinia; Arash (Vienna, VA)
Assignee: Otsuka Pharmaceutical Co., Ltd. (Rockville, MD)
Application Number:17/304,606
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 11,400,087

Introduction

Patent 11,400,087, like any other patent, is a complex document that outlines the scope and claims of an invention. To analyze this patent, it is crucial to delve into the specifics of its claims, the context provided by the patent specification, and the broader patent landscape.

Patent Claims: Definition and Importance

Patent claims are the heart of any patent, defining the scope of the invention and what is protected by the patent. The claims must be read in view of the specification, which is the detailed description of the invention[1].

Claim Construction Process

The claim construction process involves determining the meaning and scope of the patent claims. This process is critical in patent litigation and is guided by principles such as reading the claims in light of the specification. The specification is highly relevant to claim construction analysis and may contain special definitions or disclaimers that affect the claim scope[1].

Independent and Dependent Claims

Patent 11,400,087, like other patents, likely includes both independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The length and count of independent claims can be metrics for measuring patent scope, with narrower claims often associated with a higher probability of grant and a shorter examination process[3].

Claim Language and Distinct Components

The language of the claims is crucial. For example, if a claim lists elements separately, it implies that these elements are distinct components of the patented invention. This is a key principle in claim construction, ensuring that each element serves a unique function within the invention[1].

Patent Specification

The patent specification provides the context for the claims. It includes descriptions of the invention, examples, and sometimes special definitions or disclaimers that can limit the scope of the claims. The specification must be consulted to understand the full extent of what is claimed[1].

Printed Matter Doctrine

In some cases, the printed matter doctrine may come into play. This doctrine states that claim limitations directed to printed matter (or the content of information) are not entitled to patentable weight unless they are functionally related to the substrate on which the printed matter is applied. This can affect how certain claims are interpreted and validated[1].

Obviousness and Non-Obviousness

The patent must also meet the criteria of non-obviousness under 35 U.S.C. ยง 103. Recent changes in the law, such as the Federal Circuit's decision in LKQ Corporation v. GM Global Technology Operations LLC, have introduced more flexible approaches to determining obviousness, especially for design patents. However, utility patents like 11,400,087 still follow established guidelines where the motivation to combine prior art must be evident, and secondary considerations like commercial success can support non-obviousness[4].

Patent Landscape and Trends

The patent landscape is evolving, with ongoing debates about patent quality and scope. Metrics such as independent claim length and count are used to measure patent scope, and studies have shown that narrower claims are associated with higher grant rates and shorter examination processes. The USPTO's Patent Claims Research Dataset provides valuable insights into these trends, helping to understand the broader context in which patents like 11,400,087 are granted[2][3].

Litigation and Enforcement

Patents are often enforced through litigation, where the scope and validity of the claims are challenged. For example, in cases involving pharmaceutical patents, such as the one related to aripiprazole extended-release injectable suspension, defendants may challenge the validity of the patent claims or concede infringement based on the claim language and specification[5].

Industry Impact

The scope and claims of a patent like 11,400,087 can significantly impact the industry. Broad or overly broad claims can lead to increased litigation and licensing costs, while narrower, well-defined claims can provide clear boundaries and encourage innovation. The patent's impact on market competition and innovation incentives is a critical consideration[3].

Key Metrics for Patent Scope

  • Independent Claim Length: Longer independent claims often indicate a narrower scope.
  • Independent Claim Count: Fewer independent claims can suggest a more focused invention.
  • Forward Citations: The number of forward citations can indicate the patent's influence and scope.
  • Patent Maintenance Payments: Higher maintenance payments may reflect the patent's value and scope[3].

Case Studies and Examples

Real-world examples, such as the Becton, Dickinson case mentioned in the context of claim construction, illustrate how the distinct components of a claim are interpreted. In this case, the clear implication of the claim language was that the listed elements were distinct components of the patented invention[1].

Expert Insights

Industry experts emphasize the importance of clear and well-defined claims. For instance, "The clarity and specificity of patent claims are crucial for defining the scope of the invention and for ensuring that the patent is enforceable," notes a patent attorney. This clarity helps in avoiding unnecessary litigation and in providing a clear roadmap for innovation[3].

Statistics and Trends

  • Patent Grant Rates: Narrower claims are associated with higher grant rates and shorter examination processes.
  • Litigation Costs: Overly broad claims can lead to increased litigation costs.
  • Innovation Incentives: Well-defined claims can encourage innovation by providing clear boundaries[3].

Conclusion

Understanding the scope and claims of United States Patent 11,400,087 involves a detailed analysis of the claim language, the specification, and the broader patent landscape. The claim construction process, the distinction between independent and dependent claims, and the relevance of the specification are all critical factors. The evolving patent landscape, with its emphasis on clear and well-defined claims, further underscores the importance of meticulous analysis in patent law.

Key Takeaways

  • Claim Construction: Claims must be read in view of the specification.
  • Distinct Components: Separate listing of elements implies distinct components.
  • Obviousness: Non-obviousness criteria must be met, with flexible approaches emerging.
  • Patent Scope Metrics: Independent claim length and count are key metrics.
  • Industry Impact: Clear claims encourage innovation and reduce litigation costs.
  • Litigation: Enforcement of patents involves challenging the validity and scope of claims.

FAQs

Q: What is the purpose of the claim construction process in patent law?

A: The purpose of the claim construction process is to determine the meaning and scope of the patent claims asserted to be infringed.

Q: How do independent and dependent claims differ in a patent?

A: Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims.

Q: What is the significance of the specification in patent claims?

A: The specification provides the context for the claims, including descriptions, examples, and special definitions or disclaimers that can limit the claim scope.

Q: How does the printed matter doctrine affect patent claims?

A: The printed matter doctrine states that claim limitations directed to printed matter are not entitled to patentable weight unless they are functionally related to the substrate on which the printed matter is applied.

Q: What recent changes have occurred in the obviousness test for design patents?

A: The Federal Circuit has overturned the Rosen-Durling standard for obviousness in design patents, adopting a more flexible approach similar to that used for utility patents.

Sources

  1. USCOURTS-ded-1_22-cv-00464 Document 144 Filed 09/12/23
  2. USPTO Patent Claims Research Dataset
  3. Patent Claims and Patent Scope - SSRN
  4. Federal Circuit Upends Obviousness Test for Design Patents - JDSupra
  5. United States District Court Document 1 Filed 08/30/24

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Drugs Protected by US Patent 11,400,087

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No ⤷  Subscribe ⤷  Subscribe MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER ⤷  Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No ⤷  Subscribe ⤷  Subscribe TREATMENT OF SCHIZOPHRENIA ⤷  Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 RX Yes No ⤷  Subscribe ⤷  Subscribe TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF SCHIZOPHRENIA ⤷  Subscribe
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No ⤷  Subscribe ⤷  Subscribe TREATMENT OF SCHIZOPHRENIA ⤷  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

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