Details for Patent: 12,016,927

Which drugs does patent 12,016,927 protect, and when does it expire?

Patent 12,016,927 protects ABILIFY ASIMTUFII and is included in one NDA.

This patent has sixty-nine patent family members in thirty-one countries.

Summary for Patent: 12,016,927

Title:	Injectable preparation
Abstract:	An object of the present invention is to provide a storage-stable injectable preparation comprising a composition comprising a poorly soluble drug as an active ingredient and a dispersion medium. Another object of the present invention is to provide a compact, lightweight prefilled syringe by filling a syringe with the injectable preparation. The present invention provides an injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a specific suspending agent, the composition having a viscosity of 40 pascal-seconds or more in at least one point in the shear rate range of 0.01 to 0.02 s−1 end having a viscosity of 0.2 pascal-seconds or less in at least one point in the shear rate range of 900 to 1.000 s−1, as measured.
Inventor(s):	Daiki Kaneko, Takakuni Matsuda, Yusuke Hoshika
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US18/148,860
Patent Claim Types: see list of patent claims

Analyzing the Scope and Claims of a U.S. Patent: A Case Study of United States Patent 12,016,927

Introduction

When analyzing a U.S. patent, understanding the scope and claims is crucial for determining its validity, enforceability, and strategic value. This article will delve into the key aspects of patent analysis using the example of United States Patent 12,016,927, although the specific details of this patent are not provided here. We will discuss the general principles and methods that apply to any patent analysis.

Understanding Patent Claims

Patent claims are the most critical part of a patent application, as they define the scope of the invention and the rights granted to the patent holder[1].

Types of Claims

• Independent Claims: These claims stand alone and define the invention without reference to other claims.
• Dependent Claims: These claims refer back to and further limit an independent claim.

Claim Structure

Each claim typically includes several elements:

• Preamble: Introduces the claim and provides context.
• Transition Phrase: Connects the preamble to the body of the claim (e.g., "comprising," "consisting of").
• Body of the Claim: Describes the invention in detail.

Patentability Requirements

For a patent to be granted, the invention must meet several criteria:

Utility

The invention must be operable and provide some tangible benefit[1].

Novelty

The invention must not be fully anticipated by prior art, which includes previous patents, publications, and other state of the art knowledge[1].

Nonobviousness

The invention must not have been readily within the ordinary skills of a competent artisan at the time it was made[1].

The Patent Examination Process

During the examination process, a USPTO examiner evaluates the patent application against these criteria. The examiner considers statutory definitions, judicial guidance, and the Manual of Patent Examining Procedure (MPEP)[1].

Reissue Patents and Claim Amendments

In cases where a patent holder seeks to broaden or amend claims, they may file a reissue application. However, this process is subject to strict rules to prevent the recapture of surrendered subject matter[2].

Patent Analytics and Landscape Analysis

To fully understand the scope and value of a patent, companies often use patent analytics tools.

Claim Coverage Matrix

This tool helps identify which patents and claims are actively protecting the intellectual property and where gaps or opportunities exist. It categorizes patents by claims and overarching scope concepts, making it easier to filter, search, and analyze large numbers of patent claims[4].

Claim Charts

Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts. These charts help determine if a particular scope concept is applicable to a target product or method and highlight areas where claim coverage is lacking[4].

Legal Rights and Enforcement

A valid patent grants the holder the right to exclude others from making, using, offering for sale, or selling the covered invention in the United States. This includes the right to exclude others from importing the invention into the U.S.[1].

Case Study: Common Issues in Patent Claims

The case of In Re McDonald illustrates common issues that can arise during the patent examination and reissue process. In this case, the patent holder attempted to broaden claims through a reissue application but faced rejections due to improper recapture of surrendered subject matter and defective reissue declarations[2].

Strategic Importance of Patent Analysis

Understanding the scope and claims of a patent is vital for business strategy. It helps in identifying potential competitors, assessing market risks, and discovering opportunities for innovation and expansion.

Key Takeaways

• Claims Define the Invention: The claims section is the heart of a patent application.
• Patentability Requirements: Utility, novelty, and nonobviousness are crucial for patent validity.
• Patent Analytics: Tools like Claim Coverage Matrix and Claim Charts are essential for analyzing the patent landscape.
• Legal Rights: A patent grants the right to exclude others from using the invention.
• Strategic Value: Accurate patent analysis is key to business strategy and innovation.

FAQs

Q: What are the primary requirements for a patent to be granted in the U.S.?

A: The invention must be useful, novel, and nonobvious, and it must claim patentable subject matter[1].

Q: How long does a U.S. patent last?

A: A U.S. patent lasts for 20 years from the date the patent application was filed[1].

Q: What is the purpose of a reissue patent application?

A: A reissue patent application is used to correct errors in the original patent or to broaden the claims, but it must comply with strict rules to avoid recapture of surrendered subject matter[2].

Q: How can patent analytics tools help in managing intellectual property?

A: Patent analytics tools help in identifying which patents and claims are protecting the intellectual property, spotting gaps in coverage, and highlighting future design opportunities[4].

Q: What are the legal consequences of violating a patent?

A: Violating a patent can result in legal action, including lawsuits for money damages or other remedies[1].

Sources

1. Congressional Research Service, "Patents and Innovation Policy," August 2022.
2. Court of Appeals for the Federal Circuit, "In Re McDonald," August 2022.
3. U.S. Patent and Trademark Office, "U.S. Patent and Trademark Office (USPTO)," USA.gov.
4. Schwegman, Lundberg & Woessner, "Patent Analytics," SLWIP.com.

Recent additions to Drugs Protected by US Patent 12,016,927

These patents are from the daily update and have not yet been integrated into the regular database

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Type	RLD	Patent No.	Product	Substance	Delist Req.	Patent Expiration	Usecode	Patented / Exclusive Use
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE	217006	Apr 27, 2023	RX	Yes	12,016,927	Y				U-3245	MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE	217006	Apr 27, 2023	RX	Yes	12,016,927	Y				U-543	TREATMENT OF SCHIZOPHRENIA

Drugs Protected by US Patent 12,016,927

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	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	12,016,927		Y			MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No	12,016,927		Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	12,016,927		Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes	12,016,927		Y			MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER

International Family Members for US Patent 12,016,927

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	090776
Argentina	126033
Australia	2013253374
Australia	2017228608
Australia	2019200060
Australia	2020204200