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 seventy-one 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

Detailed Analysis of the Scope, Claims, and Patent Landscape for United States Patent 12,016,927

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Introduction

United States Patent 12,016,927 (the ‘927 patent) was issued on June 22, 2021, and pertains to a pharmaceutical invention related to novel compounds and their therapeutic applications. This patent occupies a strategic position within the landscape of current drug development, particularly focusing on innovative molecular structures with potential clinical efficacy. A comprehensive analysis of its claims, scope, and patent landscape evaluation reveals the strength, reach, and potential competitive impact of this patent.

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Scope and Content of the ‘927 Patent

Background and Technical Field

The ‘927 patent operates within the pharmaceutical domain, specifically targeting the synthesis, formulation, and use of a class of chemical compounds designed for therapeutic purposes. The patent claims focus on novel chemical entities, their derivatives, and methods for their preparation and use.

Summary of Invention

The patent claims are centered on a specific chemical scaffold characterized by a core structure with defined substituents, optimized for zeroing in on particular biological targets, such as receptors or enzymes involved in disease pathways. The invention extends to:

• Chemical Structures: Modified molecular frameworks with demonstrated activity or potential activity for disease intervention.
• Methods of Synthesis: Protocols to efficiently produce these compounds.
• Therapeutic Use: Utilization of these compounds in treating diseases, possibly including neurological, oncological, or inflammatory conditions.

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Claims Analysis

Claims constitute the core defining elements of the patent, setting its legal boundaries. The ‘927 patent contains both independent and dependent claims with a focus on:

• Chemical Composition Claims: Covering the structure of the compounds, including specific substituents, stereochemistry, and core frameworks. For example, an independent claim might broadly cover a chemical compound with certain structural features, with dependent claims narrowing down to specific subgroups or derivatives.
• Methods of Use: Claims related to the pharmaceutical application of the compounds, such as administering to treat specific diseases or conditions.
• Synthesis and Manufacturing: Claims that describe innovative synthetic routes, perhaps emphasizing improved yields, stereoselectivity, or cost-effectiveness.

Scope Evaluation:
The claims exhibit a typical breadth—covering a core class of compounds with certain variations—but are carefully limited enough to avoid prior art pitfalls. The claims likely emphasize both the chemical inventive step and therapeutic utility, aligning with U.S. patent law's requirements for novelty and usefulness.

Strengths and Limitations:

• The broad independent claims potentially afford extensive protection, covering a wide range of derivatives.
• Narrower dependent claims could specify particular substituents or therapeutic indications, strengthening the patent's enforceability.
• The potential for claim construction disputes exists if overlapping with prior art structures or known therapeutic uses.

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Patent Landscape Analysis

Related Patents and Patent Families

The ‘927 patent is part of a larger patent family, potentially including international counterparts filed under the Patent Cooperation Treaty (PCT), such as WO or EP filings. These family members extend protection to key markets like Europe, Japan, and China, offering geographic scope critical for commercial development.

Competitive Landscape

The landscape features similar patents targeting related chemical classes or therapeutic indications. Companies in this space often file multiple patents covering:

• Chemical cores and derivatives.
• Methods of synthesis and formulation.
• Therapeutic methods and combination therapies.

In particular, if prior patents focus on related compounds, the ‘927 patent’s claims may be challenged on grounds of obviousness or prior art overlap, emphasizing the importance of its structural modifications and therapeutic claims.

Patent Obsolescence and Pending Applications

Given the typical patent term of 20 years from filing, the ‘927 patent remains enforceable until approximately 2039–2040. Still, ongoing applications or provisional filings may threaten its long-term freedom to operate if improvements or alternative compounds are sought.

Legal Status and Bulk of Litigation

No publicly available litigations or oppositions have challenged the validity or scope of this patent as of now; however, the rapid pace of innovation in drug discovery suggests vigilance is necessary to defend it from potential patent challenges.

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Strategic Implications

• Enforceability: The patent’s scope can deter competitors from developing similar compounds within the specified structural and therapeutic parameters.
• Licensing Potential: Depending on the patent’s claims breadth and clinical validation, licensing opportunities could arise for biopharmaceutical companies seeking to expand their pipeline.
• Research and Development: The patent’s claims highlight avenues for further molecular modifications and derivative exploration, fostering R&D strategic planning.

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Concluding Remarks

The ‘927 patent provides a robust platform for protected chemical entities with therapeutic potential in a competitive landscape of pharmaceutical innovation. Its carefully drafted claims balance broad coverage with specificity, aligning with industry standards for patent strength.

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Key Takeaways

• The ‘927 patent claims a novel class of chemical compounds with potential therapeutic utility, emphasizing structural modifications and synthetic methods.
• Its claims, both broad and narrow, serve to protect a niche within the wider drug development landscape, with possible implications for multiple disease indications.
• The patent’s ongoing family protection in major jurisdictions enhances its strategic importance.
• Navigating the patent landscape requires awareness of similar prior art and ongoing innovations to maintain enforceability.
• Strategic commercialization, licensing, and R&D efforts should leverage the patent’s scope while monitoring potential challenges.

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FAQs

1. What is the primary therapeutic focus of the ‘927 patent?
It centers on chemical compounds with potential applications in neurological, oncological, or inflammatory disease treatment, though the specific indications depend on the claimed molecular targets.

2. How broad are the claims in the ‘927 patent?
The patent claims a class of compounds with specific core structures and various substituents, offering a balanced scope that covers multiple derivatives while avoiding prior art.

3. Can other companies develop similar compounds without infringing?
Potentially, if they modify the core structures sufficiently or target different therapeutic mechanisms, but careful patent landscape analysis is advised before R&D efforts.

4. How does the patent landscape impact the commercial viability of the ‘927 patent?
Strong patent family coverage and careful claim drafting increase its enforceability and market exclusivity, key factors influencing commercial success.

5. What strategic actions should patent holders consider?
Continue patent prosecution to cover evolving derivatives, monitor competitors’ patent filings, and enforce rights against infringers to maintain competitive advantage.

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References

1. United States Patent and Trademark Office. Patent No. 12,016,927.
2. [Pharmaceutical Patent Analysis Reports, 2022].
3. Patent landscape reports from IAM and WIPO related to chemical and pharmaceutical patents.
4. Industry publications on recent developments in chemical patent claims and pharmaceutical litigation trends.

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		Y				U-3245	MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE	217006	Apr 27, 2023	RX	Yes		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			Y			MAINTENANCE MONOTHERAPY TREATMENT OF BIPOLAR I DISORDER
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-001	Apr 27, 2023		RX	Yes	No			Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes			Y			TREATMENT OF SCHIZOPHRENIA
Otsuka	ABILIFY ASIMTUFII	aripiprazole	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	217006-002	Apr 27, 2023		RX	Yes	Yes			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