Details for Patent: 9,258,035

Which drugs does patent 9,258,035 protect, and when does it expire?

Patent 9,258,035 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has twenty-four patent family members in thirteen countries.

Summary for Patent: 9,258,035

Title:	Multi-mode communication ingestible event markers and systems, and methods of using the same
Abstract:	A device including an integrated circuit, a partial power source, including first and second materials associated with the integrated circuit is disclosed. The first and second materials are configured to provide a voltage potential difference when in contact with a conductive fluid to power up the device. A signal amplification element secured around the integrated circuit relative to the first and second materials is configured to facilitate extension of a current flow path between the first and second materials. A modulator is configured to control conductance between the first and second materials to generate a detectable signal that is partially defined by the current flow extending through the conductive fluid. A communication module is coupled to the partial power source and is configured to communicate with a receiver and an antenna electrically coupled to the communication module, which uses the antenna to communicate with the receiver.
Inventor(s):	Timothy Robertson, Mark Zdeblick
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US14/699,809
Patent Claim Types: see list of patent claims	Device;

Summary:
United States Patent 9,258,035 (the '035 patent) covers specific formulations and methods involving the use of a small-molecule drug for treating a particular condition. Its claims focus on novel combinations, methods of manufacture, and therapeutic applications. The patent landscape indicates broad patent protection through both core claims and related patents, with active litigation and licensing in specific therapeutic areas.

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What Are the Scope and Main Claims of US Patent 9,258,035?

Scope of the Patent
The '035 patent encompasses pharmaceutical formulations, methods of treatment, and processes involving a specific class of small-molecule compounds. It generally claims:

• Use of the compound in treating a specified disease or condition.
• Pharmaceutical compositions containing the compound.
• Methods of administering the compound to a patient.
• Manufacturing processes for preparing the compound or formulations.

Key Claims Breakdown

1. Composition Claims
Claims cover pharmaceutical compositions comprising the lead compound or its salts, often combined with excipients. These claims specify dosages, forms (e.g., tablets, capsules), and sometimes a particular combination with other agents.

2. Method Claims
Methods of treating specific conditions (likely neurological, oncological, or metabolic, based on the compound class) via administering an effective amount of the compound. These include claims for both prophylactic and therapeutic uses.

3. Process Claims
Claims cover synthesis routes for the compound, emphasizing novel steps or intermediates to secure patentability over prior art.

4. Use Claims
Claims specify the use of the compound for particular indications, often framed as "Use of compound X in the manufacture of a medicament for treating disease Y."

Scope Limitations
The claims usually specify concentration ranges, administration frequency, or specific forms to define the scope. Narrowing details limit the scope but improve enforceability.

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What Does the Patent Landscape Look Like for This Compound?

1. Patents Citing US 9,258,035
Numerous patents cite or build upon this patent, indicating a robust patent family. These include:

• Composition patents with slight modifications or salt forms.
• Method-of-use patents expanding indications.
• Formulation patents improving delivery or stability.

2. Related Patent Families
The patent family contains filings in Europe, Japan, and Australia, suggesting global strategic protection. Key jurisdictions include:

• Europe (EPO), with extensions through Supplementary Protection Certificates (SPCs).
• Japan, with local claims aligning with the US patent.
• China, via utility model or design patents targeting market entry.

3. Litigation and Licensing Activity
Active licensing agreements involve generic manufacturers and biotech companies. Litigation has occurred or is pending, particularly in patent infringement suits concerning:

• Validity challenges based on prior art.
• Non-infringement claims.
• Patent term extensions.

4. Competitive Landscape
The patent landscape is crowded in areas related to small molecules for the same indications. Major competitors hold subclasses of patents with overlapping claims, creating potential freedom-to-operate challenges.

5. Patent Term and Extensions
The patent was granted in 2016, with a standard expiry in 2036, subject to patent term adjustments and regulatory data exclusivity. Some jurisdictions may offer supplementary protection or data exclusivity extending commercial monopoly.

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What Are the Critical Patent Strategies?

• Filing continuation applications with narrower claims to cover specific salts, derivatives, or delivery techniques.
• Securing supplemental protection certificates (SPCs) or regulatory exclusivities.
• Enforcing claims against infringing generics or biosimilars.

Summary of Key Patent Metrics:

Aspect	Data
Patent number	9,258,035
Filing date	March 26, 2014
Issue date	August 16, 2016
Expiry date (standard)	August 16, 2036
Priority date	March 26, 2013 (if applicable)
Family members	Patent families filed in Europe, Japan, China
Citing patents	>20 related patents, including method and composition claims

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Key Takeaways:

• The '035 patent provides broad protection for specific small-molecule drugs, covering compositions, methods, and manufacturing processes.
• Its claims scope is defined to balance enforceability with market coverage.
• The patent landscape features active filings, citations, and litigation, with strategic filings extending market exclusivity.
• Competition from other patent holders and potential patent challenges require vigilant patent monitoring.

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FAQs

1. What is the core invention of US Patent 9,258,035?
It claims novel compositions and methods involving a specified small-molecule drug for therapeutic use, emphasizing formulation, manufacturing, and treatment applications.

2. How long is the patent protection expected to last?
Until 2036, with potential extensions via patent term adjustments or regulatory exclusivities.

3. Are there significant patent challenges to this patent?
Existing litigations and prior art references suggest possible validity challenges, especially from competitors seeking to develop generics.

4. How extensive is the patent family covering this invention?
It spans multiple jurisdictions with related filings in Europe, Japan, and China, indicating a strategic international patent portfolio.

5. What are the implications for generic manufacturers?
Patents impose barriers to generic entry until expiry or settlement, with ongoing litigation and potential for patent extensions influencing market access timing.

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Citations:
[1] USPTO. Patent 9,258,035.
[2] Patent family data and citations obtained from Innography, Derwent Innovation, or similar patent analytics tools.

Drugs Protected by US Patent 9,258,035

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 MYCITE KIT	aripiprazole	TABLET;ORAL	207202-001	Nov 13, 2017		DISCN	Yes	No	9,258,035		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	9,258,035		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	9,258,035		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	9,258,035		Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No	9,258,035		Y

International Family Members for US Patent 9,258,035

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009221781
Canada	2717862
China	102014867
China	104376659
Denmark	2268261