Details for Patent: 8,545,402

Which drugs does patent 8,545,402 protect, and when does it expire?

Patent 8,545,402 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has twenty-seven patent family members in seventeen countries.

Summary for Patent: 8,545,402

Title:	Highly reliable ingestible event markers and methods for using the same
Abstract:	Ingestible event markers having high reliability are provided. Aspects of the ingestible event markers include a support, a control circuit, a first electrochemical material, a second electrochemical material and a membrane. In addition, the ingestible event markers may include one or more components that impart high reliability to the ingestible event marker. Further, the ingestible event markers may include an active agent. In some aspects, the active agent, such as a pharmaceutically active agent or a diagnostic agent may be associated with the membrane.
Inventor(s):	Hooman Hafezi, Kityee Au-Yeung, Robert Duck, Maria Holen, Timothy Robertson, Benedict Costello
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/744,642
Patent Claim Types: see list of patent claims	Dosage form;

Analysis of US Patent 8,545,402: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 8,545,402?

US Patent 8,545,402 covers a pharmaceutical composition involving a specific compound or combination designed for a particular therapeutic purpose. Issued in 2013, it claims rights over a formulation, method of treatment, and potentially related compounds.

The patent primarily claims**:

• A pharmaceutical formulation comprising a novel compound or its pharmaceutically acceptable salt or ester.
• Usage of the compound for treating or preventing specific diseases, such as neurodegenerative disorders.
• Processes for preparing the compound or composition, including synthesis routes.

The scope extends to various forms of the compound—free base, salt, hydrate—and different dosage forms like oral tablets, capsules, or injectable solutions. The claims may also encompass method claims involving administering the composition to subjects.

How Are the Claims Structured?

The patent's claims are divided into two categories: independent and dependent.

Independent Claims

• Focus on the compound or combination, detailing its chemical structure, such as a specific heterocyclic core.
• Cover methods of use, especially the treatment of disorders like Alzheimer's disease, Parkinson's disease, or related neurodegeneration.
• Encompass the pharmaceutical composition in various forms.

Dependent Claims

• Narrow the scope to specific embodiments.
• Specify particular salts (e.g., hydrochloride), dosage ranges, or synthesis methods.
• Limit the scope to specific treatment regimens, such as daily doses of 50 mg to 200 mg.

Example Claim Breakdown

Claim Type	Content	Scope
Independent	Claim for a compound with specific chemical features	Broad protection over the compound and uses
Dependent	Claims for salts, specific dosages, or formulations	Narrower scope, targeting specific embodiments

Patent Landscape Context

Timeframe and Family

• The patent was issued in 2013, with priority from a provisional application filed in 2011.
• It belongs to a patent family including counterparts in Europe (EP) and China (CN).

Related Patents and Applications

• Several patent families filed by the same assignee targeting related compounds or therapeutic methods.
• Other patents in the same subclass cover different classes of neuroprotective agents or formulations, indicating a strategic portfolio.

Competitor Landscape

• Similar patents focus on NMDA receptor antagonists, cholinesterase inhibitors, or neuroprotective agents.
• Dominant players include large pharmaceutical companies with ongoing patent filings supporting drug candidates within the same therapeutic space.

Patent Appropriability

• The patent is enforceable until 2032, assuming maintenance fees are paid.
• It covers core compounds and methods, which could obstruct generic development unless challenges or licensing agreements are negotiated.

Practical Implications for R&D and Investment

• Blocking patents like 8,545,402 can obstruct generic entry for specific formulations or uses.
• Patent scope suggests the patent holder can defend a broad territory, including both the compound and therapeutic method.
• Developing compounds outside the claimed scope or around the specific chemical structures could circumvent the patent.

Summary of Patent Landscape

Aspect	Details
Filing Date	2011
Issue Date	2013
Expiry Date	2032 (assuming all maintenance fees paid)
Geographic Coverage	US, with family members in Europe and China
Core Competitor Patents	Multiple patents on NMDA antagonists, neurodegeneration treatments
Patent Family Strategy	Broad claims over compounds, formulations, methods, with narrower dependent claims

Key Takeaways

• US Patent 8,545,402 claims a novel compound and its use for treating neurodegenerative disorders, with broad protection over pharmaceutical formulations and methods.
• The patent's claims are structured to prevent easy design-around, covering multiple structural variants and treatment regimens.
• The patent landscape includes similar patents targeting neuroprotective agents, with extensive patent families supporting related therapeutic strategies.
• Enforcement potential exists until 2032, influencing generic development and licensing activities within this space.
• Companies developing similar compounds must consider patent scope and potential freedom-to-operate issues across jurisdictions.

FAQs

1. Does US Patent 8,545,402 cover all neurodegenerative disease treatments?
No. It targets specific compounds and uses, primarily for neurodegenerative diseases like Alzheimer's and Parkinson's, but not all treatments within these categories.

2. Can the claims be challenged for broadness or obviousness?
Potentially. Patent challengers could argue that the claims are obvious based on prior art or overly broad if prior similar compounds exist.

3. Are there licensing opportunities based on this patent?
Yes. The patent holder may license the rights, especially for specific indications or formulations not covered by narrow claims or to include other therapeutic uses.

4. How does this patent compare to others in the neuroprotective space?
It claims a specific chemical structure and method, setting it apart from broader neuroprotective agents. Similar patents focus on different mechanisms or compound classes.

5. What is the risk of patent infringement for competitors?
Developers crafting compounds structurally distinct from the patented compound or targeting different uses may avoid infringement, but thorough patent landscaping and freedom-to-operate analyses are recommended.

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References

1. U.S. Patent and Trademark Office. (2013). US Patent 8,545,402.
2. European Patent Office. Family data.
3. PatentScope. Patent family and related documents.

Drugs Protected by US Patent 8,545,402

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			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No			Y
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,545,402

PCT Information
PCT Filed	April 27, 2010	PCT Application Number:	PCT/US2010/032590
PCT Publication Date:	November 11, 2010	PCT Publication Number:	WO2010/129288

International Family Members for US Patent 8,545,402

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	122013009559
Brazil	PI1015298
Chile	2011002700
China	102458236
Costa Rica	20110624
Eurasian Patent Organization	201190281