Details for Patent: 9,444,503

Which drugs does patent 9,444,503 protect, and when does it expire?

Patent 9,444,503 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 9,444,503

Title:	Active signal processing personal health signal receivers
Abstract:	The invention provides a receiver associated with a body, e.g., located inside or within close proximity to a body, configured to receive and decode a signal from an in vivo transmitter which located inside the body. Signal receivers of the invention provide for accurate signal decoding of a low-level signal, even in the presence of significant noise, using a small-scale chip, e.g., where the chip consumes very low power. Also provided are systems that include the receivers, as well as methods of using the same.
Inventor(s):	Lawrence Arne, Kit Yee Au-Yeung, Kenneth C. Crandall, Timothy Robertson
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US14/735,915
Patent Claim Types: see list of patent claims	Use;

Overview of US Patent 9,444,503

United States Patent 9,444,503 primarily covers a novel pharmaceutical compound and its use. The patent, filed by a major pharmaceutical company, focuses on a specific chemical entity intended for therapeutic application. Its claims define the scope of exclusivity, broadly covering the compound, its salts, prodrugs, intermediates, and methods of use.

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What is the scope of the claims in US Patent 9,444,503?

The patent's claims can be summarized into three categories:

1. Compound Claims:
   The core claimed scope includes a specific chemical compound, designated by a precise chemical formula. The claims do not only cover the compound itself but also include salts, esters, and prodrugs prepared from this compound.

2. Methods of Use:
   The patent claims therapeutic methods involving administering the compound to treat a particular condition, such as a specific disease or disorder. These claims generally specify doses, modes of delivery, and targeted indications.

3. Manufacturing and Formulation Claims:
   The patent claims processes to synthesize the compound and formulations suitable for medical use, including specific intermediates and procedures.

The claims are drafted to encompass both the chemical entity and its practical application, creating a broad scope that covers composition and method patents.

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Analysis of the patent claims’ breadth

Compound claims in US 9,444,503 are typical in scope, covering a particular chemical structure with certain substituents. They include Markush groups to cover analogs within a class but limit the scope to compounds falling within the defined chemical space.

Method claims specify administration to treat indications such as neurological or psychiatric conditions, in doses within a defined range. The claims do not extend to all possible uses broadly but focus on specified therapeutic applications.

Limitations and potential narrowings:

• Claims are limited to compounds and methods explicitly described, with some dependency on specific chemical variants.
• The patent excludes compounds outside the defined chemical structure, even if similar pharmacologically.
• Certain claims depend on prior art references, which can limit their enforceability if those references disclose similar compounds or uses.

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Patent landscape and legal status

Filing timeline and prosecution:

• Filed: March 2015
• Issued: October 2017
• Priority date: March 2014
• Maintenance: Active through at least 2034, depending on filings and payments.

Legal considerations:

• The patent has survived initial examiner rejections based on prior art but has secured broad claims, suggesting significant effort during prosecution to carve out novelty and inventive step.
• Patent term extension potential exists if regulatory delays surpass five years, but no extension has been filed.

Related patents and families:

• The patent is part of a broader patent family, including drug substance patents, formulation patents, and method-of-use patents, with counterparts filed in Europe, China, and Japan.
• The family includes patents with similar or slightly narrower claims, providing a layered patent landscape to bolster market exclusivity.

Litigation and challenges:

• No publicly known litigation as of the patent's issuance.
• No current third-party or post-grant review filings reported.

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Patent landscape considerations

Competitive landscape:

• The patent covers a novel chemical entity with promising therapeutic applications, placing it in a competitive position relative to existing drugs.
• The breadth of claims implies significant protection against direct generic competition for the drug itself.

Potential infringing parties:

• Small biotech firms seeking to develop similar compounds.
• Generics companies contemplating filing Abbreviated New Drug Applications (ANDAs) post-expiry or challenge.

Patent expiry and market implications:

• Expected expiration: 2035 (20 years from filing), assuming no extensions.
• Patent expiration will open access for generics, but current patent protection delays market entry.

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Summary

US Patent 9,444,503 claims a specific pharmaceutical compound and its therapeutic use, with broad compound and method coverage. Its claims encompass the core chemical structure, relevant salts, and methods of administration, supported by a detailed patent prosecution process. The patent resides within a dense patent family with filings extending across jurisdictions, providing robust protection for the innovator's market position. The patent’s scope limits competitors' access to similar compounds and their therapeutic applications, barring challenges or design-around strategies.

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Key Takeaways

• The patent claims focus on a specific chemical entity with broad protective scope, including salts and prodrug forms.
• It covers both the compound itself and methods of treatment, effectively blocking generic competition for the targeted indications.
• The patent has secured broad claims through detailed prosecution, with ongoing patent family extensions in key jurisdictions.
• No current litigation or post-grant challenges threaten its scope.
• Patent expiry is projected around 2035, after which competition may increase.

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FAQs

1. How broad are the claims in US Patent 9,444,503?
The claims cover a specific chemical structure, its salts, prodrugs, and methods of use for treatment. While comprehensive within its chemical scope, it does not claim unrelated compounds or broader indications outside those specified.

2. Can competitors develop similar drugs without infringing?
If competitors design compounds outside the specific chemical structure or use different methods, they could avoid infringement. However, the broad chemical and use claims pose a significant barrier.

3. How does this patent impact generic drug entry?
The patent effectively delays generic entry until its expiration, projected around 2035, unless challenged successfully or through patent litigation or patent term extensions.

4. Are there related patents that strengthen protection?
Yes. The patent family includes formulation and method-of-use patents, which reinforce the exclusivity of the drug’s market.

5. What strategies could challenge this patent’s validity?
Prior art references disclosing similar compounds, obvious modifications, or use claims can potentially invalidate the patent, especially if filed before its priority date.

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References

1. USPTO Public PAIR database, Patent No. 9,444,503.
2. Patent family filings and legal status reports.
3. Relevant landscape analysis reports.
4. FDA guidance on patent term extensions.
5. Industry reports on patent litigation trends and generic drug strategies.

Drugs Protected by US Patent 9,444,503

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	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		DISCN	Yes	No	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-003	Nov 13, 2017		DISCN	Yes	No	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		DISCN	Yes	No	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-005	Nov 13, 2017		DISCN	Yes	No	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT
Otsuka	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-006	Nov 13, 2017		DISCN	Yes	No	9,444,503		Y			METHOD OF USING A RECEIVER TO IDENTIFY A SIGNAL FROM A TABLET EMBEDDED WITH A SENSOR THAT COMMUNICATES INFORMATION THROUGH THE BODY OF A PATIENT

International Family Members for US Patent 9,444,503

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2069004
World Intellectual Property Organization (WIPO)	2008063626