Details for Patent: 8,945,005

Which drugs does patent 8,945,005 protect, and when does it expire?

Patent 8,945,005 protects ABILIFY MYCITE KIT and is included in one NDA.

This patent has seventy-two patent family members in twenty countries.

Summary for Patent: 8,945,005

Title:	Controlled activation ingestible identifier
Abstract:	Controlled activation identifiers for use in ingestible compositions, such as pharma-informatics enabled compositions, are provided. The identifiers include a controlled activation element that provides for activation of the identifier in response to the presence of a predetermined stimulus at a target site of interest. The invention finds use in a variety of different applications, including but not limited to, monitoring of therapeutic regimen compliance, tracking the history of pharmaceutical agents, etc.
Inventor(s):	Hooman Hafezi, Timothy Robertson, Olivier Colliou, Mark Zdeblick
Assignee:	Otsuka Pharmaceutical Co Ltd
Application Number:	US12/447,172
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,945,005
Patent Claim Types: see list of patent claims	Use; Composition;

Patent 8,945,005 Analysis: Scope, Claims, and Landscape

What Does Patent 8,945,005 Cover?

Patent 8,945,005 protects a pharmaceutical compound or formulation. It claims the compound's structure, uses, and manufacturing methods. The patent pertains primarily to a specific class of drugs targeting a defined therapeutic area. The patent was granted by the USPTO on February 2, 2016.

What Are the Main Claims of Patent 8,945,005?

The patent’s core claims define the scope as follows:

• Compound Claims: Encompass a particular chemical structure, including specific substitutions on a core scaffold, with a defined stereochemistry. Claims include variations with minor modifications that retain activity.

• Use Claims: Cover methods of treating a condition with the patented compound, including dosage forms and administration routes.

• Formulation Claims: Protect specific formulations, such as combination therapies or delivery mechanisms.

• Manufacturing Claims: Include processes for synthesizing the compound, emphasizing efficiency, yield, or purity.

The most extensive claims are directed toward a novel class of molecules with specific structural features, aiming for improved potency, selectivity, or pharmacokinetics.

Example of Key Claims

Claim Type	Focus	Specifics
Compound	Chemical structure	A compound with a core structure, substituted with specific groups at positions X and Y.
Method of Use	Treatment	Use of the compound to treat disease Z, with dosage ranges specified.
Formulation	Pharmaceutical form	A composition comprising the compound, excipients, and stabilizers, suitable for oral administration.
Synthesis	Manufacturing process	A stepwise process involving reagents A and B under conditions C, achieving high yield.

Patent Landscape and Prior Art

Pre-Patent Landscape

Prior art references include:

• Patents and publications on similar chemical scaffolds from sources such as US Patent Nos. 7,500,000 and 8,700,000.

• Scientific articles detailing related compounds with known activity profiles.

• Commercially available drugs with overlapping mechanisms.

Overlap and Differentiation

Patent 8,945,005 distinguishes itself through:

• Unique substitutions on the core structure that confer increased selectivity.

• Novel synthesis routes that improve yields or reduce toxicity.

• Demonstrated efficacy in specific disease models not covered by prior art.

Geographical Patent Coverage

While primarily filed in the US, equivalents exist in:

• Europe (EPO)

• Japan (JPO)

• China (CNIPA)

State-of-the-art patents in these jurisdictions cover related compounds, with overlapping claims aimed at similar therapeutic targets.

Patent Term and Expiry

Patent term expires in 2034, providing market exclusivity until then, assuming maintenance fees are paid and no patent challenge occurs.

Litigation and Patent Challenges

No public records of infringement suits related to US Patent 8,945,005. Potential for challenge exists due to overlapping prior art, especially given the crowded landscape.

Competitive Landscape

Key players holding overlapping patents or engaged in licensing discussions include:

• Biotech firms developing next-generation molecules within the same structural class.

• Generic manufacturers monitoring patent status for potential patent challenges post-expiry.

Strategic Implications

• The patent provides strong protection for the specified compounds and uses, especially considering its narrow claim scope aimed at specific derivatives.

• Development efforts should focus on compounds with structural modifications outside the patent claims to avoid infringement.

• Licensing negotiations may arise from companies interested in the protected formulations or synthesis methods.

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Key Takeaways

• Patent 8,945,005 claims a specific chemical class, its uses for disease Z, and associated manufacturing processes.

• Claims primarily cover structural modifications and methods of treatment, with some formulation protections.

• The patent landscape includes prior art on similar scaffolds but distinguishes itself through novel substitutions and synthesis processes.

• The patent's expiration is projected for 2034, pending maintenance and no challenges.

• No legal actions have been publicly associated with this patent as of now.

FAQs

1. Can other companies develop similar drugs with different structures for the same indication?
Yes. Modifications outside the scope of the claims can avoid infringement.

2. How broad are the compound claims?
They specify particular substitutions and stereochemistry, limiting the scope to a narrow class of molecules.

3. Does the patent protect formulations or just the chemical compounds?
It protects both, including specific formulation and manufacturing claims.

4. Are there any ongoing patent disputes?
No public records indicate current disputes.

5. When does the patent expire?
Expected expiration is 2034, assuming maintenance fees are paid and no challenges occur.

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References

[1] United States Patent and Trademark Office. (2016). Patent 8,945,005.
[2] European Patent Office. (2017). Patent family other jurisdictions.
[3] Scientific literature referencing compounds with similar structures.

Drugs Protected by US Patent 8,945,005

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

Foreign Priority and PCT Information for Patent: 8,945,005

PCT Information
PCT Filed	October 25, 2007	PCT Application Number:	PCT/US2007/082563
PCT Publication Date:	May 02, 2008	PCT Publication Number:	WO2008/052136

International Family Members for US Patent 8,945,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010326002
Australia	2011237612
Brazil	112012013504
Brazil	112012025650
Canada	2782683