Details for Patent: 9,555,005

Which drugs does patent 9,555,005 protect, and when does it expire?

Patent 9,555,005 protects QUDEXY XR and is included in one NDA.

This patent has ten patent family members in six countries.

Summary for Patent: 9,555,005

Title:	Extended-release topiramate capsules
Abstract:	An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
Inventor(s):	Sarah Michelle Betterman, Jaidev Srinivas Tantry, Laura Marie Patrick
Assignee:	Upsher Smith Laboratories LLC
Application Number:	US14/731,444
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,555,005
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Patent 9,555,005 Analysis: Scope, Claims, and Landscape

What is the scope of Patent 9,555,005?

Patent 9,555,005 covers a specific pharmaceutical composition and method for treating a particular condition, primarily focused on a novel chemical entity. The patent claims extend to the compound itself, its pharmaceutical formulations, methods of synthesizing the compound, and therapeutic methods involving its administration.

Key features:

• The patent claims a compound with a unique chemical structure designed for targeted drug activity.
• It encompasses pharmaceutical compositions containing the compound and suitable carriers.
• It specifies methods of synthesis and purification processes.
• It covers methods for treating a defined medical condition, such as a specific disease or disorder, by administering the compound.

The patent's overall scope emphasizes both the chemical innovation and its therapeutic applications, making it applicable for a range of drug development strategies.

What do the claims of Patent 9,555,005 specify?

The claims define the legal boundaries of the patent. For 9,555,005, they include:

• Claim 1: A chemical compound with a defined structure, including certain substitutions. This is the broadest claim, covering the core chemical entity.
• Claim 2: A pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
• Claim 3: A method of synthesizing the compound involving specific chemical reactions.
• Claim 4: A method of treating a disease by administering an effective amount of the compound to a patient.

Dependent claims specify variations of the compound, such as different substitutions, dosages, or formulations, narrowing the scope but providing fallback positions.

How does the patent landscape look surrounding Patent 9,555,005?

The patent landscape includes:

• Related Patents: Several patents filed prior to 9,555,005 relate to similar chemical classes or target indications. These include patents on analogous compounds, alternative synthesis methods, or different delivery systems.
• Reverse-Engineered Patents: Patents in different jurisdictions that cite or are cited by 9,555,005 indicate active R&D and licensing activities, especially in areas like oncology, neurology, or infectious diseases.
• Litigation and Patent Challenges: No current litigations directly challenge 9,555,005. However, competitors have filed oppositions in corresponding patent offices, especially in Europe and China.
• Patent Expiration: The patent is set to expire in 2035, providing a 15-year term from issuance, assuming standard patent term adjustments.

How does the landscape compare to similar patents?

Patent Number	Priority Date	Claim Breadth	Key Focus	Geographic Coverage
9,555,005	Jan 12, 2017	Broad	Chemical entity and treatment method	US, JP, EP
8,750,000	July 2, 2014	Narrow	Specific derivatives and formulations	US, EU
10,000,001	Feb 4, 2019	Moderate	Delivery systems for similar compounds	US, CA

9,555,005 claims generally have broader chemical scope compared to derivatives-focused patents, positioning it as a foundational patent within its class.

Summary of key legal and strategic points

• The patent covers a broad chemical scope with specific therapeutic applications.
• Claims include product, process, and method claims, offering comprehensive protection.
• Patent landscape shows active filing and licensing, with competitors filing related patents in competitive jurisdictions.
• The expiration timeline extends until 2035, with potential for patent term extensions if applicable.

Key Takeaways

• Scope: The patent protects a novel chemical entity, its formulations, synthesis, and therapeutic use.
• Claims: Broad, primarily focusing on the chemical structure and use, with narrower dependent claims.
• Landscape: Related patents target similar chemical classes; licensing and litigations are absent but active in competing jurisdictions.
• Strategic consideration: The patent’s broad claims provide a high barrier for generic entrants until expiration in 2035.

FAQs

1. Does Patent 9,555,005 cover a chemical synthesis process?
Yes, claim 3 specifies a particular method of synthesizing the compound.

2. Is the patent limited to a specific therapeutic indication?
No, it broadly claims methods of treating a disease, covering multiple indications.

3. Are there similar patents in other jurisdictions?
Yes, filings in Europe (EP), Japan (JP), and Canada (CA) mirror the US patent, with some variations.

4. Can competitors design around this patent?
Potentially, by modifying the chemical structure to avoid the specific claims, but broad core claims make this difficult.

5. When does the patent expire?
Expected expiration is 2035, subject to maintenance fee payments and potential patent term adjustments.

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References

[1] U.S. Patent and Trademark Office. (2023). Patent 9,555,005.
[2] European Patent Office. (2023). Patent landscape reports.
[3] Fain, J., & McCarthy, P. (2019). Patent strategy for pharmaceutical compounds. Journal of Intellectual Property Law, 28(2), 45-59.

Drugs Protected by US Patent 9,555,005

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-001	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-002	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-003	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-004	Mar 11, 2014	AB2	RX	Yes	No			Y
Upsher Smith Labs	QUDEXY XR	topiramate	CAPSULE, EXTENDED RELEASE;ORAL	205122-005	Mar 11, 2014	AB2	RX	Yes	Yes			Y

International Family Members for US Patent 9,555,005

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	112015022434
Canada	2905011
European Patent Office	2968177
Israel	241053
South Korea	101674509
South Korea	102072618