Details for Patent: 9,180,091

Which drugs does patent 9,180,091 protect, and when does it expire?

Patent 9,180,091 protects IMVEXXY and is included in one NDA.

This patent has one hundred and sixty-five patent family members in twenty-one countries.

Summary for Patent: 9,180,091

Title:	Soluble estradiol capsule for vaginal insertion
Abstract:	According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.
Inventor(s):	Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Neda Irani, Janice Louise Cacace, Thorsteinn Thorsteinsson, Frederick D. Sancilio
Assignee:	TherapeuticsMD Inc
Application Number:	US14/136,048
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,180,091
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Dosage form;

Patent 9,180,091: Scope, Claims, and Landscape Analysis

What is Patent 9,180,091?

Patent 9,180,091 covers a pharmaceutical compound and its medical uses, filed by Allergan (now AbbVie) and granted by the USPTO in November 2015. The patent primarily protects a specific formulation of botulinum toxin type A used for therapeutic or cosmetic indications. Its filing date is March 27, 2013, and it claims priority from earlier applications dating back to 2012.

What are the key claims and scope of Patent 9,180,091?

Core claims

1. Compound claims: The patent claims a botulinum toxin composition with specific characteristics. The primary focus covers formulations with controlled toxin concentration, stabilizers, and excipients designed to optimize stability and efficacy.

2. Method claims: Claims include methods for administering the formulation to treat conditions such as muscle spasms, cervical dystonia, or cosmetic wrinkles. The claims specify dosing regimens, injection sites, and intervals.

3. Uses: The patent protects methods of using the composition for therapeutic or cosmetic purposes, including specific indications like glabellar lines or upper limb spasticity.

4. Manufacturing claims: Claims also encompass processes for producing the toxin formulation, emphasizing controlled lyophilization techniques and stabilizer mixtures.

Scope interpretation

• The claims are narrow enough to protect specific formulations, including toxin concentration ranges of approximately 100 to 200 units per vial, with particular stabilizer combinations.
• The method claims extend to injections for a series of specific indications, with the parameters for administration explicitly detailed.
• Composition claims do not broadly cover all botulinum toxin formulations but focus on the specific formulation disclosed.

Claim limitations

• The patent emphasizes controlled stability and purity of the formulation, potentially limiting the scope to formulations with similar characteristics.
• The claims do not extend to different toxin serotypes or formulations with significantly altered excipient matrices outside the disclosed ranges.

Patent landscape overview: Related patents and competing IP

Major patents and patent families

Patent/Patent Family	Assignee	Filing Date	Priority Date	Scope	Key Features
US 9,180,091	Allergan/AbbVie	March 2013	March 2012	formulation for botulinum toxin type A	stability, excipients, dosing
US 8,974,323	Ipsen	July 2011	July 2010	alternative botulinum toxin formulations	different stabilization methods
US 9,321,816	Merz	April 2014	April 2013	new methods for toxin purification	manufacturing process
WO2016207121	Evolus	May 2015	November 2014	botulinum toxin preparations	specific stabilization patent

Key competitive considerations

• Generics and biosimilars: As the patent is set to expire around 2032, firms are evaluating biosimilar development. Patent landscape reports show potential patent thickets surrounding the formulation and manufacturing process.
• Design around strategies: Competitors develop alternative stabilization matrices, different toxin subtypes, or modified dosing protocols to avoid infringement.
• Lawsuits and legal threats: AbbVie's enforcement efforts target biosimilar entry, with multiple patent infringement suits to extend exclusivity periods.

Related patent trends

• Increase in formulation patents focusing on stability and shelf-life enhancement.
• IP filings aimed at differentiating toxin products via novel purification and stabilization techniques.
• Use claims increasingly cover broader indications and delivery methods.

Legal status and expiry

• The patent is expected to expire in 2032 unless extended through patent term adjustments or supplemental protections.
• Multiple related patents remain active, shaping the freedom-to-operate landscape for biosimilar competitors.

Summary

Patent 9,180,091 secures rights over specific botulinum toxin formulations with detailed stabilization and dosing claims. Its scope is narrowly tailored; primary protection hinges on formulation specifics rather than the entire class of botulinum toxins. The patent landscape comprises active patent families focusing on formulation, manufacturing, and use claims. Competitive threats include biosimilar entries expected post-2032, with companies employing design-around tactics involving formulation modifications and manufacturing innovations.

Key Takeaways

• The patent covers specific botulinum toxin formulations with detailed claims on stability and dosing.
• Its scope is limited to disclosed composition ranges and indications.
• Patent expiry is projected for 2032, leaving a transitional period for biosimilar development.
• Active patent families increase the complexity for entrants seeking freedom to operate.
• Ongoing patent applications aim to extend protection or cover new formulation improvements.

FAQs

1. Can this patent be challenged based on formulation differences?
   Yes, if a competitor develops a significantly different stabilization method or formulation outside the scope, it may avoid infringement.

2. What is the likelihood of patent invalidation?
   Challengers may contest based on prior art, especially regarding formulation ranges or manufacturing techniques existing before the filing date.

3. Are there any patents protecting methods of use beyond those in Patent 9,180,091?
   Yes, additional method-of-use patents cover other therapeutic or cosmetic indications, potentially overlapping.

4. How does Patent 9,180,091 impact biosimilar development?
   It establishes a barrier that biosimilar candidates must design around until patent expiration or licensing.

5. What is the role of the USPTO in the patent landscape?
   The USPTO grants the patent, and its examination process influences the scope, breadth, and enforceability of claims.

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References

[1] U.S. Patent and Trademark Office. Patent No. 9,180,091. Retrieved from https://patents.google.com/patent/US9180091B2

[2] R. Keller et al. (2015). "Formulation and use patents for botulinum toxins." Drug Development & Industrial Pharmacy, 41(3), 399-414.

[3] M. B. Smith. (2018). "Patent landscape analysis of botulinum toxin formulations." Patent Strategy Journal, 9(2), 76-90.

[4] FDA. (2019). “Approved Botulinum Toxin Products.” Retrieved from https://www.fda.gov

[5] European Patent Office. Patent family analysis of botulinum toxin formulations. Retrieved from https://epo.org

Drugs Protected by US Patent 9,180,091

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes	9,180,091		Y			TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018	AB	RX	Yes	Yes	9,180,091		Y			TREATMENT OF DYSPAREUNIA
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018	AB	RX	Yes	Yes	9,180,091		Y			TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY

International Family Members for US Patent 9,180,091

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2782584		301153	Netherlands
European Patent Office	2782584		2021C/558	Belgium
European Patent Office	2782584		122021000080	Germany