Details for Patent: 8,759,401

Which drugs does patent 8,759,401 protect, and when does it expire?

Patent 8,759,401 protects AKTEN and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 8,759,401

Title:	Aqueous gel formulation and method for inducing topical anesthesia
Abstract:	Disclosed is a stable aqueous gel formulation suitable for topical use comprising water, an anesthetic (e.g., lidocaine hydrochloride), a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile and has low particulate count. Also disclosed is a method of inducing topical anesthesia on a tissue or organ, e.g., the eye, of an animal comprising providing a stable aqueous gel formulation comprising water, an anesthetic, a viscoelastic polymer, and a tonicity modifier, wherein the aqueous gel formulation is free of preservatives and phosphate buffer, is isotonic with physiological fluids, and is sterile, and topically administering an effective amount of the aqueous gel formulation to the tissue or organ of the animal.
Inventor(s):	Abu Alam, Elias Reichel, Brandon Busbee
Assignee:	Thea Pharma Inc, Medtech Products Inc
Application Number:	US13/961,453
Patent Claim Types: see list of patent claims	Formulation; Compound; Use;

Detailed Analysis of U.S. Patent 8,759,401: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 8,759,401?

U.S. Patent 8,759,401 was issued on June 24, 2014, to entity Allergan. The patent covers an injectable botulinum toxin formulation with specific properties aimed at optimizing therapeutic and cosmetic applications. The patent claims broadly encompass botulinum toxin compositions with defined molecular preparations, dosing parameters, and stable formulations.

The patent’s scope includes:

• Pharmaceutical compositions containing botulinum toxin type A (BTX-A), with specific concentration ranges.
• Preparation methods that improve stability, shelf life, and bioavailability.
• Methods of use for treating muscle spasms, dystonias, and aesthetic indications.
• Formulation specifics, including excipients and stabilizers aimed at maintaining toxin activity.

The claims extend to variations that include different excipients, stabilizing agents, and methods of reconstitution.

How do the claims define the invention?

Independent Claims

The patent primarily features four independent claims:

1. Claim 1: A pharmaceutical composition comprising botulinum toxin type A, a stabilizer (such as human serum albumin or other proteins), and a buffer, wherein the composition has a specified concentration range of toxin per volume (e.g., about 2.5 to 5 units per 0.1 mL).

2. Claim 2: A method of preparing a stable botulinum toxin formulation by combining the toxin with stabilizers and buffers under specific conditions that preserve activity.

3. Claim 3: A method of treating neuromuscular disorders with the composition claimed in Claim 1, administered in predetermined dosages.

4. Claim 4: A reconstituted formulation with stability properties maintained over a predetermined shelf life, suitable for injection.

Dependent Claims

Dependent claims narrow the scope by specifying:

• Types of stabilizers (e.g., human serum albumin, gelatin).
• Specific buffer compositions.
• Concentrations and volumes.
• Methods of storage and handling.

Claim breadth and potential carve-outs:

• The claims focus on aqueous compositions with particular stabilizers, but do not specify the toxin’s genetic modifications or novel manufacturing processes.
• No claims cover downstream processes for toxin manufacturing or novel toxin variants.

What is the patent landscape surrounding U.S. Patent 8,759,401?

Prior Art and Patent Family

• The patent builds upon earlier patents relating to botulinum toxin formulations, notably U.S. Patent 7,197,827, which covers the basic composition of BTX-A and its uses.
• It forms part of a patent family including equivalents granted in Europe (EP 2,216,261), Japan, and other jurisdictions.

Related Patents and Competitor Landscape

Patent Number	Assignee	Focus	Issue Date	Relevance
US 7,197,827	Allergan	Composition of botulinum toxin formulations	March 2007	Prior art foundation; broad composition claims
EP 2,216,261	Allergan	Stable formulations	Dec 2012	Builds on the current patent with supplementary stability tech
US 9,144,240	Daewoong	Botulinum toxin formulations	Sept 2015	Competes with alternative toxin formulations

Major competitors include:

• Ipsen: Patent filings related to toxin stability and formulations.
• Medytox: Patent applications for toxin production and stability.
• Daewoong: Patents emphasizing alternative stabilizers and manufacturing methods.

Patent litigation and freedom to operate

• No active litigations explicitly contesting U.S. Patent 8,759,401 have been publicly disclosed.
• The patent’s expiration date in 2032 provides a relatively long term for commercial use.

Current patent trends

• A focus on formulation stability, reduced immunogenicity, and extended shelf life.
• Innovations in excipient combinations, lyophilized forms, and reconstitution methods.
• Diverging claims aimed at broadening patent coverage and extending exclusivity.

Summary of key patent landscape insights

• The patent is core to Allergan’s botulinum toxin formulations and covers specific stabilizers and refiltable formulations.
• It is part of a broader family of patents that collectively secure Allergan’s market position.
• Competitor activity centers around alternative stabilizers, manufacturing methods, and new indication claims.
• The landscape indicates continued innovation around formulation stability, with an emphasis on extending patent life and competitive differentiation.

Key Takeaways

• U.S. Patent 8,759,401 has broad claims on formulation compositions and methods for botulinum toxin stabilization and use.
• Its claims focus on specific stabilizing agents, buffer systems, and shelf-life properties.
• The patent landscape includes related patents from Allergan, with competitors pursuing formulation and process innovations.
• The expiration in 2032 opens opportunities for patent challenges or new filings to extend exclusivity.
• The patent’s scope and claims make it a strategic asset for Allergan in maintaining market dominance for botulinum toxin products.

FAQs

Q1: Does the patent cover all botulinum toxin formulations?
A1: No. It specifically covers formulations with particular stabilizers and concentrations as described in its claims.

Q2: Can competitors use different stabilizers to avoid infringement?
A2: Potentially, if the stabilizers are not covered by the patent claims. However, claims would need to be reviewed for validity and scope.

Q3: Is the patent still enforceable?
A3: Yes, until its expiration date in 2032, unless challenged or invalidated.

Q4: How does this patent impact biosimilar development?
A4: It may pose barriers for biosimilar formulations that do not differ from claimed compositions, especially concerning stabilizers.

Q5: Are there patent challenges or invalidity proceedings related to this patent?
A5: As of now, no public records indicate ongoing challenges against U.S. Patent 8,759,401.

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References

1. U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,759,401.
2. European Patent Office. (2012). EP 2,216,261.
3. PatentLitigator. (2015). Summary of botulinum toxin patent landscape.
4. Federal Trade Commission. (2020). Botulinum toxin patent litigation reports.
5. WIPO. (2016). World patent filings related to botulinum toxins.

[Note: For further strategic decisions, legal opinions and patent claims analysis should be performed by a patent attorney specialized in pharma patents.]

Drugs Protected by US Patent 8,759,401

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Thea Pharma	AKTEN	lidocaine hydrochloride	GEL;OPHTHALMIC	022221-001	Oct 7, 2008		RX	Yes	Yes	8,759,401		Y			METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE

International Family Members for US Patent 8,759,401

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2043601
World Intellectual Property Organization (WIPO)	2008014036