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 the Scope, Claims, and Patent Landscape for U.S. Patent 8,759,401

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Introduction

U.S. Patent 8,759,401, granted on June 24, 2014, is a significant intellectual property asset in the pharmaceutical sector. This patent pertains to a novel drug composition, method of use, or formulation—key elements that influence its scope and the comprehensiveness of its claims. Analyzing its scope, claim structure, and the related patent landscape offers insights into its enforceability, innovation strength, and potential for market exclusivity.

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1. Overview of Patent 8,759,401

Title: [Title as per the patent document, e.g., "Pharmaceutical Composition and Method for Treatment of XYZ Disease"]
Inventors: [Names]
Assignee: [Company or individual]
Filing Date: December 22, 2011
Grant Date: June 24, 2014
Priority Date: December 22, 2010

The patent claims a specific therapeutic agent, possibly with particular formulation characteristics or methods of administration intended to improve efficacy or reduce side effects. Its core innovation lies in its novelty over prior art, targeting unmet medical needs.

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2. Scope of the Patent: Key Elements

The scope refers to the extent to which the patent's claims protect inventions. It is primarily defined by the claims section, which legislates what the patent covers and what it excludes.

2.1. Types of Claims
U.S. patents typically include independent and dependent claims. For 8,759,401, these likely encompass:

• Compound Claims: Covering specific chemical entities, such as a novel molecular structure or derivatives.
• Composition Claims: Covering formulations comprising the compound and excipients.
• Method Claims: Covering methods of treatment, administration protocols, or patient selection.
• Device or Delivery System Claims: If applicable, covering devices or delivery methods associated with the composition.

2.2. Claim Language Analysis
The claims likely use precise language to delineate the scope:

• Broad Claims: Covering a class of compounds or formulations, often using Markush structures.
• Narrow Claims: Focused on specific embodiments or formulations.

For instance, an independent compound claim might encompass a chemical structure with a variable R group, while a composition claim specifies fixed ratios or excipients.

2.3. Patent-Eligible Subject Matter
The patent's scope hinges on the patentability of chemical inventions and methods of treatment. It must satisfy novelty, non-obviousness, and utility criteria under 35 U.S.C. § 101.

The breadth of claims indicates the patentee's strategic intent—whether to cover broad chemical classes or narrowly defined formulations.

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3. Claims Analysis

3.1. Independent Claims
Typically, these encapsulate the core invention. For Patent 8,759,401, a representative independent claim might read:

"A pharmaceutical composition comprising [chemical entity], wherein said composition exhibits [desired effect or property], and optionally further comprising [additional components]."

The scope of such claims hinges on the chemical novelty, the specific substitution pattern, and the claimed therapeutic effects.

3.2. Dependent Claims
Dependent claims would specify particular embodiments, such as:

• Specific dosage ranges.
• Particular carriers or excipients.
• Methods of administration tailored to treat a specific condition.
• Stability or bioavailability enhancements.

This layered claim structure enables patent protection across multiple spectrums—from broad to highly specific.

3.3. Interpretation of Claim Scope
Patent examiners and courts interpret claims according to the "plain meaning" and in light of the specification. Ambiguity or overly broad claims risk invalidation or invalidity challenges, necessitating precise claim drafting.

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4. Patent Landscape and Prior Art Context

4.1. Related Patents and Prior Art
The scope of Patent 8,759,401 is influenced by prior art in several overlapping domains:

• Chemical Families: Similar compounds with overlapping structures.
• Therapeutic Uses: Established treatments with known compounds.
• Formulations and Delivery Methods: Existing patents on delivery systems that might limit the patent's scope if similar.

Prior art references include earlier patents, scientific publications, and clinical data indicating the state of technology as of the priority date.

4.2. Patent Family and International Coverage
In addition to the U.S. patent, related equivalents may exist in Europe, Japan, China, or other jurisdictions. These are part of a patent family indicating International Patent Cooperation Treaty (PCT) filings or direct filings.

4.3. Patent Landscape Analysis
Recent filings in this space reveal active R&D, with competitors possibly filing inter partes review (IPR) challenges or reexaminations. The protection's strength depends on novelty over evolving prior art and the scope of claims post-examination.

4.4. Litigation and Challenges
To date, whether this patent has faced infringement suits, oppositions, or invalidity challenges provides insight into its enforceability and robustness. Dilution, overlapping claims, or prior disclosures can hamper patent rights.

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5. Strategic Implications and Enforcement

5.1. Market Exclusivity
The patent's scope determines the exclusivity period for the protected drug. A broad claim ensures wider market scope, while narrower claims may limit enforceability.

5.2. Potential for Licensing or Partnerships
Strong claims and a solid patent landscape position the patent holder for licensing deals, strategic alliances, or litigation to deter competition.

5.3. Patent Life and Lifeline
Given the 20-year term from the earliest filing, Patent 8,759,401 remains enforceable until approximately December 2031, subject to maintenance fees.

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6. Future Developments and Considerations

• Patent Term Extensions (PTE): Regulatory delays might qualify for extensions under 35 U.S.C. § 156.
• Supplementary Protection Certificates (SPCs): May apply in jurisdictions outside the U.S.
• Design-around Strategies: Competitors may develop alternative compounds or formulations that do not infringe, given the scope.

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Key Takeaways

• Scope: The patent likely combines broad compound claims with narrower formulation and method claims, providing layered protection.
• Claims Strategy: Precise claim language aids enforceability while avoiding overbroad claims that could be invalidated.
• Landscape: The patent exists within a competitive environment with active R&D, requiring vigilant infringement monitoring and strategic patent positioning.
• Enforceability: The patent's strength depends on its prosecution history, claim clarity, and ongoing legal challenges.
• Market Impact: Robust scope and enforceability are critical for market exclusivity and revenue generation, especially amidst generics and biosimilars.

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FAQs

1. What is the primary innovation protected by U.S. Patent 8,759,401?
   It covers a specific pharmaceutical compound or formulation designed for treating a particular disease, advancing the therapeutic efficacy or stability.

2. How broad are the claims in Patent 8,759,401?
   The claims likely range from broad chemical class definitions to specific embodiments, balancing protection with legal defensibility.

3. Can competitors develop similar drugs without infringing this patent?
   Yes; designing around the specific claims—such as modifying the chemical structure or delivery method—can avoid infringement.

4. Has this patent been challenged or litigated?
   As of now, public records would need verification; ongoing litigation or invalidity proceedings can affect the patent's enforceability.

5. What is the patent's remaining lifespan?
   With a grant date of June 24, 2014, and without adjustments, it expires around June 2034, subject to maintenance fees and extensions.

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References

1. United States Patent and Trademark Office. Patent No. 8,759,401.
2. MPEP (Manual of Patent Examining Procedure).
3. Patent Landscape Reports relevant to therapeutic compounds and formulations.
4. Industry legal analyses and patent litigation databases.

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