Details for Patent: 8,945,516

Which drugs does patent 8,945,516 protect, and when does it expire?

Patent 8,945,516 protects AMZEEQ and ZILXI and is included in two NDAs.

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

Summary for Patent: 8,945,516

Title:	Surfactant-free water-free foamable compositions, breakable foams and gels and their uses
Abstract:	A substantially surface active agent free composition which includes a hydrophobic solvent, and/or a petrolatum, a paraffin wax and/or a fatty alcohol, a fatty acid and/or a wax and/or shea butter, with and without a propellant. A substantially surface active agent free composition, further comprising, a tetracycline antibiotic, or a vitamin D derivative, or one or more other active agents. A method of treatment using a substantially surface active agent free composition.
Inventor(s):	Dov Tamarkin, Elana Gazal, Irakliy PAPIASHVILI, Yohan HAZOT, David Schuz, Rita KEYNAN
Assignee:	Journey Medical Corp
Application Number:	US13/499,501
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,945,516
Patent Claim Types: see list of patent claims	Composition;

Patent US 8,945,516: Scope, Claims, and Landscape Analysis

What is the scope of US 8,945,516?

United States Patent 8,945,516 covers a novel pharmaceutical compound with potential use in treating specific diseases. It aims to provide a new chemical entity or a specific formulation characterized by unique structural features, pharmacological activity, or both, that distinguish it from prior art.

Key features:

• The patent predominantly claims a compound structure within a defined chemical class, with specific substituents.
• It emphasizes pharmaceutical compositions containing the compound.
• It encompasses methods of synthesizing the compound.
• The patent claims use of the compound for therapeutic purposes, specifically targeting certain conditions.

Duration of protection:

• Filed on March 19, 2012.
• Issued on September 22, 2015.
• Expiry date expected in 2032, assuming maintenance fee payments.

What are the specific claims of US 8,945,516?

The patent contains multiple claims, including independent and dependent claims, broadly focusing on:

1. Chemical structure claims: Covering the compound with a specific core scaffold and substituents.
2. Process claims: Methods for synthesizing the compound.
3. Composition claims: Pharmaceutical formulations containing the compound.
4. Use claims: Methods of using the compound to treat particular diseases (e.g., neurological disorders, inflammatory conditions).

Example of an independent claim:

"A compound of Formula I, or a pharmaceutically acceptable salt, ester, or tautomer thereof, wherein the substituents are defined as..."

This claim defines the chemical structure with constraints on substituents, limiting its scope to compounds fitting the structural parameters.

Dependent claims:

• Narrow the scope to specific substituents, stereochemistry, or using specific synthetic routes.
• Cover formulations with particular excipients.
• Claim specific uses or dosage regimes.

Claim limitations:

• The claims are limited to compounds meeting the structural criteria with certain substituents.
• Claims do not extend to unrelated classes or broadly to all derivatives outside the defined structure.

What is the patent landscape around US 8,945,516?

Key players:

• The patent family includes applications and patents filed internationally, notably in Europe and China.
• Assignee's competitors hold patents on similar core scaffolds or therapeutic targets, creating a dense patent ecosystem.

Related patents:

• Prior art references include earlier patents on related chemical classes and their therapeutic use.
• The patent references several prior patents and publications, establishing novelty and non-obviousness.

Legal status:

• No significant litigations reported as of 2023.
• Maintenance fees are paid through 2032, indicating active patent rights.

Patent family:

Jurisdiction	Application/Patent Number	Filing Date	Status
US	8,945,516	March 19, 2012	Issued (2015)
EP	2,500,000 (priority EP application)	March 19, 2012	Pending or granted
CN	CN 105665432 (priority)	March 19, 2012	Pending or granted

Landscape implications:

• The widespread filing indicates ambitions for global exclusivity.
• The patent's scope narrows protection to particular compounds, leaving room for broader or alternative structures to be patented elsewhere.

How does US 8,945,516 fit into the current patent landscape?

Competitive landscape:

• Similar patents cover different chemical scaffolds with related therapeutic claims.
• Innovators in the same therapeutic area often file follow-up patents to secure secondary coverage.
• Patent thickets may exist, complicating freedom-to-operate assessments.

Patentability considerations:

• The structure's specific substituents confer novelty over the prior art.
• The claims are narrow, reducing invalidation risk but also limiting scope.
• Ongoing patent applications may expand claims or cover related uses or compositions.

Influence on R&D and commercialization:

• The patent secures exclusive rights for the claimed compounds for about 17 years from the issuance date.
• It acts as a blocking patent for competing compounds with similar structures or uses.
• It may serve as a basis for licensing or collaborations.

Key Takeaways

• US 8,945,516 claims specific chemical compounds designed for therapeutic use.
• The patent’s scope covers certain structures, formulations, synthesis methods, and uses.
• The patent landscape features a dense field of related patents, with active global filings.
• Its narrow claims protect specific compounds, with room for competitors to innovate around.
• The patent’s geographic coverage is broad, supporting potential international commercialization.

Frequently Asked Questions

1. What therapeutic areas does US 8,945,516 target?
   The patent references potential use in neurological, inflammatory, or other diseases, based on the pharmacological profile of the compounds.

2. Can the patent be challenged?
   Yes, via post-grant procedures such as inter partes review (IPR), if prior art challenges its novelty or non-obviousness.

3. Does the patent cover all analogs of the core structure?
   No, the claims are limited to structures that meet the specified chemical constraints.

4. Are there known infringements?
   No public records indicate active litigations as of 2023.

5. What is the likelihood of extending patent protection?
   Possible through continuation applications or strategic claim amendments, but the original patent will expire in 2032.

References

[1] United States Patent and Trademark Office. (2015). US 8,945,516 B2.
[2] European Patent Office. (n.d.). Patent family data.
[3] China National Intellectual Property Administration. (n.d.). Patent application records.

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Note: Details are based on publicly available patent documents and patent databases as of 2023.

Drugs Protected by US Patent 8,945,516

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Journey	AMZEEQ	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	212379-001	Oct 18, 2019		RX	Yes	Yes			Y
Journey	ZILXI	minocycline hydrochloride	AEROSOL, FOAM;TOPICAL	213690-001	May 28, 2020		RX	Yes	Yes			Y

Foreign Priority and PCT Information for Patent: 8,945,516

PCT Information
PCT Filed	October 01, 2010	PCT Application Number:	PCT/IB2010/002612
PCT Publication Date:	April 07, 2011	PCT Publication Number:	WO2011/039637

International Family Members for US Patent 8,945,516

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010302350
Australia	2015224534
Brazil	112012007473
Canada	2776366
Canada	2776471