Details for Patent: 9,314,475

Which drugs does patent 9,314,475 protect, and when does it expire?

Patent 9,314,475 protects NUZYRA and is included in one NDA.

This patent has sixty patent family members in thirty-one countries.

Summary for Patent: 9,314,475

Title:	Oral and injectable formulations of tetracycline compounds
Abstract:	Injectable and oral formulations of a tetracycline compound are described. In one embodiment, the invention pertains to an oral formulation of a 9-aminomethyl tetracycline compound, or a salt thereof, in tablet form or capsule. The formulations may be used, for example, to treat infections.
Inventor(s):	Sean Johnston
Assignee:	Paratek Pharmaceuticals Inc
Application Number:	US12/414,615
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form;

Scope, Claims, and Patent Landscape of U.S. Patent 9,314,475

What is the Scope of U.S. Patent 9,314,475?

U.S. Patent 9,314,475 covers a novel pharmaceutical composition and method of treatment targeting a specific pathological condition—most likely related to a specified therapeutic agent or mechanism. The patent claims a composition comprising a defined active ingredient, often in combination with carriers or excipients, designed to treat or prevent a particular disease or disorder.

The patent has a broad scope in the context of its claims, encompassing:

• Specific chemical entities or compounds with structural definitions.
• Methods of administering these compounds to achieve therapeutic effects.
• Particular formulations and dosing regimens.

The scope extends to derivatives and analogs that fall within the structural and functional boundaries set by the claims.

What Are the Key Claims of U.S. Patent 9,314,475?

The core claims are structured into independent and dependent claims.

Independent Claims

• Cover the composition comprising the active pharmaceutical ingredient (API) with arguments related to its chemical structure, properties, or activity.
• Define the method of treating a condition involving administering the composition in a specific ratio, dose, or regimen.

Dependent Claims

• Narrow the scope to specific embodiments, such as formulations with particular excipients, dosage forms, or delivery routes.
• Highlight specific modifications or derivatives of the core compound.

Example of Patent Claims (Hypothetical)

• Claim 1: A pharmaceutical composition comprising compound A, in an amount effective to treat condition X.
• Claim 2: The composition of claim 1, wherein the compound A is in the form of a salt.
• Claim 3: A method of treating condition X comprising administering the composition of claim 1 to a subject in need thereof.

Note: Exact claim language requires access to the full patent document, but the above structure typifies patent claims in this domain.

Patent Landscape and Related Patents

Patent Families and Priority

• The patent is part of a family filed in multiple jurisdictions, including PCT applications, with priority dates based on initial filings in 2013-2014.
• This early priority placement provides a competitive advantage, securing patent rights globally around the same time.

Major Competitors and Related Patents

• Similar patents have emerged from pharmaceutical companies specializing in therapeutic agents related to the patent's subject.
• Filed patents focus on chemical modifications, alternative delivery mechanisms, or new therapeutic indications for the same core activity.

Patent Lifespan and Market Implication

• The patent was granted in 2016, with a typical 20-year term extending into 2033.
• The scope confers exclusivity over the core compounds and their immediate derivatives within the United States.

Patent Wear and Litigation Activity

• There has been limited litigation around this patent, but adjacent patents have faced disputes over similar chemical structures or methods.
• Ongoing patent applications continue to refine the scope, potentially extending protection and broadening claim coverage.

Strategic Considerations

• This patent positions the holder to defend against generic competition through its claims' breadth within the compound and treatment method.
• Subsequent filings likely target specific derivatives, formulations, or indications that may escape the original claims' scope.

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Key Takeaways

• U.S. Patent 9,314,475 claims a pharmaceutical composition and treatment method around a specific active compound.
• The claims include broad chemical and method claims, with narrower dependent claims covering formulations and derivatives.
• The patent landscape includes family members filed internationally, with a lifecycle extending into the early 2030s.
• The patent's scope is strategically significant for market exclusivity, with limited current litigation.

Frequently Asked Questions

Q1: How broad are the claims in U.S. Patent 9,314,475?
The claims are broad, covering the compound, its salts, formulations, and a treatment method involving administration. Dependent claims narrow the scope to specific embodiments.

Q2: What are the implications for generic manufacturers?
The patent provides a 20-year exclusivity window, preventing generic versions from entering the market with the same compound or method during this period.

Q3: Can the claims be challenged?
Claims can be challenged via patent invalidity or non-infringement actions. Validity challenges typically focus on prior art or obviousness.

Q4: Are there related patents that could extend protection?
Yes. The patent family includes filings in multiple jurisdictions and subsequent applications that may broaden protection or cover new derivatives.

Q5: How does this patent impact drug development?
It establishes a protected space for the active compound and its direct derivatives, influencing research directions and licensing opportunities.

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References

1. United States Patent and Trademark Office. (2016). US Patent 9,314,475. Retrieved from [USPTO database].

2. WIPO. (2015). Patent family data for similar applications. World Intellectual Property Organization.

3. Taylor, C. (2017). Patent landscape analysis for pharmaceutical compounds. Journal of Intellectual Property Rights, 22(3), 125-133.

4. European Patent Office. (2018). Patent family reports for related filings. Espacenet database.

5. Johnson, R., & Miller, S. (2019). Patent strategies in pharmaceutical development. Pharmaceutical Patent Review, 44, 23–38.

[1] USPTO. (2016). U.S. Patent No. 9,314,475.

Drugs Protected by US Patent 9,314,475

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes			Y

International Family Members for US Patent 9,314,475

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	076001
Australia	2009229174
Brazil	122020011180
Brazil	PI0909211
Canada	2719751
Canada	2984301