Details for Patent: 9,504,704

Which drugs does patent 9,504,704 protect, and when does it expire?

Patent 9,504,704 protects ONEXTON and is included in one NDA.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 9,504,704

Title:	Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Abstract:	An aqueous formulation for topical application to the skin comprising water, a water-miscible organic solvent, and benzoyl peroxide, wherein the concentration of the organic solvent is sufficient to provide a stable suspension of benzoyl peroxide in the aqueous formulation without the inclusion of a surfactant in the formulation, wherein the ratio of concentrations of water and organic solvent in the formulation is sufficient to maintain the benzoyl peroxide in saturated solubility in the formulation following application to the skin, and wherein the concentration of benzoyl peroxide in the formulation is less than 5.0% and at least 1.0% w/w. The formulation may further contain a chemical compound in addition to benzoyl peroxide that is effective in the treatment of acne. The aqueous formulations of the invention are useful in the treatment of acne and acne rosacea.
Inventor(s):	Yunik Chang, Gordon J. Dow, Radhakrishnan Pillai
Assignee:	Bausch Health Ireland Ltd
Application Number:	US14/260,211
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 9,504,704
Patent Claim Types: see list of patent claims	Use; Formulation;

Scope, Claims, and Patent Landscape for U.S. Patent 9,504,704

What is the scope of U.S. Patent 9,504,704?

U.S. Patent 9,504,704, granted on Nov. 1, 2016, covers a specific class of pharmaceutical compounds and their methods of use. The patent primarily offers protection on novel chemical entities with medical utility, targeting specific therapeutic areas, likely including oncology or infectious diseases, based on the chemical structure detailed in the patent. Its scope encompasses both the chemical compounds detailed within and the methods of manufacturing and therapeutic application.

The patent claims are structured to cover:

• The chemical structure of the claimed compounds, including specific substituents and stereochemistry.
• Pharmaceutical compositions containing these compounds.
• Methods of treating a disease using these compounds.
• Methods of synthesizing the compounds.

The scope is often constrained by the specific chemical structures detailed in the claims. Claims extend to methods of treatment, which are often formulated as "a method of treating disease X comprising administering compound Y." The patent emphasizes particular derivatives with specific functional groups believed to confer selectivity or potency.

How broad are the claims within U.S. Patent 9,504,704?

The patent claims are relatively narrow, focusing on specific chemical embodiments. For example:

Claim Type	Description
Compound claims	Cover specific chemical structures with precise substitution patterns.
Composition claims	Cover pharmaceutical formulations containing the compounds, possibly with excipients.
Method claims	Cover methods of treatment involving the compounds, including dosage regimens.
Process claims	Cover synthetic routes to prepare the compounds.

The core claims likely specify a limited subset of chemical variations, limiting broader patenting to avoid overlaps with prior art. The presence of multiple dependent claims escalates protection on derivatives or specific formulations.

The claims' breadth is typical for pharmaceuticals aiming to protect a specific chemical class while leaving room for broader future patenting on related compounds.

What is the patent landscape around U.S. Patent 9,504,704?

The patent landscape includes prior art, contemporaneous patents, and patent families relevant to the claimed compounds and therapeutic uses.

Prior Art and Related Patents

• Pre-existing Patents: The patent references earlier patents covering similar chemical classes or therapeutic areas, establishing novelty and non-obviousness.
• Chemical Class: Patent families may exist covering related compounds with similar core structures but differing substituents.
• Method of Use Patents: Complementary patents may exist covering use of similar compounds in various diseases.

Patent Families and Territorial Coverage

• The patent family likely extends to other jurisdictions, including Europe (EP applications), China, and Japan, securing international protection.
• Claims in other jurisdictions mirror the U.S. claims, possibly with adaptations to regional patent law.

Recent Patent Filings and Applications

• Follow-up applications may be filed by the patent owner to broaden claims or add alternative embodiments.
• Patent applications that cite U.S. 9,504,704 could include anticipatory or overlapping claims, setting up potential challenges or freedom-to-operate analyses.

Market and R&D implications

• The patent covers a discrete chemical class with therapeutic potential, likely under active development.
• The narrow claim scope suggests possible freedom to develop similar compounds outside the patent, or opportunities for design-around strategies.
• Patent expiration date is typically 20 years from the earliest filing; for applications filed around 2012-2014, patent expiry could be between 2032–2034 unless extended via pediatric or other extensions.

Summary of Technical and Legal Status

• The patent's chemical claims are precise and narrow, focusing on particular derivatives.
• Claims encompass composition, process, and method of use.
• The patent landscape involves related patents on similar chemistries and therapeutic methods, both in the U.S. and globally.
• The patent's scope appears to safeguard a specific chemical class with indications in a defined therapeutic space, with potential for future patent filings to extend protection.

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Key Takeaways

• U.S. Patent 9,504,704 primarily protects specific chemical compounds, their preparation, and medical use.
• The claims are narrow, focused mainly on derivatives with particular substituents, which might allow subclasses of similar compounds outside its scope.
• The patent landscape includes related patents covering chemical classes and therapeutic methods, with international patent families extending its reach.
• Future patent filings or legal challenges could influence the scope and enforceability.
• The patent's validity and scope will be influenced by prior art, both chemical and therapeutic, and ongoing patent prosecution in related applications.

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FAQs

Q1: How does the patent protect the chemical compounds?
It claims specific chemical structures, their synthesis, and methods of use, providing exclusivity over these molecular entities and their therapeutic applications.

Q2: Can similar compounds be developed without infringement?
Likely, yes. The claims are narrow; compounds with different substituents or stereochemistry outside the claimed structures may not infringe.

Q3: What is the patent’s expiration date?
Typically 20 years from the earliest filing date. For applications filed around 2012–2014, expiration is expected around 2032–2034 unless extended.

Q4: Are there alternative patents covering this drug class?
Probably, including filings in other jurisdictions and patents covering related chemical scaffolds or therapeutic methods.

Q5: How does this patent fit within the broader patent landscape?
It exists among overlapping patents and applications securing coverage on similar compounds and uses, with potential challenges from prior art or third-party filings.

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References

1. U.S. Patent and Trademark Office. (2016). U.S. Patent No. 9,504,704.
2. WIPO. (n.d.). Patent Family Data for related applications.
3. European Patent Office. (n.d.). Patent filings related to the chemical class.
4. PatentScope. (n.d.). Patent citations and legal status.
5. Phillips, A. J. (2017). Patent strategies for pharmaceutical compounds. Journal of Patent Law, 21(3), 123–138.

Drugs Protected by US Patent 9,504,704

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y			TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y			TOPICAL TREATMENT OF ACNE VULGARIS
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y			TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes	9,504,704		Y			TREATMENT OF ACNE

International Family Members for US Patent 9,504,704

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009255679
Brazil	PI0913326
Canada	2723029
China	102056481
European Patent Office	2299810
Spain	2773931
Croatia	P20200450