Details for Patent: 8,663,699

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Which drugs does patent 8,663,699 protect, and when does it expire?

Patent 8,663,699 protects ACANYA and is included in one NDA.

This patent has twenty patent family members in fourteen countries.

Summary for Patent: 8,663,699

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
Assignee:	Dow Pharmaceutical Sciences Inc
Application Number:	US13/869,494
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,663,699
Patent Claim Types: see list of patent claims	Use; Composition; Formulation;

US Patent 8,663,699: Claim Scope, Expiration, Orange Book Status, and Acne Drug Patent Landscape

US Patent 8,663,699 protects a once-daily topical acne treatment combining 2.5% benzoyl peroxide and 1.2% clindamycin phosphate in a stable aqueous gel. Its core protection is a method-of-treatment claim rather than a broad composition claim. The dependent claims add benzoyl peroxide particle-size limits and specified gelling agents.

The patent is commercially relevant to fixed-dose benzoyl peroxide/clindamycin products, particularly Acanya Gel or products using the same 2.5%/1.2% strength. The principal generic risk is a label-based method-of-use challenge. A formulation that uses a different strength, omits one of the claimed physical parameters, or is labeled for a different dosing regimen may reduce infringement exposure, although it may not eliminate regulatory or inducement risk.

What does US Patent 8,663,699 protect?

The independent claim protects a specific acne-treatment regimen with five central elements:

1. Topical treatment of acne.
2. A stable, pharmaceutically acceptable aqueous gel.
3. Benzoyl peroxide at 2.5% w/w.
4. Clindamycin phosphate at 1.2% w/w.
5. Once-daily application.

Claim 1 also requires a comparative clinical-performance limitation. The once-daily product must have:

• Lower irritation potential than twice-daily treatment with a 5.0% benzoyl peroxide/1% clindamycin topical gel containing dicotyl sodium sulfosuccinate and water; and
• Similar efficacy, measured by reduction of inflammatory and non-inflammatory acne lesions, to that twice-daily comparator.

The claim therefore combines structural formulation limitations with dosing and clinical-performance limitations.

Claim element	Scope and commercial effect
"Method for treating acne"	Limits the claim to therapeutic use, not merely manufacture or sale of a composition
"Topically applying"	Requires topical administration to acne-affected skin
"Stable ... aqueous gel formulation"	Excludes nonaqueous systems, unstable formulations, and products not properly characterized as gels
"2.5% w/w benzoyl peroxide"	Creates a narrow active-strength limitation
"1.2% w/w clindamycin phosphate"	Requires the specified clindamycin-phosphate concentration
"Once daily"	A twice-daily label does not literally meet this limitation
Active ingredients "consisting of" benzoyl peroxide and clindamycin phosphate	Narrows the claimed anti-acne active ingredients to those two actives
Lower irritation and similar efficacy	Introduces factual and claim-construction issues tied to comparative clinical performance

The use of "comprising" for the formulation generally permits additional inactive ingredients. The phrase "anti-acne active pharmaceutical ingredients consisting of" is narrower. It is directed to the specified active ingredients rather than to every excipient in the formulation.

How do claims 2 and 3 narrow the patent?

Claim 2 requires the benzoyl peroxide to be suspended and to have an average particle size of 2.5 to 30 microns. This limitation may be important because benzoyl peroxide particle size can affect suspension stability, sensory properties, irritation, release, and manufacturing controls.

Claim 3 depends on claim 2 and requires a gelling agent selected from:

• Carbomer;
• Hydroxyethyl cellulose; or
• Hydroxypropyl cellulose.

A product that satisfies claim 1 but uses a different gelling agent may avoid literal infringement of claim 3. It could still fall within claim 1 if all claim 1 limitations are met.

Claim	Additional requirement	Design-around significance
Claim 1	2.5% benzoyl peroxide, 1.2% clindamycin phosphate, stable aqueous gel, once daily, comparative performance	Principal infringement risk
Claim 2	Suspended benzoyl peroxide with 2.5-30 micron average particle size	Narrows physical formulation scope
Claim 3	Carbomer, hydroxyethyl cellulose, or hydroxypropyl cellulose	Narrows excipient scope further

Is US 8,663,699 a composition patent or a method-of-use patent?

US 8,663,699 is principally a method-of-use patent. The claims do not broadly cover every composition containing 2.5% benzoyl peroxide and 1.2% clindamycin phosphate. They cover use of that formulation in a once-daily acne regimen meeting the stated efficacy and irritation limitations.

That distinction affects enforcement:

• A manufacturer may face induced-infringement exposure if its label directs once-daily treatment of acne with the claimed formulation.
• A product may be physically identical to the claimed formulation but create less direct method-of-use risk if it is marketed without instructions for the claimed acne treatment.
• A label that instructs twice-daily use would not literally satisfy the once-daily limitation, but the regulatory and commercial consequences of a nonmatching label must be evaluated separately.
• A product sold for a different dermatological indication may avoid literal method-of-use infringement if the acne-treatment limitation is absent from the label and actual use.

The claim’s comparative performance language creates another issue. A generic applicant could argue that "less irritation potential" and "similar efficacy" are result limitations that require proof of actual performance. The patent holder could argue that a product with the claimed formulation and dosing regimen inherently produces the recited results.

When does US Patent 8,663,699 lose exclusivity?

The patent was granted on March 4, 2014. Its effective expiration depends on the patent-family priority and any patent-term adjustment or extension recorded by the USPTO. The relevant commercial assessment should use the expiry date shown in the USPTO patent-term data and FDA Orange Book listing rather than the grant date.

The patent appears to be associated with the 2.5% benzoyl peroxide/1.2% clindamycin phosphate product Acanya. The ordinary 20-year patent term is generally measured from the earliest effective nonprovisional filing date, not from the issue date. Any pediatric extension would add six months only if the statutory requirements were satisfied and the extension was recorded.

Exclusivity category	Relevance to this product
Patent exclusivity	Potentially protects the once-daily 2.5%/1.2% regimen and related formulation limitations
New-drug exclusivity	Acanya received FDA approval as an NDA product; the applicable regulatory exclusivity period is separate from the patent term
Orphan exclusivity	Not generally relevant to acne treatment
Biologic exclusivity	Not applicable
Pediatric exclusivity	Possible only if granted and recorded; it must be confirmed in FDA and USPTO records

The patent’s practical blocking period is the later of enforceable patent rights and any remaining FDA exclusivity that prevents approval of an abbreviated application.

What is the Orange Book status of US 8,663,699?

The Orange Book is the controlling FDA source for listed patents associated with approved drug products. A patent listing can include composition, formulation, method-of-use, or process claims, subject to FDA listing rules.

For a fixed-dose topical acne product, the relevant Orange Book questions are:

1. Whether the patent is listed against the reference listed drug.
2. Whether the listing covers the product, a method of use, or both.
3. Whether the listed use is identified as patent-protected.
4. Whether the patent has an unexpired term.
5. Whether a later holder or product owner updated the listing after corporate acquisitions.

The patent’s relevance to an ANDA depends on the FDA product reference and the use codes associated with that reference. An ANDA applicant generally must make a certification for each listed patent:

• Paragraph I: no patent information has been submitted;
• Paragraph II: the patent has expired;
• Paragraph III: approval is sought after patent expiration; or
• Paragraph IV: the patent is invalid, unenforceable, or will not be infringed.

The exact Orange Book status should be verified against the current FDA Orange Book patent table and the applicable Acanya reference listing. Patent ownership and FDA listing status can diverge after asset transfers, acquisitions, or licensing transactions.

What Paragraph IV challenges could affect the patent?

A Paragraph IV challenge to US 8,663,699 would likely focus on one or more of four positions.

Noninfringement

An ANDA applicant could design around the method claim by using:

• A different benzoyl peroxide concentration;
• A different clindamycin concentration;
• A twice-daily rather than once-daily label;
• A nonaqueous vehicle;
• A formulation that is not a gel;
• A product without the claimed active-ingredient combination; or
• A label that omits the patented acne-treatment use.

For claims 2 and 3, further design-around positions include a benzoyl peroxide particle size outside the 2.5-30 micron range or a gelling agent outside the listed group.

Invalidity for lack of written description or enablement

The claim requires a broad performance comparison covering irritation and efficacy, while also defining a particular formulation and regimen. An accused infringer could argue that the specification does not adequately support the full scope of formulations falling within the "stable aqueous gel" language or does not enable the claimed performance across all permitted excipient systems.

Obviousness

The principal obviousness issue would be whether the prior art taught:

• Benzoyl peroxide/clindamycin fixed-dose products;
• Lower-strength benzoyl peroxide regimens;
• Once-daily application;
• Reduced irritation through lower benzoyl peroxide concentration; and
• Comparable efficacy relative to twice-daily higher-strength treatment.

The patentee’s strongest response would likely rely on an unexpected combination of lower irritation and similar lesion reduction, provided the clinical data support the full claim scope.

Indefiniteness

The phrases "stable," "effective amount," "less than," "similar," and "irritation potential" could generate indefiniteness disputes if the patent does not supply sufficiently objective measurement methods, acceptance criteria, or comparator protocols. The strength of such a challenge depends on the specification and prosecution history, not the issued claim text alone.

What patent litigation affects US 8,663,699?

A complete litigation assessment requires review of PACER, district-court dockets, Federal Circuit decisions, ANDA litigation records, and FDA patent-certification events. The supplied claim text does not establish whether the patent has been litigated, settled, disclaimed, reissued, or subjected to a terminal disclaimer.

For commercial diligence, the relevant searches are:

Record	Purpose
USPTO Patent Center	Ownership, prosecution history, terminal disclaimer, PTA, maintenance fees
FDA Orange Book	Listed patent, reference product, use codes, expiry information
PACER and district-court dockets	Paragraph IV complaints and settlement terms
Federal Circuit and PTAB databases	Appeals, inter partes review, post-grant validity proceedings
FDA approval letters and labels	Approved strength, dosing, indication, and reference product

No settlement terms should be inferred solely from the existence of the patent or its association with Acanya.

How does the patent compare with competing acne products?

The competitive patent landscape is divided between fixed-dose benzoyl peroxide/clindamycin products and other topical acne products.

Product or product type	Benzoyl peroxide	Clindamycin	Typical dosing distinction	Relationship to US 8,663,699
Acanya-type product	2.5%	1.2% phosphate	Once daily	Closest commercial match
Duac-type product	5%	1%	Often once daily	Different strengths; separate patent estate
Benzaclin-type product	5%	1%	Commonly twice daily historically	Different strengths and comparator profile
Onexton-type product	3.75%	1.2% phosphate	Once daily	Different benzoyl peroxide strength
Clindamycin-only gel	0%	Variable	Once or twice daily	Does not contain the claimed combination
Benzoyl peroxide-only products	Variable	0%	Variable	Does not contain the claimed combination
Clindamycin/tretinoin products	0%	1.2%	Once daily	Different active combination

US 8,663,699 is strongest against products that reproduce the 2.5%/1.2% combination and direct once-daily acne use. It is materially less relevant to 3.75% benzoyl peroxide products, 5% benzoyl peroxide products, and clindamycin/tretinoin products.

Are biosimilar risks relevant?

No. Benzoyl peroxide and clindamycin phosphate are small-molecule active ingredients. Products competing with an Acanya-type gel would generally proceed through the abbreviated new drug application pathway, not the biosimilar pathway under the Biologics Price Competition and Innovation Act.

The relevant risks are:

• Paragraph IV certification;
• Hatch-Waxman patent litigation;
• Label carve-outs;
• Formulation equivalence;
• Device or container differences, if applicable;
• Manufacturing reproducibility; and
• Regulatory requirements for topical bioequivalence.

What manufacturing and formulation barriers remain?

The patent’s formulation limitations create technical barriers even where legal design-around is available. A competitor must control:

• Benzoyl peroxide particle-size distribution;
• Suspension uniformity;
• Chemical stability;
• Clindamycin-phosphate compatibility;
• Gel viscosity and spreadability;
• Preservative performance;
• Microbial quality;
• Packaging compatibility; and
• Product homogeneity throughout shelf life.

A formulation outside the claimed 2.5-30 micron range may avoid claim 2 but introduce stability, irritation, or bioequivalence problems. A different gelling agent may avoid claim 3 while creating a different rheological and release profile.

The patent does not, based on the supplied claims, broadly claim every manufacturing process for the gel. Manufacturing-process protection would have to be found in separate issued claims or related family members.

What is the likely generic launch risk?

The launch risk is highest for an ANDA product that matches all of the following:

• 2.5% benzoyl peroxide;
• 1.2% clindamycin phosphate;
• Stable aqueous gel;
• Once-daily acne label;
• Suspended benzoyl peroxide within the claimed particle-size range; and
• Carbomer, hydroxyethyl cellulose, or hydroxypropyl cellulose.

The risk decreases where the applicant can establish:

• A noninfringing strength;
• A different dosing regimen;
• A label carve-out;
• A different formulation architecture;
• Particle size outside the claimed range; or
• Lack of the claimed comparative clinical performance.

Revenue exposure depends on the commercial size of the Acanya-type market, the remaining patent term, approved generic competition, payer substitution, and whether the product retains meaningful share after patent expiry. The patent alone does not establish revenue or market-share figures.

Key Takeaways

• US 8,663,699 is primarily a method-of-use patent for once-daily treatment of acne with a 2.5% benzoyl peroxide/1.2% clindamycin phosphate aqueous gel.
• Claim 1 is narrower than a broad composition claim because it requires dosing and comparative irritation and efficacy results.
• Claim 2 adds a 2.5-30 micron benzoyl peroxide particle-size limitation.
• Claim 3 limits the gelling agent to carbomer, hydroxyethyl cellulose, or hydroxypropyl cellulose.
• The closest commercial product is an Acanya-type formulation.
• Generic risk is highest for an ANDA label that directly instructs once-daily use of the claimed 2.5%/1.2% gel.
• Biosimilar law is not relevant; Hatch-Waxman and Paragraph IV procedures are the applicable framework.
• Patent expiry, Orange Book status, ownership, litigation, and settlement positions must be confirmed from current USPTO, FDA, and court records.

FAQs

Does US 8,663,699 cover all clindamycin and benzoyl peroxide acne gels?

No. The issued claims require the 2.5% benzoyl peroxide and 1.2% clindamycin phosphate combination, an aqueous gel, and once-daily acne treatment, together with the stated performance limitations.

Can a product with 3.75% benzoyl peroxide infringe US 8,663,699?

It would not literally satisfy the 2.5% benzoyl peroxide limitation in claim 1. Separate patent rights, regulatory issues, or an equivalence theory could still require analysis.

Is the particle-size range in claim 2 a product specification or a method limitation?

It is a limitation of the formulation used in the claimed treatment method. The accused product would need to contain suspended benzoyl peroxide with the specified average particle-size range.

Does a different gelling agent avoid the patent?

A different gelling agent may avoid claim 3, but it does not automatically avoid claim 1. Claim 1 does not require one of the three gelling agents listed in claim 3.

Can a generic applicant use a Paragraph III certification?

Yes, if approval is sought after the relevant patent expiration date. If the applicant contends that the patent is invalid, unenforceable, or not infringed, a Paragraph IV certification may be used instead, subject to the Hatch-Waxman litigation process.

References

1. United States Patent and Trademark Office. (2014). U.S. Patent No. 8,663,699, Methods for treating acne. https://patents.google.com/patent/US8663699B2/en

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

3. U.S. Food and Drug Administration. (2024). FDA regulatory information for abbreviated new drug applications and patent certifications. https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

4. U.S. Food and Drug Administration. (2008). Acanya gel prescribing information. FDA drug labeling database. https://dailymed.nlm.nih.gov/dailymed/

Drugs Protected by US Patent 8,663,699

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	ACANYA	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-001	Oct 23, 2008	AB	RX	Yes	Yes						TREATMENT OF ACNE

International Family Members for US Patent 8,663,699

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2009255679
Brazil	PI0913326
Canada	2723029