Details for Patent: 7,553,835
Summary for Patent: 7,553,835
| Title: | Topical antifungal composition | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | The subject matter relates to a topical, foamable composition including at least one antifungal agent, said composition characterised in that said at least one antifungal agent is able to penetrate the upper layers of skin and is retained in or on an area to be treated for a prolonged period of time, and in that it has a residual non-volatile component content of less than 25%. The subject matter furthermore relates to a method of treating fungal diseases including jock itch, tinea, dandruff and sebborheic dermatitis by applying to the affected area of a patient requiring such treatment the antifungal composition. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Greg Davey, Albert Zorko Abram | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Delcor Asset Corp | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US09/529,033 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Composition; | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 7,553,835: Claim Scope, Expiration, Orange Book Relevance, and Antifungal Foam Patent LandscapeU.S. Patent No. 7,553,835 protects topical antifungal foam compositions and methods using a volatile, alcohol-rich, quick-breaking foam. Its core commercial scope is a low-residue aerosol foam containing an imidazole or triazole antifungal, ethanol or another lower alcohol, water, a long-chain alcohol, specified surfactants, and a hydrocarbon propellant. The strongest claim cluster is claims 23-28, which narrows the invention to an ethanol-based composition containing up to 5% antifungal, up to 5% polysorbate-type surfactant, up to 5% cetyl or stearyl alcohol, propylene glycol, 5-34% water, and less than 10% hydrocarbon propellant. The patent's nominal term ended in 2024 based on its earliest claimed priority date, making it unlikely to present a current U.S. launch barrier unless a term adjustment, extension, or related unexpired family patent applies. What does U.S. Patent 7,553,835 protect?U.S. Patent 7,553,835 protects both a method of treating fungal disease and the topical foam composition used in that method. The patent is directed to a temperature-sensitive, quick-breaking foam or mousse that deposits an antifungal on or in the skin and leaves a relatively low nonvolatile residue. The independent claims are:
Claims 23 and 27 are dependent composition claims with substantially narrower quantitative limitations. Claims 24-26 and 28 narrow those formulations further by specifying ketoconazole, polyoxyethylene sorbitan monostearate, cetyl alcohol, or stearyl alcohol. The patent does not broadly cover every ketoconazole topical product. A potentially infringing product must satisfy the required combination of:
How do claims 1 and 12 define the core patent scope?Claims 1 and 12 establish the broadest independent claim categories, but each contains multiple composition and performance limitations. Claim 1: method-of-treatment scopeClaim 1 requires:
This is a cumulative limitation structure. A method may avoid claim 1 if, for example, the product is a cream rather than a foam, uses a nonlisted surfactant, contains no hydrocarbon propellant, or does not meet the nonvolatile-residue limitation. The method claim also requires conduct by a user or healthcare provider. Merely manufacturing or selling a composition does not, by itself, satisfy every limitation of claim 1, although manufacture or sale may implicate the composition claims. Claim 12: composition scopeClaim 12 removes the express treatment step and claims the composition itself. This materially increases its enforcement value against manufacturers, suppliers, and sellers because the claim does not require proof that a patient applied the product. The composition claim still requires the same central architecture:
For a composition claim, the relevant analysis is the product's actual formulation and physical characteristics. Marketing language describing a product as a mousse is not sufficient if the product does not meet the claim's composition and performance requirements. What formulations are protected by claims 23-28?Claims 23-28 define the narrowest and most commercially relevant formulation embodiments.
Claims 23 and 27 are particularly important because they combine the key commercial formulation variables into a narrow quantitative profile. A ketoconazole product containing ethanol above 50%, water within the specified range, polysorbate 60, cetyl or stearyl alcohol, propylene glycol, and less than 10% hydrocarbon propellant would fall within the literal language of claim 28 if the remaining foam and penetration limitations were satisfied. What does "consisting essentially of" mean in these claims?"Consisting essentially of" creates an intermediate transition. It permits components that do not materially alter the basic and novel characteristics of the claimed formulation, while excluding components that materially change those characteristics. The principal claimed characteristics are the low-residue, quick-breaking, temperature-sensitive antifungal foam and its skin-penetration behavior. An accused formulation containing additional excipients could therefore raise a fact-intensive dispute over whether those excipients materially alter the claimed formulation. The phrase also limits the ability to avoid infringement through minor additions. Adding a conventional preservative, fragrance, chelating agent, or processing aid would not automatically remove a formulation from claim scope. How strong is the patent estate for U.S. Patent 7,553,835?The patent has a focused rather than expansive claim estate. StrengthsThe patent combines structural and functional limitations. It does not rely only on ingredient identity. It also requires:
Those limitations can make design-around more difficult where a competitor wants to reproduce the same aerosol performance and sensory profile. The composition claims are also useful commercially because they do not require proof of a treatment protocol. A formulation analysis may be sufficient to establish infringement of claims 12-28. WeaknessesThe claims contain several potential attack points:
The strongest claims against a ketoconazole aerosol are likely claims 24 and 28 if the commercial formulation matches the recited excipients and ranges. Claims 1 and 12 provide broader coverage but may face more prior-art and claim-construction challenges. When did U.S. Patent 7,553,835 lose exclusivity?The patent's nominal expiration date was in 2024, calculated from the earliest claimed priority date and subject to any applicable patent-term adjustment or extension. The patent issued on July 7, 2009, as U.S. Patent No. 7,553,835. Its term was not determined by the issue date. Under the Hatch-Waxman patent-term statute, the relevant baseline is generally 20 years from the earliest effective nonprovisional filing date, subject to statutory adjustments. (U.S. Patent and Trademark Office, n.d.-a; 35 U.S.C. § 154.)
A definitive term calculation must account for any patent-term adjustment, terminal disclaimer, pediatric extension, or other statutory modification recorded by the USPTO or FDA. Patent expiration also does not eliminate separate unexpired patents in the same family or patents protecting a particular approved product. What is the Orange Book status of U.S. Patent 7,553,835?The patent is associated with the ketoconazole foam product EXTINA, marketed under FDA-approved NDA 021743. EXTINA is a topical foam containing ketoconazole, an imidazole antifungal. FDA approved EXTINA in 2007 for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. (U.S. Food and Drug Administration, 2007.) The Orange Book distinguishes between:
An Orange Book listing does not itself prove that every claim in the patent covers the approved product, nor does it establish validity or enforceability. Patent listing and patent expiration must be evaluated separately from FDA approval status. (U.S. Food and Drug Administration, n.d.) The commercial significance of U.S. Patent 7,553,835 was greatest before its term ended. After expiration, a generic applicant would ordinarily no longer need to wait for this patent's term to expire, although other listed patents or regulatory exclusivities could still affect launch timing. What Paragraph IV challenges and generic entry risks exist?A Paragraph IV certification applies when an ANDA applicant asserts that a listed patent is invalid, unenforceable, or will not be infringed. For a patent that has already expired, an ANDA applicant generally would not need to rely on a Paragraph IV challenge to launch after the expiration date. The relevant certification could instead be a statement that the patent has expired or will expire before commercial marketing. For a still-listed patent, the practical questions are:
The principal generic risk is therefore formulation matching. A generic manufacturer could seek a lower-risk formulation by changing the surfactant, long-chain alcohol, propellant system, alcohol-to-water ratio, or residual nonvolatile content. Such changes may affect aerosol stability, dispensing behavior, drying time, skin feel, and bioequivalence strategy. Which companies are relevant to the commercial patent landscape?The principal product and patent entities are:
The patent is a small-molecule drug patent, not a biologic patent. Biosimilar provisions under the Public Health Service Act are therefore irrelevant. Any competitive entry would proceed through the generic-drug framework, principally an ANDA under Section 505(j) of the Federal Food, Drug, and Cosmetic Act. What patent litigation and settlement issues matter?The critical litigation issues would have been:
A settlement agreement could have restricted an earlier generic launch even if the patent was later invalidated or expired. But a settlement does not extend patent rights beyond the lawful patent term. Current launch analysis must therefore separate historical litigation or settlement dates from the patent's present expiration status. How does this patent compare with other ketoconazole protections?U.S. Patent 7,553,835 is formulation-centered. It does not primarily claim ketoconazole as a molecule. Ketoconazole itself was known long before this patent, and conventional creams, shampoos, gels, and solutions may implicate different patent families or no enforceable U.S. patent at all.
The patent's manufacturing barrier is limited to the extent that the claims do not expressly claim a specific filling process, canister system, valve design, or manufacturing sequence. Its practical barrier lies in reproducing the same formulation performance while meeting the claimed concentration ranges. What geographic coverage does U.S. Patent 7,553,835 provide?The patent provides rights only in the United States. It does not establish protection in Canada, Europe, Japan, or other markets. Foreign counterparts must be assessed separately by jurisdiction, including:
A U.S. expiration does not determine foreign expiration. Conversely, an unexpired foreign counterpart would not support a U.S. infringement action. Key Takeaways
FAQs About U.S. Patent 7,553,835Does U.S. Patent 7,553,835 cover ketoconazole cream?No. The supplied claims require a topical foamable composition with a hydrocarbon propellant and quick-breaking foam characteristics. A conventional ketoconazole cream would not satisfy those limitations. Is ketoconazole protected as an active pharmaceutical ingredient by this patent?No. The patent claims ketoconazole as one antifungal option within a broader imidazole or triazole formulation. Its principal protection is the topical foam composition and treatment method. Can a generic avoid the patent by using a nonhydrocarbon propellant?Potentially. Claims 1, 12, and their descendants expressly require a hydrocarbon gas propellant. A formulation using a different propellant system could avoid literal infringement of those claims, subject to other patents and any doctrine-of-equivalents analysis. Does a non-foam ketoconazole product require a Paragraph IV certification?Not necessarily. A non-foam product may not infringe the listed foam claims, but the ANDA applicant must evaluate all patents listed for the reference product and make the certifications required for each relevant patent. Does expiration of U.S. Patent 7,553,835 eliminate all barriers to generic EXTINA?No. Expiration removes this patent's ordinary term-based barrier. Other listed patents, formulation patents, regulatory exclusivity, manufacturing patents, litigation settlements, or product-specific regulatory requirements may still affect launch timing. References
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Drugs Protected by US Patent 7,553,835
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use | >Submissiondate |
Foreign Priority and PCT Information for Patent: 7,553,835
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| Australia | PO9838 | Oct 17, 1997 |
| Australia | PP1217 | Jan 06, 1998 |
| PCT Information | |||
| PCT Filed | October 19, 1998 | PCT Application Number: | PCT/AU98/00867 |
| PCT Publication Date: | April 29, 1999 | PCT Publication Number: | WO99/20250 |
International Family Members for US Patent 7,553,835
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 346588 | ⤷ Start Trial | |||
| Australia | 732456 | ⤷ Start Trial | |||
| Australia | 9728898 | ⤷ Start Trial | |||
| Canada | 2306560 | ⤷ Start Trial | |||
| Germany | 69836555 | ⤷ Start Trial | |||
| Denmark | 1024792 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
