Details for Patent: 8,071,644
Which drugs does patent 8,071,644 protect, and when does it expire?
Patent 8,071,644 protects EPIDUO and is included in one NDA.
This patent has thirty-five patent family members in twenty-two countries.
Summary for Patent: 8,071,644
| Title: | Combinations of adapalene and benzoyl peroxide for treating acne lesions | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | Adapalene or a pharmaceutically acceptable salt thereof formulated into a pharmaceutical composition is useful for reducing the number of acne lesions, via daily topical application, in combination or in association with benzoyl peroxide (BPO); such treatment may be via administration of a pharmaceutical composition combining adapalene and BPO or by a concomitant application of two pharmaceutical compositions, one containing adapalene and the other containing BPO. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Marie-line Abou-Chacra Vernet, Denis Gross, Christian Loesche, Michel Poncet | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Galderma Research and Development SNC | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US12/318,937 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for patent 8,071,644 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 8,071,644: Scope, Claims, Expiration, and Adapalene/Benzoyl Peroxide Patent LandscapeU.S. Patent No. 8,071,644 protects a narrowly defined therapeutic use of a fixed-dose adapalene 0.1% and benzoyl peroxide 2.5% combination. The patent does not broadly claim every adapalene and benzoyl peroxide composition. Its principal limitations are a single topical formula, fixed concentrations, use of the two ingredients as the only anti-acne actives, and a synergistic clinical effect. Dependent claims narrow the product to a gel and, for claim 3, require once-daily treatment for 12 weeks. The patent is associated with the Epiduo product concept, which was approved by the FDA as adapalene and benzoyl peroxide gel, 0.1%/2.5%, for topical acne treatment.[1] Its commercial value rested on protecting the combination rather than either active ingredient individually. What does U.S. Patent 8,071,644 cover?The patent covers two related method categories:
The patent is a use patent. It does not, based on the quoted claims, claim a composition in the abstract, a manufacturing process, a container, a package, or a particular excipient system. How should claim 1 be construed?Claim 1 contains several cumulative limitations. A potentially infringing use must satisfy all of them. Fixed active concentrationsThe formula must contain:
A product containing adapalene 0.3%, benzoyl peroxide 2.5%, or another concentration pair falls outside the literal scope of claim 1 unless another claim or an infringement theory applies. The claim is directed to concentrations in the administered formula, not merely to the amount dispensed. A product labeled as 0.1% adapalene and 2.5% benzoyl peroxide is the clearest match. Single formulaThe two active ingredients must be combined in one formula and delivered together. Separate tubes, sequential application, or a kit containing two products would not literally satisfy the “single formula” limitation. This limitation distinguishes the patent from treatment protocols that use adapalene and benzoyl peroxide separately. It also reduces the patent’s reach against dual-product regimens. Topical administrationThe claimed therapy is topical. Oral administration, systemic administration, or non-topical delivery is outside the literal language. Only anti-acne active ingredientsAdapalene and benzoyl peroxide must be the only anti-acne active ingredients in the formula. The limitation does not necessarily exclude inactive excipients, preservatives, emulsifiers, penetration enhancers, stabilizers, or other formulation components. A formula containing a third anti-acne active, such as clindamycin, would not satisfy the claim as written. A formula containing a non-anti-acne ingredient would require analysis of whether that ingredient is legally classified as an active ingredient and whether it has an anti-acne function. Synergistic deliveryThe claim requires the actives to be delivered “together in synergistically.” The wording ties the combination to a synergistic or potentiating effect. This creates an evidentiary issue in enforcement because the patentee may need to show that the accused use produces, or is represented as producing, the claimed clinical relationship. The specification and prosecution history would be important in determining whether “synergistically” is merely a result limitation, a limitation requiring a particular level of efficacy, or a limitation supported by the clinical data disclosed during prosecution. What additional limitations do claims 2, 3, and 4 add?Claim 2: gel dosage formClaim 2 narrows claim 1 to a gel. It does not claim every adapalene and benzoyl peroxide gel. The gel must also satisfy the fixed-dose, single-formula, topical, two-active, potentiation limitations of claim 1. A lotion, cream, emulsion, foam, solution, or suspension would not literally satisfy claim 2, although it could remain relevant to claim 1 if the product otherwise qualifies as a single topical formula. Claim 3: once-daily 12-week regimenClaim 3 is materially narrower than claim 1. It requires:
The comparative limitation is the most technically demanding part of claim 3. The claim refers to superiority in at least one of two outcomes:
The superiority must occur at least one of weeks 1, 2, 4, 8, or 12. The claim therefore does not require superior results at every time point or for both endpoints. The phrase “sum of the net clinical benefits” is directed to an additive comparison. The relevant question is whether the combination produces a result greater than the combined results associated with adapalene 0.1% alone and benzoyl peroxide 2.5% alone at a corresponding assessment point. Claim 4: gel plus regimen limitationsClaim 4 combines the limitations of claim 3 with the gel requirement. It is the narrowest claim in the set. What is the likely infringement exposure for generic Epiduo products?A generic product closely matching the FDA reference product presents the highest literal exposure under claims 1 and 2 because it would likely have the following characteristics:
For a generic approved through an abbreviated new drug application, the label and proposed use are central. A label instructing once-daily use for acne with the same fixed-dose gel could support a claim of induced infringement if the patent were enforceable and the labeled use satisfied the remaining limitations. The patent does not automatically block all generic adapalene or benzoyl peroxide products. A product may avoid literal claim coverage by changing the concentration, separating the actives, using a different dosage form, adding another anti-acne active, or omitting the once-daily 12-week regimen. Those changes may create regulatory or commercial disadvantages even where they reduce patent exposure. What is the FDA and Orange Book status of Epiduo?Epiduo, adapalene and benzoyl peroxide gel 0.1%/2.5%, received FDA approval in 2008 under NDA 022320.[1] The product is a topical acne treatment and is not a biologic. Biosimilar provisions therefore do not apply. The relevant competitive pathway is an ANDA for a generic drug, not a 351(k) biosimilar application. The FDA Orange Book identifies patents and regulatory exclusivity associated with approved drug products. Patent listing, however, does not establish that every claim is valid, infringed, or enforceable. A listed patent may be challenged through Paragraph IV certification.
The quoted claims are method claims rather than a simple composition claim. The precise Orange Book use code and any patent-listing history are therefore important to determine which labeling language a generic applicant would need to address. When does U.S. Patent 8,071,644 lose exclusivity?The patent’s earliest priority date is generally reported as September 17, 2001, based on the Galderma adapalene/benzoyl peroxide development family.[2] On a standard 20-year patent-term calculation, the base term would have expired in September 2022, subject to patent-term adjustment, patent-term extension, pediatric exclusivity, or other statutory adjustments.
A six-month pediatric extension, if applicable, would move the effective exclusivity endpoint into March 2023. Patent-term adjustment must be determined from the USPTO’s official term calculation rather than inferred solely from the priority date. The patent’s commercial blocking effect should therefore be assessed against the official legal-status record and the Orange Book entry, not the grant date. Which patent family is associated with the Epiduo combination?U.S. Patent 8,071,644 belongs to the Galderma adapalene/benzoyl peroxide development family. The family’s central technical concept is the combination of a retinoid, adapalene, with the oxidizing antibacterial agent benzoyl peroxide in a single topical product. The family should be separated into four categories:
U.S. Patent 8,071,644 is principally a combination-use and clinical-use patent. It should not be treated as proof that every gel formulation or every manufacturing process for adapalene and benzoyl peroxide is covered by the same claims. Later patents may address higher-strength adapalene products, improved formulations, stability, or delivery systems. Those patents must be analyzed separately. A later formulation patent can remain relevant after expiration of an earlier combination-use patent, but it cannot extend the expired claims of U.S. Patent 8,071,644. What formulation patents may create separate barriers?Formulation patents can create independent exposure even when a generic avoids the method claims of U.S. Patent 8,071,644. Typical formulation claim elements include:
A generic manufacturer can avoid one formulation patent by using a non-infringing excipient system, but that may affect bioequivalence, product stability, manufacturing cost, or regulatory risk. The formulation estate is therefore commercially separate from the expired or expiring clinical-use estate. What Paragraph IV challenges and settlements affect the patent?A Paragraph IV certification would assert that the listed patent is invalid, unenforceable, or not infringed. For this patent, the most credible challenge theories would include:
The patentee would likely rely on clinical data showing that the combination produced results greater than the expected additive effect of the two monotherapies. No settlement terms should be inferred from the patent grant, Orange Book listing, or FDA approval alone. A settlement agreement, launch date, license, or covenant not to sue requires a docketed court filing, public settlement statement, or other authenticated record. The patent itself contains no evidence of a generic settlement. How strong is the patent estate for the adapalene/benzoyl peroxide combination?The estate was strongest against a product that reproduced the reference product exactly: a 0.1%/2.5% gel, administered topically once daily, with no other anti-acne active. Its principal strengths were:
Its principal weaknesses were:
The patent was therefore commercially important during its enforceable term but did not create a permanent barrier to all adapalene or benzoyl peroxide products. What generic launch scenarios exist?Exact generic matchA generic 0.1%/2.5% gel with once-daily acne labeling most closely maps to claims 1 through 4. During the enforceable patent term, this was the highest litigation-risk scenario. Different strengthA product containing adapalene 0.3% or another adapalene concentration may avoid the literal fixed-dose limitation. It may face separate patents or clinical and regulatory considerations. Separate productsA two-product regimen may avoid the single-formula limitation. It may not be therapeutically or commercially equivalent to Epiduo. Different dosage formA cream, lotion, foam, or other dosage form may avoid the gel-dependent claims while still requiring analysis under claim 1. Combination with a third anti-acne activeAdding another anti-acne active may avoid the “only anti-acne active ingredients” limitation. It would create a different product, regulatory, safety, and formulation profile. How does this patent compare with biosimilar and biologic exclusivity?U.S. Patent 8,071,644 concerns a small-molecule topical drug. It has no biosimilar exclusivity implications. The relevant exclusivity categories are:
A biosimilar applicant does not challenge Epiduo through the Biologics Price Competition and Innovation Act. Generic competition proceeds under the Hatch-Waxman framework. Key Takeaways
FAQsDoes U.S. Patent 8,071,644 claim Epiduo as a composition?No. The quoted claims are method and regimen claims. They require use or administration of the fixed-dose combination and do not independently claim every composition containing adapalene and benzoyl peroxide. Would a 0.3% adapalene and 2.5% benzoyl peroxide product infringe claim 1?Not literally, because claim 1 specifies 0.1% adapalene and 2.5% benzoyl peroxide. A separate patent analysis would be required for other concentrations. Does a separate adapalene tube and benzoyl peroxide tube fall within the claims?Generally, no literal infringement of the quoted claims would arise because the claims require the actives to be combined in a single formula and delivered together. Can a generic avoid claims 3 and 4 by omitting a 12-week treatment instruction?Omitting the 12-week regimen may avoid the literal duration limitation in claim 3, but claims 1 and 2 do not contain the same express 12-week requirement. The complete label and actual induced-use theory remain relevant. Are excipients prohibited by the “only anti-acne active ingredients” limitation?No. The language targets anti-acne active ingredients. It does not, on its face, exclude ordinary inactive excipients, although an ingredient’s regulatory classification and functional role may affect claim analysis. References
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Drugs Protected by US Patent 8,071,644
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Galderma Labs Lp | EPIDUO | adapalene; benzoyl peroxide | GEL;TOPICAL | 022320-001 | Dec 8, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | Y | TREATMENT OF ACNE | ⤷ Start Trial | |||
| >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: 8,071,644
| Foriegn Application Priority Data | ||
| Foreign Country | Foreign Patent Number | Foreign Patent Date |
| France | 06 52968 | Jul 13, 2006 |
International Family Members for US Patent 8,071,644
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 061989 | ⤷ Start Trial | |||
| Australia | 2007274288 | ⤷ Start Trial | |||
| Brazil | PI0713182 | ⤷ Start Trial | |||
| Canada | 2656456 | ⤷ Start Trial | |||
| China | 101541320 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
