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Details for Patent: 6,682,348
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Summary for Patent: 6,682,348
| Title: | Dispensing apparatus and cartridge | ||||||||||||||||||||||||||||||||||||||
| Abstract: | A device for the treatment of periodontal disease includes a handle that has a configuration familiar to dental professionals, and a cartridge, that is locked into the handle when use, typically delivery of a composition to a periodontal pocket is desired. The cartridge provides for effective delivery of compositions, such as agents, as its tip is deformable, typically from a circular to an oval shape so as to flatten. The deformation may be made, either manually, by the dental professional, or upon contact with teeth or other tissues, whereby this flattened tip can penetrate deeply into periodontal pockets for quick and direct application of the composition, for example, therapeutic agents. | ||||||||||||||||||||||||||||||||||||||
| Inventor(s): | James R. Lawter, Michael G. Lanzilotti, Mark Bates, Gregory H. Hunter | ||||||||||||||||||||||||||||||||||||||
| Assignee: | OraPharma Inc | ||||||||||||||||||||||||||||||||||||||
| Application Number: | US10/112,450 | ||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Delivery; Device; | ||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Drug Patent 6,682,348: Claim Scope, Expiration, Patent Landscape, and Generic RiskUS Patent No. 6,682,348 protects a periodontal delivery system rather than minocycline chemistry alone. Its core combination is a deformable dispensing tip, a plunger-driven cartridge, and, in the narrower claims, dry therapeutic particles such as minocycline hydrochloride microspheres. The patent also covers a dedicated handle, anti-rotation structure, sterile packaging, radiation-sterilizable components, and methods for placing dry particles into periodontal pockets. The patent was granted on January 27, 2004. Based on the ordinary 20-year patent term measured from its effective nonprovisional filing date, the US term appears to have expired in 2021, subject to any patent-term adjustment or terminal disclaimer recorded in the official prosecution file. An expired patent cannot block a current US generic launch, although it remains relevant to historical Orange Book listings, freedom-to-operate analysis, and claim interpretation. What does US Patent 6,682,348 protect?The patent protects three related claim categories:
The broadest apparatus claim containing the drug-delivery system is claim 1. The broadest apparatus claim overall is claim 34 because it does not require dry particles. Claim 40 is the principal method claim. The patent therefore has two commercial layers:
A product can implicate claim 34 without containing a drug. A drug-filled product must satisfy the additional limitations of claim 1 and its dependent claims if infringement is asserted under that claim set. How broad is independent claim 1?Claim 1 requires all of the following:
The claim does not require a particular commercial drug, particle-release rate, exact tip shape, exact handle design, or particular polymer unless those limitations are imported through dependent claims. The most commercially important limitations are the deformable tip and dry particles located in the tip. A conventional syringe with a rigid needle would not naturally satisfy the deformable-tip limitation. A liquid-filled periodontal syringe would not satisfy the dry-particle limitation of claim 1, although it could raise different issues under the device-only claims if the structural requirements are met. The phrase "configured for being deformed" is potentially broad. It can cover a tip supplied in one geometry and manually flattened, compressed against a tooth or tissue, or otherwise reshaped before insertion. Claim 40 expressly covers deforming the tip to a substantially flattened geometry. What does claim 34 add to the patent landscape?Claim 34 covers an apparatus for dispensing material without requiring the presence of dry particles. It repeats the core mechanical design:
This claim is structurally significant because it can reach an unfilled cartridge or delivery device. A competitor cannot avoid claim 34 merely by selling the device without minocycline. The competitor would need to avoid at least one structural limitation, such as the flange-locking arrangement, deformable tip, or plunger-to-actuator interface. Claims 35-39 narrow claim 34 by adding:
These claims have less reach than claim 34 but provide more specific coverage of the commercial applicator architecture. What therapeutic agents and formulations are covered?Claims 2-17 create a broad formulation and particle hierarchy. Therapeutic-agent categoriesClaim 7 covers a wide list of agents, including:
Claims 8-11 narrow the field to antibiotics, tetracyclines, doxycycline and minocycline. Claim 21 specifically identifies minocycline hydrochloride. The claim language does not require the product to be marketed under the Arestin name. A different brand containing dry minocycline particles could fall within the same claim scope if it also uses the claimed cartridge and tip configuration. Biodegradable dry matrixClaim 3 requires the therapeutic agent to be dispersed in a dry matrix containing a biocompatible and biodegradable polymer. Claim 4 identifies polymers including:
Claim 5 covers a block copolymer based on polyglycolide, trimethylene carbonate and polyethylene oxide. Claim 6 covers polymers that become tacky on contact with water. These limitations matter because periodontal products may use microspheres or particles that hydrate, adhere to tissue, and release antibiotic locally. A formulation using a nonbiodegradable carrier, liquid vehicle, or substantially different particle structure may avoid particular dependent claims, but it could still be evaluated against claims 1, 2, 8, 9, 10 or 11. Particle size and drug loadingThe particle-size range is nested:
The drug-loading ranges are also nested:
The use of "about" creates ordinary claim-construction questions concerning measurement method, rounding, manufacturing tolerances and whether the accused product falls within a technically meaningful range. These ranges are narrower than claim 1 and should be treated as formulation-specific fallbacks rather than the primary scope of the patent. What mechanical features are protected?Cartridge and handle interfaceThe body has flexible flanges that temporarily lock against an external force-applying member. Claims 23-26 define the external member as a handle having:
This arrangement distinguishes the patented system from a standard medical syringe. The handle is not merely an accessory in the dependent claims. It is part of the claimed combination and may be important in assessing literal infringement. Anti-rotation structureClaims 22 and 35 require at least one nub on the barrel and a corresponding indent in the actuator. The structure prevents rotation of the barrel during use. A competitor using friction alone, a keyed rail, a polygonal barrel, or another anti-rotation mechanism may avoid these dependent claims, although the broader claims remain relevant. Deformable tipThe tip must be capable of assuming at least one geometry different from its initial geometry. Claim 40 narrows the method to a substantially flattened tip before insertion into the periodontal pocket. Claim 43 states that deformation may occur manually. Claim 44 covers deformation through contact with a tooth or other tissue. A flexible or heat-formable tip is more likely to meet this limitation than a rigid cannula. The analysis will depend on whether the tip is intended and capable of deformation during the claimed procedure, not simply whether it can be damaged or bent accidentally. What packaging and sterilization features are covered?Claims 27-33 cover commercial presentation and manufacturing attributes:
These claims are narrow. An aluminum-laminate pouch is not required by claim 1. It becomes relevant only where a product practices claims 28-32. A competitor using a glass vial, blister, foil pouch of a different construction, or nonresealable package may avoid specific packaging claims while remaining exposed to the apparatus claims if the cartridge structure is the same. What does claim 40 protect?Claim 40 covers a method for treating dental disease using:
Claim 41 adds delivery of the particles. Claim 42 requires movement of the force-applying member to move the plunger and release the particles. Claims 43 and 44 specify manual deformation or deformation upon contact with a tooth or tissue. The method claims are narrower than a general claim to administering minocycline for periodontitis. They require the claimed cartridge-and-tip procedure. A practitioner using a different delivery method may not practice claim 40, even if the same antibiotic is used. When did US Patent 6,682,348 lose exclusivity?The patent was granted on January 27, 2004. US utility patents generally expire 20 years from the earliest effective nonprovisional filing date under 35 U.S.C. §154(a)(2). The relevant expiration date appears to have fallen in 2021, subject to any recorded patent-term adjustment or terminal disclaimer.
The patent’s expiration means that claims 1-44 no longer create a current US exclusionary right if the term expired without a later adjustment. Historical Orange Book listing does not extend patent enforceability. What is the Orange Book status of US Patent 6,682,348?US 6,682,348 was associated with the periodontal drug-delivery technology used for minocycline hydrochloride products, including Arestin-related regulatory and patent analysis. FDA Orange Book listings must be evaluated at the NDA level and by the patent-use-code information submitted by the NDA holder. The listing of a patent does not itself establish infringement or validity. For a generic applicant, the relevant pathway would historically have involved:
Because the patent’s ordinary term has ended, it should not independently support a present Paragraph IV barrier. Other formulation, composition, process or regulatory exclusivities must be reviewed separately. Which companies challenged the minocycline periodontal market?The principal commercial reference product associated with this technology is Arestin, originally developed by OraPharma and later associated with Valeant Pharmaceuticals and other commercial owners. Arestin contains minocycline hydrochloride microspheres for localized treatment of periodontal disease. A complete current challenger list, including every ANDA filer, litigation docket, settlement agreement and licensed manufacturer, cannot be established from the patent claims alone. The patent itself does not identify all later ANDA applicants or private settlement terms. The relevant competitive set includes generic manufacturers targeting minocycline microspheres, dental anti-infective products, systemic tetracycline products, and alternative local periodontal delivery systems. What patent landscape surrounds US 6,682,348?The surrounding landscape has four principal layers. Minocycline and biodegradable microsphere patentsEarlier composition patents, including patents associated with minocycline-containing biodegradable microspheres, may cover the drug-polymer particle independent of the applicator. US Patent No. 5,538,715 is a prominent related Arestin-era patent and should be analyzed separately from US 6,682,348 because its term and claim scope are different. Applicator patentsUS 6,682,348 concentrates on:
A competing product can avoid this patent by changing the delivery architecture even if its drug formulation is similar. Method-of-use patentsThe method claims focus on introducing dry particles into a periodontal pocket with a flattened tip. Other patents may claim treatment of periodontitis, local tetracycline administration, dosing schedules, or adjunctive scaling and root planing. Those claims require separate validity, expiration and regulatory-use analysis. Manufacturing and packaging patentsThe patent includes selected polymer and packaging limitations, but it does not comprehensively cover all manufacturing processes. Relevant freedom-to-operate issues may include:
A manufacturer can avoid the packaging claims while still facing unrelated process or formulation patents. How strong is the patent estate?The estate was commercially meaningful while active because it combined a specialized applicator with a localized antibiotic-particle formulation. Its strongest practical features were the integrated cartridge, dry particles positioned in the tip, and deformable tip designed for periodontal-pocket access. Its current legal strength is limited by expiration. The principal remaining business value is historical and technical:
The broadest surviving design-around question is claim 34. A product that lacks the claimed flexible-flange engagement or deformable tip may avoid the device claims even if it delivers dry minocycline particles. A liquid formulation, rigid cannula, conventional syringe, or separately packaged applicator could materially change the infringement analysis. What generic launch risks exist?The patent itself does not present a current US launch block after expiration. Generic risk shifts to:
A generic applicant should not assume that expiration of US 6,682,348 eliminates all Arestin-related risk. The patent is one component of a broader drug-device and formulation estate. Key Takeaways
FAQs About US Patent 6,682,348Does US 6,682,348 cover Arestin?It covers delivery-system configurations and, in narrower claims, dry therapeutic particles including minocycline hydrochloride. Arestin-related infringement analysis also requires review of separate composition, formulation and regulatory patents. Can a generic use liquid minocycline and avoid this patent?A liquid product would not meet the dry-particle limitation in claim 1. It may also avoid claim 40 if it does not use the claimed deformable-tip procedure. Other patents and regulatory requirements could still apply. Does the patent cover every periodontal syringe?No. The claims require specific structural features, including flexible flange engagement and a deformable tip. A conventional rigid syringe is not automatically within the patent’s scope. Are the aluminum-laminate pouch claims commercially important?They are narrow dependent claims. They apply only when the product uses the claimed packaging configuration. They do not define the principal scope of the cartridge or drug-delivery claims. Is a Paragraph IV challenge still required for this patent?After expiration, this patent should not independently require a Paragraph IV certification. An ANDA applicant must still review the current Orange Book and certify against any other listed, unexpired patents for the reference product. References
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Drugs Protected by US Patent 6,682,348
| 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 |
International Family Members for US Patent 6,682,348
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 039205 | ⤷ Start Trial | |||
| Australia | 2003223384 | ⤷ Start Trial | |||
| Australia | 2009201777 | ⤷ Start Trial | |||
| Brazil | 0308859 | ⤷ Start Trial | |||
| Canada | 2479995 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
