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Details for Patent: 5,656,286
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Summary for Patent: 5,656,286
| Title: | Solubility parameter based drug delivery system and method for altering drug saturation concentration |
| Abstract: | A blend of at least two polymers, or at least one polymer and a soluble polyvinylpyrrolidone, in combination with a drug provides a pressure-sensitive adhesive composition for a transdermal drug delivery system in which the drug is delivered from the pressure-sensitive adhesive composition and through dermis when the pressure-sensitive adhesive composition is in contact with human skin. According to the invention, soluble polyvinylpyrrolidone can be used to prevent crystallization of the drug, without affecting the rate of drug delivery from the pressure-sensitive adhesive composition. |
| Inventor(s): | Jesus Miranda, Steven Sablotsky |
| Assignee: | Noven Pharmaceuticals Inc |
| Application Number: | US08/178,558 |
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Patent Claim Types: see list of patent claims | Composition; Compound; Process; Delivery; Device; |
| Patent landscape, scope, and claims: | US Patent 5,656,286: What Is Claimed in the Transdermal Adhesive System and Where It Sits in the LandscapeUS 5,656,286 claims a specific transdermal drug delivery architecture built around a pressure-sensitive adhesive (PSA) blend plus a defined solubilized polyvinylpyrrolidone (PVP) component and optional enhancer. The claims are drafted to cover a wide drug genus while tying composition scope to particular PSA polymer families and, in dependent claims, to specific drug classes (notably steroids, β2-agonists, cardioactives, CNS agents, and others). What is the core claim scope (independent claim 1)?Independent claim 1 (composition-first)Claim 1 is a transdermal drug delivery system that comprises:
Composition logicThe claim’s “center of gravity” is not the drug. It is the adhesive formulation system:
Practical scope implicationIf a product matches the PSA blend ranges and contains soluble PVP within 1 to 20 wt% and uses transdermal delivery, it is within the claim framework regardless of whether the drug is an estrogen, antiseptic, CNS agent, or other listed genus. Which dependent claims materially narrow or expand the patent’s coverage?Polymer-level narrowing/variations
Structural format coverage
These claims widen the product-form footprint: not just “any patch,” but patches, defined shapes, sheet or unit forms, and reservoir architectures. Process coverage
Process claims expand leverage for formulation manufacture even if end-product design attempts to shift certain order-of-addition details, though infringement still requires meeting all claim elements. What formulation element drives patent defensibility: PVP plus PSA blend plus solubility engineering?PVP is a fixed composition anchor
This creates two layered coverage bands around soluble PVP. Solubility parameter engineering in claim 4Claim 4 adds a formulation requirement that is unusually specific:
That element functions as a technical filter. It can separate “close” formulations that otherwise use similar polymer families and PVP. How broad is the drug coverage (and where is it concentrated)?Claim 1 drug scope is essentially genus-drivenClaim 1 states “one drug or mixture of two or more drugs” with no further limitation in the independent. Dependent claims then map major drug categories. Concentrated steroid coverageThe patent gives extensive dependent detail for steroid selection and dosing:
This is the clearest “hot zone” of claim-specificity because it defines:
Other high-enumeration categories
Net effectThe drug portion is drafted to be broad at claim 1 and expansive via many dependent claims, which can support multiple infringement theories across different commercial drug candidates if they use the same adhesive system. What optional add-ons extend coverage beyond the base PSA blend?Enhancer
Clay
Clays can be used to affect water uptake, swelling, and mechanical properties. Claim 16 and 17 create another axis of differentiation for formulations that add inorganic particles. Defined impermeable backing and release liner
How does the patent landscape likely organize around this patent type (US filing context)?US 5,656,286 is structured as a transdermal PSA formulation patent with:
In practice, landscape separation tends to fall into these competitive buckets: 1) “Same adhesive platform” competitorsFormulators who use:
These face direct platform-level claim risk, especially for estrogen and steroid products where dependent claims provide more anchors. 2) “Solubility-parameter engineered polyacrylate” competitorsClaim 4 introduces a distinct technical filter:
Products designed to avoid that condition may still fall under claim 1 if they omit polyacrylate entirely but still include the claim 1 PSA blend plus PVP. 3) “Drug-specific transdermal” competitorsMany later patents in transdermal space focus on:
US 5,656,286 creates vulnerability for those entrants if they use the same PSA blend and soluble PVP architecture, even when their innovation is “just” a drug selection. 4) “Structure-only” variantsEven if a competitor matches the structure layers (backing, liner, sheet/unit), infringement still requires meeting the adhesive composition claims. US 5,656,286’s emphasis on the PSA blend and PVP reduces the ability for competitors to “design around” by changing only patch geometry. What does claim 4 add to the landscape (and why it matters)?Claim 4 is a second major independent-like anchor within your provided claim set:
From a landscape perspective, claim 4 creates a second formulation family within the same patent:
This dual-track drafting is a common way to capture:
Where are the strongest commercially relevant claim hooks?Based on the dependent claim enumerations, the most commercially visible drug categories include:
Key Takeaways
FAQs1) Does claim 1 require a specific drug?No. Claim 1 recites “one drug or a mixture of two or more drugs,” and dependent claims then enumerate drug classes and examples. 2) What is the fixed PVP requirement?Across claim 1 and the claim 4 branch, soluble PVP must be present at about 1% to about 20% by weight of the total pressure-sensitive adhesive composition (dependent claims specify molecular weight bands). 3) What adhesive polymers are mandatory in the PSA blend?The PSA blend is defined as including (i) a PSA polymer selected from a listed group at 14% to 94%, (ii) polyisobutylene at 10% to 90%, and (iii) polysiloxane at 5% to 95%. 4) How does claim 4 differ from claim 1?Claim 4 adds polyacrylate (5% to 85%) and a constraint that the solubility parameter difference between polyacrylate and the base PSA (a) is at least 2 (J/cm³)^(1/2), while still requiring soluble PVP and drug plus optional enhancer. 5) Do the device-layer claims create standalone infringement risk?They do not appear standalone in this claim set. Backing, release liner, and reservoir architecture are dependent to the composition-focused claim framework, so infringement still requires meeting the adhesive/PVP composition elements. References[1] US Patent No. 5,656,286. Transdermal drug delivery systems using pressure-sensitive adhesive blends with soluble polyvinylpyrrolidone and optional enhancers. More… ↓ |
Drugs Protected by US Patent 5,656,286
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
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| >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 5,656,286
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 002355 | ⤷ Start Trial | |||
| Austria | 122240 | ⤷ Start Trial | |||
| Austria | 144704 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
