Details for Patent: 6,706,276
Summary for Patent: 6,706,276
| Title: | Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa |
| Abstract: | Antimicrobial and contraceptive compositions and methods which prevent and/or reduce the risk of transmission of sexually transmitted diseases through sexual activity as well as prevent and/or reduce the risk of pregnancy are provided. The compositions contain (1) a matrix-forming agent, (2) a bio-adhesive agent, (3) a buffering agent, (4) optionally a humectant, (5) optionally a preservative, and (6) water; wherein the composition is suitable for application within the vagina; wherein the compositions forms a semisolid matrix on contact with ejaculate (thereby trapping ejaculated microbes and spermatozoa); wherein the composition causes hardening of cervical mucus (thereby decreasing the probability of sperm entry); wherein the composition forms a bio-adhesive layer over vaginal surfaces (thereby preventing or reducing the risk of contact of STD-causing microbes with the vaginal surfaces); wherein the composition maintains an acidic vaginal pH of less than about 5 in the presence of semen ejaculated from the male; and wherein the composition does not significantly impair the natural microbiological balance within the vagina. The antimicrobial and contraceptive compositions may also contain additional antimicrobial and/or contraceptive agents (e.g., nonoxynol-9, octoxynol-9, benzalkonium chloride, phosphorylated hesperidins, sulfonated hesperidins, polystyrene sulfonates, substituted benzenesulfonic acid formaldehyde co-polymers, H2SO4-modified mandelic acids, povidone iodine, itraconazole, ketoconazole, metronidazole, clotrimazole, fluconazole, teraconazole, miconazole, tinidazole, iconazole, chloramphenicol, nystatin, cyclopiroxolamine, and the like). |
| Inventor(s): | Sanjay Garg, Lourens Jan Dirk Zaneveld, Robert Anthony Anderson, Jr., Donald Paul Waller |
| Assignee: | Rush University Medical Center |
| Application Number: | US09/800,036 |
|
Patent Claim Types: see list of patent claims | Use; Composition; Dosage form; |
| Patent landscape, scope, and claims: | United States Patent 6,706,276: scope, claim coverage, and US patent landscape for vaginal antimicrobial-contraceptive matrix formulations Executive summary. US Patent 6,706,276 claims vaginal compositions and related use methods that are simultaneously (i) antimicrobial and contraceptive, (ii) matrix-forming and bio-adhesive, (iii) buffered to maintain acidic vaginal pH (<5, and in dependent claims about pH 3.5-4.5 in semen presence), and (iv) hypertonic, with semen contact producing semisolid matrix formation and cervical mucus hardening. The independent claim set is composition-centric and method-centric, plus a separate “solid composition” dispersible form. Claim scope is broad in polymer, buffering, humectant, preservative, and optional antimicrobial/contraceptive agent selection via Markush groups, while tightening via numeric ranges (typically 1-10% each key polymer/buffer component; narrower preferred ranges in dependents) and functional limitations (matrix/adhesion, pH maintenance against semen, mucus hardening, microbiological balance preservation). The optional-agent dependent claims expand coverage to specific known actives (notably nonoxynol-9 and multiple antifungals/antiprotozoals), creating compound-and-combination overlay risk for later formulators and generic/line-extension entrants. How broad are the claims in US Patent 6,706,276, and what exactly do they cover?Short answer (scope map). The patent claims a vaginal drug-delivery concept: a hypertonic, buffered, bio-adhesive matrix that (a) forms a semisolid matrix on semen contact, (b) hardens cervical mucus, (c) maintains acidic vaginal pH despite semen, and (d) is antimicrobial and contraceptive without adding separate antimicrobial/contraceptive agents (subject to dependent claims that permit added actives). It covers both preformulated “composition” and “solid composition” (dispersible) presentations, plus a method of administration/use. Independent claim coverage (what’s protected)US 6,706,276 claim structure (user-provided):
Implication for scope: Practically, infringement risk tracks whether a product is (i) vaginally applied, (ii) hypertonic, (iii) buffered acidic and maintains pH under semen load, (iv) uses one of the listed matrix-formers and one of the listed bio-adhesives at claimed levels, and (v) exhibits semisolid matrix formation and cervical mucus hardening plus bioadhesion. Core component Markush breadthThe claims use multiple Markush lists. Under US claim construction norms, infringement exposure remains if an accused formulation uses any one listed species for each functional role. Matrix-forming agents (claims 1/11/21/25):
Bio-adhesive agents (claims 1/11/21/25):
Buffering agents (claims 1/11/21/25):
System behavior is also claimed functionally
Numeric ranges and presentation types
What do the dependent claims add: humectants, preservatives, optional actives, and tighter pH/microbiome constraints?Short answer. Dependent claims substantially expand the “design space” by explicitly listing humectants and preservatives and by naming specific antimicrobial or contraceptive actives. They also tighten pH behavior and add a microbiome-sparing limitation. Humectant and preservative dependent coverageClaim 2/12/22/26: add humectant + preservative.
Key coverage consequence: If an accused product uses any listed humectant and preservative within allowed ranges, it fits additional dependent layers, even if the formulation’s novelty lies in the polymer/buffer system. Optional antimicrobial/contraceptive agent expansionClaims 3/13/4/14 and 7/17 and corresponding solid variants add an “antimicrobial or contraceptive agent” option. Large Markush list (claim 9/19/33): includes surfactant microbicides and multiple antifungal/antiprotozoal/antimicrobial actives:
Tighter enumerations in later dependents (claim 10/20/24/34):
Key design implication: Any vaginal microbicide or contraceptive additive that matches the Markush list creates an “overlay” infringement risk where the base matrix/buffer/pH/hypertonicity and semen-resistant acidic pH constraints are also met. pH and microbiological balance dependent limitationsClaim 5/15/29/?? (as provided):
Operational effect on claim validity and infringement:
Where is the “line” between claims 1 and 21: no added actives vs optional actives?Short answer. Claim 1 requires “antimicrobial and contraceptive without addition of antimicrobial or contraceptive agents.” Claim 21 allows a separate “antimicrobial or contraceptive agent” component at 0 to about 10%. Practical claim partitioning
Business/legal implication: Product developers who use common spermicides or microbicides (e.g., nonoxynol-9 or similar surfactants) face risk that both the “base concept” and the “option with added actives” are covered. How does the solid dosage form claim work, and what does “readily dispersable” change?Short answer. Claim 25 recasts the technology into a powder/granule/tablet form that disperses in aqueous medium inside or outside the vagina to yield the same in situ semisolid matrix and pH/hardening/bioadhesion behavior. Key additional element in claim 25
Dosage presentation dependents
Infringement relevance: A competitor can try to avoid “composition” liquid/semi-solid infringement by using a solid pre-dispersion format. Claim 25 and its dependents are designed to capture that fallback. What is the functional claim theme: semisolid matrix + semen-triggered hardening + acidic hypertonic environment?Short answer. The patent’s claim logic requires multiple functional outcomes in combination: semen contact triggers matrix formation, cervical mucus hardens, the vaginal environment stays acidic (pH <5 or pH 3.5-4.5), and hypertonicity supports antimicrobial/contraceptive effects. Functional outcomes and likely test correlates
How strong is the US patent estate for this technology, based on claim design?Short answer. The claim language is broad on composition ingredients (Markush lists) and broad on component roles (matrix forming, bio-adhesion, buffering). It adds several “anchor” functional limitations that are harder to satisfy by random vaginal formulations, which increases validity defensibility if those anchors were supported by data. Strength drivers (from claim content)
Primary vulnerability vectors (from claim content)
(These are litigation and prosecution considerations inferred from claim structure.) What generic or competitive entry risks exist if a product matches the polymer/buffer/hypertonic pH behavior?Short answer. Risk is high for any vaginal prophylactic/contraceptive product using the claimed matrix-former + bioadhesive polymer + acidic buffer system in hypertonic conditions that maintain acidic pH in semen exposure and cause cervical mucus hardening. Most direct infringement fact pattern
Common design-arounds and their likely limitations under this claim language
How do you operationalize the claim elements for infringement mapping and freedom-to-operate?Short answer. Treat the patent like a matrix: match each element in priority order, then verify dependent-range and optional-component coverage. Element-by-element claim checklist (US 6,706,276)
When does exclusivity end, and what is the Orange Book / Hatch-Wax relevance for this patent?Short answer (based on provided information). Nothing in the prompt identifies an FDA-approved drug product, NDC, reference listed drug, Orange Book listing, or Hatch-Wax exclusivity period tied to US 6,706,276. Without that product linkage, the exclusivity and Orange Book status cannot be determined from the claim text alone. Which companies are challenging this patent via Paragraph IV, and what litigation affects its scope?Short answer (based on provided information). The prompt does not include any patent litigation records, PTAB filings, district court case captions, Paragraph IV notices, settlements, or assignee/company mapping. Without that, a company-by-company challenge landscape cannot be produced. Key Takeaways
FAQs
References (APA)
More… ↓ |
Drugs Protected by US Patent 6,706,276
| 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 6,706,276
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Austria | 489937 | ⤷ Start Trial | |||
| Australia | 2001243431 | ⤷ Start Trial | |||
| Australia | 4343101 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
