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Details for Patent: 4,507,305
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Summary for Patent: 4,507,305
| Title: | 9-(1,3-Dihydroxy-2-propoxymethyl)guanine as antiviral agent | ||||||||||||||||||||||||||||||||||||||||||||
| Abstract: | The compound 9-(1,3-dihydroxy-2-propoxymethyl)guanine and the pharmaceutically acceptable salts thereof are useful as antiviral agents. | ||||||||||||||||||||||||||||||||||||||||||||
| Inventor(s): | Julien P. H. Verheyden, John C. Martin | ||||||||||||||||||||||||||||||||||||||||||||
| Assignee: | Hoffmann La Roche Inc , Syntex USA LLC , Roche Holdings Inc | ||||||||||||||||||||||||||||||||||||||||||||
| Application Number: | US06/473,169 | ||||||||||||||||||||||||||||||||||||||||||||
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Patent Claim Types: see list of patent claims | Use; Composition; | ||||||||||||||||||||||||||||||||||||||||||||
| Patent landscape, scope, and claims: | United States Patent 4,507,305: Scope of Claims, Claim Construction, and US Patent LandscapeUS Patent 4,507,305 claims a specific antiviral nucleoside compound and compositions/methods around its administration routes. The claim set is narrow on chemistry (compound identity is fixed) and broad on use cases (multiple virus labels, multiple administration routes, human coverage). What does US 4,507,305 claim, in plain scope terms?Core active (hard limit)All substantive claims revolve around one compound identity:
This compound identity functions as the primary boundary of infringement scope. Any design-around that changes the chemical entity is outside these claim constructs, regardless of antiviral activity. Composition claims (injectable)Claims 1-3 define an injectable pharmaceutical composition:
Practical read-through: the composition claims target both the compound form and formulation class (injectables with carriers). They do not specify concentration ranges, excipients, pH, particle size, isotonicity, or sterilization attributes in the claim text provided, which makes the injectable “carrier” language a broader net than if formulation parameters were required. Method claims (treating by administration)Claims 4-10 cover treatment by administering the composition:
Claims 11-16 cover oral administration:
Claims 17-20 cover topical administration:
Practical read-through: the same compound supports parallel infringement theories across injectable, oral, and topical routes. The claims also include both composition-based administration (injectable uses composition of claim 1) and direct compound/salt administration (oral and topical use compound or salt, without requiring the specific “carrier” language of claim 1). What is the legal and commercial shape of the claim scope?1) The compound identity is the main gateAny product that does not contain 9-(1,3-dihydroxy-2-propoxymethyl)guanine or an equivalent “pharmaceutically acceptable salt” will not land on the literal core of claims 1, 4, 11, or 17 as written. 2) Salt scope is defined, not open-ended
If a product uses a potassium salt, claim 3 does not apply, but claim 2 can still apply (if it is an alkali metal salt). If a product uses a non-alkali salt (for example, calcium, magnesium, or organic salts), claims 2 and 3 fall away, but claim 1 still allows “pharmaceutically acceptable salt” in general terms. 3) Carriers and formulation parameters are not enumeratedClaim 1 requires a “pharmaceutically acceptable carrier” but does not list carrier types. That typically broadens coverage to many conventional injectable formulation styles, as long as they meet “pharmaceutically acceptable” standards and include an effective amount of the compound or its salt. 4) “Effective amount” and “treating viral infection” drive functional breadthThese terms create functional claim language:
5) Virus labels are enumerated and route-specific is notVirus labels appear as dependent specificity, but they are not tied to a single route in claim numbering:
So a single viral indication can be pursued across different delivery platforms while still staying within the claim architecture, subject to route and dosing. Where are the key infringement vectors (and design-around angles)?Infringement vectorsThe cleanest infringement posture is a product or regimen that satisfies all of:
Most likely “non-infringing” leversGiven the claim text:
How strong is the claim reach across competitors’ programs?Product-format reachThe claim set supports several product-format shapes:
If a competitor formulates the same compound in any of those formats, they likely face at least a subset of these claims, assuming the regimen is marketed or used for one of the listed viruses. Indication reachThe indication labels are a focused herpesvirus panel:
This panel covers a broad segment of established antiviral clinical use, particularly for immunocompromised patients and herpes-associated disease settings. What is the patent landscape around US 4,507,305 in the US system?What can be concluded from the claim text providedThe claim text indicates the patent is drawn around a specific antiviral nucleoside and its use across multiple administration routes and virus types. That type of drafting typically appears in a patent family where:
What cannot be concluded from the information providedA complete “US patent landscape” requires, at minimum, the following to be sourced and compared across documents:
Those fields are not included in the input, and no bibliographic metadata is provided for US 4,507,305. Without that, a landscape would be speculative rather than actionable. Result: A full landscape map (e.g., “which US patents are controlling,” “which are design-around blockers,” “which are follow-on improvements”) cannot be produced from the claim list alone. Claim-by-claim scope map (US 4,507,305)
How to interpret breadth vs. enforceability pressureBreadth inside the allowed perimeterWithin the allowed perimeter (same compound/salt), the claims are broad in:
Narrowness where it mattersThe perimeter is narrow because the claim does not cover:
That combination typically yields strong specificity for litigation but requires competitors to stay close to the exact chemical and use pattern. Key Takeaways
FAQs1) Does claim 1 cover injectable formulations using any salt?Claim 1 covers the compound “or a pharmaceutically acceptable salt.” Dependent claims 2 and 3 restrict salt types to alkali metal salts and then specifically the sodium salt. 2) Are oral and topical methods limited to the injectable carrier definition?No. Claims 11 and 17 require oral/topical administration of the compound or a pharmaceutically acceptable salt. They do not incorporate the “carrier” requirement from claim 1. 3) Does the injectable method require human treatment?Yes. Claim 5 limits the injectable method chain (claims 4-10) to mammal = human. 4) Which virus indications are explicitly covered?HSV-1, HSV-2, CMV, EBV, and VZV. 5) What is the most direct design-around?Using a different active ingredient (not 9-(1,3-dihydroxy-2-propoxymethyl)guanine) avoids the claim’s chemical anchor. References
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Drugs Protected by US Patent 4,507,305
| 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 4,507,305
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 244227 | ⤷ Start Trial | |||
| Austria | 15899 | ⤷ Start Trial | |||
| Australia | 572086 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
