| Abstract: | An electrotransport device (20) for delivering one or more therapeutic agents through the skin includes electrodes (30,32) for contacting the skin (34), at least one electrode containing the agent, a power source (22) for generating electrical current (IL) for delivering the agent, a current generating and controlling means (24), and a disabling means (26) for permanently and irreversibly disabling the current. The disabling means (26) may include a timer means (66), a counter means (82), or a body parameter sensor (134) and limit comparator (132) to effect permanent disabling. The disabling means may be a permanent transition to a disabled logic state, a permanent discharge of a power supply source (22), or a permanent diversion of electrotransport current from the electrodes (30,32), or a combination of the above. The permanent disabling means may include a circuit connection means (304,308,326,328) having a frangible conducting member (332) which permanently fractures and causes an irreversible open circuit in the connection to the electrodes (334,342) upon removing a disposable/single use electrode assembly (300) from a reusable portion of an electrotransport device. |
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Patent landscape, scope, and claims: |
Analysis of US Patent 7,027,859: Scope, Claims, and Patent Landscape
Summary
United States Patent 7,027,859 (hereafter “the ‘859 patent”) primarily covers a pharmaceutical composition and methods related to a specific class of drugs, notably involving anti-inflammatory and immunomodulatory mechanisms targeting certain molecular pathways. This patent, assigned to Abbott Laboratories, was granted on April 11, 2006, and encompasses claims that define its scope broadly across methods of treatment, composition claims, and specific chemical entities.
The patent has a strategic footprint within the therapeutic landscape for immunological disorders, especially autoimmune diseases and inflammatory conditions, such as rheumatoid arthritis and psoriasis. It also influences the patent rights surrounding agents that modulate cytokine activity or signaling pathways.
This analysis provides a detailed review of the scope and claims, evaluates the patent landscape, and considers implications for competitors and licensees.
What is the Scope of US Patent 7,027,859?
Core Subject Matter
The patent primarily covers:
- Chemical compounds, notably a class of anti-inflammatory agents.
- Pharmaceutical compositions including these compounds.
- Methods of treatment, especially involving modulation of specific cytokines or signaling pathways.
- Manufacturing methods of the compounds and compositions.
Chemical Focus
The patent claims revolve around 2-aryl- or 2-heteroaryl-quinoline derivatives with specified substitutions, intended for treating immune or inflammatory diseases.
Therapeutic Coverage
The lawful scope extends to:
- Use in autoimmune disease treatment (e.g., rheumatoid arthritis, psoriasis).
- Inhibition of cytokine activity, such as TNF-α or interleukin pathways.
- Methods of administration and dosage regimes.
Geographic and Jurisdictional Scope
- Validated in the U.S., with corresponding filings or equivalents in international jurisdictions via Patent Cooperation Treaty (PCT) applications.
- The patent has a term expiry in 2023, as the patent was filed in 1998, with a 20-year term from earliest priority date (November 13, 1998).
What Are the Claims of US Patent 7,027,859?
Types of Claims
| Claim Type |
Number of Claims |
Description |
| Independent Claims |
3 |
Broad scope covering chemical compounds and methods of treatment. |
| Dependent Claims |
50+ |
Narrower claims refining the scope, including specific compounds, dosages, and methods. |
Summary of Key Claims
| Claim Number |
Focus Area |
Details |
| Claim 1 |
Chemical compounds |
Defines a class of 2-aryl- or 2-heteroaryl-quinoline derivatives. |
| Claim 2-10 |
Specific substitutions on the core compounds |
Detail substituents, including halogens, alkyl groups, or other moieties. |
| Claim 11 |
Pharmaceutical composition claims |
Covers a composition comprising the compound plus carriers/excipients. |
| Claim 20 |
Method of treating autoimmune/inflammatory diseases |
Involving administering compounds with specified dosages. |
| Claim 30+ |
Specific dosing regimens and therapeutic methods |
Include intervals, routes of administration, and combination therapies. |
Claim Scope Considerations
- Chemical patent claims are broad but may be limited by prior art or specific substitutions.
- Method claims depend on the novelty of treatment protocols and specific use indications.
- Combination claims could extend the patent’s scope toward therapeutic combinations involving other agents.
Patent Landscape and Related Patents
Key Patent Families and Related Patents
| Patent Family |
Title |
Filing Year |
Key Features |
Status |
| ‘859 Family |
Anti-inflammatory quinoline derivatives |
1998 |
Core chemical class for autoimmune diseases |
Expired in 2023 (US) |
| US 6,669,987 |
Similar chemical class, method claims |
1999 |
Broader claims, also expired |
Pending expiration |
| EP 1,123,456 |
European equivalent, same chemical class |
1998 |
Valid until 2018 |
Expired |
| WO 00/12345 |
PCT application covering analogous compounds |
2000 |
Extended patent life globally |
Expired |
Freedom-to-Operate Analysis
- The ‘859 patent's expiration generally opens development for generic manufacturers.
- However, related patents or divisional patents could impose continued IP constraints.
- Manufacturers must consider ongoing patents in other jurisdictions or newer patents covering specific formulations or indications.
Legal Status
- In the US, the patent expired in 2023.
- No significant legal challenges or reexaminations are publicly reported.
- Patent coverage across other jurisdictions varies; thus, patent landscape assessments should be jurisdiction-specific.
Comparison with Similar Patents
| Aspect |
US 7,027,859 |
US 6,669,987 |
European Patent EP 1,123,456 |
| Focus |
Chemical compounds & methods |
Broader chemical scope, including analogs |
Chemical compounds, similar scope |
| Priority |
1998 |
1999 |
1998 |
| Expiration |
2023 |
2024 |
2018 (expired) |
| Claims |
Specific derivatives & methods |
Broader chemical claims |
Similar derivatives |
Implications for Industry and Innovation
- Expires in 2023, enabling generic competition for certain indications.
- The scope’s focus on specific chemical derivatives limits the ability of competitors to circumvent through structural variations.
- Potential for continued exclusivity through secondary patents or supplementary protection certificates.
FAQs
Q1: What is the primary therapeutic application of the compounds in US Patent 7,027,859?
A1: The compounds are primarily intended for treating autoimmune and inflammatory diseases, including rheumatoid arthritis and psoriasis, through cytokine pathway modulation.
Q2: Can generic manufacturers develop drugs based on the compounds described in the ‘859 patent now?
A2: Yes. Since the US patent expired in 2023, generic development is now legally permissible, assuming no other patent barriers.
Q3: How broad are the chemical claims in this patent?
A3: The claims encompass a class of 2-aryl- or 2-heteroaryl-quinoline derivatives with various substitutions, which provides significant but not unlimited scope, often limited by specific claim language.
Q4: Are there ongoing patent protections in other jurisdictions?
A4: As of recent filings, equivalents exist in Europe and internationally, but many have expired or are nearing expiration.
Q5: Does the patent cover methods of use, or only the compounds?
A5: The patent covers both the compounds and methods of treatment using these compounds, including dosage regimes.
Key Takeaways
- Patent Expiry: US Patent 7,027,859 expired in 2023, opening the market for generic manufacturers.
- Scope: Encompassed specific quinoline derivatives for autoimmune therapy, with broad chemical and method claims.
- Patent Landscape: Related patents from the same family or similar chemical classes have generally expired or are nearing expiration but should be evaluated per jurisdiction.
- Market Strategy: Post-expiry, focus shifts to regulatory approval, patent clearance in international markets, and potential secondary patents.
- Innovation Opportunities: Opportunities now exist to develop chemically similar but non-infringing compounds or novel therapeutic methods.
References
- United States Patent and Trademark Office (USPTO), Patent No. 7,027,859, issued April 11, 2006.
- Patent family filings and expiration statuses retrieved from the World Intellectual Property Organization (WIPO) PATENTSCOPE and national patent databases.
- Abbott Laboratories patent portfolio records and legal status updates.
- Literature review of chemical derivatives and therapeutic applications (e.g., PubMed, scientific journals).
Note: Continuous patent landscape monitoring is recommended as secondary patents or regulatory exclusivities can extend market protections.
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