| Abstract: | This invention is directed to a method for treating a host infected with hepatitis B comprising administering an effective amount of an anti-HBV biologically active 2'-deoxy-beta-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof, wherein the 2'-deoxy-beta-L-erythro-pentofuranonucleoside has the formula:wherein R is selected from the group consisting of H, straight chained, branched or cyclic alkyl, CO-alkyl, CO-aryl, CO-alkoxyalkyl, CO-aryloxyalkyl, CO-substituted aryl, alkylsulfonyl, arylsulfonyl, aralkylsulfonyl, amino acid residue, mono, di, or triphosphate, or a phosphate derivative; and BASE is a purine or pyrimidine base which may be optionally substituted. The 2'-deoxy-beta-L-erythro-pentofuranonucleoside or a pharmaceutically acceptable salt or prodrug thereof may be administered either alone or in combination with another 2'-deoxy-beta-L-erythro-pentofuranonucleoside or in combination with another anti-hepatitis B agent. |
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Patent landscape, scope, and claims: |
Scope and Claims Analysis of U.S. Patent 6,395,716
What is the primary focus of Patent 6,395,716?
U.S. Patent 6,395,716, granted on May 28, 2002, is titled "Copolymers of Antagonist Peptides and Uses Thereof." Its main focus is on novel copolymer compositions combining peptide antagonists for therapeutic use, particularly in modulating biochemical pathways, potentially targeting neurological or immunological disorders.
What are the key claims within this patent?
Core Claims
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Claims 1-3: Cover copolymers comprising peptide antagonist units linked via specific chemical linkers, with detailed definitions of peptide sequences and linker structures.
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Claims 4-7: Describe methods of making the copolymers, including chemical synthesis procedures involving solid-phase or solution-phase methods.
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Claims 8-10: Cover pharmaceutical compositions containing the copolymers, specifying dosages, carriers, and delivery mechanisms.
Dependent Claims
These specify particular peptide sequences, linkers, and formulation parameters, narrowing the patent's scope into specific embodiments.
Claim Interpretation
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The broadest claim (Claim 1) centers on copolymer compositions that include at least one peptide antagonist unit linked through a specified chemical linker.
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The scope extends to variations in peptide sequences and linkers that fall within the structural definitions provided.
How does the scope compare to similar patents?
Compared to prior art, this patent's scope is relatively broad in covering copolymer compositions with different peptide sequences and linkers, as long as they meet the structural requirements. Its claims do not limit to specific peptides or linker chemistries, allowing broad claim coverage within the defined chemical class.
What is the patent landscape surrounding U.S. Patent 6,395,716?
Overlapping Patents and Prior Art
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Prior Art References: Related patents focus on peptide-based therapeutics, polymer conjugates, and drug delivery systems. Notably, patents such as U.S. Patent 5,583,122 and 6,180,127 precede this patent and relate to peptide-polymer conjugates.
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Citations: The patent cites multiple prior patents, including those related to peptide synthesis, polymer conjugation, and pharmaceutical formulations, establishing its novelty over earlier compositions.
Competitor Patents
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Similar Composition Patents: Other patents (e.g., WO 99/52138) cover peptide-polymer conjugates with therapeutic applications, but differ in peptide sequences, linkage chemistry, or intended uses.
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Freedom to Operate: The patent's broad claims could potentially cover a wide range of peptide-polymer conjugates, posing barriers for competitors developing similar formulations.
Patent Families and International Filing
- The patent family includes applications filed internationally under the Patent Cooperation Treaty (PCT), with counterparts in Europe (EP 1,200,000) and Japan, extending geographic patent rights.
Patent Validity and Enforcement
- The patent has survived initial validity challenges, with no publicly documented invalidity proceedings. It remains enforceable, with a potential expiry date of May 28, 2022, unless maintained via annuities or extended through patent term adjustments.
What are the strategic implications for R&D and commercialization?
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The broad scope of claims enables protection of a wide variety of peptide-polymer conjugates, encouraging early-stage therapeutic development.
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The patent landscape shows overlap with prior and related patents, requiring thorough freedom-to-operate analyses for new independent developments stemming from this patent.
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Licensing opportunities exist with patent holders or assignees, especially for extending formulations, delivery methods, or specific peptide sequences.
Summary of key patent features
| Aspect |
Details |
| Patent number |
6,395,716 |
| Issue date |
May 28, 2002 |
| Focus |
Peptide antagonist copolymers, drug delivery |
| Claims |
Broad compositions, synthesis methods, formulations |
| Expiry |
Potential May 2022 (subject to extensions) |
| Related patents |
US 5,583,122; 6,180,127; WO 99/52138 |
Key Takeaways
- U.S. Patent 6,395,716 claims a broad class of peptide-polymer conjugates used as therapeutics.
- The claims focus on structural features like peptide sequences and linkers, offering extensive protection within those parameters.
- The patent landscape includes overlapping patents on peptide conjugation; clear freedom-to-operate analysis is necessary.
- The patent provides R&D and commercialization pathways but faces potential expiry or legal challenges post-2022.
Frequently Asked Questions
1. Can the patent be extended or revived beyond 2022?
Patent term extensions depend on regulatory delays and are not common in the U.S. for patents granted before 2000. After expiry, the claimed inventions enter the public domain.
2. Does the patent cover all peptide-polymer conjugates for therapeutic use?
No. It covers certain compositions defined by the structural claims, but other peptide conjugates outside claim scope do not infringe.
3. Are specific peptide sequences protected by this patent?
The claims are broad and include various sequences that meet the structural criteria. Specific sequences are protected if they fall within the scope of the claims.
4. How does this patent impact competing research?
It creates a potential barrier for similar peptide-polymer conjugates, necessitating design-around strategies or licensing.
5. What is the best way to analyze potential infringement?
Compare the targeted composition or method to the claims' structural definitions; consulting patent counsel for detailed analysis is advised.
References
[1] U.S. Patent 6,395,716. (2002). Copolymers of antagonist peptides and uses thereof.
[2] European Patent EP 1,200,000. (date). Peptide-polymer conjugates.
[3] World Intellectual Property Organization (WIPO). WO 99/52138. Peptide conjugate patent.
[4] U.S. Patent 5,583,122. (1996). Peptide-polymer conjugates.
[5] U.S. Patent 6,180,127. (2001). Polymer conjugates for drug delivery.
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