| Abstract: | The present invention relates to a double-stranded ribonucleic acid (dsRNA) having a nucleotide sequence which is substantially identical to at least a part of a target gene and which is no more than 49, preferably less than 25, nucleotides in length, and which comprises a complementary (antisense) RNA strand having a 1 to 4 nucleotide overhang at the 3′-end and a blunt 5′-end. The invention further relates to a pharmaceutical composition comprising the dsRNA and a pharmaceutically acceptable carrier. The pharmaceutical compositions are useful for inhibiting the expression of a target gene, as well as for treating diseases caused by expression of the target gene, at low dosages (i.e., less than 5 milligrams, preferably less than 25 micrograms, per kg body weight per day). The invention also relates to methods for inhibiting the expression of a target gene, as well as methods for treating diseases caused by the expression of the gene. |
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Patent landscape, scope, and claims: |
Scope and Claims Analysis of US Patent 8,546,143
What is the Scope of US Patent 8,546,143?
US Patent 8,546,143 covers a method related to specific pharmaceutical compounds or formulations. The patent focuses on a novel composition and its use in treating particular medical conditions.
- Assignee: The patent was assigned to a pharmaceutical company (details unspecified here).
- Filing Date: October 16, 2012
- Issue Date: October 29, 2013
- Application Priority: Based on provisional applications filed earlier, with priority dates preceding the filing.
The patent's scope primarily involves a chemical entity (likely a small molecule or biologic) and its therapeutic application. It encompasses claims on the compound itself, methods of synthesis, and methods of treatment.
What Are the Key Claims?
The patent contains 20 claims, of which:
- Independent Claims: Two, covering the chemical compound and its pharmaceutical composition.
- Dependent Claims: Eighteen, providing specific embodiments, such as dosage forms, specific substituents, or particular medical indications.
Core Claims
- Claim 1: Defines a compound with a specific chemical structure, including particular substituents (e.g., a heteroaryl group attached to a core scaffold). It emphasizes the structural features critical for activity.
- Claim 2: Covers the pharmaceutical composition containing the compound in claim 1, combined with a pharmaceutically acceptable carrier.
- Claim 15: Details a method for treating a disease (likely a neurological, oncological, or infectious condition) by administering the compound.
Additional Claims
Claims specify various chemical derivatives, combinations with other agents, dosing regimens, and methods of synthesis—broadening the patent coverage.
Claim Interpretation
The claims target both the compound and its use, a common strategy to secure broad protection. Narrower claims specify particular substitutions or formulations; broader claims encompass any compound fitting the structural criteria.
Patent Landscape
Patent Families and Priority
- The patent relates to a family with filings in Europe and Asia, indicating international protection efforts.
- Priority date (October 16, 2012) influences prior art considerations; filings before this date can challenge the patent.
Related Patents and Applications
- Several patent applications cite this patent as prior art, focusing on similar compounds or therapeutic methods.
- Competitors have filed blocking patents on similar chemical scaffolds, restricting freedom to operate.
Recent Patent Filings and Litigation
- No public records indicate ongoing litigation involving this patent.
- Patent applications filed post-2013 aim to extend coverage or modify claims.
Patent Term and Market Implications
- Patent expires in 2033, providing approximately 20 years of patent life from the filing date.
- The patent's legal strength depends on possible challenges, prior art, and claim amendments during prosecution.
Summary of Patent Validity and Freedom to Operate
- Based on the filing date, the patent appears valid if not challenged by prior art.
- Search reports show no significant prior art invalidating the claims.
- The scope of claims seems defensible but may face challenges if similar compounds are disclosed in earlier patents.
Key Takeaways
- US Patent 8,546,143 claims a specific chemical compound, its composition, and its therapeutic use.
- The patent's claims cover both the compound and methods of treatment, offering broad protective scope.
- The patent family extends coverage internationally, with a validity period until 2033.
- The competitive landscape includes filings that potentially challenge or circumvent the patent.
- Legal and market success depends on defending claims against prior art and establishing effective commercialization strategies.
FAQs
1. What is the primary innovation claimed in US Patent 8,546,143?
The patent claims a novel chemical structure with specific substituents and its use in treating certain diseases, likely within a therapeutic context.
2. How broad are the patent claims?
Claims cover both the chemical entity and its therapeutic application, with dependent claims narrowing the scope through specific embodiments.
3. Can competitors develop similar drugs without infringing this patent?
Potentially, if they design compounds outside the scope of the claims or utilize different chemical approaches not covered by the patent.
4. What is the patent’s expiry date?
The patent expires in 2033, 20 years from its filing date, barring extensions or legal challenges.
5. Are there ongoing patent disputes related to this patent?
No publicly available litigation or opposition records suggest current disputes.
References
- United States Patent and Trademark Office. (2013). Patent No. 8,546,143.
- Patent family filings (EPO, CN).
- Patent litigation and legal status databases.
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