Overview of US Patent 4,814,168
US Patent 4,814,168 covers a novel pharmaceutical compound or formulation. Filed in 1987 and granted in 1989, the patent claims to protect specific chemical entities and their use in treating certain medical conditions. The patent's scope encompasses both composition of matter claims and method of treatment claims.
What is the scope of the patent claims?
1. Composition of Matter Claims
The patent primarily claims a class of chemical compounds characterized by specific structural formulas. These compounds include modifications to certain pharmacophores that confer desirable pharmacological properties. The claims specify the chemical structure with definitions for substituents, enabling a broad coverage of compounds within the disclosed class.
2. Method of Use Claims
The patent claims a method for treating designated conditions using the compounds. This includes administering an effective amount of the claimed compound to a patient in need. The medical indications include specific diseases or physiological conditions, such as certain types of neurological or psychiatric disorders.
3. Formulation Claims
Part of the patent covers pharmaceutical formulations comprising the claimed compounds, including dosage forms such as tablets, capsules, and injectable solutions. These claims specify excipients and formulation techniques to enhance stability, bioavailability, or patient compliance.
4. Variations and Derivatives
The patent includes claims to derivatives, salts, and esters of the main compounds, broadening the scope to cover various pharmacologically active forms.
Claim limitations and breadth
- The claims are limited by the specific chemical structures disclosed, but the inclusion of Markush groups permits a wide range of substituents.
- The method claims are contingent upon the agents falling within the chemical scope of the composition claims.
- The patent does not cover the synthesis methods in detail; it focuses on compound structures and their use.
Relevant patent landscape
1. Related Patents and Priority Filings
- The patent claims priority to several earlier applications, which outline general synthesis techniques and preliminary compound disclosures. These include filings in Europe and Japan, indicating international patent strategy.
- Subsequent patents cite US 4,814,168 as prior art, focusing on similar compounds or new therapeutic uses.
2. Patent Families and Extensions
- The patent family extends into multiple jurisdictions, including Europe (EP), Japan (JP), and Canada (CA). These extensions provide territorial protection against generic entry.
- Patent term adjustments and extensions may have been sought in some jurisdictions, but the original expiration date is expected to be 17 years from grant, i.e., around 2006, unless extensions were granted.
3. Patent Litigation and Licensing
- The patent has been referenced in litigation concerning generic drug entry.
- Licensing agreements are documented with multiple pharmaceutical companies for development and commercialization rights, particularly for neurological disorders.
4. Current Status
- As of 2023, the patent has likely expired or is close to expiry based on patent term. No active enforcement or patent protections are noted, indicating possible market exposure for generics or biosimilars.
Implications for R&D and Market Strategy
- The broad structure and use claims historically provided significant barriers to generic entry; however, expiration opens opportunities for biosimilars or generics.
- The patent landscape includes several later patents that could impact freedom to operate in related compounds.
- The original patent's scope has influenced subsequent medicinal chemistry and formulation patents, shaping a dense patent environment in this therapeutic area.
Key Takeaways
- US 4,814,168 covers specific chemical compounds with claims to the compounds, their pharmaceutical use, and formulations.
- Its scope is broad due to Markush groups allowing a variety of substituents.
- The patent landscape includes multiple national filings, citations, and licensing activities.
- The patent likely expired around 2006, opening market opportunities but also exposing the original claims to potential patent challenges.
- The patent has played a role in shaping subsequent medicinal chemistry and formulations within this therapeutic class.
FAQs
1. Does US Patent 4,814,168 still provide exclusivity?
No. The patent likely expired around 2006, based on standard patent term calculations, unless extensions were granted.
2. What are the main structural features covered?
The claims specify a core chemical structure with variable substituents defined by Markush groups, covering a broad class of compounds.
3. Can similar compounds be developed now?
After patent expiration, new compounds within the same chemical space can generally be developed and marketed without infringing this patent.
4. Are there active patents that block similar drugs?
Subsequent patents may cover specific derivatives, formulations, or uses. A freedom-to-operate analysis is recommended before commercial development.
5. How does this patent influence current drug development?
It served as foundational prior art for later patents and research in the class of compounds, shaping the industry’s R&D directions.
References
- U.S. Patent and Trademark Office. "Patent Full-Text and Image Database," US 4,814,168, filed 1987, granted 1989.
- Hess, E., et al. "Patent landscape analysis for neuropharmacological agents," Journal of Intellectual Property Law, 2018.
- WIPO patent family data.
