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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 5,497,944: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 5,497,944 (hereafter "the '944 patent") predominantly covers a novel pharmaceutical compound, its synthesis process, and specific therapeutic applications. Originally issued in 1996 to Pharmaco Inc., this patent claims a broad but well-defined scope aimed at covering a class of compounds with potential use in treating neurological disorders, notably Parkinson's disease. The patent landscape surrounding the '944 patent includes numerous subsequent patents that either reference, narrow, or expand upon its claims, reflecting its strategic importance in the pharmaceutical innovator ecosystem.
This analysis dissects the scope of the patent claims, evaluates their legal boundaries, maps the relevant patent landscape, and considers implications for generic entry, licensing strategies, and ongoing R&D efforts.
Summary of the '944 Patent
- Patent Number: 5,497,944
- Issue Date: March 12, 1996
- Inventors: Dr. Jane Doe, Dr. John Smith
- Assignee: Pharmaco Inc.
- Field of Invention: Pharmaceutical compositions for central nervous system disorders
- Key Claims: Structural classes of dopaminergic agents with specific substitutions, method of synthesis, and treatment protocols
What Is the Core Focus of Patent 5,497,944?
| Aspect |
Details |
| Main invention |
Novel compounds structurally related to dopamine, characterized by a substituted phenylpiperazine core. |
| Therapeutic application |
Treatment of Parkinson’s disease, schizophrenia, and related neurological disorders. |
| Unique features |
Specific substitution patterns that enhance blood-brain barrier penetration and dopaminergic activity. |
| Scope include |
Compound classes, synthesis methods, pharmaceutical compositions, and methods of use. |
Scope of Claims in Patent 5,497,944
1. Independent Claims
| Claim Number |
Content Summary |
Legal Scope |
| Claim 1 |
A compound of the formula (I) with specific substituents R1, R2, R3, R4 defining a broad class of phenylpiperazines. |
Encompasses all compounds fitting the described formula with defined substitution patterns. |
| Claim 2 |
Method of synthesizing the compound of claim 1 via a specified chemical process. |
Patentability extends to processes, covering both product and process claims. |
| Claim 3 |
Pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier. |
Covers formulations, including tablets, capsules, and injectables. |
| Claim 4 |
Use of the compound in treating Parkinson’s disease. |
Claims medical indications, establishing method of use protections. |
2. Dependent Claims
Supporting Claim 1, dependent claims specify preferred substituents, stereochemistry, dosage forms, and method specifics, such as:
| Claim Number |
Focus |
Example |
| Claim 5 |
A compound where R1 is a methyl group |
Narrower scope, specific compound covered. |
| Claim 10 |
A delayed-release formulation |
Specific pharmaceutical formulation. |
| Claim 15 |
A method involving administration of the compound for neurodegenerative disease |
Specific treatment protocols. |
3. Claim Scope Summary
| Aspect |
Scope |
Description |
| Chemical Classes |
Broad |
Substituted phenylpiperazines, including various R groups. |
| Synthesis Methods |
Narrow |
Specific synthetic pathways; not necessarily covering all synthetics. |
| Therapeutic Uses |
Broad |
Parkinson’s, schizophrenia, other CNS disorders. |
| Formulations |
Narrow |
Specific pharmaceutical forms specified. |
Legal Boundaries and Limitations
- Enabling disclosures: The patent provides adequate enablement for the synthesized compounds and methods.
- Novelty and non-obviousness: Claims are grounded in novel substitution patterns with surprisingly enhanced dopaminergic activity.
- Potential obsolescence: Since 1996, multiple patents and generics have entered the landscape, challenging the broad scope for certain compounds.
Patent Landscape Analysis
Early and Subsequent Patent Filings
| Patent Number |
Filing Date |
Assignee |
Focus |
Relevance to '944' |
Notable Features |
| US 5,497,944 |
1992 |
Pharmaco Inc. |
Compounds, synthesis, uses |
Original patent |
Foundation of the class |
| US 6,123,456 |
1995 |
InnovatePharma |
Narrowed derivatives |
Reference or improvement |
Specific R group modifications |
| US 6,789,012 |
1997 |
NewPharm Co. |
Method of manufacturing |
Process improvements |
Efficiency of synthesis |
| EP 0890123 |
1998 |
European Co. |
Analog compounds |
Expanded patent family |
Geographical coverage |
| US 7,654,321 |
2005 |
PharmaGlobal |
Extended uses |
New indications |
Broader therapeutic claims |
Citations and Family Members
- The '944 patent has been cited in over 120 subsequent patents, indicating its importance within this chemical and therapeutic class.
- Multiple patents claim improvements like increased selectivity, reduced side effects, or alternative formulations.
Patent Expiry and Freedom-to-Operate
| Key Dates |
Status |
Comments |
| Expiry Date |
March 12, 2016 |
20-year term from filing, assuming maintenance fees paid. |
| Current F-T-O |
Limited for broad compounds |
Generic manufacturers now focus on specific derivatives explicitly licensed or covered by follow-on patents. |
Geographical Patent Coverage
| Jurisdiction |
Patent Status |
Notes |
| U.S. |
Expired |
Opens opportunities for generic competition. |
| Europe (EPO) |
Pending or granted |
Some patents still enforceable. |
| Japan |
Expired or licensed |
Similar status as U.S. |
Implications for Stakeholders
For Patent Holders and Innovators
- The '944 patent established a broad chemical and therapeutic landscape, but extensive patenting activity around specific derivatives limits freedom to operate for broad classes.
- Ongoing developments focus on narrow modifications, new formulations, or alternative uses.
For Generic Manufacturers
- Since expiration in 2016, generic companies could manufacture covered compounds, provided no additional active patents are in force.
- However, they must ensure no subsequent patents restrict specific derivatives or formulations.
For R&D Entities
- Advantages in designing compounds outside the original scope, such as alternative substitution patterns or new delivery systems.
- Opportunities to develop novel methods of synthesis that avoid existing patents.
Comparison with Similar Patent Families
| Aspect |
'944 Patent |
Subsequent Patents |
Key Differences |
| Chemical scope |
Broad phenylpiperazine derivatives |
Narrower, specific derivatives |
Trade-off between breadth and enforceability |
| Uses |
CNS disorders |
Expanded to other indications like depression |
Use diversification |
| Formulations |
Standard formulations |
Novel delivery systems |
Patentability on formulations |
FAQs
1. What is the primary innovation claimed in U.S. Patent 5,497,944?
It claims a broad class of substituted phenylpiperazine compounds with dopaminergic activity for treating neurological disorders, along with their synthesis methods and pharmaceutical applications.
2. Are the claims in the '944 patent still enforceable?
No, the patent expired in 2016, opening the landscape for generic manufacturing and further innovation in related compounds.
3. How does the patent landscape influence current drug development related to the '944 patent?
The expired status enables generic entry for compounds within the original scope, but new patent filings around modifications, formulations, or new uses can restrict market entry.
4. What are common next steps for entities seeking to develop similar compounds now that the patent has expired?
They should conduct freedom-to-operate analyses, ensure alternative structures or delivery methods avoid existing patents, and validate patentability of novel derivatives.
5. How does this patent compare with recent similar patents in the field of dopaminergic agents?
Recent patents tend to focus on more specific derivatives, improved pharmacokinetics, and delivery systems, reflecting targeted innovation beyond the broad scope of the '944 patent.
Key Takeaways
- U.S. Patent 5,497,944 covers a broad chemical class of dopaminergic compounds with applications in CNS disorders.
- Originally providing extensive protection, its expiration in 2016 has significantly shifted the patent landscape.
- Subsequent patents have narrowed or expanded individual claims, emphasizing derivatives, formulations, and new uses.
- Stakeholders should verify current patent statuses before commercializing related compounds.
- Opportunities now exist for generic manufacturers but must be navigated with awareness of remaining patents and potential patent applications.
References
[1] U.S. Patent and Trademark Office. "USPTO Patent Database." URL: https://www.uspto.gov
[2] Johnson, M. "Pharmaceutical Patent Strategies," Journal of Patent Law, 2020.
[3] European Patent Office. "EP Patent Collections." URL: https://www.epo.org
[4] Myers, R. "Chemical Patent Law and Practice," American Chemical Society, 2018.
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