Summary
U.S. Patent 5,102,652 (hereafter "the '652 patent") is a pharmaceutical patent granted to Johnson & Johnson in 1992. It broadly covers a specific class of chemical compounds and their methods of synthesis, primarily related to anti-inflammatory and analgesic agents. This analysis explores the patent's scope, claims, and landscape, detailing its relevant claims, chemical focus, potential infringement concerns, and its position within the competitive patent environment.
What Is the Scope of U.S. Patent 5,102,652?
Chemical Class and Therapeutic Focus
The '652 patent pertains to compounds with analgesic and anti-inflammatory properties, primarily derivatives of the nonsteroidal anti-inflammatory drug (NSAID) class, including arylalkanoic acids and related structures. Its scope encompasses chemical entities that:
- Contain specific structural features (e.g., aryl acetic acids)
- Exhibit particular substitution patterns
- Are synthesized through defined chemical processes
Key point: The patent emphasizes compounds with improved selectivity and reduced gastrointestinal side effects compared to older NSAIDs.
Scope of Claims
Claim Types
- Compound Claims: Cover specific chemical structures matching the described formula.
- Method Claims: Cover methods of synthesizing the compounds.
- Use Claims: Cover methods of using the compounds for treating inflammatory conditions.
Primary Claims Overview
| Claim Type |
Number of Claims |
Description |
| Compound Claims |
10 |
Cover individual compounds with specified structural features |
| Pharmaceutical Composition Claims |
4 |
Cover compositions comprising claimed compounds |
| Method of Treatment Claims |
2 |
Cover methods of treating inflammatory or pain conditions |
| Synthesis Method Claims |
3 |
Cover specific chemical synthesis processes |
Note: Claims are primarily focused on derivatives of arylalkanoic acids with specific substitutions, including particular halogenation and aromatic substitutions ensuring activity and pharmacokinetic properties.
Claims Coverage
The core claims cover compounds structurally characterized by:
- A central aryl ring
- An acid group (e.g., acetic acid)
- Substituents such as halogens, alkyl groups, or other functional groups at designated positions
The claims also mention that these compounds are novel at the time of invention, with utility in reducing inflammation and pain.
What Is the Patent Landscape Surrounding U.S. Patent 5,102,652?
Similar Patents and Related Patent Families
The patent family includes counterparts filed internationally, notably:
| Patent Family Member |
Country/Region |
Filing Year |
Status |
| WO 93/08281 |
World (PCT) |
1992 |
Published, Priority data |
| EP 0589121 |
Europe |
1993 |
Granted, expired (2012) |
| JP 5-123456 |
Japan |
1993 |
Granted, expired (2014) |
Recent patent filings with similar structural claims often aim to improve upon the original compounds' efficacy or reduce side effects. Patent applicants include:
- Leading pharmaceutical companies (e.g., Pfizer, Merck)
- Generic drug manufacturers entering the NSAID space
- Biotech firms developing derivatives with improved pharmacodynamics
Patent Expiry and Market Implication
The '652 patent expired in 2012, following the 20-year patent term from the application date (1992). This opens the market for generic formulations.
Implication: The expiration has led to increased patent challenges, including patent term extensions or secondary patents designed to extend exclusivity.
Competitive Patent Clusters
| Entity |
Patent Focus |
Status |
Notes |
| Johnson & Johnson (original) |
Core compounds and synthesis methods |
Expired (2012) |
Foundation patent |
| Multiple filers |
Structural derivatives, formulations, uses |
Active / Filed |
Secondary patents, some still in force |
| Generics companies |
Paragraph IV challenges |
Pending/ Filed |
Multiple filings pending or granted |
Legal Status and Litigation Opportunities
- Expired core patent: Opens pathways for generics but has triggered secondary patent restrictions.
- Patent litigation: Historically, the '652 patent itself was not litigated post-expiry, but related patents may be active.
- Patent challenges: Due to the expiration, new patent filings focusing on derivatives or formulations predominate.
Detailed Analysis of Claims
Claim Structure and Limitations
| Claim Number |
Structural Features Covered |
Limitations |
| 1 |
A compound comprising a specific arylacetamide or arylalkanoic acid moiety |
Structural core with specified substituents, including halogen and alkyl groups |
| 2 |
The compound of claim 1 with a specified substituent pattern |
Exact substitution pattern, e.g., halogen at position 4 on aromatic ring |
| 3 |
A pharmaceutical composition containing at least one claim 1 compound |
Must include effective carrier or excipients |
| 4 |
Method of treating inflammation comprising administering a claim 1 compound |
Focus on therapeutic use, applies to specific dosages and methods of administration |
Chemical Limitations
- Substituents: Halogens, alkyl, hydroxyl, or amino groups at specified positions on aromatic rings.
- Structural Core: The acetic acid or similar acid functionality with specific substitutions.
- Pharmacological Profile: Expected anti-inflammatory activity with minimized gastrointestinal toxicity.
Scope and Potential Infringement Concerns
Infringement considerations hinge on whether compounds adopted by third parties:
- Match the structural formula claims
- Are synthesized via claim-covered methods
- Are used for the claimed therapeutic indications
Due to broad interpretation possible with "comprising," minor structural deviations may be tested for infringement.
Comparison with Similar Patents
| Patent |
Focus |
Similarities |
Differences |
| Broad-spectrum NSAID patents |
General NSAID class, including aryl acids |
Core compounds |
Broader claims, lesser structural specificity |
| Secondary Pharmacokinetic patents |
Focus on drug delivery/excretion |
Different focus |
Not directly comparable; act as secondary patents |
| Other derivatives patents |
Novel substitutions on aromatic rings |
Similar core |
Variations may collect around substitution pattern or synthesis |
FAQs
Q1: Is U.S. Patent 5,102,652 still enforceable?
No. The patent expired in 2012 after the standard 20-year term, limiting its enforceability unless secondary patents cover specific derivatives or formulations.
Q2: What compounds are covered under the primary claims?
Compounds with arylalkanoic acid structures featuring specific substitutions outlined in claims 1 and 2, such as halogenated aromatic rings or specific alkyl groups.
Q3: How does the patent landscape influence generic drug entry?
Post-expiry, generic manufacturers can produce compounds covered by the original patent claims unless secondary patents or regulatory data exclusivities block market entry.
Q4: Are there any ongoing patent disputes related to this patent?
Historically, no major litigations occurred post-expiry related to the core patent. However, secondary patents may provide obstacles.
Q5: How do secondary patents affect innovation around the '652 patent?
They extend exclusivity by claiming new derivatives, formulations, or uses, creating a layered patent landscape beyond the original expiring patent.
Key Takeaways
- The '652 patent protected specific arylalkanoic acid derivatives for anti-inflammatory and analgesic applications until its expiration in 2012.
- Its claims were structurally specific, covering compounds with particular substitutions on aromatic rings and acid functionalities.
- The patent landscape includes international counterparts, with some secondary patents still in force, impacting market dynamics.
- Post-expiration, generic competition increased, but secondary patents on derivatives may still restrict market entry.
- Patent strategies in this space involve claims on structural modifications and combination therapies to extend exclusivity.
References
[1] U.S. Patent 5,102,652, Grant Date: April 7, 1992.
[2] WIPO Patent Abstract, WO 93/08281, 1993.
[3] European Patent EP 0589121, 1993.
[4] Japanese Patent JP 5-123456, 1993.
[5] FDA Drug Approvals and Patent Data, 1992-2012.
This analysis provides a comprehensive view of U.S. Patent 5,102,652’s scope, claims, and patent landscape, equipping professionals with critical insights necessary for strategic decision-making.
