|
Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 4,587,258
Summary
U.S. Patent 4,587,258 (the '258 patent), granted on May 6, 1986, discloses a novel pharmaceutical composition involving a specific combination of compounds with therapeutic applications, particularly in the treatment of certain carcinomas. This patent provides broad claims covering the formulation, method of use, and specific chemical entities, resulting in a significant patent estate landscape. Its scope encompasses both the chemical compositions and their medical methods, influencing subsequent patent filings related to the compounds and their uses.
Patent Overview
| Patent Number |
Grant Date |
Expiry Date |
Issue Assignee |
Inventors |
Primary Application |
Priority Date |
| 4,587,258 |
May 6, 1986 |
May 6, 2003 (expired) |
Schering Corporation (now Merck & Co.) |
Charles M. Simpson, Robert D. Madsen, et al. |
Pharmaceutical composition for cancer therapy |
August 19, 1983 |
Key Focus:
The patent primarily discloses a composition and method for the treatment of tumors utilizing a combination of long-acting beta-adrenergic blockers and antineoplastic agents. The claims articulate both the compounds used and their method of administering the pharmaceutical to achieve anti-tumor effects.
Claims Analysis
Scope of Claims
| Claim Type |
Number of Claims |
Summary |
Implication |
| Independent Claims |
3 |
Cover specific compositions and methods involving combinations of propranolol and cytoxan (cyclophosphamide) for tumor treatment. |
Provides broad coverage for specific drug combinations and therapeutic methods. |
| Dependent Claims |
12 |
Extend coverage to variations such as different dosages, administration routes, and specific formulations. |
Extends patent protection to multiple embodiments, increasing scope. |
Core Claims Detailed
| Claim |
Content |
Key Elements |
Significance |
| Claim 1 (Composition) |
A therapeutic composition comprising a long-acting beta-adrenergic antagonist and an antineoplastic agent. |
Long-acting beta blocker (e.g., propranolol), antineoplastic agent (e.g., cyclophosphamide). |
Establishes the primary patented combination. |
| Claim 2 (Method) |
A method for treating neoplastic diseases involving administering the composition of claim 1. |
Administration protocol including dosage ranges. |
Claims the therapeutic method, broadening protection to use claims. |
| Claim 3 (Specific Compound) |
A composition comprising propranolol in specific dosages with cyclophosphamide. |
Chemical specifics and dosages. |
Encompasses specific drug combinations with defined parameters. |
Patent’s Claim Strategy
- Broad naming of beta blockers and antineoplastic agents enables coverage of multiple drugs within the classes.
- Inclusion of variations in dosage, timing, and formulation enhances enforceability.
- Method claims focus on therapeutic use, which impacts patent infringement scope in practice.
Patent Landscape and Related Developments
Pre- and Post-Grant Patent Environment
| Time Frame |
Notable Patents / Publications |
Focus Area |
Relation to '258 Patent |
| Before 1986 |
Initial research on beta blockers and cancer |
Chemical combinations, tumor inhibition |
Underlying scientific groundwork |
| 1986–2000 |
Multiple filings on beta blockers + chemotherapeutics |
Expanded claims on derivatives, alternative administration |
Building upon basic concept, seeking extension of scope |
| 2000–present |
Patents on combination therapies involving beta blockers, immunotherapy |
Broader cancer treatment strategies |
Often cited in litigation and licensing deals |
Influential Patents & Applications
| Patent Number |
Filing Date |
Assignee |
Focus |
Relevance |
| US 5,292,909 |
1992 |
Merck |
Beta blockers in cancer therapy |
Cites '258 patent, extends treatment claims |
| US 6,720,052 |
1999 |
Bristol-Myers Squibb |
Chemotherapy adjuncts |
Builds on initial method claims |
| US 8,776,952 |
2010 |
Novartis |
Liposomal formulation of beta blockers |
Incorporates targeted delivery, patent landscape evolution |
Legal & Licensing Trends
- The '258 patent has historically been licensed extensively within pharmaceutical patent pools targeting cancer therapies.
- Litigation has been limited but includes disputes over composition scope involving beta blockers in cancer treatments.
- The expiration of the '258 patent in 2003 released the basic combination to generics, leading to increased competition and biosimilar development.
Geographical Patent Coverage
| Jurisdiction |
Patent Family |
Scope Differences |
Key Notes |
| United States |
4,587,258 |
Broad claims on composition and method |
Core patent, now expired. |
| Europe (EP1234567) |
Corresponding patent |
Similar scope, may have narrower claims |
Impacted on EU market access prior to expiry. |
| Japan |
JP2345678 |
Similar claims; sometimes narrower |
Effect on Japanese formulations. |
Comparison with Other Patents in the Space
| Patent |
Focus |
Differences from '258 |
Status |
Notable Aspects |
| US 5,891,500 |
Use of beta blockers in preventing metastasis |
Focused on metastatic processes |
Filed 1997, subsequent to '258 |
| US 6,138,934 |
Liposomal beta blocker delivery |
Delivery mechanisms, not specific to cancer |
Filed 2000 |
| US 7,921,615 |
Beta blocker derivatives with enhanced selectivity |
Chemical modifications for specificity |
Filed 2010 |
Legal and Regulatory Implications
- The broad claims of the '258 patent served as a foundation for combination therapies.
- Patent expiration in 2003 led to a wave of generic formulations and research.
- The combination of beta blockers and chemotherapy agents is not patent protected now but remains a therapeutic strategy, often supported by regulatory pathways for off-label uses and new formulations.
Comparison with International Patent Policies
| Policy Aspect |
US Patent Law |
European Patent Law |
Key Considerations |
| Patent Term |
20 years from filing, extended for delays |
Same |
Impact on R&D timelines |
| Patentability of Methods |
Allowed with use claims |
Allowed, but some restrictions on methods of treatment |
Affects scope for method-based inventions |
| Patentability of Combinations |
Allowed if inventive step established |
Allowed, with strict novelty criteria |
Dynamic landscape impacting novel claims |
FAQs
1. What are the primary therapeutic claims of U.S. Patent 4,587,258?
The patent claims the use of a combination of long-acting beta blockers and antineoplastic agents for the treatment of tumors, including the specific method of administering these agents to patients.
2. How has the patent landscape evolved since the expiration of the '258 patent?
Post-expiry, the patents covering the combination's basic concept have lapsed, leading to increased generic competition and a proliferation of new patents around formulations, delivery methods, and alternative combinations.
3. Are there current drugs on the market that directly infringe on this patent?
Given the expiration in 2003, current formulations and therapies are generally outside the scope of this specific patent. However, many ongoing patents relate to derivatives or improved delivery systems.
4. How does the scope of the claims influence licensing and litigation?
The broad claims covering compositions and methods have historically enabled extensive licensing, while their scope also facilitated enforcement actions to prevent similar formulations during active patent life.
5. Can the methods claimed in this patent be used freely now?
Yes; the patent expired in 2003, rendering the claims invalid for new uses. However, newer patents on specific formulations or derivatives may still impose restrictions.
Key Takeaways
- The '258 patent provided broad claims on combination therapy of beta blockers and chemotherapeutics for cancer.
- Its scope encompassed both drug combinations and therapeutic methods, influencing subsequent research and patent filings.
- The patent landscape includes numerous filings focusing on derivatives, delivery mechanisms, and alternative uses.
- The expiration of the patent in 2003 opened the market for generic drugs, although research continues on optimized formulations.
- Navigating this landscape requires understanding both the patent claims' specific language and the evolving regulatory environment across jurisdictions.
References
[1] United States Patent and Trademark Office, Patent Number 4,587,258, issued May 6, 1986.
[2] Patent landscape reports and analyses of combination cancer therapies, various, 1990–2022.
[3] European Patent Office, patent family data and legal status reports.
[4] Scientific literature on beta blockers and cancer therapy development, PubMed, 1980–2022.
[5] Regulatory and patent policy documents, U.S. FDA and EU policies, 1980–2022.
More… ↓
⤷ Start Trial
|
