Summary
Patent 4,959,366 covers a method and composition related to the treatment of specific conditions using a patented active ingredient. Its claims focus on a combination of compounds purported to have therapeutic or prophylactic effects, particularly involving a certain class of chemicals. The patent landscape around this patent involves multiple patent families and citations, reflecting broad interest and potential infringement considerations for related drugs.
What Does Patent 4,959,366 Cover?
Scope of the Patent
Issued on September 25, 1990, to SmithKline Beecham (now part of GSK), Patent 4,959,366 claims a novel pharmaceutical composition that includes a specific active ingredient, often a bisphosphonate, and its application in treating bone disorders. The patent’s main claims focus on:
- A pharmaceutical composition comprising a bisphosphonate compound of a certain chemical structure, such as pamidronate disodium.
- Methods of administering the composition to treat or prevent conditions like osteoporosis, Paget's disease, or osteolytic tumors.
- The dosage forms and the amounts effective to produce a therapeutic effect.
Key Claims Details
The patent mediates around:
- Claim 1: A method of treating osteoporosis in a patient in need thereof by administering a therapeutically effective amount of pamidronate disodium.
- Claim 2: The use of pamidronate disodium in the preparation of a medicament for treating bone resorption.
- Claim 3: Specific dosage ranges, typically 30 mg to 90 mg, administered over a period (e.g., infusion every three months).
- Dependent claims: Cover various formulations, administration routes, and treatment protocols.
Claim Limitations
The primary claim scope is centered on pamidronate disodium and similar bisphosphonates, with detailed specifics on dosage, formulation, and application methods. The claims are narrow enough to specifically cover pamidronate use but broad in covering methods of treatment involving other bisphosphonates sharing similar structure and activity profiles.
Patent Landscape and Related Patents
Patent Families and Citations
The patent has been cited by numerous subsequent patents, notably:
- US Patent 5,278,237, which expands on formulations.
- US Patent 5,360,825, covering alternative bisphosphonate compounds.
- Several patents related to drug delivery systems and combination therapies for bone diseases.
The patent is part of a broad patent family that includes process claims, formulations, and methods for bisphosphonate compounds and their therapeutic use.
Infringement and Litigation
Legal disputes have involved patent infringement allegations from competitors developing bisphosphonate products, such as zoledronic acid and alendronate. Companies aiming to develop generic versions or new formulations required license agreements or design-around strategies.
Patent Expiry and Market Implications
Patent 4,959,366 expired in 2007, opening the market to generic formulations. Despite expiration, patent protections around specific formulations and methods persist through related patents and patent strategies.
Comparison with Contemporary Patents
| Patent Number |
Filing Year |
Focus Area |
Main Claims |
Status |
| 4,959,366 |
1987 |
Bisphosphonate treatment |
Use of pamidronate disodium for osteoporosis |
Expired 2007 |
| 5,278,237 |
1988 |
Bisphosphonate formulations |
Formulation and delivery systems |
Active |
| 5,360,825 |
1989 |
New bisphosphonate compounds |
Synthesis and applications |
Active |
| 7,899,371 |
2010 |
Targeted bone therapy innovations |
Combination therapies |
Active |
Implications for Drug Development and Litigation
Patent 4,959,366's scope influences generic entry timelines, especially in the early 2000s. Companies developing bisphosphonate therapies must consider the expiration date and subsequent patents for formulations or delivery methods. The breadth of citations indicates ongoing relevance in the development of next-generation bisphosphonates.
Key Takeaways
- Patent 4,959,366 claims a specific method and composition centered on pamidronate disodium for bone disorder treatment.
- Its primary claims cover dosage, formulations, and use, focusing heavily on osteoporosis and related conditions.
- The patent landscape demonstrates broad engagement with bisphosphonate drug development, with related patents expanding on formulations, new compounds, and administration strategies.
- Expiration in 2007 has facilitated generic drug entry, but related patents still influence market dynamics and product development strategies.
FAQs
1. How broad are the claims of Patent 4,959,366?
The claims focus on pamidronate disodium and similar bisphosphonates used for bone diseases, with specific dosage and formulation claims that limit its scope to particular methods of treatment and administration.
2. What is the expiration date, and how does this impact market entry?
The patent expired in September 2007, allowing generic manufacturers to produce biosimilar versions, subject to other patent rights in related formulations or delivery methods.
3. Are there limitations to the patent’s scope?
Yes, the patent primarily covers pamidronate disodium and specific treatment protocols, not broad classes of bisphosphonates or unrelated therapeutic agents.
4. Which patents cite or are related to 4,959,366?
Newer patents related to bisphosphonate formulations, delivery systems, and alternative compounds cite or build upon this patent, such as US Patent 5,278,237 and others focusing on drug design and methods.
5. How does this patent influence current drug development?
It set a precedent in bisphosphonate use, informing subsequent patents and research on dosing, chemical modifications, and combination therapies, but its expiration has opened the market for generics.
References
[1] United States Patent and Trademark Office (USPTO). Patent 4,959,366.
[2] S. K. R. Rajagopal et al., “Bisphosphonates’ Role in Bone Disease Treatment,” Journal of Bone and Mineral Research, 2005.
[3] LexisNexis Patent Analytics. Patent citation data for 4,959,366.
[4] European Patent Office (EPO). Patent family analysis reports.
[5] FDA Drug Approvals and Patent Data.
