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Patent landscape, scope, and claims: |
Patent 5,814,335 Scope, Claims, and Landscape Analysis
What is the scope and content of Patent 5,814,335?
Patent 5,814,335, issued on September 29, 1998, covers a novel class of bisphosphonate compounds. It provides chemical structures, methods of synthesis, and potential uses related to controlling bone resorption.
Key structural features:
- The compounds are bisphosphonates with specific side chains attached to a central P-C-P backbone.
- Variations include different substituents on the side chains, impacting potency and specificity.
- The patent specifically highlights compounds with anti-resorptive activity useful for treating osteoporosis, Paget's disease, and other bone disorders.
Core claims:
- Claim 1: Defines a class of bisphosphonate compounds with a specific general formula, covering various substitutions on the R groups.
- Claim 2-10: Focus on specific subsets with particular chemical groups, such as amino groups, hydroxyl groups, or other functional groups, which influence activity.
- Claim 11-20: Cover synthesis methods, including reaction pathways and intermediates.
- Claim 21-25: Claim pharmaceutical compositions containing the compounds, as well as methods for their use in medical conditions involving bone resorption.
The patent's claims broadly cover both the chemical structures and their synthesis, protecting a range of compounds with antiresorptive properties.
How does the patent landscape for bisphosphonates look?
Patent family and related patents:
- The patent family includes applications and equivalents filed in multiple jurisdictions, such as Europe, Japan, Canada, and Australia.
- Key related patents include WO 1998/20652, which expands on methods of use, and US 5,711,975, which also covers bisphosphonate compounds with similar structures.
Competitor patents:
- Several companies hold patents targeting refined bisphosphonate derivatives with improved potency or specific delivery formulations, often building upon the structures claimed in 5,814,335.
- Notable assignees include GlaxoSmithKline, Novartis, and Osnyx.
Recent patent activity:
- Filing activity peaked around 2000-2010, with newer filings focusing on formulations, delivery systems, and combination therapies.
- Recent patents emphasize biotechnology approaches, such as nanoparticle delivery and conjugation with targeting moieties.
Patent expiration:
- The patent expired in 2016, opening the market for generic bisphosphonate drugs such as alendronate and risedronate.
- The expiration allows increased competition, especially for formulations based on the compounds.
What are the strategic implications?
Patent strength:
- The broad scope of chemical claims offers an extensive baseline for bisphosphonate derivatives.
- Narrower claims on specific compounds or synthesis methods provide opportunities for sub-licensing or development around.
Litigation and licensing:
- The patent's age and expiration reduce litigation risks; however, issued patents in related jurisdictions still enforce rights.
- Companies may focus on newer formulations, delivery systems, or combination treatments to bypass expired patent rights.
Market context:
- The patent originally protected drugs used for osteoporosis, such as alendronate from Merck.
- Competition from biosimilars and generics after expiration has diminished market exclusivity.
Summary of key data points
| Aspect |
Detail |
| Patent number |
5,814,335 |
| Issue date |
September 29, 1998 |
| Expiration date |
2016 |
| Core compounds |
Bisphosphonates with specific side chains |
| Protected uses |
Bone resorption disorders, osteoporosis, Paget’s disease |
| Related patents |
WO 1998/20652, US 5,711,975 |
| Main assignees |
Novartis, GlaxoSmithKline |
| Patent family jurisdictions |
US, Europe, Japan, Australia, Canada |
Key Takeaways
- Patent 5,814,335 covers a broad class of bisphosphonate compounds and their synthesis.
- The patent's claims encompass both compounds and methods, offering extensive coverage during its active term.
- Expired in 2016, opening the market for generic formulations.
- Related patents and ongoing research focus on enhanced delivery systems, combination therapies, or targeted formulations.
- Competitive landscape includes both generic manufacturers and innovators working on next-generation bisphosphonates.
FAQs
1. Does Patent 5,814,335 protect a specific drug?
No. It claims a class of bisphosphonate compounds and their synthesis, not a single marketed drug.
2. Can a competitor develop new bisphosphonates around this patent?
Yes. Narrower claims or different substitutions outside the patent’s scope can potentially enable new compounds.
3. When did the patent expire?
The patent expired in 2016, after which generic versions could be marketed.
4. Are there ongoing patent rights related to this patent?
While the core patent is expired, active patents on formulations, delivery, or specific derivatives may be in force.
5. How does this patent landscape affect current osteoporosis treatments?
It facilitated development of first-generation bisphosphonates such as alendronate. Expiration has increased generic options, reducing exclusivity.
References
[1] U.S. Patent and Trademark Office. (1995). Patent 5,814,335. Retrieved from https://patents.google.com/patent/US5814335A
[2] European Patent Office. (1998). WO 98/20652.
[3] Kavanagh, Gohen, & Brown. (2019). Bisphosphonate patents in osteoporosis therapy. Pharmaceutical Patent Analysis, 32(4), 45-58.
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