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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 4,634,697
What does U.S. Patent 4,634,697 cover?
U.S. Patent 4,634,697, issued on January 6, 1987, filed by Merck & Co., Inc., primarily pertains to the synthesis and pharmaceutical composition of a class of derivatives known as prostaglandin derivatives. The patent aims at methods of producing specific prostaglandin compounds, their chemical modifications, and therapeutic applications, particularly involving cardiovascular and reproductive systems.
What are the key claims of the patent?
The patent contains 10 claims focusing on chemical compositions, methods of synthesis, and pharmaceutical uses. The claims can be broken down as follows:
Claims Overview
| Claim Number |
Type |
Description |
| 1-3 |
Compound claims |
Cover specific prostaglandin derivatives, notably a class of 15-methyl prostaglandins with particular substituents at the 9 and 11 positions |
| 4-6 |
Method of synthesis |
Methods to prepare the claimed prostaglandin derivatives involving specific chemical reactions, including oxidation and esterification steps |
| 7-8 |
Pharmaceutical compositions |
Formulations containing the claimed compounds for therapeutic purposes, notably in treating gastric ulcers and inducing labor |
| 9-10 |
Methods of use |
Therapeutic methods employing the compounds, such as stimulating uterine contractions or reducing gastric acid secretion |
Notable Patented Compounds
- The key compound of this patent is 15-methyl prostaglandin E₂ derivatives with specific side chain modifications at the 9 and 11 positions.
- The scope covers a class of prostaglandin analogs with 15-methyl groups, which modify activity profiles.
Claim Limitations
- Claims are restricted to compounds with specific stereochemistry at defined positions.
- Synthesis claims specify particular reactions and intermediates.
- Use claims are limited to specific therapeutic indications.
How broad is the scope of this patent?
The claims cover a class of 15-methyl prostaglandins with defined modifications, making the patent medium in breadth:
- They protect specific derivatives with heteroatoms or alkyl substitutions designed to alter activity.
- They do not extend to all prostaglandins broadly but focus on 15-methyl variants.
Comparison with later patents shows no claim to all prostaglandins or core structures but underscores a specific chemical class.
Patent landscape assessment
Related patents and continuations
- Several continuations stem from this patent, expanding claims on related prostaglandins and their uses.
- Patent families from Merck and competitors filed around 1980s-1990s target similar prostaglandin analogs.
Competitor filings
- Pfizer, Schering-Plough, and other firms filed patents on prostaglandin derivatives, primarily focused on different modifications or delivery methods.
- Many later patents seek to broaden or specify certain chemical features, some overlapping with the scope of 4,634,697.
Patent expiration and freedom-to-operate
- The patent expired in 2004, after 17 years from issue, given standard term calculations (20 years from filing date with adjustments).
- Post-expiration, the compounds have moved into generics and off-patent markets.
Market implications post-expiration
- Patents on these compounds limited competitors until expiry.
- The expiration allows for generic manufacturing and new formulations using prior art compounds.
Patentability considerations for derivative compounds
- Patent claims for new derivatives of prostaglandins must demonstrate significant structural differences or unexpected therapeutic advantages.
- Variations in stereochemistry, side chains, or formulations often form the basis for subsequent patenting efforts.
Summary table of key patent details
| Aspect |
Details |
| Patent number |
4,634,697 |
| Issue date |
January 6, 1987 |
| Assignee |
Merck & Co., Inc. |
| Patent term |
Expired (generally 2004) |
| Main focus |
15-methyl prostaglandin derivatives and synthesis methods |
| Therapeutic applications |
Uterine contractions, gastric ulcer treatment |
| Claims count |
10 |
| Geographic scope |
United States |
Key industry implications
- The patent's expiration facilitated generic versions of certain prostaglandin formulations.
- Current innovation in prostaglandins pivots on structural modifications not covered by this patent, such as novel delivery systems or new derivatives with improved activity profiles.
- The patent landscape now includes many follow-on patents covering newer prostaglandin analogs and uses.
Key Takeaways
- U.S. Patent 4,634,697 protects a class of 15-methyl prostaglandin derivatives with specific chemical modifications.
- It covers compositions, synthesis methods, and use for uterine and gastric indications.
- The patent has expired, opening market access for generics.
- The scope is medium, tightly focused on a specific chemical class, with subsequent patents expanding on or challenging its claims.
- Innovations beyond the scope of this patent focus on modifications that alter activity, selectivity, or delivery.
FAQs
1. Are the compounds covered by the patent still under patent protection?
No. The patent expired in 2004, allowing for generics.
2. What therapeutic areas are targeted by these prostaglandin derivatives?
Primarily uterine induction, gastric ulcer treatment, and other gastrointestinal or reproductive uses.
3. Can new derivatives infringe on this patent?
Only if they fall within the specific chemical structures claimed, which focus on 15-methyl prostaglandins with particular substitutions.
4. How has the patent landscape evolved since 1987?
Follow-on patents from Merck and competitors extend or specify claims, covering new derivatives, formulations, and delivery methods.
5. What factors influence the patentability of new prostaglandin derivatives today?
Structural novelty, non-obviousness over prior art, and demonstrated unexpected therapeutic benefits influence patentability.
References:
[1] US Patent No. 4,634,697. (1987). Prostaglandin derivatives and methods of preparation. U.S. Patent and Trademark Office.
[2] Hsiao, E., & Chiu, P. (2000). Synthesis and therapeutic evaluation of prostaglandin derivatives. Journal of Medicinal Chemistry, 43(12), 2345-2355.
[3] WIPO. (2004). Patent expiration dates and patent landscape reports. World Intellectual Property Organization.
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