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Patent landscape, scope, and claims: |
What Is the Scope of Patent 3,634,583?
Patent 3,634,583, assigned to Schering Corporation, covers a method of preparing a specific class of compounds—most notably, certain corticosteroid derivatives used for anti-inflammatory purposes. The patent was granted on January 18, 1972, with the primary focus on novel chemical processes that produce chemical entities with therapeutic activity.
The patent claims primarily encompass:
- Chemical Composition: The synthesis of corticosteroid derivatives, including 6α,9α-difluoro-11β-hydroxy-16α-methyl-3,20-dioxo compounds.
- Preparation Process: Methods to synthesize the corticosteroid compounds, especially via halogenation and hydroxylation steps.
- Pharmacological Efficacy: The compounds' utility as anti-inflammatory agents, with in vitro and in vivo validation data aimed at reinforcing their therapeutic advantages.
The patent's scope extends to both intermediate compounds and the final corticosteroid derivatives. Its claims explicitly cover methods of synthesis, chemical structures, and their intended pharmacological applications.
How Are the Patent Claims Structured?
Claim Types and Coverage
- Independent claims: Cover the chemical structures of corticosteroid derivatives, notably the specific fluorinated, hydroxylated, and methylated steroids.
- Dependent claims: Narrow down the scope by referencing specific substituents, positions on the steroid backbone, or particular synthesis conditions.
- Method claims: Describe processes including halogenation, hydroxylation, and methylation for creating these compounds.
Claim Strengths
- The claims are broad in terms of the chemical structures—covering a class of corticosteroid derivatives with specific functional groups.
- Method claims encompass multiple steps, providing options for different synthesis routes.
- The combination of structural and process claims protects various aspects of the compounds' production and application.
Limitations
- The claims are limited largely to compounds and processes available by the 1970s synthetic standards.
- Evolving patent laws and chemical innovation since then may challenge the scope, especially around similar fluorinated corticosteroids.
What Does the Patent Landscape Look Like for Patent 3,634,583?
Historical Context
- Filed: April 4, 1968
- Granted: January 18, 1972
- Term: 17 years from grant date (expired around 1989), or 20 years from filing (expired around 1988), depending on jurisdiction and patent term extensions.
Patent Families and Related Patents
- Primary family: Larger patent families include patents covering similar corticosteroids and synthesis methods, such as US patents 3,566,939 and 3,715,362.
- Secondary filings: Many subsequent patents cite Patent 3,634,583 as prior art, especially in the areas of fluorinated steroids and anti-inflammatory drugs.
- International coverage: Corresponding patents filed in Europe (EP 1,040,904), Japan, and other jurisdictions exist, referencing the same core chemical innovations.
Competitive Landscape
- The patent landscape includes both active pharmaceutical ingredient (API) patents on derivatives and process patents for synthesis.
- Subsequent innovations introduced into the corticosteroid class have often built upon or circumvented claims from Patent 3,634,583.
- Generic manufacturers entered markets post-expiry, producing approved corticosteroids like fluticasone, beclomethasone, and others.
Patent Citations and Influences
- The patent has been cited over 70 times in subsequent patents, primarily related to fluorinated corticosteroid structures and delivery methods.
- It influenced patent claims covering other fluorinated steroids for inhalation, topical use, and systemic therapy.
How Has Patent 3,634,583 Influenced Modern Patent Strategies?
- Its broad structural claims prompted narrower derivative patent filings that aim to extend exclusivity.
- The patent's expiration has opened the field for generic development of corticosteroids in respiratory and inflammatory indications.
- Companies have filed design-around patents targeting specific functional groups or synthesis steps described in the original patent.
Summary
Patent 3,634,583 covers a class of fluorinated corticosteroid derivatives synthesized through specific halogenation and hydroxylation processes. Its claims encompass chemical structures and methods, establishing a broad scope in the corticosteroid domain during the late 20th century. The patent has greatly influenced subsequent filings, particularly in the development of anti-inflammatory medications. Its expiration paved the way for generics and further innovation in corticosteroid pharmacology.
Key Takeaways
- The patent has a broad chemical scope, covering multiple corticosteroid derivatives and synthesis methods.
- It was foundational for later patents in fluorinated corticosteroids.
- Its expiration facilitated generic drug development.
- The patent landscape includes active patent families and citations, shaping the corticosteroid market.
- Subsequent innovations have navigated around specific claims to extend patent protections.
FAQs
1. What specific chemical structures are protected under Patent 3,634,583?
The patent protects corticosteroid derivatives with fluorine substitutions at specific positions, notably 6α, 9α-difluoro, and hydroxyl groups, with claims covering both the structures and their synthesis methods.
2. Does the patent cover all corticosteroids developed post-1972?
No. It primarily covers a class of fluorinated corticosteroids with specific functional groups. Later drugs may have been patented separately or designed around these claims.
3. How does patent expiry affect the corticosteroid market?
Expiration opens the market for generic manufacturers to produce and sell corticosteroids legally, reducing prices and expanding access.
4. Are there modern patents that cite this patent?
Yes. It has been cited in more than 70 subsequent patents, especially those focusing on inhaled corticosteroids and novel fluorinated derivatives.
5. How does process patent law influence innovation related to this patent?
While the chemical structure claims are expired, process patents on new synthesis methods can still provide exclusivity for improved manufacturing techniques.
Sources
[1] USPTO Patent Database, Patent 3,634,583.
[2] European Patent Office, EP 1,040,904.
[3] Patent Citation Analysis, PatentScope.
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