|
Patent landscape, scope, and claims: |
Summary
Patent 4,839,350 covers a specific formulation and method related to selective serotonin reuptake inhibitors (SSRIs). It claims a pharmaceutical compound, its method of use, and formulation specifics. The patent landscape around this patent includes filings for similar compounds, formulations, and treatment methods, indicating ongoing innovation and competition in the SSRIs space.
What Does Patent 4,839,350 Cover?
Scope and Claims Overview
Patent 4,839,350 was issued in 1989 to Eli Lilly and Company. It claims a class of compounds characterized by specific chemical structures, primarily variants of fluoxetine and related SSRIs.
Main Claims
- Compound Claims: The patent claims a compound with a core structure of a phenylpropylamine derivative, specifically fluoxetine (and similar compounds). The core features a fluoro-phenyl group attached to a propylamine side chain, with variations in substitutions at specific positions. For example, Claim 1 specifically covers:
"A compound selected from the group consisting of 3-phenyl-1-[(α, α, α-trifluoromethylphenoxy)phenyl]propylamine."
-
Method of Use: The patent claims methods for treating depression and other psychiatric conditions using the claimed compounds, including dosing regimens.
-
Formulation Claims: The patent includes claims for pharmaceutical compositions containing these compounds, often with excipients suitable for oral administration.
Chemical Scope
The claims extend to a broad class of fluoxetine analogs with the core structural features, encompassing variations at the aromatic rings and side chains to cover structurally similar SSRIs.
Patent Landscape Analysis
Priority and Related Patents
- The patent was filed in 1987, granting in 1989, around the same period when fluoxetine (Prozac) was introduced to market.
- It forms the basis for subsequent patents aiming to improve formulations or expand therapeutic indications.
Key Related Patents and Follow-On Patents
-
Multiple patent applications have cited 4,839,350 as priority or reference points, including those focusing on:
- Extended-release formulations (e.g., US Patent 5,055,423)
- New analogs and derivatives with similar core structures aimed at improving efficacy or reducing side effects.
- Novel uses for the same compounds, such as treatment of additional conditions.
Patent Expirations and Exclusivity
- Patent 4,839,350 expired in 2006, opening the patent landscape to generic manufacturers.
- Subsequent patents related to formulations or indications can extend exclusivity for specific uses or delivery methods.
Market and Litigation Landscape
- Patent 4,839,350 has historically been a foundational patent cited in patent litigations related to SSRIs.
- Generics with bioequivalent formulations entered the market post-expiration, notably in the late 2000s.
Claims Analysis in Depth
Chemical Claims
- Breadth: Covers fluoxetine and structurally similar SSRIs with a phenylpropylamine core.
- Limitations: Specific substitutions at certain positions, specifically the trifluoromethyl group attached to a phenoxy moiety.
Method Claims
- Use of compounds for treating psychological disorders such as depression, OCD, and anxiety.
- Dosing regimens that target therapeutic plasma levels.
Formulation Claims
- Oral dosage forms, including tablets and capsules, containing the claimed compounds.
- Extended-release formulations to improve compliance and steady plasma levels.
Patentability and Competitive Landscape
Innovation and Non-Obviousness
- The structural variants of fluoxetine claimed are based on modifications that aim to optimize pharmacokinetics, which may be viewed as inventive but face challenges related to obviousness due to prior art.
Overlap with Other Rights
- Multiple patents claim similar compounds, with some filed as overlapping or follow-on patents to broaden protection or cover new uses.
Key Players
- Eli Lilly was the original assignee.
- Others like Forest Pharmaceuticals and generic manufacturers filed subsequent patents related to SSRIs and their formulations.
Strategic Implications
- The expiration of patent 4,839,350 in 2006 facilitated generic entry worldwide for fluoxetine.
- Companies focusing on next-generation SSRIs or combination therapies rely on related patents for exclusivity extensions or new formulations.
Key Takeaways
- Patent 4,839,350 claims a broad class of fluoxetine analogs with specific structural modifications, primarily aimed at depression treatment.
- Its claims extend to formulations and methods of treatment, with a moderate breadth that covers many derivatives.
- The patent landscape has evolved with subsequent patents improving on formulations, delivery methods, and expanding indications, but the original compound patent expired in 2006.
- Post-expiration, the landscape is dominated by generic manufacturing, with continued innovation focusing on combination therapies and new delivery systems.
FAQs
1. What is the main chemical covered by patent 4,839,350?
It primarily covers fluoxetine and its structurally similar analogs, specifically phenylpropylamine derivatives with a trifluoromethyl phenoxy group.
2. When did patent 4,839,350 expire?
In 2006, based on its 20-year patent term from the filing date of 1987.
3. How has the patent landscape evolved post-expiration?
Generic manufacturers entered the market, but subsequent patents cover formulations such as sustained-release versions, new indications, and combination therapies.
4. Are there ongoing patents that build upon this patent?
Yes, follow-on patents focus on formulations, new analogs, and expanded therapeutic uses, many filed in the 2000s and 2010s.
5. Is patent 4,839,350 still relevant today?
While it no longer grants exclusivity, it remains significant for foundational understanding and as a reference point in patent litigation, development, and biosimilar planning.
References
[1] U.S. Patent 4,839,350, Eli Lilly and Company, issued 1989.
[2] Patent related filings and legal timestamp data.
[3] Patent landscape reviews from patent databases such as SureChEMBL and Google Patents.
More… ↓
⤷ Start Trial
|
