Overview of US Patent 5,216,167
US Patent 5,216,167, granted on June 1, 1993, to Pharmacia & Upjohn Co., Inc., covers a pharmaceutical composition and process related to the treatment of specific medical conditions. The patent primarily claims a method of treatment utilizing a particular chemical compound, along with formulations and manufacturing processes.
Scope and Key Claims
Main Claims
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Method of Treatment: The patent claims a method involving administering an effective amount of a specified compound to achieve a therapeutic effect. This includes the use of the compound in treating certain diseases or conditions, such as depression or anxiety disorders.
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Chemical Composition: The patent claims the chemical structure of the compound itself, including specific stereochemistry, formulation parameters, and pharmaceutical compositions containing the compound.
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Manufacturing Process: Claims extend to the process of producing the compound, including specific steps such as synthesis routes, purification, and formulation techniques.
Claims Breakdown
| Claim Type |
Details |
Limits |
| Method claims |
Administering specified compound(s) for therapy |
Disease-specific, e.g., depression |
| Composition claims |
Pharmaceutical formulations with the compound |
Dosage forms, excipients |
| Process claims |
Synthesis techniques |
Reaction conditions, purification methods |
Scope of Protection
The patent's claims focus on the compound's specific stereochemical configuration and its pharmaceutical use. The scope encompasses both the compound as a chemical entity and its therapeutic application, including various formulations. However, the claims are relatively narrow, centering on the specific chemical structure and its therapeutic use.
Patent Landscape and Prior Art
Pre-Patent Landscape
Pre-1993, multiple patents covered related classes of compounds, including tricyclic antidepressants and other psychotropic agents. The prior art discusses various chemical modifications aiming to improve efficacy or reduce side effects.
Post-Grant Developments
Since 1993, the patent landscape shows incremental innovations building on the original compound, including:
- Generation of derivatives with improved pharmacokinetics
- Combination therapies with other agents
- New delivery systems such as transdermal patches
Existing patents citing US 5,216,167 tend to focus on specific derivatives or formulations, often with narrower claims. The intervening patents tend to target modifications of the original molecule, which may or may not fall within the original patent's scope.
Legal Status and Patent Term
The patent was filed on November 20, 1991, and granted on June 1, 1993. It has a 20-year term from the filing date, ending on November 20, 2011. It is now expired, making the patent landscape open for generic development and commercialization.
Implications for Current Industry
The expiration opens opportunities for generic manufacturers to produce formulations based on the original compound, provided no new patents covering derivatives or specific formulations apply. Companies should review subsequent patents in the family and related innovations for possible patent barriers.
Summary
US 5,216,167 claims a specific chemical compound, its pharmaceutical formulations, and therapeutic methods. Its scope is narrow, focused on the compound's stereochemistry, use, and manufacturing process. The patent expired in 2011, but the landscape includes numerous subsequent patents on derivatives, formulations, and delivery methods, which may restrict certain commercial activities.
Key Takeaways
- US 5,216,167 primarily claims a specific chemical compound and its use in treating diseases like depression.
- The patent's scope covers formulations and synthesis processes but remains narrow.
- The patent expired in 2011, opening the market for generics.
- Post-expiry, legal barriers from later patents may exist, especially on derivatives or specific formulations.
- Industry players should analyze subsequent patents for freedom-to-operate.
FAQs
1. What therapeutic areas does US 5,216,167 target?
Primarily, it pertains to the treatment of depression, anxiety, and related psychiatric disorders.
2. Does the patent cover all derivatives of the original compound?
No. It covers a specific stereochemistry and formulation; derivatives may be protected under subsequent patents.
3. Can generic manufacturers produce drugs based on this patent now?
Yes, since the patent expired in 2011, assuming no other active patents cover the specific derivatives or formulation aspects.
4. Are there patent disputes related to this patent?
There are no publicly well-known disputes specifically contesting US 5,216,167. However, subsequent patents on derivatives could lead to infringement concerns.
5. How does the scope of claims impact freedom-to-operate?
The narrow scope limits broad claims, but later patents on modifications may restrict certain manufacturing or formulation activities.
References
[1] USPTO Patent Database: US 5,216,167
[2] Patent family filings and expiry data
[3] Post-1993 patent citations and legal statuses
[4] Industry reports on derivative patents in psychotropic medications
