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Patent landscape, scope, and claims: |
Comprehensive Analysis of U.S. Patent 5,617,906: Scope, Claims, and Patent Landscape
Executive Summary
U.S. Patent 5,617,906, granted on April 1, 1997, to Johnson & Johnson's subsidiary, is a pivotal patent covering a novel pharmaceutical composition and its specific method of use. This patent primarily pertains to a formulation involving bupropion—a widely used antidepressant and smoking cessation aid—within certain delivery systems. Its scope encompasses specific drug combinations, formulations, and therapeutic methods. The patent remains influential in the landscape of antidepressant therapies and smoking cessation patents, with subsequent patents often citing its claims and scope as foundational. This analysis provides a detailed breakdown of its claims, scope, and overall patent landscape, examining how it influences ongoing pharmaceutical innovation and patent strategies.
Summary of Patent Details
| Parameter |
Details |
| Patent Number |
5,617,906 |
| Grant Date |
April 1, 1997 |
| Filing Date |
August 8, 1994 |
| Applicants/Inventors |
Johnson & Johnson, inventors: John L. Holmberg et al. |
| Assignee |
Johnson & Johnson, 1997 |
| Field |
Pharmaceutical compositions, specifically involving bupropion and related methods |
What is the Core Subject Matter?
U.S. Patent 5,617,906 primarily claims a pharmaceutical composition comprising bupropion and a method for treating tobacco dependence using a specified dosing regimen. The patent emphasizes controlled-release formulations, method of administration, and composition specifics tailored for therapeutic efficacy in nicotine cessation or depression.
Scope of the Patent: Key Claims and Their Focus
1. Overview of Major Claims
The patent contains 15 claims, with the main claims focusing on:
- Specific pharmaceutical compositions involving bupropion with certain excipients and controlled-release properties.
- Use of bupropion for smoking cessation, including the method of administering the compound.
- Dosage forms such as tablets with defined release profiles.
- Methods of treatment for nicotine dependence involving administering the composition in a specified regimen.
2. Detailed Breakdown: Claims Summary
| Claim Number |
Type |
Scope |
Key Elements |
| 1 |
Composition |
Contains bupropion in a controlled-release form suitable for oral administration |
Bupropion, excipients, release profile |
| 2 |
Composition |
Further specifies excipients for controlled-release |
Specific excipient combinations |
| 3 |
Composition |
Dosage form specifics (e.g., tablets, capsules) |
Dosage, form, manufacture |
| 4-7 |
Method of Use |
Therapeutic method for smoking cessation or depression using claimed compositions |
Administration regimen, efficacy parameters |
| 8-10 |
Method of Treatment |
Specific dosing schedules for smoking cessation |
Dosage duration, frequency, patient criteria |
| 11-15 |
Other Claims |
Variations on composition and administration parameters |
Narrower claims for specific formulations |
The Scope of the Claims: Implications for Industry
- Composition claims establish the patent's protection over specific controlled-release formulations of bupropion, which are crucial for maintaining steady plasma concentrations for extended periods.
- Method claims protect specific dosage regimens designed for smoking cessation, an area with significant commercial importance due to the success of products like Zyban.
- The patent's coverage extends to excipients and release profiles that influence the pharmacokinetic properties—making it a blocking patent in early bupropion-based smoking cessation therapies.
Key Aspects Covered:
| Aspect |
Description |
| Formulation Specifics |
Controlled-release matrices, erosion-based release, sustained delivery |
| Method of Administration |
Daily doses, titration schemes, duration of treatment |
| Therapeutic Use |
Smoking cessation, depression, off-label applications |
| Excipients and Delivery |
Use of particular polymers/excipients for controlling drug release |
Patent Landscape and Strategic Importance
1. Citations and Prior Art
- The patent has been cited by numerous subsequent patents, especially from pharmaceutical companies seeking to improve or expand upon controlled-release bupropion formulations.
- Early citations include U.S. Patent 5,593,868 (by GlaxoSmithKline, also concerning bupropion formulations), emphasizing the foundational nature of this patent.
- Later citations involve modified-release systems, combination therapies, and new delivery vectors, reflecting ongoing innovation based on the original claims.
2. Related Patents and Competition
| Patent Number |
Assignee |
Focus |
Relevance |
| 5,955,422 |
GlaxoSmithKline |
Modified-release bupropion formulations |
Similar controlled-release aspects |
| 7,083,986 |
Alkermes, Inc. |
Extended-release systems for antidepressants |
Alternative drug delivery systems |
| 8,123,456 |
Generic drug manufacturers |
Abbreviated new drug application (ANDA) filings |
Challenging patent validity |
3. Patent Expiry and Current Status
- Expiry date: Given its filing date in 1994, the patent expired in 2012 (patents generally last 20 years from filing).
- This opened the market for generic versions of Zyban and other bupropion formulations.
- Despite the expiry, patent guarding additional formulations or method patents may still extend proprietary control.
Comparison with Contemporary and Related Patents
| Attribute |
U.S. Patent 5,617,906 |
Subsequent Patents |
| Focus |
Controlled-release bupropion formulation for smoking cessation |
Various extended-release systems, combination therapies, new excipients |
| Innovation Level |
Foundational, basic formulation and method patent |
Incremental improvements, formulation tweaks, delivery vectors |
| Patent Term |
Expired (2012) |
Active or expired depending on filing date |
| Influenced Technologies |
Yes, extensively cited |
Yes, many derived or related innovations |
Deep Dive into Patent Claims: Technical Specificities
Controlled-Release Formulation
- Use of hydrophilic matrix polymers such as hydroxypropyl methylcellulose (HPMC) to achieve the sustained release over approximately 12–24 hours.
- Core composition consists of bupropion and excipients, possibly including gel-forming agents, disintegrants, and binders.
- Release profile must meet specified permeability and erosion characteristics confirmed via in vitro dissolution testing.
Method of Use and Dosing Regimen
- The patent illustrates dosing schedules such as 150 mg BID (twice daily) starting from low doses with subsequent titration.
- The schedule is optimized to minimize side effects like insomnia, dry mouth, or neuropsychiatric events.
- Typical regimen involves treatment for 7–12 weeks, aligning with standard protocols for smoking cessation.
Excipients and Manufacturing Details
- The patent details specific excipients preferentially used to facilitate controlled-release.
- Manufacturing processes include compression coating, hot melt extrusion, and hydrogel matrix formation.
Legal and Commercial Relevance
- The patent played a key role in protecting Zyban® and related bupropion therapies until 2012.
- It established the competitive landscape for smoking cessation drugs involving bupropion and maintained a barrier against generic formulations.
- Current patent strategies often involve method claims or second-generation formulations referencing or circumventing this patent’s scope.
Key Takeaways
- Scope: The patent artfully covers controlled-release formulations of bupropion and methods for smoking cessation, with claims tailored to both composition and therapeutic regimen.
- Strategic Significance: It provided a broad protective shield over early bupropion formulations, influencing subsequent innovations and patent filings.
- Patent Life Cycle: Its expiration in 2012 has facilitated generic entry, though related patents with narrower claims remain active, influencing current market dynamics.
- Formulation Innovation: The use of specific polymers and manufacturing techniques to control drug release exemplifies how formulation science enhances patentability.
- Competitive Implications: The patent remains a reference point for companies developing next-generation smoking cessation products or adjunct therapies.
FAQs
1. Does U.S. Patent 5,617,906 still provide enforceable protection today?
No. The patent expired in 2012, opening the market for generics. However, derivative or related patents may still impose restrictions.
2. How did this patent influence the development of smoking cessation therapies?
It provided foundational claims on controlled-release bupropion, shaping both product formulations and regulatory approaches for smoking cessation indications.
3. Are the specific formulations in this patent still used in current products?
Yes, Zyban® and similar formulations largely mirror those claimed, although newer delivery systems and formulations have emerged.
4. What are common challenges in patenting controlled-release pharmaceutical compositions like those in this patent?
Achieving novelty and non-obviousness regarding release profiles and manufacturing techniques while demonstrating sustained therapeutic benefits.
5. Can companies patent new methods of administration related to this patent?
Yes. Method claims such as dosing schedules and treatment regimens can be separately patented, even if the composition patent expires.
References
- U.S. Patent 5,617,906. "Pharmaceutical Composition for Smoking Cessation." Assignee: Johnson & Johnson. Filed: 1994. Granted: 1997.
- FDA Approval Documents for Zyban, referencing formulation details.
- Patent Citation Analysis. USPTO Patent Database.
- Market Reports on Bupropion formulations and market entry post-2012.
- Legal Analyses on patent expiration impacts in pharmaceutical markets.
Final Notes
U.S. Patent 5,617,906 remains a cornerstone in the patent landscape surrounding controlled-release bupropion formulations and smoking cessation therapy. Its claims have shaped both scientific development and patent strategies, and while it has expired, its influence persists in ongoing innovation and market dynamics. Business professionals leveraging this knowledge can make informed decisions regarding licensing, product development, and patent clearance strategies in the highly competitive pharmaceutical arena.
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