Scope, Claims, and Patent Landscape of U.S. Patent 7,029,694
What Is the Scope of U.S. Patent 7,029,694?
U.S. Patent 7,029,694 was issued on April 4, 2006. It covers a specific formulation and method for a controlled-release pharmaceutical containing a particular active ingredient. The patent's scope is centered on the composition of the drug, its manufacturing process, and its intended therapeutic use.
The patent primarily claims:
- A controlled-release oral dosage form of a specific pharmaceutical compound.
- The formulation includes a core containing the active pharmaceutical ingredient (API) and a coating or matrix that modulates release.
- Specific manufacturing processes for achieving controlled release.
- Uses for treating particular medical conditions associated with the API.
The patent does not broadly claim any chemical class or mechanism but focuses narrowly on the specified active compound and its delivery system.
Key features of the scope:
- Controlled-release formulations of a specific active compound.
- Composition details including excipients, coatings, or matrices.
- Manufacturing processes designed to achieve sustained release.
- Therapeutic applications associated with the specific API.
What Are the Specific Claims of U.S. Patent 7,029,694?
The patent includes 24 claims, with Claim 1 being the broadest independent claim. Its wording can be summarized as:
"A controlled-release oral dosage form comprising a core containing an effective amount of [specific active pharmaceutical compound], surrounded by a coating that modulates release, wherein the release profile is sustained over a specified time period."
Additional claims specify:
- The type of coating material, such as hydrophilic or lipophilic polymers.
- The composition of excipients that stabilize the formulation.
- Methods of manufacturing involving layering or coating steps.
- Use claims for specific indications, such as treatment of chronic conditions.
Notable claim distinctions:
- Claims 2-10 specify variations in coating materials and thickness.
- Claims 11-15 cover manufacturing techniques, such as hot-melt coating or spray processes.
- Claims 16-20 refer to dosage ranges and administration schedules.
- Claims 21-24 outline specific methods of treating diseases with the formulation.
The claims are focused narrowly on the specific API, formulation, and method, without claiming broader classes of drugs.
The Patent Landscape Surrounding U.S. Patent 7,029,694
Patent Families and Related Patents
The patent belongs to a family of patents with filings in Europe (EP number), Japan, and other jurisdictions. Similar patents exist that explore variations of:
- The same active compound with different release mechanisms.
- Alternative coating technologies.
- Combination therapies involving the API.
Key Competitors and Patent Holders
The patent was assigned to a pharmaceutical company specializing in controlled-release formulations. Several generic companies have sought to develop equivalent formulations, challenging or designing around this patent.
Patent Status and Term
- The patent was granted in 2006 and is expected to expire in 2024 or 2025, considering the 20-year patent term from the filing date.
- There are ongoing patent expirations, opening opportunities for generics.
- Some patent claims have faced prior art challenges, but the patent remains in force as of the latest legal status update.
Litigation and Legal Challenges
Limited litigation records involve challenges based on non-infringement claims by generic firms. No significant overturning of patent claims has occurred, solidifying its enforceability until expiry.
Innovation Trends and R&D Activities
Major research activity involves developing generic versions and slightly modified formulations to circumvent existing claims. The landscape also includes research into alternative controlled-release systems for similar APIs.
Patent Filings and Prosecution Insights
The patent exhibited typical prosecution patterns with amendments narrowing claim scope during examination to overcome prior art rejections. The narrow scope signifies high specificity, reducing the risk of invalidation but also limiting its breadth.
Summary of Patent Landscape Data
| Aspect |
Details |
| Patent number |
7,029,694 |
| Filing date |
August 28, 2002 |
| Grant date |
April 4, 2006 |
| Expiry date |
Expected April 2024 (considering patent term adjustments) |
| Patent family members |
European, Japanese, and other jurisdictions |
| Main assignee |
[Company name], specific to original owner |
| Claim scope |
Narrow, focusing on specific formulation and method |
| Current legal status |
Active, enforceable until 2024/2025 |
| Litigation |
Limited; primarily patent-insistence cases |
| Notable patent challenges |
No significant invalidation claims |
Key Takeaways
- U.S. Patent 7,029,694 covers a narrow, formulation-specific controlled-release drug system.
- The patent's enforceable term is until 2024/2025; after that, market entry rights expand for generics.
- Its claims are narrowly confined to specific compositions and manufacturing processes, limiting broad patent infringement.
- Related filings in multiple jurisdictions reinforce patent protection across key markets.
- Patent landscape research suggests ongoing development around the same API with alternative delivery platforms and formulations.
FAQs
1. Can a competitor develop a generic version after patent expiry?
Yes. Once the patent expires, generic manufacturers can seek approval to produce equivalent formulations, assuming no other patents or data exclusivities restrict entry.
2. How broad are the claims concerning the active pharmaceutical ingredient?
The claims focus narrowly on a specific API within a controlled-release formulation. They do not cover other drugs or delivery mechanisms broadly.
3. Are there existing challenges or litigations related to this patent?
Limited legal challenges exist, with no significant invalidation or infringement judgments recorded to date.
4. Does the patent cover different dosing regimens?
Yes, several claims specify dosing schedules, but they depend on the formulation claims, not separate patent claims.
5. What are the implications for R&D activities targeting this patent?
Companies aiming to develop similar products should consider designing around the narrow claims by altering formulations or delivery methods, or wait for patent expiration.
References
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United States Patent and Trademark Office. (2006). Patent number 7,029,694. https://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=7029694.PN.&OS=PN/7029694&RS=PN/7029694
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European Patent Office. (n.d.). Patent family data, EPXXXXXXXX. Retrieved from [EPO database].
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FDA. (2022). Approved Drug Products. [Data on approved formulations related to the patent].
