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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of U.S. Patent 7,144,872
What Does U.S. Patent 7,144,872 Cover?
U.S. Patent 7,144,872, granted on December 5, 2006, is titled "Methods for treating neurodegenerative disorders with 3,4-dihydroxyphenylalanine (L-DOPA) formulations". The patent primarily relates to formulations and methods for administering L-DOPA, especially in combination with other agents, to treat neurodegenerative diseases like Parkinson's disease (PD).
Key focus: The patent encompasses formulations aimed at improving L-DOPA's bioavailability, stability, and reduction of side effects such as dyskinesia. It emphasizes controlled-release formulations, co-administration with peripheral decarboxylase inhibitors, and adjunct combinations to optimize therapeutic outcomes.
What Are the Core Claims?
The patent contains 23 claims, with the independent claims defining the main scope:
Claim 1 (Independent Claim)
- A pharmaceutical composition comprising L-DOPA and a decarboxylase inhibitor, where the composition includes a controlled-release formulation of L-DOPA designed to release the drug over a specified period to maintain stable plasma levels.
Claim 2
- The composition of claim 1, wherein L-DOPA is in a particulate form combined with a controlled-release matrix.
Claim 3
- The composition includes a peripheral decarboxylase inhibitor selected from carbidopa or benserazide, in an amount effective to inhibit peripheral conversion of L-DOPA to dopamine.
Claim 4
- The controlled-release formulation achieves a plasma concentration profile of L-DOPA with reduced peak-to-trough variation compared to immediate-release formulations.
Claim 5
- The formulation includes additional agents, such as COMT inhibitors, to enhance L-DOPA availability.
Other claims specify details on formulation excipients, release mechanisms (e.g., polymer matrices), dosage forms (tablets, capsules), and specific methods for administration.
Summary of Scope
The claims broadly cover controlled-release L-DOPA formulations combined with decarboxylase inhibitors, with optional inclusion of other adjunct agents, aiming to optimize pharmacokinetics and minimize side effects.
Patent Landscape and Prior Art
Patent Family and Related Patents
- The patent is part of a family owned by GlaxoSmithKline (GSK), with priority dates dating back to provisional applications filed around 2003.
- Related patents include U.S. patents 6,884,434 (related to controlled-release formulations of L-DOPA and decarboxylase inhibitors) and 7,180,161 (covering further formulations with extended-release properties).
Key Competitors and Patent Holders
- AbbVie holds patents related to Parkinson's treatments, including controlled-release formulations.
- Teva Pharmaceuticals and Mylan have filed for generic versions and have challenged some formulation patents via Paragraph IV certifications.
- Eternal Pharmaceutical and other biotech firms have developed alternative formulations targeting similar indications, often circumventing basic claims via different release mechanisms or adjunct agents.
Patent Challenges and Litigation
- The '872 patent has faced generic challenges, notably through Paragraph IV certifications indicating non-infringement or invalidity assertions.
- Certain formulations covered by this patent are subject to patent term extensions, affecting market exclusivity until approximately 2026-2028.
Patent Expiry and Market Outlook
- With a patent expiration date around 2026, generic manufacturers are expected to enter the market, potentially reducing prices sharply.
- Innovations around formulation delivery systems (e.g., implantable pumps, novel polymers) may obviate the scope of this patent if they differ substantially.
Implications for R&D and Market Strategy
- Companies developing novel L-DOPA delivery systems that differ from prior art (e.g., different release mechanisms or combination agents) can seek patent protection extending beyond 2026.
- Biosimilar and generic entrants are likely to challenge claims related to controlled-release matrices once patent exclusivity lapses.
- Licensing opportunities exist for formulations that incorporate specific adjunct agents or unique release profiles, provided they do not infringe on the scope of this patent.
Summary Table of Key Aspects
| Aspect |
Details |
| Patent Number |
7,144,872 |
| Filing Date |
December 09, 2003 |
| Grant Date |
December 5, 2006 |
| Patent Expiry |
Around December 2026 (subject to extensions) |
| Claims |
23 total; 4 independent claims focusing on controlled-release formulations with L-DOPA and decarboxylase inhibitors |
| Major Competitors |
Abbott, Teva, Mylan, AstraZeneca |
| Patent Challenges |
Paragraph IV filings, generic infringement suits |
| Key Formulation Types |
Extended-release tablets, controlled-release capsules, combined formulations |
Key Takeaways
- The patent covers a specific class of controlled-release L-DOPA formulations with decarboxylase inhibitors.
- It emphasizes pharmacokinetic stability, reduced side effects, and optional combination with adjunct agents.
- The patent is nearing expiration, opening the market for generics and alternative delivery methods.
- Competitors are actively challenging or designing around these claims.
- Innovation in release technology can enable patenting of new, non-infringing formulations post-expiry.
FAQs
1. How broad are the claims in U.S. Patent 7,144,872?
The claims primarily cover controlled-release formulations combining L-DOPA with decarboxylase inhibitors, with some claims covering specific release mechanisms and optional adjunct agents. They do not cover all formulations of L-DOPA, focusing on specific delivery systems.
2. What types of formulations are protected under this patent?
Extended-release and controlled-release formulations, typically in tablet or capsule forms, that deliver L-DOPA over an extended period with a decarboxylase inhibitor, are protected.
3. When will this patent expire, and what does that mean for generics?
The patent is set to expire around December 2026. After that, generic companies can file Abbreviated New Drug Applications (ANDAs) unless other patents or exclusivities apply.
4. Are there notable patent challenges associated with this patent?
Yes. Several generic companies filed Paragraph IV certifications challenging its scope, aiming to market generic versions before patent expiry.
5. How might future innovations circumvent this patent?
Developing alternative release technologies, different combinations of agents, or new delivery devices can create patentably distinct formulations that do not infringe on this patent.
References
[1] United States Patent and Trademark Office. "U.S. Patent No. 7,144,872."
[2] Davis, M. P., et al. (2011). "Advances in Parkinson’s Disease Treatment." Pharmacol Ther.
[3] European Patent Office. Patent Family information.
[4] FDA. (2006). "Approved Drug Products. NDA 21-292."
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