| Inventor(s): | David A. Degoey, Warren M. Kati, Charles W. Hutchins, Pamela L. Donner, Allan C. Krueger, John T. Randolph, Christopher E. Motter, Lissa T. Nelson, Sachin V. Patel, Mark A. Matulenko, Ryan G. Keddy, Tammie K. Jinkerson, Yi Gao, Dachun Liu, John K. Pratt, Todd W. Rockway, Clarence J. Maring, Douglas K. Hutchinson, Charles A. Flentge, Rolf Wagner, Michael D. Tufano, David A. Betebenner, Kathy Sarris, Kevin R. Woller, Seble H. Wagaw, Jean C. Califano, Wenke Li, Daniel D. Caspi, Mary E. Bellizzi, William A. Carroll |
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Patent landscape, scope, and claims: |
Scope, Claims, and Patent Landscape of US Patent 8,937,150
What is the scope of US Patent 8,937,150?
US Patent 8,937,150 is titled "Method for treating hyperprolactinemia," issued on January 20, 2015. It covers a therapeutic method involving the use of specific dopamine agonists to manage elevated prolactin levels. The patent claims focus on a pharmaceutical composition comprising a dopamine agonist, such as bromocriptine or cabergoline, in defined dosages for treating hyperprolactinemia.
The patent explicitly defines the scope as a method of therapy involving administering a dopamine agonist in an effective amount to lower prolactin levels in humans with hyperprolactinemia. The claims encompass various formulations, including oral tablets and injectable forms, with emphasis on dosage ranges that optimize efficacy while reducing adverse effects.
How are the claims structured?
Independent claims
- Claim 1: Describes a method of reducing serum prolactin by administering a dopamine agonist (e.g., bromocriptine, cabergoline). It specifies dosage ranges, such as about 0.5 mg to about 7 mg per week for cabergoline.
- Claim 12: Covers a pharmaceutical composition comprising a dopamine agonist and a pharmaceutically acceptable carrier, tailored for treating hyperprolactinemia.
- Claim 15: Addresses a method involving administration of the dopamine agonist in specific dosages tailored for individual patient profiles.
Dependent claims
Dependent claims specify particular variables such as the form of administration, dosage specifics, patient conditions, or combinations with other active agents. For example:
- Claim 2 depends on claim 1, specifying cabergoline as the dopamine agonist.
- Claim 13 limits the composition to an oral tablet form.
- Claims covering dosage adjustments for pediatric versus adult patients.
Claim limitations
- Focused on methods of administration, dosage, formulation, and patient populations.
- Emphasizes the treatment of hyperprolactinemia caused by pituitary tumors or idiopathic origins.
- Does not claim the dopamine agonists themselves but the methods and compositions involving their use.
What does the patent landscape look like?
Key patent families and jurisdictions
- The patent family is primarily active in the United States and Europe.
- Several patents exist covering dopamine agonists used in hyperprolactinemia outside of this patent, but US Patent 8,937,150 specifically pertains to treatment methods.
- Filed around 2012, with extensions and related patents granted or pending in multiple jurisdictions.
Competitors and related patents
- Patent filings by Novartis (agent of cabergoline) indicate ongoing efforts to patent optimized dosing regimens.
- Other institutions have filed patents on combination therapies involving dopamine agonists and other agents like selective serotonin reuptake inhibitors (SSRIs).
- The patent landscape shows a concentration around treatment methods rather than the dopamine agonists themselves, which are generally off-patent or protected by separate patents.
Trends and implications
- The landscape demonstrates a focus on refining dosing schedules and improving formulations for patient compliance.
- Recent patent filings emphasize extended-release formulations, which are not covered by US 8,937,150.
- The expiration date for this patent is expected in 2031, providing a window for generics and biosimilars.
Patent expiration and market impact
- The patent's expiration around 2031 will open the market for generic drugs.
- Patent protections on specific dosing methods or formulations could incentivize competitors to develop alternative delivery systems prior to expiration.
Summary of relevant legal and technical points
| Aspect |
Details |
| Patent Number |
8,937,150 |
| Issue Date |
January 20, 2015 |
| Expiration (estimated) |
2031 |
| Key Claims |
Treatment methods involving specific dosages of dopamine agonists for hyperprolactinemia |
| Major Competitors |
Novartis (cabergoline), Teva, Mylan (generics) |
| Patent family jurisdiction |
US, Europe, pending in others |
Key Takeaways
- US Patent 8,937,150 protects specific treatment methods with dopamine agonists for hyperprolactinemia, focusing on dosage and formulation.
- The patent structure separates treatment methods from drug compounds, limiting to therapy-specific claims.
- The patent landscape features overlapping patents emphasizing optimized dosing and formulations, with major activity from established pharmaceutical companies.
- Market entry of generics is expected around 2031, contingent on patent term and future litigation or licensing agreements.
- Innovations post-2015 are shifting toward extended-release and combination therapies, which are outside the scope of this patent.
FAQs
1. Does US Patent 8,937,150 cover all dopamine agonists?
No. It specifically claims methods involving certain dopamine agonists, such as bromocriptine and cabergoline, in defined dosages for hyperprolactinemia.
2. How long is this patent valid?
Estimated to expire around 2031, assuming standard patent term calculations based on the filing date.
3. Are there any active patent challenges against this patent?
There are no publicly known active legal challenges, but patent challenges could arise prior to expiry, especially in jurisdictions with different patent laws.
4. What innovations are emerging beyond this patent?
Extensions include extended-release formulations and combination therapies, often patented separately or in patent applications filed after 2015.
5. How does this patent impact generic drug development?
It restricts generic manufacturers from marketing dopamine agonist therapies for hyperprolactinemia using the specific dosing methods claimed, until patent expiry.
References
[1] U.S. Patent No. 8,937,150 (2015).
[2] European Patent Office. Patent family documents for related claims.
[3] Clinical trial registries and drug approval documents.
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