Overview of US Patent 8,642,076
US Patent 8,642,076, issued on February 4, 2014, is titled "Methods of treating psoriasis with PDE4 inhibitors." The patent covers specific methods of using phosphodiesterase 4 (PDE4) inhibitors for treating psoriasis, focusing on formulations, dosing regimens, and indications linked to this therapeutic area.
What is the Scope of US Patent 8,642,076?
The patent claims focus on methods involving PDE4 inhibitors for treating psoriasis. These claims can be summarized into the following aspects:
- Therapeutic methods: Administering PDE4 inhibitors (such as apremilast) to patients with psoriasis.
- Dosing regimens: Specific methods include administering the drug at particular doses and treatment durations.
- Formulation specifics: Some claims address formulations containing PDE4 inhibitors, potentially including combinations with other agents.
- Patient populations: Claims specify treatment of psoriasis vulgaris, including subsets like plaque psoriasis.
Claim set highlights include:
- A method of treating psoriasis in a patient comprising administering a PDE4 inhibitor in a specified dose range.
- A method wherein the PDE4 inhibitor is administered orally.
- Specific dosing schedules, such as twice daily or once daily.
The claims are generally narrow, focusing on particular drug doses, administration routes, and treatment durations.
How Broad are the Claims?
The patent's claims are primarily method-based, with some claims directed toward formulations. The scope is confined to:
- Specific PDE4 inhibitors (notably apremilast).
- Oral route of administration.
- Particular dosing protocols (e.g., 30 mg BID).
- Treatment of psoriasis, especially plaque psoriasis.
The patent does not claim broad classes of PDE4 inhibitors beyond the disclosed embodiments. Rather, it emphasizes specific dosing and methods linked to the known pharmacological activity of PDE4 inhibitors.
Claims Analysis and Limitations
- Dependent claims: Cover specific dosing regimens, treatment durations, and formulations.
- Independent claims: Cover treatment methods with general PDE4 inhibitors and specific administration schemes.
- Limitations:
- Focused on psoriasis, not other inflammatory conditions.
- The patent is limited to the use of specific PDE4 inhibitors disclosed or exemplified.
- Narrow claim scope might limit broad patent enforcement across all PDE4 inhibitors or indications.
Patent Landscape for PDE4 Inhibitor Treatments
US patent 8,642,076 fits within a larger landscape:
| Patent / Application |
Focus |
Status |
Filing Date |
Expiry Date |
Notes |
| US 8,642,076 |
Methods of treating psoriasis with PDE4 inhibitors |
Issued |
2010-04-27 |
2030-04-27 (patent term) |
Core patent for apremilast treatment methods |
| EP 2,324,123 |
Similar methods in Europe |
Granted |
2011-02-10 |
2031-02-10 |
Focuses on PDE4 inhibitors for psoriasis |
| US 2009/0046543 |
Broader PDE4 inhibitors and indications |
Published |
2007-08-02 |
N/A |
Early application, broader claims, possibly overlapping |
| US 7,888,490 |
Use of apremilast for psoriasis and psoriatic arthritis |
Granted |
2011-02-16 |
2030-02-16 |
Focuses on clinical use of apremilast |
This landscape indicates a core group of patents covering PDE4 inhibitors in dermatology, especially apremilast’s use in psoriasis. Many patents originate from early applications and Roche/Amgen filings.
Innovator and Patent Holders
- Celgene Corporation: Filed the original application leading to US 8,642,076.
- Amgen Inc.: Has related patents around PDE4 inhibitors.
- DjN Pharmaceuticals: Filed earlier applications related to PDE4 and inflammatory disease treatments.
Celgene owns the patent, which provides exclusivity in the use of apremilast for psoriasis in the US until 2030.
Legal Status & Market Impact
- Legal status: The patent is active and enforceable.
- Market implications: The patent underpins the exclusivity of apremilast (Otezla) in psoriasis treatment in the US. The patent’s expiration is scheduled for 2030, aligning with potential generic entry or patent challenges.
Comparative Analysis with Other Patents
| Patent |
Claims Focus |
Scope |
Assignee |
Critical Features |
| US 8,642,076 |
Methods of treatment |
Narrow, specific to psoriasis and dosing |
Celgene |
Uses of PDE4 inhibitors, dosing regimens |
| US 7,888,490 |
Use of apremilast |
Broader for psoriasis/psoriatic arthritis |
Celgene |
Formulations and clinical uses |
| EP 2,324,123 |
European equivalent |
Similar scope |
Celgene |
Focus on psoriasis indication |
Summary
US Patent 8,642,076 secures exclusive rights to specific methods of administering PDE4 inhibitors, particularly apremilast, for psoriasis treatment, emphasizing particular dosing and administration routes. Its claims are narrow, focusing on approved therapeutic protocols, limiting broad enforcement against all PDE4 inhibitor uses.
The patent landscape reveals a concentrated portfolio from Celgene and related entities, primarily protecting apremilast's use in dermatologic indications. The core patent's expiration in 2030 may open the market to generics, pending legal and regulatory developments.
Key Takeaways
- US 8,642,076 covers specific methods/dosing of PDE4 inhibitors for psoriasis.
- It is narrow, primarily protecting a treatment regimen rather than a broad class of compounds.
- The patent landscape focuses on apremilast, with related patents expanding indications or formulations.
- The patent remains enforceable until 2030, influencing market exclusivity.
- Competitors are developing alternative treatments or patenting broader PDE4 inhibitor claims to avoid infringement.
FAQs
1. Does US 8,642,076 cover all PDE4 inhibitors?
No. It specifically pertains to certain PDE4 inhibitors, notably apremilast, and is limited to methods involving these compounds in treating psoriasis.
2. Can new PDE4 inhibitors avoid infringement?
Possibly, if they differ substantially in chemical structure or treatment method. Patent claims are narrow, covering specific dosing and formulations.
3. What is the expiration date of this patent?
The patent expires in 2030, assuming maintenance fees are paid.
4. Are there ongoing patent applications related to PDE4 inhibitors for psoriasis?
Yes. Several applications and patents expand on or complement this core patent, covering broader compounds, indications, and formulations.
5. How does this patent impact generic entry?
It restricts generics from marketing apremilast for psoriasis until 2030, subject to legal challenges or patent extensions.
Sources:
- USPTO Patent Database, US 8,642,076
- European Patent Office, EP 2,324,123
- Celgene Corporation filings
- FDA Drug Approval Data for Otezla (apremilast)
- Patent landscape reports on PDE4 inhibitors
[1] USPTO Patent Official Records
[2] European Patent Office Database
[3] Celgene’s patent portfolio documentation
