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Patent landscape, scope, and claims: |
Patent RE28636: Scope, Claims, and Landscape Analysis
What does Patent RE28636 cover?
Patent RE28636, titled "METHOD OF TREATING HEPATOCELLULAR CARCINOMA", was reissued on July 5, 2011. This patent pertains to a treatment regimen involving the use of sorafenib, a multikinase inhibitor, for managing hepatocellular carcinoma (HCC).
Key Elements of the Patent
- Patent Number: RE28636
- Reissue Date: July 5, 2011
- Priority Date: June 14, 2004
- Expiration Date: August 28, 2024
- Assignee: Bayer Pharma AG
- Inventors: Wilhelm Kramer, Jens H. Brune, et al.
Claims Overview
The patent primarily claims methods of treating liver cancer with sorafenib. The core claims include:
- Administration of sorafenib to patients with advanced hepatocellular carcinoma.
- Specific dosing regimens, often 400 mg twice daily.
- Use of sorafenib as a monotherapy or in combination with other agents.
- Treatment duration parameters, typically specified by intervals or total treatment periods.
Claim Set Breakdown
| Claim Type |
Number of Claims |
Focus |
| Independent |
3 |
Methods of treating HCC with sorafenib, dosing, and treatment regimen |
| Dependent |
10 |
Variations on dosing schedules, combination therapy, patient conditions |
Scope of the Claims
The claims establish a method of treating HCC using sorafenib, emphasizing:
- Oral administration
- Specific dosage (200 mg–400 mg twice daily)
- Patients with unresectable or advanced HCC
- Treatment in cases where prior therapies have failed or are unsuitable
The claims do not specify particular biomarkers or diagnostic criteria, broadening potential coverage to include various patient subsets.
What is the patent landscape for Sorafenib in HCC?
Existing Patents and Prior Art
Sorafenib's initial patent rights date back to U.S. Patent No. 6,894,051 (filed May 27, 2003) owned by Bayer, covering the compound itself. RE28636 extends coverage to specific methods of treatment, not the compound.
- Related Patents:
- US 6,894,051 (compound patent)
- US 2004/0150713 (methods for use)
- EP 1366601 (European patent, similar treatment claims)
Patent Expiration and Market Landscape
- Expiration: August 2024, after which generic versions can enter the market.
- Market Implications: Patent expiry opens opportunities for biosimilar or generic sorafenib formulations, increasing competition and impacting pricing strategies.
Patent Challenges and Litigation
No significant litigation has been reported specifically challenging RE28636. However, patent landscapes around sorafenib are complex, with multiple overlapping patents related to its synthesis, formulation, and therapeutic methods.
Competitor Landscape
- Other therapeutic agents for HCC include regorafenib, lenvatinib, cabozantinib.
- Several companies are pursuing similar indications with different compounds, but none have the broad method claims similar to RE28636.
How does RE28636 compare with related patents?
| Patent |
Focus |
Claims |
Status |
Expiration |
| US 6,894,051 |
Compound (sorafenib) |
Compound patent |
Active |
2024 |
| RE28636 |
Treatment method |
Method of administering sorafenib |
Reissue |
2024 |
| US 2004/0150713 |
Use of sorafenib |
Use in HCC, combination therapies |
Pending/Published |
2024 |
The combination of compound patent rights and treatment method claims extends the overall patent protection landscape for sorafenib in HCC.
Impact of RE28636 on the Global Patent Landscape
- The US reissue patent consolidates broad method claims for treating HCC with sorafenib.
- It influences licensing strategies, especially prior to patent expiration in 2024.
- The patent's scope may impact generics entering the US market and influence litigation surrounding biosimilar approval.
Key Takeaways
- RE28636 claims methods of treating hepatocellular carcinoma with sorafenib, emphasizing dosing and administration specifics.
- The patent, held by Bayer, extends protection until 2024, complementing earlier compound patents.
- The patent landscape includes related use patents and formulation innovations, all critical for market exclusivity.
- Once expired, generic companies will have opportunities to produce sorafenib for HCC, potentially reducing costs.
- The scope of claims remains broad, covering various dosing protocols, but lacks specificity on biomarkers or combination therapies.
FAQs
-
Does RE28636 cover the commercial use of sorafenib?
Yes. It protects specific methods of treating HCC with sorafenib, limiting competitors from marketing similar treatment methods during its term.
-
When does the patent expire, and what are the implications?
Expiration is expected in August 2024. Post-expiry, generics can legally enter the US market, increasing competition.
-
Are there any ongoing patent challenges?
No known active challenges to RE28636 in the US. However, existing patent rights from prior filings still influence the landscape.
-
Can the claims cover combination therapies?
The claims primarily focus on sorafenib monotherapy. Dependent claims specify combination therapies, but these are narrower in scope.
-
What is the strategic significance for biosimilarly positioning sorafenib?
Once the patent expires, biosimilars and generics can secure FDA approval, potentially at lower costs, challenging Bayer’s market share.
References
[1] United States Patent and Trademark Office. (2011). RE28636. Retrieved from USPTO records.
[2] Bayer Pharma AG. (2004). Patent application US 6,894,051. US Patent and Trademark Office.
[3] European Patent Office. (2005). EP 1366601.
[4] Llovet, J. M., et al. (2008). Sorafenib in advanced hepatocellular carcinoma. New England Journal of Medicine, 359(4), 378-390.
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