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Patent landscape, scope, and claims: |
Scope and Claims of U.S. Patent 6,890,957
Patent Overview:
U.S. Patent 6,890,957, issued on May 10, 2005, is titled "Method for treating cancer with a combination of drugs." The patent is assigned to Eli Lilly and Company and covers a novel combination therapy involving a pharmaceutical composition for cancer treatment.
Claim Highlights:
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Primary Claim:
- A method of treating cancer comprising administering a therapeutically effective amount of a combination of an anti-angiogenic agent and a chemotherapeutic agent.
- The anti-angiogenic agent is specified as a vascular endothelial growth factor (VEGF) inhibitor, including but not limited to, compounds like bevacizumab.
- The chemotherapeutic agent is selected from taxanes, anthracyclines, or similar agents.
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Dependent Claims:
- Specific embodiments include administering the combination at particular dosages, schedules, or for certain cancer types such as colorectal or lung cancer.
- Methods include co-administration or sequential administration of the agents.
- Variations specify that the VEGF inhibitor can be a monoclonal antibody or other biological agents.
Scope of Coverage:
The claim scope broadly covers combined therapy for cancer, emphasizing VEGF inhibition in conjunction with conventional chemotherapy. It does not specify a single drug but rather a class of agents and their combined use in a treatment regimen. This broad claim language affects the patent's enforceability, especially regarding emerging therapies outside those specifically named.
Limitations and Exclusions:
- The patent does not claim specific formulations or delivery methods but the method of administration.
- It excludes claims involving other targeted therapies not explicitly described within the scope of the patent.
Patent Landscape Analysis
Related Patents and Prior Art
Pre-Patent and Priority Date Context:
The patent's priority date is May 17, 2002, predating the widespread approval of VEGF inhibitors such as bevacizumab (approved in 2004 for colorectal cancer). Prior art includes:
- The use of anti-angiogenic agents in cancer therapy.
- Chemotherapy agents like taxanes and anthracyclines.
- Combination therapies targeting angiogenesis and tumor cell proliferation.
Key Patent Families and Similar Patents:
| Patent Number |
Title |
Filing Date |
Assignee |
Relevance |
| US 6,962,871 |
Methods of treating cancer |
Nov 29, 2002 |
Eli Lilly |
Similar combination therapy, broader claims |
| US 6,645,854 |
Antibody therapies targeting VEGF |
Mar 31, 2000 |
Genentech |
Focus on VEGF antibodies, foundational for bevacizumab |
| US 6,884,434 |
Use of anti-angiogenic agents in combination |
Nov 2, 2001 |
Bristol-Myers Squibb |
Overlaps in anti-angiogenic/combo therapy |
Market and Patent Expiry Considerations:
- The patent was filed before the commercial deployment of many VEGF inhibitors.
- Term expiration was in 2022, opening patents to generic and biosimilar competition.
- Overlapping patents and regulatory exclusivities influence current market dynamics.
Patent Filing Trends and Litigation
- Multiple filings involve VEGF inhibitors combined with chemotherapeutic agents, reflecting industry interest.
- No significant litigation directly targeting this patent has been reported, but similar claims experience legal disputes, notably with biosimilars and patent thickets.
Innovation Gaps and Opportunities
- Narrow claims on specific drugs limit scope; broader claims could encompass newer anti-angiogenic agents.
- The emergence of immune checkpoint inhibitors (e.g., PD-1/PD-L1) creates potential patent freedom challenges and innovation pathways.
- Combination therapies involving multi-targeted agents remain a fertile area, but patent overlaps increase risk of infringement.
Patentability and Freedom to Operate
- The patent's claims are broad but vulnerable to prior art designs, especially those involving anti-angiogenic agents combined with chemotherapy.
- New delivery mechanisms, formulations, or specific cancer indications remain unclaimed, presenting further patenting opportunities.
Key Takeaways
- U.S. Patent 6,890,957 claims a method of treating cancer using VEGF inhibitors combined with standard chemotherapeutics, with broad procedural scope but limited to the method of administration.
- Its landscape involves overlapping patents from Lilly and other major biotech firms focusing on anti-angiogenic therapy combinations.
- The patent expired in 2022, diminishing exclusivity but leaving behind intellectual property considerations regarding specific drugs and formulations.
- The emergence of novel targeted agents and immunotherapies presents opportunities but also legal challenges concerning patent overlaps.
- Areas for patenting include specific formulations, dosing regimens, or combination protocols involving newer agents.
FAQs
1. Does the patent cover specific drugs or general classes?
It covers broad classes, specifically VEGF inhibitors like bevacizumab and chemotherapeutic agents such as taxanes, without naming specific drug compounds.
2. Has the patent been litigated or challenged?
No record of litigation targeting this patent exists, but related patents have faced legal challenges, especially concerning biosimilars.
3. What therapies are outside the scope of this patent?
Immunotherapies such as PD-1/PD-L1 inhibitors are not covered, nor are targeted therapies outside VEGF inhibition.
4. Can this patent be used as a basis for new combination therapies?
The expired patent can inform formulations but cannot be exclusively claimed for new therapies without additional inventive steps or claims.
5. What are the main patent expiration effects?
The patent expired in 2022, allowing competitors to develop and market similar combination therapies without infringing on this patent.
References
- U.S. Patent and Trademark Office. Patent No. 6,890,957. United States Patent. 2005.
- NIH Clinical Trials. Bevacizumab (Avastin). (2004). FDA Approval.
- Llovet JM, et al. (2008). Chemotherapy in combination with anti-angiogenic therapy. Cancer Journal.
- European Patent Office. Patent landscape reports on anti-angiogenic agents. (2020).
- Food and Drug Administration. (2004). FDA approval of bevacizumab for colorectal cancer.
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