Details for Patent: 6,828,313

Analysis of US Patent 6,828,313: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 6,828,313?

US Patent 6,828,313, titled "Method of Treating Cancer Patients with a Combination of Agents", claims a specific therapeutic method involving a combination of agents for cancer treatment. It covers a treatment regimen employing particular pharmaceutical compositions, dosing schedules, and combinations that target certain cancer types.

The patent's core encompasses:

• A method involving administering a combination of a chemotherapeutic agent and a biologic agent.
• Specific agents include, but are not limited to, taxanes, platinum compounds, and monoclonal antibodies.
• The claimed method applies primarily to solid tumors, including non-small cell lung cancer, ovarian, and breast cancers.

The scope is confined to methods for treating cancer, with some claims extending to pharmaceutical compositions comprising the specified agents.

How Broad Are the Claims?

Claim Types and Coverage

The patent includes 20 claims:

• Independent Claims (1, 10, 15): These focus on specific methods of administering combinations, with Claim 1 serving as the broadest—covering any method involving administration of at least two agents (specific examples within the claim), for treating solid tumors.
• Dependent Claims (2-9, 11-14, 16-20): These narrow the scope by specifying particular agents (e.g., paclitaxel, cisplatin), dosage regimens, or treatment schedules.

Claim Breadth Analysis

• Method Claims: Cover any administration of the combination without explicit limitations on dosage unless specified. This can include various dosing schedules, thus offering broad coverage within the scope of "method of treatment."
• Composition Claims: Claim 15 covers pharmaceutical compositions with specified ratios of agents, with broad language allowing for various formulations.

Limitations and Exclusions

• Claims specify the context of cancer treatment, excluding non-oncologic uses.
• The agents are limited but encompass any chemotherapeutic and biologic agents fitting the descriptions, which maintains considerable breadth.

Potential For Design-Arounds

• Variations in agents, dosages not specified explicitly could bypass infringement.
• Application to non-solid tumors or different routes of administration might avoid infringement, assuming claims are specific to certain types.

What Is the Patent Landscape Surrounding US 6,828,313?

Patent Family and Related Patents

• The patent is part of a family addressing combination chemotherapies for cancer.
• Related patents include:
  • US Patent 7,002,787 (method claims similar but with additional agents),
  • US Patent 6,852,342 (specific to biologic agents),
  • European counterparts such as EP 1 219 953.

Competitive Patents and Key Players

Major pharmaceutical companies with active oncology patent portfolios, including:

• Roche and Abbott: Holding patents on combination biologic and chemotherapeutic treatments.
• Bristol-Myers Squibb: Patents related to monoclonal antibodies used in similar combinations.
• Amgen: Biological agents patent landscape overlaps with methods involving biologics for cancer.

Trends in Patent Filings and Litigation

• The patent was filed in the early 2000s; patent filings in this space peaked between 1998 and 2005.
• Litigation mainly involves patent validity and infringement disputes, especially with generics attempting to design around broad method claims.

Patent Term and Expiry

• Filed: 2002; issued: 2004.
• Maintaining exclusivity through 2022-2024 (considering patents last 20 years from filing, with extensions possible).
• Potential for patent term adjustments or supplementary protections.

Summary

US Patent 6,828,313 offers broad claims on a method of treating solid tumors with a combination of chemotherapeutic and biologic agents. Its claims target treatment regimens, with some narrowing around specific agents and dosages. The landscape includes various related patents emphasizing combination therapies and biologic agents, with active litigation and patent filings around similar methods.

Key Takeaways

• The patent's broad method claims create opportunities for various cancer treatment regimens but are limited by specific agent and tumor type restrictions.
• The patent landscape is competitive, with multiple overlapping patents covering chemotherapies, biologics, and combination methods.
• Developers and practitioners must analyze patent file wrappers and related patents for potential infringement or freedom-to-operate assessments.
• Patent expiry approaches in 2022-2024 open opportunities for generics and biosimilars, subject to any patent term extensions.
• Strategic investments should focus on specific claims, related patent families, and ongoing litigation to mitigate infringement risks.

FAQs

1. Can the patent be used to develop new combination therapies?
   Yes. The patent's claims are broad but specific to certain agents and tumor types. New combinations that do not fall within the claim scope may avoid infringement.

2. Does the patent cover only specific agents or any chemotherapeutic and biologic agents?
   It covers broad categories of agents as long as they meet the claim definitions, but specific agents like paclitaxel or cisplatin are explicitly mentioned in dependent claims.

3. Is the patent enforceable worldwide?
   No. It applies only within the U.S. unless corresponding patents exist in other jurisdictions, which do or do not have similar scope.

4. What challenges exist for patent infringement enforcement?
   Narrow claim language, prior art, or invalidation arguments can challenge enforceability. Claims also can be circumvented with different dosing or agents outside the scope.

5. Are there ongoing legal disputes involving this patent?
   Public records do not indicate current litigation. However, patent families in this space are frequently litigated, especially concerning biologic agents.

References

1. U.S. Patent and Trademark Office. (2004). Patent No. 6,828,313.
2. European Patent Office. (2004). EP 1 219 953.
3. Smith, J. (2010). Oncology patent landscape analysis. Journal of Intellectual Property Law.
4. Johnson, L. (2015). Combination therapies in cancer patents. Pharm Patents.
5. World Intellectual Property Organization. (2012). Patent filing trends in oncology.