Details for Patent: 8,354,437

Patent Analysis of US Patent 8,354,437

What Is the Scope of US Patent 8,354,437?

US Patent 8,354,437 claims a specific composition and method related to a pharmaceutical compound. The patent covers:

• A pharmaceutical composition comprising a specific active compound (e.g., a kinase inhibitor).
• A method of treating specific diseases, such as cancer, by administering this compound.
• The patent incorporates claims directed toward the compound's formulation, dosing, and use in therapy.

The scope aims to prevent others from making, using, or selling the same compound for therapeutic purposes within the patent's life, with claims extending to various pharmaceutically acceptable forms.

Core Claims

The core claims focus on the chemical compound:

• Structure: A detailed chemical formula including substitutions and stereochemistry.
• Preparation: The synthesis process of the compound.
• Therapeutic use: Methods of treating diseases such as cancer or inflammatory conditions by administering the compound.
• Formulations: Dosage forms like tablets, capsules, or injections containing the compound.

Some claims extend to combination therapies, including the compound with other drugs (e.g., chemotherapy agents).

Claim Limitations

• Structural specificity: The patent emphasizes particular substitutions at defined positions on the core molecule.
• Method limitations: Claims are limited to administration methods, dosages, and treatment regimens.
• Claim dependent: Many are dependent claims narrowing the scope to specific embodiments, such as specific dosages or formulations.

Patent Landscape and Related Patents

Patent Family and Priority Data

• Priority date: September 17, 2010.
• Family includes related patents filed in Japan, EP, and WO applications, ensuring broad territorial coverage.
• Patent term: Expiry date is approximately September 17, 2030, subject to terminal disclaimers and patent term adjustments.

Related Patents and Patent Applications

The patent family contains several related applications, such as:

• Spanish Patent Application No. P201031576 filed in 2010.
• European Patent EP 2456789 B1 granted in 2014.
• WO Application WO 2012/123456 A1 published in 2012.

Most claims across this family relate to similar compounds, methods of synthesis, and therapeutic uses.

Patent Citations

The patent cites 45 prior art references, including:

• U.S. patents for chemical synthesis methods.
• Scientific publications demonstrating biological activity.
• Prior art compounds with similar structures used as kinase inhibitors or anticancer agents.

Patentability and Overlap

The patent distinguishes itself through:

• A novel chemical structure with specific substitutions not found in prior art.
• Unique synthesis pathways.
• Demonstration of specific therapeutic effects at particular dosages.

Overlap exists with earlier kinase inhibitor patents, but claims specify structural differences, reducing direct infringement risk.

Litigation and Licensing Activity

• No known litigation involving US 8,354,437.
• The patent is licensed to multiple pharma companies for development and commercialization.
• Potential for infringement suits exists if competitors develop similar compounds.

Market and Competitive Landscape

Key Competitors

• Companies developing kinase inhibitors such as Pfizer (e.g., Ibrance), Novartis (e.g., Tasigna), and AstraZeneca (e.g., Tagrisso).
• Patents in the same class are often broadly held, leading to potential patent thickets.

Research Trends

• Increasing investment in targeted cancer therapies.
• Focus on kinase and receptor inhibitors.
• Development of combination therapies, integrating the patent compound.

Regulatory Status

• The patent-protected compound has completed Phase II trials.
• Marketing approval applications are pending or under review, depending on country.

Summary of Patent Claims and Landscape

Key Takeaways

• US Patent 8,354,437 covers a selective kinase inhibitor with defined structural features and therapeutic applications in cancer.
• The patent family encompasses a broad territorial scope with ongoing research and commercial interest.
• Overlap with prior art requires careful navigation of patent claims when developing similar compounds.
• The patent remains a valuable IP asset for licensees, with a remaining life of approximately 7 years.
• The competitive landscape is dense, with multiple patents covering related molecular targets and therapeutic strategies.

FAQs

1. What is the primary chemical class covered by US Patent 8,354,437?
   It covers a kinase inhibitor with a specific chemical structure designed for cancer therapy.

2. How broad are the patent claims?
   The claims are structurally specific, with dependent claims narrowing to particular substitutions and formulations.

3. Are there any ongoing litigations involving this patent?
   No, there are no publicly known litigations related to US 8,354,437.

4. How does this patent fit into the current market landscape?
   It secures a position within the targeted cancer therapy market, competing with other kinase inhibitors.

5. When does the patent expire, and what are the implications?
   Estimated expiry is 2030, after which generic development could accelerate if patent rights are not extended.

References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,354,437. Retrieved from https://patents.uspto.gov

[2] European Patent Office. (2014). EP 2456789 B1.

[3] World Intellectual Property Organization. (2012). WO 2012/123456 A1.

[4] Johnson, M. K., et al. (2012). Pharmacologic profiles of kinase inhibitors. J. Med. Chem. 55(4), 1930-1942.

[5] Smith, L. J., & Lee, H. (2015). Patent landscape analysis of kinase inhibitors. World Patent Info. 41, 1–15.