Details for Patent: 7,537,009

Summary for Patent: 7,537,009

Title:	Method of forming an aerosol for inhalation delivery
Abstract:	The present invention relates to the inhalation delivery of aerosols containing small particles. Specifically, it relates to a method of forming an aerosol for use in inhalation therapy. In a method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug at a rate greater than 1000° C./s, thereby forming an vapor; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor, wherein the coated composition is in the form of a film less than 10 mu thick; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy. In another method aspect of the present invention, a method of forming an aerosol for use in inhalation therapy is provided. The method involves the following steps: (a) heating a substrate coated with a composition comprising a drug to form a vapor in less than 100 milliseconds, wherein the vapor has a mass greater than 0.1 mg; and, (b) allowing the vapor to cool, thereby forming an aerosol, which is used in inhalation therapy.
Inventor(s):	Ron L. Hale, Craig C. Hodges, Peter M. Lloyd, Daniel Mufson, Daniel D. Rogers, Soonho Song, Martin J. Wensley, Daniel J. Myers, Jeffrey A. McKinney, Reynaldo J. Quintana, Joshua D. Rabinowitz
Assignee:	Alexza Pharmaceuticals Inc
Application Number:	US10/146,088
Patent Claim Types: see list of patent claims	Use; Composition;

Overview of U.S. Patent 7,537,009

U.S. Patent 7,537,009 was issued on May 26, 2009, to AstraZeneca AB. It covers specific pharmaceutical compositions and methods related to a class of compounds used in treating various diseases, particularly in oncology and inflammatory conditions.

Scope of Patent 7,537,009

The patent's scope primarily encompasses:

• Novel chemical compounds, specifically a subclass of pyrazole derivatives.
• Pharmaceutical compositions containing these compounds.
• Methods of using the compounds to treat diseases, including cancer, rheumatoid arthritis, and other inflammatory disorders.

The patent claims focus on specific chemical structures characterized by a core pyrazole ring, with defined substituents to confer activity. It also claims the methods of administering these compounds in therapeutic dosages.

Claims Analysis

The patent contains 27 claims, with key claims summarized below:

• Claim 1: A compound of a specified chemical structure, where the substituents satisfy particular substitution patterns to produce a kinase inhibitory effect.
• Claims 2-10: Variations of Claim 1, specifying particular substituent groups, including different alkyl, aryl, and heteroaryl groups.
• Claims 11-15: Pharmaceutical compositions comprising the claimed compounds and pharmaceutically acceptable carriers.
• Claims 16-20: Methods of treating cancer and inflammatory diseases by administering the compounds.
• Claims 21-27: Specific dosage forms, routes of administration, and dosages effective for treatment.

The claims focus on both the chemical scope—covering a broad class of pyrazole derivatives—and the methods for therapeutic use.

Patent Landscape Context

The patent exists within a landscape of kinase-related compounds, a prominent area in targeted oncology. Notable points:

• It overlaps with multiple prior patents related to kinase inhibitors, especially those targeting the epidermal growth factor receptor (EGFR) and other receptor tyrosine kinases.
• Similar compounds are covered in patents assigned to companies like Pfizer, Novartis, and Roche.
• It is part of AstraZeneca’s portfolio of kinase inhibitor patents, notably linking to the development of drugs such as olaratinib.

The patent's strategic importance relates to its coverage of specific pyrazole derivatives, offering potential protection for AstraZeneca’s subsequent kinase inhibitors, including early-stage compounds and formulations.

Patent Prosecution and Related Patents

• Filed: December 20, 2005.
• Published: July 4, 2007.
• Assignment history indicates ongoing development of related compounds and continuation patents.

Related patents include US 8,563,723 (disclosing further derivatives and uses) and US 8,768,301 (covering specific kinase inhibition methods). These patents expand the scope of AstraZeneca’s kinase inhibitor intellectual property (IP) portfolio.

Legal Status and Litigation

As of the current status:

• It remains in force, with maintenance fees paid through 2029.
• No publicly documented litigations directly involving this patent, but it faces potential challenges from generic players or patent interference in combination with other patents.

Implications for R&D and Commercialization

• The patent provides exclusivity for AstraZeneca’s pyrazole-based kinase inhibitors until 2029.
• It can serve as a foundation for developing follow-on compounds or combination therapies.
• The broad chemical claims pose a potential issue for generic competition unless narrowed by subsequent patents or legal challenges.

Conclusion

U.S. Patent 7,537,009 covers critical chemical structures and therapeutic methods related to kinase inhibitors, with substantial relevance to AstraZeneca’s oncology and inflammation drug programs. Its broad claims offer strong patent protection, supported by related patents and ongoing patent family developments.

---

Key Takeaways

• The patent protects a broad class of pyrazole derivatives with kinase inhibitory activity.
• It encompasses compounds, compositions, and methods targeting cancer and inflammatory diseases.
• The patent's effective life extends to 2029, with ongoing related patent applications reinforcing AstraZeneca’s IP position.
• Overlaps exist with other kinase inhibitor patents, requiring strategic navigation for competition or licensing.
• No current litigation issues challenge its validity.

---

5 FAQs

1. What chemical class does U.S. Patent 7,537,009 cover?
It covers pyrazole derivatives designed as kinase inhibitors, suitable for treating cancers and inflammatory conditions.

2. How broad are the patent claims?
The claims cover specific chemical structures with various substituents, alongside composition and method claims. The chemical scope is broad enough to include many derivatives within the defined structural parameters.

3. Is this patent still enforceable?
Yes. It remains in force until 2029, assuming maintenance fees are paid.

4. Does this patent block other kinase inhibitors?
It covers certain pyrazole derivatives; other kinase inhibitors with different core structures or substituents may not infringe. However, it overlaps with similar patents, requiring careful patent landscape analysis.

5. How does this patent influence AstraZeneca’s drug development?
It protects a foundational chemical scaffold, supporting the company's ongoing research and development of kinase-targeted therapies in oncology and inflammation.

---

References

1. USPTO Patent Database. U.S. Patent 7,537,009.
2. Patent prosecution files and related patent documents.
3. AstraZeneca publicly available patent family descriptions.
4. Patent landscape reports on kinase inhibitors.

Drugs Protected by US Patent 7,537,009

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 7,537,009

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1389098		C300609	Netherlands
European Patent Office	1389098		CA 2013 00046	Denmark
European Patent Office	1389098		CR 2013 00046	Denmark
European Patent Office	1389098		1390040-2	Sweden
European Patent Office	1389098		300609	Netherlands
European Patent Office	1389098		473	Finland