Detailed Analysis of the Scope and Claims of United States Patent 9,447,089
Overview of the Patent
United States Patent 9,447,089, issued on September 20, 2016, is a significant patent in the pharmaceutical sector, particularly related to the drug Zelboraf (vemurafenib). This patent is jointly owned by Plexxikon Inc. and Hoffmann-La Roche Inc.
Inventors and Assignees
The patent lists several inventors, including Dipen Desai, Ralph Diodone, Zenaida Go, Prabha N. Ibrahim, Raman Iyer, Hans-Juergen Mair, Harpreet K. Sandhu, Navnit H. Shah, Gary Visor, Nicole Wyttenbach, Stephan Lauper, Johannes Pudewell, and Frank Wierschem. The assignees are Plexxikon Inc., Berkeley, CA, and Hoffmann-La Roche Inc., Nutley, NJ[4].
Patent Claims and Scope
Composition Claims
The patent primarily focuses on compositions involving the active ingredient of Zelboraf, specifically propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide. The claims include various forms of this compound, such as solid dispersions, solid molecular complexes, salts, and crystalline polymorphs[4].
Method Claims
In addition to the composition claims, the patent also covers methods for preparing these compositions. These methods are crucial for ensuring the stability, efficacy, and bioavailability of the drug. The patent details specific processes for manufacturing these pharmaceutical compositions, which are essential for maintaining the drug's quality and performance[4].
Therapeutic Uses
The patent also includes claims related to the therapeutic uses of these compositions. Specifically, it covers the treatment of diseases and conditions associated with aberrant activity of protein kinases, such as certain types of cancer. The inventors have identified specific kinase modulators that are effective in treating these conditions, and the patent protects these therapeutic applications[4].
Patent Landscape
Related Patents
The patent landscape surrounding Zelboraf is complex, with multiple patents protecting various aspects of the drug. Here are some key related patents:
- US 7,504,509: This patent covers compounds and methods for kinase modulation and expires on October 22, 2026[5].
- US 7,863,288: This patent also deals with kinase modulation and expires on June 20, 2029[5].
- US 8,143,271: Issued for compounds and methods for kinase modulation, this patent expires on June 21, 2026[5].
- US 8,470,818: This patent covers the process for the manufacture of pharmaceutically active compounds and expires on August 2, 2026[5].
- US 8,741,920: This patent, related to the manufacture of Zelboraf, expires on July 27, 2030[5].
Expiration Dates
The expiration dates of these patents are critical for understanding when generic versions of Zelboraf can be introduced to the market. Here are the key expiration dates:
- October 22, 2026: US 7,504,509
- June 21, 2026: US 8,143,271
- August 2, 2026: US 8,470,818
- June 20, 2029: US 7,863,288
- July 27, 2030: US 8,741,920
- June 6, 2032: US 9,447,089[5].
Impact on Innovation and Competition
Patent Scope and Quality
The scope and quality of patents like US 9,447,089 are often debated in terms of their impact on innovation. Broad and unclear claims can lead to increased litigation and licensing costs, potentially hindering innovation. However, well-defined patents like this one, which clearly outline the compositions and methods, can provide strong protection for the inventors while also guiding future research and development[3].
Generic Competition
The expiration of these patents will open the door for generic competition. Generic manufacturers will be able to produce and market their versions of Zelboraf once the relevant patents expire. This competition is expected to reduce the cost of the drug, making it more accessible to patients[5].
Key Takeaways
- Composition and Method Claims: The patent covers various forms of the active ingredient of Zelboraf and methods for their preparation.
- Therapeutic Uses: The patent protects the therapeutic applications of these compositions, particularly in treating diseases associated with aberrant kinase activity.
- Patent Landscape: The patent is part of a broader landscape of patents protecting Zelboraf, with various expiration dates affecting generic competition.
- Impact on Innovation: Well-defined patents like US 9,447,089 can balance protection for inventors with the need to foster future innovation.
- Generic Competition: The expiration of these patents will lead to increased competition from generic manufacturers, potentially reducing drug costs.
FAQs
What is the main subject of United States Patent 9,447,089?
The main subject of this patent is the compositions and uses of propane-1-sulfonic acid {3-[5-(4-chloro-phenyl)-1H-pyrrolo[2,3-b]pyridine-3-carbonyl]-2,4-difluoro-phenyl}-amide, specifically related to the drug Zelboraf.
Who are the inventors and assignees of this patent?
The inventors include Dipen Desai, Ralph Diodone, Zenaida Go, Prabha N. Ibrahim, and others. The assignees are Plexxikon Inc. and Hoffmann-La Roche Inc.
What are the key expiration dates for related Zelboraf patents?
Key expiration dates include October 22, 2026 (US 7,504,509), June 21, 2026 (US 8,143,271), August 2, 2026 (US 8,470,818), June 20, 2029 (US 7,863,288), and July 27, 2030 (US 8,741,920).
How does this patent impact innovation and competition?
This patent provides strong protection for the inventors while guiding future research. Its expiration will allow for generic competition, reducing drug costs and increasing accessibility.
What are the therapeutic uses protected by this patent?
The patent protects the therapeutic uses of the compositions in treating diseases and conditions associated with aberrant activity of protein kinases, such as certain types of cancer.
How does the scope and quality of this patent affect the broader patent landscape?
The clear and well-defined claims of this patent help maintain a balance between protecting inventors and fostering future innovation, unlike overly broad or unclear patents that can hinder innovation.
Sources
- United States Patent and Trademark Office - US 11,103,505 B2[1].
- Pharsight - Zelboraf patent expiration[2].
- Hoover Institution - Patent Claims and Patent Scope[3].
- United States Patent and Trademark Office - US 9,663,517 B2[4].
- Drugs.com - Generic Zelboraf Availability[5].
