United States Patent 7,504,509: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,504,509, titled "Compounds and methods for development of Ret modulators," is a significant patent in the pharmaceutical sector, particularly in the field of kinase modulation. This patent, assigned to Plexxikon Inc., is part of a broader portfolio of patents protecting the drug Zelboraf (vemurafenib), which is used in the treatment of certain types of cancer.
Patent Overview
Inventors and Assignee
The patent was invented by a team of researchers including Prabha N. Ibrahim, Dean R. Artis, Ryan Bremer, and others, and is assigned to Plexxikon Inc., a biotechnology company based in Berkeley, California[5].
Issue Date and Expiration
The patent was issued on March 17, 2009, and is set to expire on October 22, 2026[5].
Scope of the Patent
Claims
The patent includes a series of claims that define the scope of protection for the invented compounds and methods. These claims cover:
- Specific chemical compounds that modulate Ret kinase activity.
- Methods for synthesizing these compounds.
- Methods for using these compounds to treat diseases associated with aberrant Ret kinase activity, such as certain cancers and neurological disorders[5].
Independent and Dependent Claims
The patent includes both independent and dependent claims. Independent claims stand alone and define the broadest scope of the invention, while dependent claims narrow down the scope by adding additional limitations to the independent claims. For example, Claim 1 might describe a broad class of compounds, while Claim 2 might describe a specific subset of those compounds with additional structural features[3].
Patent Claims Analysis
Claim Length and Count
Research has shown that the length and count of independent claims can be indicative of the patent's scope and quality. Patents with narrower claims at publication tend to have a higher probability of grant and a shorter examination process. In the case of US 7,504,509, the claims are carefully crafted to balance breadth with specificity, ensuring robust protection for the invention while avoiding overly broad claims that might be challenged for lack of clarity or validity[3].
Patent Landscape
Related Patents
The patent is part of a larger family of patents related to Zelboraf, including US 7,863,288, US 8,143,271, and US 8,470,818. These patents collectively protect various aspects of the drug, such as its active ingredient, manufacturing processes, and methods of use. This strategic patent portfolio ensures comprehensive protection for the drug, delaying the entry of generic competitors into the market[2][5].
Exclusivities and Generic Launch Date
The combination of these patents and exclusivities extends the market exclusivity period for Zelboraf. As of the current date, no generic version of Zelboraf has been approved, and the estimated generic launch date is June 6, 2032, based on the expiration dates of the relevant patents[2][5].
Legal Activities and Maintenance Fees
The patent's life and scope can be influenced by various legal activities, such as maintenance fee payments, term extensions, or amendments to the claims. For US 7,504,509, regular maintenance fee payments have been made to keep the patent active. For instance, the 12th-year maintenance fee was paid on September 17, 2020, ensuring the patent remains in force until its scheduled expiration date[2].
Impact on Innovation and Competition
The breadth and clarity of patent claims, as well as the overall patent landscape, play crucial roles in innovation and competition. Overly broad patents can stifle innovation by increasing licensing and litigation costs, while well-defined patents like US 7,504,509 can encourage further research and development by providing clear boundaries and incentives for innovation[3].
Clinical Applications
The compounds and methods described in the patent are used in the treatment of various diseases, including cancers such as melanoma, and other conditions associated with aberrant kinase activity. The specificity of these compounds and the methods for their use are critical in ensuring efficacy and safety in clinical applications[5].
Economic and Market Implications
The patent protection afforded to Zelboraf has significant economic and market implications. By delaying the entry of generic competitors, the patent ensures that the original drug remains a market leader, generating substantial revenue for the patent holder. This revenue can be reinvested in further research and development, driving innovation in the pharmaceutical sector[2].
Key Takeaways
- Patent Scope: US 7,504,509 covers specific compounds and methods for Ret kinase modulation, with a focus on treating diseases associated with aberrant kinase activity.
- Claims Analysis: The patent includes carefully crafted claims to ensure robust protection while avoiding overly broad claims.
- Patent Landscape: Part of a larger family of patents protecting Zelboraf, ensuring comprehensive protection and delaying generic competition.
- Legal Activities: Regular maintenance fee payments and other legal activities ensure the patent remains active until its expiration date.
- Impact on Innovation: Well-defined patents like US 7,504,509 encourage innovation by providing clear boundaries and incentives.
- Clinical Applications: The patent is crucial for the treatment of various diseases, including certain cancers.
FAQs
What is the main subject of US Patent 7,504,509?
The main subject of US Patent 7,504,509 is the development of compounds and methods for modulating Ret kinase activity, particularly in the context of treating diseases associated with aberrant kinase activity.
Who are the inventors of US Patent 7,504,509?
The inventors include Prabha N. Ibrahim, Dean R. Artis, Ryan Bremer, and others, all associated with Plexxikon Inc.
When is the patent set to expire?
The patent is set to expire on October 22, 2026.
What is the impact of this patent on generic competition for Zelboraf?
The patent, along with other related patents, delays the entry of generic competitors into the market, with the estimated generic launch date being June 6, 2032.
How do maintenance fees affect the patent's life?
Regular maintenance fee payments ensure the patent remains active until its scheduled expiration date, preventing it from lapsing due to non-payment.
Cited Sources:
- United States Patent and Trademark Office - US007893.075B2
- Pharsight - Zelboraf patent expiration
- Hoover Institution - Patent Claims and Patent Scope
- United States Patent and Trademark Office - US 9,096,593 B2
- Drugs.com - Generic Zelboraf Availability
