United States Patent 4,567,264: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 4,567,264, issued on January 28, 1986, is a significant patent in the pharmaceutical industry, particularly for the drug ranolazine. This patent, originally owned by Syntex (USA) Inc. and later by Roche Palo Alto LLC, has been a subject of interest due to its implications in the concept of "evergreening" and the broader patent landscape.
Patent Overview
Patent Owner and Issue Date
The patent was issued to Syntex (USA) Inc., now known as Roche Palo Alto LLC, on January 28, 1986[2].
Claimed Subject Matter
U.S. Patent 4,567,264 claims ranolazine as a composition of matter. Ranolazine is a medication used to treat chronic angina, and the patent covers its chemical structure and preparation methods[1][4].
Claims and Scope
Claim Language and Scope
The patent includes multiple claims that define the scope of the invention. The claims are crucial in determining the patent's breadth and the protection it offers. For instance, the patent teaches two methods for the preparation of ranolazine, highlighting the specific chemical reactions and processes involved[4].
Metrics for Measuring Patent Scope
Research on patent scope often uses metrics such as independent claim length (ICL) and independent claim count (ICC) to assess the breadth and clarity of patent claims. These metrics can indicate the complexity and specificity of the claims, which in turn affect the patent's scope and potential for litigation[3].
Patent Term Extension (PTE)
Legislative Background
The patent term of U.S. Patent 4,567,264 was extended under Section 156 of the Patent Act, part of the Hatch-Waxman Act. This provision allows pharmaceutical innovators to extend the patent term to compensate for the time spent in the FDA approval process. The maximum extension is five years, and the total patent term cannot exceed 14 years after the drug's approval date[1].
Application to Ranolazine
For U.S. Patent 4,567,264, five years of PTE were added, extending the patent term from its original expiration in 2003 to 2008. However, this extension did not provide additional exclusivity beyond the five-year New Chemical Entity (NCE) data exclusivity granted by the FDA, as both the PTE and NCE exclusivity ran concurrently[1].
Evergreening and the Evergreen Drug Patent Search Database
Definition of Evergreening
Evergreening refers to pharmaceutical company actions that artificially extend the protection horizon of their patents. The Evergreen Drug Patent Search Database, created by the Center for Innovation at UC Hastings, aims to identify and quantify such practices[1].
Critique of the Database
The Database has been criticized for its methodology, particularly in how it counts protections and extensions. For example, the 11 patents associated with ranolazine were counted twice for each approved strength of the drug, and a request to delist a patent was also counted as an additional protection. These practices are misleading and do not accurately reflect the true extent of patent protection or evergreening[1].
Exclusivity and Market Protection
New Chemical Entity (NCE) Exclusivity
The FDA grants five years of NCE data exclusivity to incentivize pharmaceutical companies to develop new active ingredients. This exclusivity period runs concurrently with any patent protection and is awarded to all innovators who successfully bring a new active ingredient to market. For ranolazine, the NCE exclusivity was counted twice in the Database, once for each approved strength, which is also misleading[1].
Impact on Generic Competition
The combination of patent protection and NCE exclusivity delays the entry of generic competitors into the market. While the PTE and NCE exclusivity for ranolazine did not extend beyond the initial five-year period due to concurrent running, they still played a significant role in maintaining market exclusivity for the innovator[1].
Patent Landscape and Industry Implications
Patent Quality and Scope
The quality and scope of patents are critical in the pharmaceutical industry. Broader or overly broad patents can lead to increased litigation and licensing costs, potentially diminishing innovation incentives. The examination process at the USPTO tends to narrow the scope of patent claims, ensuring that only valid and specific claims are granted[3].
Regulatory and Legislative Context
The Hatch-Waxman Act and subsequent regulations aim to balance innovation incentives with the need for generic competition. The PTE provision is designed to compensate innovators for the time spent in regulatory approval processes, ensuring that they have a reasonable period to recoup their investments[1].
Conclusion
U.S. Patent 4,567,264 is a pivotal patent in the pharmaceutical industry, particularly in the context of ranolazine. The patent's scope, claims, and the associated PTE and NCE exclusivity highlight the complex interplay between patent protection, regulatory approvals, and market exclusivity. Understanding these elements is crucial for navigating the patent landscape and addressing concerns around evergreening.
Key Takeaways
- Patent Scope and Claims: The patent claims ranolazine as a composition of matter and includes specific preparation methods.
- Patent Term Extension: The patent term was extended by five years under Section 156 of the Patent Act.
- NCE Exclusivity: Five years of NCE data exclusivity were granted, running concurrently with the patent term.
- Evergreening: The Evergreen Drug Patent Search Database's methodology has been criticized for inaccurately counting protections.
- Regulatory Context: The Hatch-Waxman Act and FDA regulations balance innovation incentives with generic competition.
FAQs
What is the main subject matter claimed in U.S. Patent 4,567,264?
The main subject matter claimed is ranolazine as a composition of matter.
How was the patent term of U.S. Patent 4,567,264 extended?
The patent term was extended by five years under Section 156 of the Patent Act due to the time spent in the FDA approval process.
What is the significance of New Chemical Entity (NCE) exclusivity?
NCE exclusivity is a five-year period granted by the FDA to incentivize the development of new active ingredients, running concurrently with any patent protection.
What are the criticisms of the Evergreen Drug Patent Search Database?
The Database has been criticized for its methodology, which inaccurately counts protections and extensions, potentially misrepresenting the extent of evergreening.
How does the Hatch-Waxman Act impact pharmaceutical patents?
The Hatch-Waxman Act balances innovation incentives by providing patent term extensions and NCE exclusivity, while also facilitating generic competition through abbreviated approval pathways.
Sources
- UC Hastings' Evergreen Drug Patent Search Database: A Look Behind the Statistics Reveals Problems with This Approach to Identifying and Quantifying So-Called Evergreening. Center for Innovation, UC Hastings College of the Law.
- Administrative Document(s) & Correspondence - accessdata.fda.gov. FDA.
- Patent Claims and Patent Scope. Hoover Institution.
- NOVEL PROCESS FOR THE PREPARATION OF RANOLAZINE. European Patent Application.
