United States Patent 10,105,323: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,105,323, hereafter referred to as the '323 patent, is a significant patent in the pharmaceutical sector, particularly related to the drug Ofev (nintedanib). This article provides a comprehensive analysis of the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The '323 patent, titled "Substituted indolines which inhibit receptor tyrosine kinases," is owned by Boehringer Ingelheim, the manufacturer of Ofev.
Expiration Date
The patent is set to expire on June 4, 2029, which is crucial for understanding the timeline for generic competition and the protection period for the patented invention[4].
Scope and Claims
Technical Description
The '323 patent covers specific substituted indolines that inhibit receptor tyrosine kinases. These compounds are used in the treatment of various diseases, including idiopathic pulmonary fibrosis (IPF) and non-small cell lung cancer (NSCLC). The patent describes the chemical structure, synthesis, and pharmaceutical compositions of these indolines[4].
Claim Structure
The patent includes multiple claims that delineate the invention with particularity. These claims typically include:
- Independent Claims: These define the broadest scope of the invention, often focusing on the chemical structure and therapeutic use of the indolines.
- Dependent Claims: These narrow down the scope by adding specific limitations or features to the independent claims, such as particular dosages or modes of administration.
Patent Landscape
Related Patents
The '323 patent is part of a larger patent portfolio protecting Ofev. Other relevant patents include:
- US 6,762,180: Expired on October 1, 2025, this patent covers earlier aspects of the indoline compounds.
- US 7,119,093: Expired on February 21, 2024, this patent focuses on specific pharmaceutical compositions.
- US 9,907,756: Set to expire on June 7, 2029, this patent covers additional aspects of the drug's formulation and use[4].
Patent Thickets
The collection of patents surrounding Ofev, including the '323 patent, forms a patent thicket. This strategy is common in the pharmaceutical industry to extend patent protection and deter generic competition. However, it has been a subject of controversy, as it can potentially stifle innovation and increase drug prices[1].
Regulatory Environment
FDA Approval and Orange Book Listings
The '323 patent is listed in the FDA's Orange Book, which catalogues approved drugs and their corresponding patents. This listing is crucial for generic drug manufacturers, as it informs them about the patents they must navigate to bring a generic version to market. The FDA requires generic applicants to certify the validity or non-infringement of listed patents, such as the '323 patent[2].
Paragraph IV Certifications
Generic drug applicants often file Paragraph IV certifications with the FDA, asserting that the listed patents are invalid, unenforceable, or not infringed. This can lead to patent litigation and is a key aspect of the regulatory landscape for patented drugs[2].
Economic and Competitive Impact
Protection of Market Share
The '323 patent, along with other patents in the portfolio, helps Boehringer Ingelheim maintain market exclusivity for Ofev until the patents expire. This protection is critical for the company's revenue and market share.
Generic Competition
Once the '323 patent expires, generic versions of Ofev can enter the market, potentially reducing the drug's price and impacting Boehringer Ingelheim's sales. The expiration of this patent is a significant event in the lifecycle of the drug, marking the end of a period of exclusive market rights[4].
Legal and Policy Considerations
Terminal Disclaimer Practice
The USPTO's recent withdrawal of a proposed rule change related to terminal disclaimers is relevant to the broader patent landscape. Terminal disclaimers allow patent owners to file continuation applications while ensuring that the patents do not extend beyond the term of the original patent. This practice is crucial for managing patent portfolios and avoiding issues of nonstatutory double patenting[1].
Patent Quality and Examination
The quality of patent examination is a recurring theme in patent law. The '323 patent, like many others, must meet the statutory requirements of being useful, novel, nonobvious, and directed to patentable subject matter. The assurance of high-quality patent examination is essential to prevent the issuance of overly broad or invalid patents, which can have negative impacts on innovation and competition[5].
Conclusion
The United States Patent 10,105,323 is a vital component of the patent portfolio protecting Ofev. Understanding its scope, claims, and the surrounding patent landscape is essential for both the pharmaceutical industry and generic drug manufacturers. The patent's expiration in 2029 will mark a significant shift in the market dynamics for this drug.
Key Takeaways
- Patent Expiration: The '323 patent expires on June 4, 2029.
- Scope and Claims: The patent covers specific indoline compounds and their therapeutic use.
- Related Patents: Part of a larger patent portfolio protecting Ofev.
- Regulatory Environment: Listed in the FDA's Orange Book and subject to Paragraph IV certifications.
- Economic Impact: Protects market exclusivity until expiration, after which generic competition can begin.
- Legal Considerations: Subject to broader patent law and policy discussions, including terminal disclaimers and patent quality.
FAQs
What is the '323 patent, and what does it cover?
The '323 patent covers specific substituted indolines that inhibit receptor tyrosine kinases, used in the treatment of diseases such as IPF and NSCLC.
When does the '323 patent expire?
The '323 patent is set to expire on June 4, 2029.
What is the significance of the '323 patent in the pharmaceutical industry?
The '323 patent is part of a patent thicket protecting Ofev, helping Boehringer Ingelheim maintain market exclusivity until the patent expires.
How does the FDA's Orange Book relate to the '323 patent?
The '323 patent is listed in the FDA's Orange Book, informing generic drug manufacturers about the patents they must navigate to bring a generic version to market.
What happens when the '323 patent expires?
Upon expiration, generic versions of Ofev can enter the market, potentially reducing the drug's price and impacting Boehringer Ingelheim's sales.
How does the USPTO's withdrawal of the proposed rule on terminal disclaimers affect patents like the '323 patent?
The withdrawal of the proposed rule ensures that patents like the '323 patent are not subject to new requirements that could lead to invalidation based on the invalidity of a single claim in a patent grouping.
Sources
- Threat to Many Patent Portfolios Fades as USPTO Withdraws Controversial Proposed Rule - Procopio
- Nintedanib Capsules - FDA
- Patent Claims and Patent Scope - SSRN
- Ofev patent expiration - Pharsight
- Patenting Around Failure - University of Pennsylvania Law Review
