United States Patent 7,119,093: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,119,093, hereafter referred to as the '093 patent, is a significant patent related to the drug Nintedanib, a tyrosine kinase inhibitor used in the treatment of various conditions, including idiopathic pulmonary fibrosis (IPF) and non-small cell lung cancer (NSCLC). This patent has recently expired, marking a critical juncture in the pharmaceutical landscape.
Background of Nintedanib
Nintedanib, marketed under the brand name Ofev, is a small molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim. It targets multiple receptor tyrosine kinases involved in the regulation of angiogenesis, metastasis, and tumor growth.
Scope of the '093 Patent
Claims and Description
The '093 patent specifically claims a stable nintedanib esylate salt, characterized by good crystallinity and low amorphization during grinding and compression. This stability is crucial for the formulation and manufacturing of the drug, ensuring consistent quality and efficacy[5].
Importance of the Salt Form
The stable salt form of nintedanib esylate is essential for its pharmaceutical application. The patent describes the physical and chemical properties of this salt, including its crystalline structure, which enhances its stability and bioavailability. This is a key factor in the development of solid dosage forms such as tablets and capsules.
Expiration and Impact
Patent Expiration Date
The '093 patent expired on February 21, 2024. This expiration opens the door for generic competitors to enter the market, potentially reducing the cost of the drug and increasing accessibility for patients[2].
Generic Competition
With the expiration of the '093 patent, generic drug manufacturers can now file Abbreviated New Drug Applications (ANDAs) with the FDA to market their own versions of nintedanib. This competition is expected to drive down prices and expand patient access to this critical medication.
Patent Landscape and Trends
Filing Trends
The patent landscape for nintedanib has seen a significant increase in patent filings, particularly from 2017 onwards. Over 100 patents have been filed since 2022, indicating a heightened interest in this drug by various pharmaceutical companies, including Boehringer Ingelheim, Sunshine Lake Pharma, Jiangsu Hengrui Medi, Aiviva Biopharma, Hoffmann La Roche, and Gilead[1].
Jurisdictional Focus
The majority of patents related to nintedanib have been filed in the US and China, reflecting the strategic market interests of pharmaceutical companies in these regions. Other countries like Canada, Australia, and Japan have fewer patent filings, highlighting the differing market priorities[1].
Other Relevant Patents
Complementary Patents
In addition to the '093 patent, other patents such as US9907756B2 and US10105323B2, which expire in 2029, cover different aspects of nintedanib, including its formulation and methods of use. These patents continue to protect the intellectual property of the originator company until their expiration dates[1][2].
Method-of-Use Patents
Some patents, like the '990 patent, are method-of-use patents that do not claim any indications or other conditions of use for which generic manufacturers are seeking approval. This distinction is crucial in ANDA filings, as it affects the certification process and potential litigation[2].
Regulatory and Legal Implications
ANDA Filings and Certifications
Generic drug manufacturers filing ANDAs must address the '093 patent and other relevant patents. They may submit paragraph IV certifications, stating that the patents are invalid, unenforceable, or will not be infringed by the generic product. This process can lead to litigation and affects the approval timeline of generic versions[2].
Compliance with FDA Regulations
Companies involved in generic drug manufacturing must comply with FDA regulations, including self-identification and payment of facility fees. Non-compliance can result in significant legal and regulatory consequences, such as misbranding and potential site inspections[2].
Industry Participation and Collaborations
University and Institute Involvement
Universities and research institutes, such as the University of California, have been actively involved in patent filings related to nintedanib. This participation suggests potential collaborations between academic institutions and generic drug companies, which could accelerate the development of generic versions[1].
Big Pharma Interest
The involvement of major pharmaceutical companies in patent filings indicates their strategic interest in nintedanib. This interest could lead to future collaborations or acquisitions, shaping the market dynamics post-patent expiration[1].
Market Impact and Future Outlook
Price Reduction and Accessibility
The expiration of the '093 patent and the subsequent entry of generic competitors are expected to reduce the price of nintedanib, making it more accessible to patients. This is particularly significant for chronic conditions like IPF, where long-term treatment is necessary.
Innovation and Competition
The patent expiration also encourages innovation, as companies may focus on developing new formulations, combinations, or indications for nintedanib. This competition can drive further research and development in the field of tyrosine kinase inhibitors.
Key Takeaways
- The '093 patent has expired, allowing generic competition in the market.
- The patent covered a stable nintedanib esylate salt, crucial for pharmaceutical formulation.
- Other patents related to nintedanib continue to protect various aspects until their expiration.
- Generic manufacturers must comply with FDA regulations and address existing patents in their ANDA filings.
- University and big pharma involvement suggests potential collaborations and future market dynamics.
Frequently Asked Questions (FAQs)
1. What is the significance of the '093 patent expiration?
The expiration of the '093 patent allows generic drug manufacturers to enter the market, potentially reducing the cost of nintedanib and increasing patient access.
2. Which companies are involved in patent filings for nintedanib?
Apart from Boehringer Ingelheim, companies like Sunshine Lake Pharma, Jiangsu Hengrui Medi, Aiviva Biopharma, Hoffmann La Roche, and Gilead are involved in patent filings for nintedanib[1].
3. How does the '093 patent impact the formulation of nintedanib?
The '093 patent covers a stable nintedanib esylate salt, which is essential for ensuring good crystallinity and low amorphization during manufacturing, thus maintaining the drug's quality and efficacy[5].
4. What are the regulatory implications for generic manufacturers?
Generic manufacturers must comply with FDA regulations, including self-identification and payment of facility fees, and address existing patents in their ANDA filings to avoid legal and regulatory issues[2].
5. How might the expiration of the '093 patent affect future research and development?
The expiration could drive innovation as companies focus on developing new formulations, combinations, or indications for nintedanib, encouraging further research and competition in the field of tyrosine kinase inhibitors.
Cited Sources:
- GreyB, "The Ofev Patent Thicket: Patents expiring in 2026," GreyB Blog.
- U.S. Food & Drug Administration, "Nintedanib Capsules," accessdata.fda.gov.
- Seyfarth Shaw LLP, "The BioLoquitur Bulletin," Seyfarth Shaw LLP.
- United States Patent and Trademark Office, "United States Patent 11,160,805 B2," googleapis.com.
- MDPI, "Innovations and Patent Trends in the Development of USFDA-Approved Drugs," MDPI.
