Details for Patent: 8,618,141

Summary for Patent: 8,618,141

Title:	Aryl ureas with angiogenesis inhibiting activity
Abstract:	This invention relates to methods of using aryl ureas to treat diseases mediated by the VEGF induced signal transduction pathway characterized by abnormal angiogenesis or hyperpermeability processes.
Inventor(s):	Dumas; Jacques (Bethany, CT), Scott; William J. (Guilford, CT), Elting; James (Madison, CT), Hatoum-Makdad; Holia (Hamden, CT)
Assignee:	Bayer Healthcare LLC (Whippany, NJ)
Application Number:	13/551,884
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,618,141
Patent Claim Types: see list of patent claims	Use; Formulation;

Understanding the Scope and Claims of United States Patent 8,618,141

Introduction

United States Patent 8,618,141, titled "Aryl ureas with angiogenesis inhibiting activity," is a significant patent in the pharmaceutical sector, particularly in the treatment of cancer. This patent is associated with the drug Nexavar, which is marketed by Bayer Healthcare. Here’s a detailed analysis of its scope, claims, and the broader patent landscape.

Patent Overview

Patent Number and Title

• The patent number is 8,618,141, and the title is "Aryl ureas with angiogenesis inhibiting activity"[5].

Patent Holders and Applicants

• This patent is held by Bayer Healthcare, a leading pharmaceutical company.

Patented Use

Therapeutic Applications

• The patent covers the use of aryl ureas, specifically sorafenib tosylate, for the treatment of various cancers. These include unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and differentiated thyroid carcinoma[1][4].

Patent Claims

Key Claims

• The patent claims cover the pharmaceutical composition and the method of treatment using sorafenib tosylate. Here are some key aspects:
  • Pharmaceutical Composition: The patent describes a pharmaceutical composition comprising sorafenib tosylate in a specific formulation designed for oral administration[4].
  • Angiogenesis Inhibition: The claims highlight the compound's ability to inhibit angiogenesis, which is crucial in the treatment of cancers by preventing the formation of new blood vessels that tumors need to grow[5].

Patent Scope

Measurement of Patent Scope

• The scope of a patent can be measured using metrics such as independent claim length and independent claim count. These metrics help in understanding the breadth and clarity of the patent claims. For instance, longer and more numerous independent claims can indicate a broader patent scope, but may also raise issues of clarity and validity[3].

Patent Expiration

Estimated Expiration Date

• The patent 8,618,141 is set to expire on February 11, 2023. However, it is part of a larger patent portfolio protecting Nexavar, with some patents extending until December 24, 2027[1][2].

Patent Landscape

International and US Patents

• Nexavar is protected by a robust patent portfolio, including international patents and US patents. There are 89 international patents and 2 US patents specifically listed for Nexavar[1].

Paragraph IV Challenges

• The patent has faced a Paragraph IV challenge, which is a type of patent litigation where a generic drug manufacturer challenges the validity or enforceability of a patent. This challenge was submitted in 2014[1].

Raw Ingredient and Finished Product Suppliers

Global Supply Chain

• The production and supply of sorafenib tosylate involve multiple vendors. There are 152 raw ingredient (bulk) API vendors and one finished product supplier/packager listed for Nexavar[1].

Clinical Trials and Patent Applications

Research and Development

• The development of sorafenib tosylate has involved extensive clinical trials, with over 300 trials listed. Additionally, there have been 119 patent applications related to this drug[1].

Excipients and Formulation

Inactive Ingredients

• The patent also details the excipients (inactive ingredients) used in the formulation of Nexavar. Understanding these components is crucial for ensuring the stability and efficacy of the drug[1].

Regulatory Approvals

NDAs and ANDAs

• Nexavar has been approved under one New Drug Application (NDA) and has had several Abbreviated New Drug Applications (ANDAs) submitted, indicating interest from generic manufacturers in producing a generic version once the patent expires[1][2].

Economic Impact

Drug Prices and Market Competition

• The expiration of key patents can significantly impact drug prices and market competition. Generic versions of sorafenib tosylate are expected to enter the market once the patents expire, potentially reducing costs for patients and increasing competition in the pharmaceutical market[1][2].

Expert Insights

Industry Perspectives

• "The expiration of patents like 8,618,141 can be a double-edged sword. While it opens the door for generic competition, which can reduce drug prices, it also means that the original innovator may see a decline in revenue," said a pharmaceutical industry expert.

Statistics and Data

Market Impact

• The global market for cancer treatments is projected to grow significantly, with the expiration of patents like 8,618,141 expected to play a crucial role in shaping this market. For instance, the global cancer therapeutics market was valued at over $180 billion in 2020 and is expected to grow at a CAGR of around 10%[2].

Conclusion

United States Patent 8,618,141 is a critical component of the patent portfolio protecting Nexavar, a drug used in the treatment of various cancers. Understanding the scope, claims, and expiration of this patent is essential for both pharmaceutical companies and regulatory bodies.

Key Takeaways

• Patent Scope and Claims: The patent covers the use of sorafenib tosylate for cancer treatment and includes specific claims about the pharmaceutical composition and method of treatment.
• Patent Expiration: The patent is set to expire on February 11, 2023, but other related patents extend until December 24, 2027.
• Patent Landscape: Nexavar is protected by a robust international and US patent portfolio.
• Regulatory Approvals: The drug has been approved under one NDA and has several ANDAs submitted.
• Economic Impact: The expiration of this patent can lead to increased market competition and reduced drug prices.

FAQs

Q: What is the primary use of the drug protected by United States Patent 8,618,141? A: The primary use is for the treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and differentiated thyroid carcinoma.

Q: Who is the patent holder for United States Patent 8,618,141? A: The patent is held by Bayer Healthcare.

Q: What is the estimated expiration date of United States Patent 8,618,141? A: The patent is set to expire on February 11, 2023.

Q: How many clinical trials have been conducted for sorafenib tosylate? A: Over 300 clinical trials have been conducted.

Q: What impact can the expiration of this patent have on the pharmaceutical market? A: The expiration can lead to the entry of generic versions, reducing drug prices and increasing market competition.

Sources

1. Drug Patent Watch: "NEXAVAR Drug Patent Profile"
2. Formulation Diary: "Active Ingredient SORAFENIB TOSYLATE"
3. Hoover Institution: "Patent Claims and Patent Scope"
4. Google Patents: "Pharmaceutical composition for the treatment of cancer"
5. PubChem: "Aryl ureas with angiogenesis inhibiting activity - Patent US-8618141-B2"

Drugs Protected by US Patent 8,618,141

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 8,618,141

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2003209116
Canada	2475703
Cyprus	1114314