Detailed Analysis of the Scope and Claims of United States Patent 7,638,536
Introduction
United States Patent 7,638,536, titled "2-Acylaminothiazole derivative or salt thereof," is a crucial patent protecting the drug Doptelet (avatrombopag maleate), which is used for the treatment of thrombocytopenia in adult patients with chronic liver disease. Here, we delve into the scope, claims, and patent landscape surrounding this patent.
Patent Overview
Patent Number and Title
The patent number is US 7,638,536 B2, and its title is "2-Acylaminothiazole derivative or salt thereof."[4]
Inventors and Assignee
The inventors of this patent include Keizo Sugasawa, Tsukuba, Susumu Watanuki, Tsukuba, Yuji Koga, Tsukuba, Hiroshi Nagata, Tsukuba, Kazuyoshi Obitsu, Tsukuba, Ryutaro Wakayama, Tsukuba, Fukushi Hirayama, Tsukuba, and Ken-ichi Suzuki, Tsukuba. The assignee of the patent is Astellas Pharma Inc., Chuo-Ku, Tokyo, Japan.[4]
Date of Patent
The patent was granted on December 29, 2009.[4]
Scope of the Patent
Compound and Use
The patent covers compounds that are 2-acylaminothiazole derivatives or their pharmaceutically acceptable salts. These compounds are useful in treating thrombocytopenia, a condition characterized by a low platelet count in the blood.[4]
Claims
The patent includes 15 claims that describe the specific compounds, their salts, and their use in medical treatments. The claims are detailed and specify the chemical structure and properties of the compounds, ensuring broad protection for the invention.[4]
Patent Claims Analysis
Chemical Structure
The claims define the chemical structure of the 2-acylaminothiazole derivatives, including the specific substituents and their positions on the thiazole ring. This detailed description ensures that any similar compounds would fall under the scope of the patent.[4]
Pharmaceutical Use
The patent claims also cover the use of these compounds in treating thrombocytopenia. This includes the administration of the compounds in various forms, such as tablets, capsules, or other pharmaceutical formulations.[4]
Patent Landscape
Current Status
As of the latest updates, one of the patents (US 7,638,536) is still active, while two other related patents (US 8,338,429 and US 8,765,764) have expired[2].
Patent Expiration
The active patent (US 7,638,536) is set to expire on July 28, 2027. This expiration date is crucial for generic drug manufacturers, as it marks the point when they can legally produce and market generic versions of Doptelet[2][5].
Patent Term Extension
The patent term for US 7,638,536 has been extended due to the regulatory review period for the drug. The FDA determined a regulatory review period of 4,632 days, which includes both the testing and approval phases. This extension is under 35 U.S.C. 156(g)(1)(B) and has added 402 days to the patent term[1].
Regulatory Review Period
Testing Phase
The testing phase began on September 16, 2005, when the investigational new drug (IND) application became effective and lasted until the new drug application (NDA) was submitted on September 21, 2017. This phase spanned 4,389 days[1].
Approval Phase
The approval phase started with the submission of the NDA on September 21, 2017, and ended with the FDA approval of Doptelet on May 21, 2018, lasting 243 days[1].
Challenges and Opportunities
Generic Launch
The generic launch date for Doptelet is estimated to be July 28, 2027, following the expiration of the active patent. This opens up opportunities for generic manufacturers to enter the market[2][5].
Patent Analytics
To manage and analyze the patent landscape effectively, companies can use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, identifying gaps in coverage, and highlighting future design opportunities[3].
Key Takeaways
- Patent Protection: US 7,638,536 protects the active ingredient of Doptelet, ensuring exclusive marketing rights until its expiration.
- Expiration Date: The patent is set to expire on July 28, 2027.
- Regulatory Review: The patent term has been extended due to the regulatory review period.
- Generic Opportunities: Generic manufacturers can prepare for market entry post-patent expiration.
- Patent Analytics: Effective use of patent analytics tools can help in managing and optimizing the patent portfolio.
FAQs
What is the primary use of the drug protected by US 7,638,536?
The primary use of the drug protected by US 7,638,536 is the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Who is the assignee of the patent US 7,638,536?
The assignee of the patent US 7,638,536 is Astellas Pharma Inc., Chuo-Ku, Tokyo, Japan.
What is the expiration date of the patent US 7,638,536?
The patent US 7,638,536 is set to expire on July 28, 2027.
How was the regulatory review period for Doptelet determined?
The regulatory review period for Doptelet was determined by the FDA, which included both the testing phase (4,389 days) and the approval phase (243 days), totaling 4,632 days.
What tools can companies use to manage and analyze their patent landscape effectively?
Companies can use patent analytics tools, such as Claim Coverage Matrix and Claim Charts, to manage and analyze their patent landscape effectively.
Sources
- Federal Register/Vol. 88, No. 24/Monday, February 6, 2023/Notices - Federal Register
- Doptelet patent expiration - Pharsight - GreyB
- Patent Analytics - Intellectual Property Law
- United States Patent 7,638,536 B2 - Google Patents
- Generic Doptelet Availability - Drugs.com
