United States Patent 9,908,845: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,908,845, titled "Aryl ethers and uses thereof," is a significant patent in the field of pharmaceuticals, particularly for the treatment of cancer. This patent is associated with the drug Welireg, which is used for treating adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Patent Title and Number
- Patent Title: Aryl ethers and uses thereof
- Patent Number: US 9,908,845
- Issue Date: March 6, 2018[2].
Inventors and Assignee
The patent was invented by a team of researchers including Dixon Darryl David, Grina Jonas, Josey John A., Rizzi James P., Schlachter Stephen T., Wallace Eli M., Wang Bin, Wehn Paul, Xu Rui, and Yang Hanbiao. The assignee of this patent is Peloton Therapeutics, Inc., which is now part of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.[2].
Scope of the Patent
Subject Matter
The patent pertains to HIF-2α inhibitors, which are compounds designed to inhibit the hypoxia-inducible factor 2 alpha (HIF-2α) protein. HIF-2α is a transcription factor involved in the cellular response to hypoxia and is implicated in various cancers, including renal cell carcinoma.
Claims
The patent includes claims related to the chemical structure of the aryl ethers, methods of making these compounds, and their use in treating cancer. Specifically, the claims cover:
- Chemical Compounds: The patent describes a series of aryl ether compounds that are potent HIF-2α inhibitors.
- Methods of Preparation: The patent outlines various methods for synthesizing these compounds.
- Therapeutic Uses: The claims include the use of these compounds for treating cancers, particularly those associated with HIF-2α overexpression[2].
Claims Analysis
Independent Claims
The independent claims in this patent are crucial as they define the broadest scope of the invention. These claims typically include the essential features of the aryl ether compounds and their therapeutic applications. For instance, one of the independent claims might specify the general structure of the aryl ether compounds and their use in inhibiting HIF-2α.
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims might specify particular substituents on the aryl ether backbone, specific methods of synthesis, or detailed therapeutic protocols.
Patent Landscape
Related Patents
Welireg, the drug associated with this patent, is protected by multiple patents. In addition to US 9,908,845, there are other patents such as US 9,996,689 and US 9,908,845, all of which relate to aryl ethers and their uses. These patents collectively protect the active ingredient of Welireg and prevent the launch of generic or bioequivalent versions until their expiration[4].
Patent Expiration and Generic Launch
The patents protecting Welireg are set to expire in September 2034. This expiration date is crucial because it marks the time when generic versions of the drug can be launched, assuming no further exclusivities or patent extensions are granted. The FDA has also granted several exclusivities to Welireg, which further delay the generic launch[4].
Regulatory Review Period
The FDA has determined the regulatory review period for Welireg, which is relevant for patent term extension applications. The applicant seeks a patent term extension of 342 days, which is subject to various statutory limitations and potential petitions for redetermination[1].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length (ICL) and independent claim count (ICC) can be used to measure the breadth and clarity of patent claims. Narrower claims, as indicated by shorter ICL and lower ICC, are associated with a higher probability of grant and a shorter examination process[3].
Impact on Innovation and Litigation
Patent Quality and Innovation
The quality of patent claims, including their scope and clarity, can significantly impact innovation. Broad and unclear claims can lead to increased litigation costs and may diminish incentives for innovation. The examination process tends to narrow the scope of patent claims, which can improve patent quality[3].
Litigation and Post-Grant Reviews
The scope and clarity of patent claims also influence litigation outcomes. Patents with narrower and clearer claims are less likely to be involved in lengthy and complex litigation. This is particularly relevant for pharmaceutical patents, where the stakes are high and the litigation landscape is complex[3].
Key Takeaways
- Patent Scope: The patent covers aryl ether compounds as HIF-2α inhibitors, their synthesis, and therapeutic use.
- Claims Analysis: Independent claims define the broad scope, while dependent claims provide additional details.
- Patent Landscape: Multiple patents protect Welireg, with expiration dates in 2034.
- Regulatory Review: The FDA has determined the regulatory review period, which affects patent term extensions.
- Metrics for Patent Scope: Independent claim length and count are important metrics for evaluating patent breadth and clarity.
- Impact on Innovation: Clear and narrow claims can foster innovation by reducing litigation costs.
FAQs
What is the main subject matter of US Patent 9,908,845?
The main subject matter of US Patent 9,908,845 is HIF-2α inhibitors, specifically aryl ether compounds, their synthesis, and their use in treating cancer.
Who is the assignee of this patent?
The assignee of this patent is Peloton Therapeutics, Inc., now part of Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.
When is the patent set to expire?
The patents protecting Welireg, including US 9,908,845, are set to expire in September 2034.
What are the implications of the FDA's regulatory review period determination?
The FDA's determination of the regulatory review period affects the potential patent term extension for Welireg, which could extend the exclusivity period for the drug.
How do independent claim length and count impact patent scope?
Independent claim length and count are metrics that indicate the breadth and clarity of patent claims. Narrower claims (shorter ICL and lower ICC) are associated with a higher probability of grant and shorter examination processes.
Sources
- Federal Register/Vol. 88, No. 236/Monday, December 11, 2023
- Generic Welireg Availability - Drugs.com
- Patent Claims and Patent Scope - Hoover Institution
- Welireg patent expiration - Pharsight - GreyB
