Detailed Analysis of the Scope and Claims of United States Patent 10,159,759
Introduction
United States Patent 10,159,759, titled "Pet tracer for imaging of neuroendocrine tumors," is a significant patent in the field of medical diagnostics, particularly in the use of positron emission tomography (PET) for imaging neuroendocrine tumors. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background and Invention Overview
The patent, issued on December 25, 2018, describes a radiolabelled peptide-based compound designed for diagnostic imaging of neuroendocrine tumors using PET. This compound targets somatostatin receptors, which are often overexpressed in these tumors, allowing for precise imaging and diagnosis[1][4].
Scope of the Patent
Diagnostic Imaging
The patent covers a method for imaging somatostatin overexpression in tumors or other tissues. This involves administering a radiolabelled compound, such as ({}^{64})Cu-DOTATATE, and using PET to detect the uptake of this compound by cell receptors. The scope includes the preparation and administration of the compound, as well as the imaging process itself[1].
Compound Preparation
The patent details the synthesis and purification of the radiolabelled compound. For example, ({}^{64})Cu is produced using a cyclotron and then complexed with DOTATATE. The specific activity and yield of the compound are critical, with the process resulting in greater than 95% yield and a specific activity of 4.78 MBq/mmol[1].
Dosage and Administration
The patent specifies the target dose range for the compound, typically between 150-350 MBq, with a preferred range of 191-210 MBq. This dosage is crucial for effective imaging without excessive radiation exposure[1].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the core aspects of the invention:
- Claim 1: A method for imaging somatostatin overexpression in tumors or other tissues, involving the administration of a radiolabelled peptide-based compound and detection using PET[1].
- Claim 2: A method of generating an image of a human body using the radiolabelled compound and PET imaging[1].
Dependent Claims
Dependent claims further specify various aspects of the independent claims, such as:
- The specific radiolabel used (e.g., ({}^{64})Cu).
- The dosage range and preferred dosages.
- The method of producing the radiolabelled compound.
- The use of high-pressure liquid chromatography (HPLC) for purification[1].
Patent Landscape
Patent Expiration and Exclusivities
The patent is protected until August 2032, with several related patents (US10383961 and US11160888) also expiring on the same date. Additionally, the FDA has granted exclusivities to the drug Detectnet, which is based on this patent, delaying the generic launch until August 23, 2032[2][5].
Related Patents
There are several other patents related to PET tracers for neuroendocrine tumors, including WO2013029616A1, which also describes radiolabelled peptide-based compounds for PET imaging. These patents collectively form a robust intellectual property portfolio in this field[1][4].
Legal and Regulatory Activities
Recent legal activities include notices of final determination, requirements for information, and payments of maintenance fees. These activities indicate ongoing efforts to maintain and potentially extend the patent's life and exclusivities[2].
Impact on Innovation and Competition
Patent Scope and Quality
The scope of this patent, as with many others, is a subject of debate. Narrower claims, as seen in this patent, are generally associated with a higher probability of grant and shorter examination processes. This can influence the innovation landscape by providing clear boundaries for competitors and encouraging further research and development[3].
Market Exclusivity
The exclusivities granted by the FDA, in addition to the patent protection, ensure that the original manufacturer has a monopoly on the market until the exclusivities expire. This can delay the entry of generic or bioequivalent versions, affecting competition and pricing in the market[5].
Key Takeaways
- Diagnostic Imaging: The patent covers a method for imaging neuroendocrine tumors using a radiolabelled peptide-based compound and PET.
- Compound Preparation: The synthesis and purification of the compound are detailed, with specific activities and yields specified.
- Dosage and Administration: The target dose range is between 150-350 MBq, with preferred dosages specified.
- Patent Expiration and Exclusivities: The patent expires in August 2032, with FDA-granted exclusivities delaying generic launch until August 2032.
- Related Patents: Several related patents form a comprehensive intellectual property portfolio in this field.
- Impact on Innovation: The patent's scope and exclusivities influence innovation and competition by setting clear boundaries and delaying generic entry.
FAQs
What is the primary use of the compound described in US Patent 10,159,759?
The primary use is for diagnostic imaging of neuroendocrine tumors using positron emission tomography (PET).
What is the target dose range for the radiolabelled compound?
The target dose range is between 150-350 MBq, with a preferred range of 191-210 MBq.
When does the patent for Detectnet, based on this invention, expire?
The patent expires in August 2032, with FDA-granted exclusivities delaying the generic launch until the same date.
How is the radiolabelled compound produced and purified?
The compound is produced using a cyclotron and purified using high-pressure liquid chromatography (HPLC).
What is the significance of the FDA-granted exclusivities for Detectnet?
The exclusivities ensure that the original manufacturer has a monopoly on the market until the exclusivities expire, delaying the entry of generic or bioequivalent versions.
Sources
- US10159759B2 - Pet tracer for imaging of neuroendocrine tumors - Google Patents
- Detectnet patent expiration - Pharsight
- Patent Claims and Patent Scope - Hoover Institution
- WO2013029616A1 - Pet tracer for imaging of neuroendocrine tumors - Google Patents
- Generic Detectnet Availability - Drugs.com
