Understanding the Scope and Claims of United States Patent 10,646,550
Introduction
United States Patent 10,646,550, issued on May 12, 2020, is a significant patent in the field of pharmaceuticals, particularly for the treatment of skeletal dysplasias. This patent, assigned to BioMarin Pharmaceutical Inc., involves the use of C-type natriuretic peptide (CNP) variants. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.
Patent Overview
Patent Title: Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Patent Number: 10,646,550
Issue Date: May 12, 2020
Inventors: Bullens Sherry, Bunting Stuart, Chou Tianwei, Okhamafe Augustus O., Price Christopher P., Wendt Daniel J., and Yap Clarence
Assignee: BioMarin Pharmaceutical Inc.
Scope of the Patent
The patent focuses on the therapeutic use of variants of C-type natriuretic peptide (CNP) for treating skeletal dysplasias. Here are the key aspects of its scope:
Treatment of Skeletal Dysplasias
The patent covers the use of CNP variants to treat various symptoms associated with skeletal dysplasias, including long bone growth and growth velocity. This is a critical area as skeletal dysplasias are a group of disorders that affect the development of the skeleton, leading to short stature and other skeletal abnormalities[2].
Pharmaceutical Compositions
The patent includes novel pharmaceutical compositions and formulations comprising CNP variant peptides. These compositions are designed to be effective in treating the mentioned conditions, highlighting the innovative approach in drug formulation[2].
Broad Application
The scope extends beyond just skeletal dysplasias to include other disorders that have a skeletal dysplasia component or are associated with CNP. This broad application makes the patent significant in the field of orthopedic and genetic disorders.
Claims of the Patent
The claims of a patent are crucial as they define the legal boundaries of what is protected.
Independent Claims
The patent includes independent claims that define the core inventions. These claims typically outline the specific CNP variants, their use in treating skeletal dysplasias, and the pharmaceutical compositions containing these variants. Independent claims are essential as they provide a clear definition of what is novel and non-obvious about the invention[3].
Dependent Claims
Dependent claims build upon the independent claims, providing additional details and limitations. These claims may include specific dosages, administration methods, and other aspects that further define the invention.
Patent Landscape
Understanding the patent landscape is vital for assessing the patent's position and potential impact.
Technology Field
The patent falls under the "Drugs and Medical Instruments" field, one of the six broad technology fields categorized by the National Bureau of Economics Research (NBER) classification scheme. This field has seen a significant decline in patent allowance rates over the years, making the approval of this patent noteworthy[1].
Exclusivity and Patent Term
The patent assigns exclusive legal rights to BioMarin Pharmaceutical Inc. for 20 years from the date of filing, although the exact filing date is not specified in the available sources. The patent is set to expire on August 1, 2036. Additionally, the patent may be accompanied by FDA exclusivity, which can grant sole marketing rights for a period ranging from 180 days to seven years[2].
Continuation and Related Patents
While the specific details of continuation procedures or related patents for US 10,646,550 are not provided, it is common for pharmaceutical patents to have continuation applications to protect related inventions or to address issues raised during the examination process[1].
Impact on Innovation
The approval of this patent reflects the ongoing innovation in the pharmaceutical industry, particularly in the treatment of rare genetic disorders.
Encouraging Research
Patents like US 10,646,550 encourage further research and development by providing a period of exclusivity, which can help recoup the significant investment in drug development.
Licensing and Litigation
The scope and claims of the patent are crucial in determining licensing agreements and potential litigation. Narrower claims, as suggested by some studies, can lead to a higher probability of grant and shorter examination processes, which could be beneficial for BioMarin Pharmaceutical Inc.[3].
Conclusion
United States Patent 10,646,550 is a significant development in the treatment of skeletal dysplasias, offering new therapeutic options using CNP variants. The patent's scope and claims are carefully defined to protect the innovative pharmaceutical compositions and their use. Understanding the broader patent landscape, including the technology field and exclusivity terms, provides a comprehensive view of its impact and potential.
Key Takeaways
- Therapeutic Use: The patent covers the use of CNP variants for treating skeletal dysplasias.
- Pharmaceutical Compositions: Novel pharmaceutical compositions and formulations are included.
- Broad Application: The patent extends to other disorders associated with CNP.
- Exclusivity: The patent grants exclusive rights for 20 years, with potential FDA exclusivity.
- Impact on Innovation: The patent encourages further research and development in rare genetic disorders.
FAQs
Q: What is the main focus of United States Patent 10,646,550?
A: The main focus is the use of C-type natriuretic peptide (CNP) variants to treat skeletal dysplasias.
Q: Who is the assignee of this patent?
A: The assignee is BioMarin Pharmaceutical Inc.
Q: When is the patent set to expire?
A: The patent is set to expire on August 1, 2036.
Q: What are the potential benefits of this patent in the pharmaceutical industry?
A: The patent encourages innovation by providing exclusivity, which can help recoup investment in drug development and promote further research.
Q: How does the patent landscape affect the approval and maintenance of this patent?
A: The decline in allowance rates in the "Drugs and Medical Instruments" field makes the approval of this patent significant, and narrower claims can lead to a higher probability of grant and shorter examination processes.
