United States Patent 10,071,066: A Comprehensive Analysis
Introduction
United States Patent 10,071,066, issued on September 11, 2018, is a significant patent in the field of oncology, particularly for the treatment of estrogen receptor-positive breast cancer. This patent, assigned to Duke University, involves methods of treating cancer using selective estrogen receptor modulators (SERMs).
Inventors and Assignees
The patent was invented by Suzanne E. Wardell, Erik R. Nelson, and Donald P. McDonnell, and is assigned to Duke University[5].
Patent Claims
The patent includes several key claims that define its scope and application.
Claim 1: Method of Treating Cancer
The primary claim involves a method of treating estrogen receptor-positive breast cancer in a subject, where the cancer is resistant to an estrogen receptor modulator. This method includes administering a composition comprising the compound (R)-6-{2-{ethyl[4-(2-ethylaminoethyl)benzyl]amino}-4-methoxyphenyl}-5,6,7,8-tetrahydronaphthalen-2-ol, known as elacestrant[1].
Subject Definition
The term "subject" in the patent claims includes humans, specifically postmenopausal women or adult men, for whom the approved product, ORSERDU (elacestrant), is indicated[1].
Resistance to Estrogen Receptor Modulators
The patent specifically addresses cancers that are resistant to estrogen receptor modulators, a common issue in the treatment of breast cancer due to mutations in the ESR-1 gene[1].
Approved Product: ORSERDU
The approved product, ORSERDU (elacestrant), is indicated for the treatment of postmenopausal women or adult men with estrogen receptor-positive, ESR-1 mutated breast cancer that has progressed following at least one line of endocrine therapy[1][2].
Regulatory Approval
ORSERDU was approved by the FDA on January 27, 2023, following the submission of a New Drug Application (NDA 217639) on June 17, 2022[2][4].
Labeling Updates
Subsequent to the initial approval, a Supplemental New Drug Application (sNDA) was approved on November 9, 2023, which revised the labeling to update the correct established name from "elacestrant dihydrochloride" to "elacestrant hydrochloride"[1].
Patent Term Restoration
The patent holders have applied for patent term restoration due to the lengthy regulatory review period. The FDA verified that the regulatory review period for ORSERDU was 2,965 days, which includes 2,740 days in the testing phase and 225 days in the approval phase[4].
Statutory Limitations
The USPTO applies several statutory limitations to calculate the actual period for patent extension. The applicants seek various durations of patent term extension, including 724 days, 841 days, or 1,595 days[2][4].
Patent Scope and Quality
The scope of the patent is defined by its claims, which are specific to the use of elacestrant for treating estrogen receptor-positive breast cancer. The patent's scope is narrow and focused, which is generally associated with higher patent quality and a shorter examination process[3].
Related Patents and Exclusivity
Other related patents include those for polymorphic forms of RAD1901-2HCl and other SERMs, which are assigned to different entities like RADIUS PHARMACEUTICALS, INC. These patents cover various aspects of cancer treatment and have different expiration dates[5].
Generic Availability
As of now, there is no generic version of ORSERDU available in the United States, ensuring that the patent holders maintain exclusive marketing rights for the specified period[5].
Regulatory Review Period
The regulatory review period, which includes both the testing and approval phases, is crucial for determining the eligibility and extent of patent term restoration. For ORSERDU, this period began on December 17, 2014, when the exemption for clinical investigations became effective, and ended on January 27, 2023, with FDA approval[4].
Petitions and Redetermination
Any interested party can submit petitions to the FDA to challenge the dates or the due diligence of the applicant during the regulatory review period. These petitions must comply with specific requirements and be filed within the designated time frames[2][4].
Key Takeaways
- Patent Claims: The patent covers methods of treating estrogen receptor-positive breast cancer using elacestrant.
- Approved Product: ORSERDU (elacestrant) is approved for postmenopausal women or adult men with ESR-1 mutated breast cancer.
- Regulatory Approval: Approved on January 27, 2023, with subsequent labeling updates.
- Patent Term Restoration: Applicants seek extension due to lengthy regulatory review period.
- Related Patents: Other patents cover polymorphic forms and different SERMs.
- Generic Availability: No generic version available as of now.
FAQs
Q: What is the primary claim of United States Patent 10,071,066?
A: The primary claim involves a method of treating estrogen receptor-positive breast cancer using the compound elacestrant.
Q: Who are the inventors and assignees of the patent?
A: The inventors are Suzanne E. Wardell, Erik R. Nelson, and Donald P. McDonnell, and it is assigned to Duke University.
Q: What is ORSERDU, and when was it approved?
A: ORSERDU (elacestrant) is a drug approved by the FDA on January 27, 2023, for treating estrogen receptor-positive, ESR-1 mutated breast cancer.
Q: Why is the patent term restoration sought for this patent?
A: The patent term restoration is sought due to the lengthy regulatory review period of 2,965 days.
Q: Is there a generic version of ORSERDU available?
A: No, there is currently no generic version of ORSERDU available in the United States.
Cited Sources
- Suzanne E. WardeH et al. Application No. 15/214 - Regulations.gov
- Federal Register/Vol. 89, No. 179/Monday, September 16, 2024 - GovInfo
- Patent Claims and Patent Scope - SSRN
- Federal Register, Volume 89 Issue 179 (Monday, September 16, 2024) - GovInfo
- Generic Orserdu Availability - Drugs.com
