Detailed Analysis of the Scope and Claims of United States Patent 8,168,775
Introduction
United States Patent 8,168,775, titled "Compositions and methods for inhibiting expression of transthyretin," is a significant patent held by Alnylam Pharmaceuticals, Inc. This patent is crucial for the development and marketing of Onpattro (patisiran), a drug used to treat the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background
The patent in question was issued on April 1, 2013, and is assigned to Alnylam Pharmaceuticals, Inc. It is part of a series of patents related to the inhibition of transthyretin (TTR) expression, which is a key factor in the treatment of hereditary transthyretin-mediated amyloidosis[2][4].
Scope of the Patent
Invention Overview
The patent describes compositions and methods for inhibiting the expression of the transthyretin (TTR) gene. TTR is a protein that, when mutated, can lead to amyloidosis, a condition characterized by the accumulation of amyloid fibrils in various tissues. The invention involves the use of double-stranded ribonucleic acid (dsRNA) to silence the TTR gene, thereby reducing the production of the problematic TTR protein[5].
Claim Structure
The patent includes multiple claims that define the scope of the invention. These claims can be broadly categorized into two types:
Composition Claims
These claims describe the dsRNA compositions designed to target the TTR gene. For example, Claim 1 of the patent specifies a dsRNA molecule that is complementary to a region of the TTR gene, and methods for preparing such molecules[5].
Method Claims
These claims outline the methods for using the dsRNA compositions to inhibit TTR expression. This includes administering the dsRNA to a subject in need thereof, and methods for reducing TTR protein levels in cells and tissues[5].
Key Claims
Claim 1
Claim 1 is an independent claim that sets the foundation for the patent. It describes a dsRNA molecule that is complementary to a region of the TTR gene, specifying the sequence and structure of the dsRNA. This claim is critical as it defines the core invention and sets the boundaries for what is considered novel and non-obvious[5].
Claim 10
Claim 10 is a method claim that describes the administration of the dsRNA molecule to a subject to inhibit TTR expression. This claim is significant as it outlines the therapeutic application of the invention, which is central to the development of Onpattro[5].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 8,168,775 includes several related patents held by Alnylam Pharmaceuticals, Inc. For example:
- U.S. Patent 8,741,866: This patent, also related to compositions and methods for inhibiting TTR expression, was issued on June 3, 2014. It covers additional aspects of the dsRNA technology and has a patent expiration date of October 20, 2029[2].
- U.S. Patent 9,234,196: This patent is another in the series related to TTR inhibition and was issued on January 5, 2016. It further expands on the methods and compositions for treating TTR-mediated amyloidosis[4].
Patent Term Restoration
The regulatory review period for Onpattro, which includes the testing and approval phases, has been a factor in determining the eligibility for patent term restoration. The FDA has verified the regulatory review period, and the USPTO has received applications for patent term extension for the patents related to Onpattro, including U.S. Patent 8,168,775. The actual extension period will be determined by the USPTO, considering statutory limitations and the applicant's due diligence during the regulatory review period[1][4].
Challenges and Controversies
Patent Scope and Quality
There have been debates over patent quality and scope, particularly regarding the breadth and clarity of patent claims. Metrics such as independent claim length and independent claim count have been proposed to measure patent scope. Narrower claims are often associated with a higher probability of grant and a shorter examination process, which can impact the overall validity and enforceability of the patent[3].
Generic Availability
As of now, there is no generic version of Onpattro available in the United States. The patent expiration dates for the related patents, including U.S. Patent 8,168,775 (set to expire on October 3, 2027), will play a crucial role in determining when generic versions might become available[2].
Regulatory and Legal Aspects
FDA Approval and Regulatory Review
The FDA's approval of Onpattro on August 10, 2018, marked the first permitted commercial marketing or use of the product. The regulatory review period, which includes both the testing and approval phases, is a critical factor in determining the patent term extension. Any interested person can petition the FDA regarding the applicant's due diligence during this period[1][4].
Petitions and Redetermination
The FDA allows for petitions regarding the accuracy of the dates published and whether the applicant acted with due diligence during the regulatory review period. These petitions must comply with specific requirements and can be submitted electronically or in written form[1][4].
Key Takeaways
- Invention Scope: The patent covers compositions and methods for inhibiting TTR expression using dsRNA.
- Key Claims: Independent claims define the dsRNA molecules and methods for their use.
- Related Patents: Several related patents expand on the dsRNA technology and TTR inhibition methods.
- Patent Term Restoration: The patent is eligible for term extension based on the regulatory review period.
- Generic Availability: No generic version of Onpattro is currently available, with patent expiration dates influencing future availability.
- Regulatory Aspects: FDA approval and regulatory review periods are crucial for determining patent term extensions and due diligence.
FAQs
Q: What is the primary invention described in U.S. Patent 8,168,775?
A: The primary invention is the use of double-stranded ribonucleic acid (dsRNA) to inhibit the expression of the transthyretin (TTR) gene.
Q: What is the therapeutic application of the invention described in U.S. Patent 8,168,775?
A: The therapeutic application is the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults through the administration of dsRNA to reduce TTR protein levels.
Q: Are there any related patents to U.S. Patent 8,168,775?
A: Yes, there are several related patents, including U.S. Patent 8,741,866 and U.S. Patent 9,234,196, which further expand on the dsRNA technology and TTR inhibition methods.
Q: What is the current status of generic availability for Onpattro?
A: As of now, there is no generic version of Onpattro available in the United States.
Q: How is the patent term extension determined for U.S. Patent 8,168,775?
A: The patent term extension is determined based on the regulatory review period, which includes both the testing and approval phases, and is subject to statutory limitations and the applicant's due diligence during this period.
Sources
- Federal Register, Volume 88 Issue 93 (Monday, May 15, 2023)
- Generic Onpattro Availability - Drugs.com
- Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Federal Register / Vol. 88, No. 93 / Monday, May 15, 2023 / Notices
- US8168775B2 - Compositions and methods for inhibiting expression of transthyretin - Google Patents
