Detailed Analysis of the Scope and Claims of United States Patent 10,125,171
Introduction
United States Patent 10,125,171, titled "Composition and Methods for Treating Neurodegenerative Disorders," is a significant patent granted to Apellis Pharmaceuticals, Inc. This patent is crucial in the realm of pharmacological innovations, particularly for treating neurodegenerative diseases. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
- Inventors: Cedric Francois and Pascal Deschatelets
- Assignee: Apellis Pharmaceuticals, Inc.
- Issue Date: November 13, 2018
- Application Number: 14/116,591
- PCT Information: Filed on May 11, 2012, as PCT/US2012/037648[1][4].
Scope of the Patent
The patent covers compositions and methods for treating neurodegenerative disorders, which include conditions such as Alzheimer's Disease, Parkinson's Disease, amyotrophic lateral sclerosis (ALS), and other diseases characterized by progressive neuronal loss and functional impairment. The scope is broad, encompassing various therapeutic agents and treatment methods aimed at slowing or treating these disorders[1].
Claims of the Patent
The patent includes multiple claims that define its scope:
Composition Claims
- Claim 1 specifically mentions compositions containing certain fragments of growth factors with or without other substances. These compositions often involve compstatin analogs, which are cyclic peptides with specific amino acid sequences extended by terminal amino acids[4].
Method Claims
- Claim 14 includes methods of treating amyotrophic lateral sclerosis (ALS), highlighting the potential of biopharmaceutical drugs and supportive therapies in managing this neurodegenerative disorder[1].
- Additional claims expand the use to other neurodegenerative diseases, such as Alzheimer's, and related methods of treatment and diagnostics.
Key Components of the Patent
Compstatin Analogs
The patent focuses on compstatin analogs, which are designed to be cell-reactive, long-acting, or targeted. These analogs involve attaching clearance-reducing moieties to compstatin analog moieties, enhancing their therapeutic efficacy and duration of action[4].
Therapeutic Applications
The patent describes the use of these compstatin analogs in treating various neurodegenerative diseases. For instance, pegcetacoplan (marketed as EMPAVELI), a product covered by this patent, has been approved by the FDA for treating certain conditions, demonstrating the practical application of the patented compositions and methods[2][4].
Patent Landscape
Patent Family and Global Coverage
- The patent has thirty patent family members in twelve countries, indicating a robust global protection strategy for the inventions covered by this patent[1].
Patent Term Extension
An application for a patent term extension was filed under 35 U.S.C. ยง 156, based on the FDA's approval of the NDA for EMPAVELI. This application seeks to extend the patent term from August 2, 2033, to March 4, 2035, highlighting the ongoing efforts to maximize the patent's lifespan[2][4].
Related Patents
Other patents, such as U.S. Patent Nos. 10,035,822 and 10,875,893, also related to EMPAVELI, were filed concurrently for patent term extensions. This indicates a comprehensive approach to protecting the intellectual property surrounding this therapeutic product[2].
Impact on Innovation and Industry
Patent Scope and Quality
The debate on patent quality and scope is relevant here. The patent's broad claims and the use of metrics such as independent claim length and count can help assess its scope and potential impact on innovation. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Market Exclusivity
The absence of a generic version of EMPAVELI in the United States, as of the current date, underscores the market exclusivity provided by this patent. This exclusivity is crucial for Apellis Pharmaceuticals to recoup investment and drive further innovation in the field of neurodegenerative diseases[5].
Conclusion
United States Patent 10,125,171 is a pivotal patent in the field of neurodegenerative disease treatment, offering significant advancements in pharmacological innovations. Its broad scope, covering various compositions and methods, and its global protection strategy, ensure a strong intellectual property position for Apellis Pharmaceuticals.
Key Takeaways
- Broad Scope: Covers compositions and methods for treating neurodegenerative disorders.
- Compstatin Analogs: Focuses on cell-reactive, long-acting, or targeted compstatin analogs.
- Therapeutic Applications: Includes approved products like EMPAVELI.
- Global Protection: Thirty patent family members in twelve countries.
- Patent Term Extension: Application filed to extend the patent term.
- Market Exclusivity: No generic version of EMPAVELI available.
FAQs
Q: What is the primary focus of United States Patent 10,125,171?
A: The primary focus is on compositions and methods for treating neurodegenerative disorders, including Alzheimer's Disease, Parkinson's Disease, and ALS.
Q: What are compstatin analogs, and how are they used in this patent?
A: Compstatin analogs are cyclic peptides with specific amino acid sequences, designed to be cell-reactive, long-acting, or targeted. They are used in treating neurodegenerative diseases by enhancing therapeutic efficacy and duration of action.
Q: Which product is covered by this patent and has been approved by the FDA?
A: The product is pegcetacoplan, marketed as EMPAVELI, which has been approved for treating certain conditions.
Q: How many patent family members does this patent have globally?
A: This patent has thirty patent family members in twelve countries.
Q: What is the current status regarding generic versions of EMPAVELI?
A: As of the current date, there is no therapeutically equivalent generic version of EMPAVELI available in the United States.
Sources
- DrugPatentWatch - Details for Patent: 10125171
- Regulations.gov - United States Patent and Trademark Office
- SSRN - Patent Claims and Patent Scope
- Regulations.gov - Application for Patent Term Extension of U.S. Patent No. 10,125,171 B2
- Drugs.com - Generic Empaveli Availability
