Detailed Analysis of the Scope and Claims of United States Patent 10,035,822
Introduction
United States Patent 10,035,822, titled "Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods," is a significant patent in the field of pharmaceuticals, particularly in the development of complement inhibitors. This patent, assigned to Apellis Pharmaceuticals, Inc., was issued on July 31, 2018, and is crucial for understanding the intellectual property landscape surrounding the drug pegcetacoplan (Empaveli).
Inventors and Assignee
The patent was invented by Cedric Francois and Pascal Deschatelets, and it is assigned to Apellis Pharmaceuticals, Inc.[2][5].
Patent Expiration Date
The patent is set to expire on November 15, 2033, which is a critical date for both the patent holder and potential generic manufacturers[2][5].
Scope of the Patent
Cell-Reactive, Long-Acting, or Targeted Compstatin Analogs
The patent covers compstatin analogs, which are cyclic peptides designed to inhibit the complement system. These analogs are engineered to be cell-reactive, long-acting, or targeted, enhancing their therapeutic efficacy and duration of action. The compstatin analogs described in the patent include modifications such as the attachment of clearance-reducing moieties, typically polyethylene glycol (PEG) molecules, to improve their pharmacokinetic properties[1][2].
Compositions and Methods
The patent encompasses various compositions and methods related to these compstatin analogs. This includes formulations for administration, such as injectable solutions, and methods for treating diseases where complement inhibition is beneficial. The primary indication for these analogs is the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder[4].
Claims of the Patent
Key Claims
The patent includes several key claims that define the scope of protection:
- Claim 1: Describes a compstatin analog comprising one or more clearance-reducing moieties attached to one or more compstatin analog moieties. These moieties are linked via spacers, typically oligo(ethylene glycol) moieties, to amino acids with primary or secondary amines[1].
- Subsequent Claims: These claims further detail the structure and composition of the compstatin analogs, including specific amino acid sequences, types of spacers, and methods of attachment for the clearance-reducing moieties.
Coverage of Pegcetacoplan
Pegcetacoplan, the approved product under the brand name Empaveli, is specifically covered by this patent. The claims in the patent, particularly claims 1-9, 12-16, and 18-21, read on the approved product, ensuring that any generic or biosimilar version would infringe on these claims unless significant modifications are made[1][2].
Patent Landscape
Related Patents
The patent landscape surrounding U.S. Patent 10,035,822 includes several other patents related to compstatin analogs and their uses. These patents, also assigned to Apellis Pharmaceuticals, Inc., cover various aspects of compstatin analogs, including different compositions, methods of use, and manufacturing processes.
- Patent 10,125,171: Issued on November 13, 2018, this patent also covers cell-reactive, long-acting, or targeted compstatin analogs and their uses[2][5].
- Patent 10,875,893: Issued on December 29, 2020, this patent extends the coverage to additional compositions and methods related to compstatin analogs[2][5].
- Other Patents: There are several other patents, such as U.S. Patent 11,292,815 and U.S. Patent 11,661,441, that further expand the intellectual property protection for Apellis Pharmaceuticals, Inc. in this area[2][5].
Impact on Generic Availability
The absence of a generic version of Empaveli (pegcetacoplan) in the United States is directly related to the robust patent protection provided by U.S. Patent 10,035,822 and its related patents. These patents ensure that Apellis Pharmaceuticals, Inc. maintains exclusivity over the drug until the patents expire, preventing the entry of generic competitors into the market[2][5].
Patent Analytics and Claim Coverage
To fully understand the patent landscape and identify gaps or opportunities, patent analytics tools can be employed. These tools help in categorizing patents by claims and scope concepts, making it easier to analyze large numbers of patent claims concurrently. For example, using Claim Coverage Matrix and Claim Charts, companies can determine which patents and claims are actively protecting their intellectual property and where potential gaps exist[3].
Conclusion
U.S. Patent 10,035,822 is a cornerstone in the intellectual property portfolio of Apellis Pharmaceuticals, Inc., providing comprehensive protection for pegcetacoplan and related compstatin analogs. The detailed claims and compositions described in this patent ensure strong exclusivity for the drug, impacting the availability of generic versions and shaping the competitive landscape in the pharmaceutical industry.
Key Takeaways
- Patent Scope: Covers cell-reactive, long-acting, or targeted compstatin analogs with specific structural modifications.
- Claims: Include detailed descriptions of the compstatin analogs, their compositions, and methods of use.
- Patent Expiration: Set to expire on November 15, 2033.
- Impact on Generics: Prevents the entry of generic competitors until the patent expires.
- Related Patents: Part of a broader patent landscape that includes multiple patents covering various aspects of compstatin analogs.
FAQs
Q: What is the primary indication for the drug covered by U.S. Patent 10,035,822?
A: The primary indication is the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder.
Q: Who are the inventors of U.S. Patent 10,035,822?
A: The inventors are Cedric Francois and Pascal Deschatelets.
Q: What is the expiration date of U.S. Patent 10,035,822?
A: The patent is set to expire on November 15, 2033.
Q: How does the patent impact the availability of generic versions of Empaveli?
A: The patent prevents the entry of generic competitors into the market until it expires, ensuring exclusivity for Apellis Pharmaceuticals, Inc.
Q: What tools can be used to analyze the patent landscape and claim coverage?
A: Patent analytics tools such as Claim Coverage Matrix and Claim Charts can be used to analyze the patent landscape and identify gaps or opportunities.
Sources
- U.S. Patent and Trademark Office: Application for Patent Term Extension of U.S. Patent No. 10,125,171 B2.
- Drugs.com: Generic Syfovre Availability.
- SLWIP: Patent Analytics.
- DrugBank: Pegcetacoplan: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Empaveli Availability.
