Understanding the Scope and Claims of United States Patent 10,821,108
Introduction
The United States Patent 10,821,108, hereafter referred to as the '108 patent, is a significant intellectual property asset in the pharmaceutical industry. This patent, along with others, protects a specific pharmaceutical composition and is listed in the FDA's Orange Book, which catalogs approved drug products with their corresponding patent and exclusivity information.
Patent Overview
The '108 patent is titled "Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide" and was granted on December 1, 2020. It is set to expire on December 1, 2036[5].
Patent Claims
Types of Claims
The '108 patent includes various types of claims that define the scope of the invention. These typically include:
- Composition claims: These claims define the specific chemical composition of the pharmaceutical product.
- Method claims: These could include methods of making, using, or administering the pharmaceutical product.
- Use claims: These specify the therapeutic uses of the pharmaceutical composition.
Specific Claims
The '108 patent specifically claims a stabilized solid preparation containing the mentioned chemical compound. This includes claims related to the formulation, such as the presence of specific excipients like mannitol, and the total weight and content of the preparation[4].
Regulatory Exclusivities
In addition to patent protection, pharmaceutical products like those covered by the '108 patent may also benefit from regulatory exclusivities. These exclusivities, granted by the FDA, prevent the approval of generic or biosimilar versions of the drug for a specified period. For example, the '108 patent is associated with the drug Uptravi, which has various exclusivity periods listed in the Orange Book[5].
Patent Term and Effective Exclusivity Periods
The '108 patent has a term of approximately 20 years from the date of filing, which is typical for U.S. patents. However, the effective exclusivity period can be extended or shortened based on various factors, including regulatory exclusivities and litigation outcomes. For instance, if a generic drug manufacturer challenges the patent and wins, the exclusivity period could be shortened[1].
Patent Enforcement and Litigation
Patent enforcement is crucial for maintaining exclusivity. The holder of the '108 patent can initiate litigation against any entity that infringes on the patent. This litigation can occur within the statutory 45-day period after a generic drug manufacturer files an Abbreviated New Drug Application (ANDA) with paragraph IV certifications, which assert that the patent is invalid or not infringed[2].
Interaction with FDA Approval
The '108 patent is listed in the FDA's Orange Book, which means that any generic drug application must address these patents. The FDA generally cannot approve a generic drug if the reference product (the original drug) is still under patent or regulatory exclusivity. The ANDA process involves certifications regarding the validity and enforceability of the listed patents, which can lead to litigation and potential delays in generic drug approval[1][5].
Antitrust Considerations
Pharmaceutical patenting practices, including those related to the '108 patent, are subject to antitrust scrutiny. Practices such as patent evergreening (extending patent protection through minor modifications) or pay-for-delay agreements can be challenged under antitrust laws like the Sherman Act. These laws aim to prevent anti-competitive behaviors that could delay the entry of generic drugs into the market[1].
Impact on Generic and Biosimilar Manufacturers
The '108 patent, along with other patents and exclusivities, creates a barrier for generic and biosimilar manufacturers. These entities must navigate the complex landscape of patent claims and regulatory exclusivities to bring their products to market. The expiration of the '108 patent on December 1, 2036, will mark a significant milestone for potential generic competitors[5].
Industry Perspectives and Challenges
The pharmaceutical industry relies heavily on robust and predictable patent protection to support the commercialization of new drugs. However, recent jurisprudence, particularly from the Federal Circuit, has made it challenging to obtain and maintain broad patent claims, especially for genus claims. This has created a dilemma for innovators who must balance the need for broad protection against the risk of having their patents invalidated due to insufficient disclosure or enablement[3].
Key Takeaways
- Patent Scope: The '108 patent covers a specific pharmaceutical composition and includes claims related to its formulation and use.
- Regulatory Exclusivities: The patent is complemented by regulatory exclusivities that prevent the approval of generic versions.
- Patent Term: The patent has a term of approximately 20 years, with potential extensions or shortenings based on litigation and regulatory factors.
- FDA Interaction: The patent is listed in the Orange Book, affecting the approval process for generic drugs.
- Antitrust Considerations: Pharmaceutical patent practices are subject to antitrust laws to prevent anti-competitive behaviors.
- Industry Impact: The patent creates barriers for generic and biosimilar manufacturers and highlights the challenges in obtaining and maintaining broad patent claims in the pharmaceutical industry.
FAQs
Q: What is the '108 patent, and what does it protect?
A: The '108 patent protects a specific pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide.
Q: How long is the '108 patent valid?
A: The '108 patent is valid until December 1, 2036.
Q: What is the significance of the Orange Book listing for the '108 patent?
A: The Orange Book listing means that any generic drug application must address the '108 patent, potentially delaying generic drug approval if the patent is still in force.
Q: How does the '108 patent interact with FDA approval processes?
A: The FDA cannot approve a generic drug if the reference product is still under patent or regulatory exclusivity, requiring generic manufacturers to certify the validity and enforceability of the listed patents.
Q: What are the antitrust implications for pharmaceutical patent practices like those related to the '108 patent?
A: Pharmaceutical patent practices are subject to antitrust laws to prevent anti-competitive behaviors such as patent evergreening or pay-for-delay agreements.
Sources
- The Role of Patents and Regulatory Exclusivities in Drug Pricing - Congressional Research Service
- U.S. Food & Drug Administration: Approved Drug Products with Therapeutic Equivalence Evaluations - FDA
- Eviscerating Patent Scope - DigitalCommons@NYLS
- US10821108B2 - Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsulfonyl)acetamide - Google Patents
- Selexipag Tablets - FDA Approval Letter - FDA
