Understanding the Scope and Claims of United States Patent 10,828,298
Introduction
The United States Patent 10,828,298 is one of the patents protecting the pharmaceutical product Selexipag, marketed under the brand name Uptravi. This patent is part of a complex patent landscape that influences the availability and pricing of pharmaceuticals in the United States.
Patent Overview
Patent Number and Title
The patent in question is U.S. Patent Number 10,828,298. While the specific title of this patent is not detailed in the provided sources, it is part of the broader patent portfolio protecting Selexipag tablets.
Expiration Date
This patent is set to expire on December 1, 2036[2][5].
Claims and Protection
Scope of Protection
Patent 10,828,298, like other patents in the Selexipag portfolio, protects specific aspects of the drug. These can include the active ingredient, methods of production, dosage forms, and modes of administration. The patent claims are designed to prevent other manufacturers from making, using, selling, or importing the protected invention without permission from the patent holder until the patent expires[1][4].
Types of Claims
Pharmaceutical patents can claim various aspects of a drug, such as:
- Chemical Compounds: The active ingredient or specific chemical structures.
- Methods of Use: How the drug is administered or used.
- Methods of Making: The process of manufacturing the drug.
- Dosage Forms: Specific formulations, such as tablets, capsules, or liquids[1].
Regulatory Context
FDA Approval and Patent Listing
The patent is listed in the FDA's "Orange Book" (Approved Drug Products with Therapeutic Equivalence Evaluations), which is a publication that lists approved drugs and their corresponding patents. This listing is crucial for generic drug manufacturers, as it informs them about the patents they must navigate to bring a generic version to market[2][5].
Generic Drug Approval Process
For a generic version of Selexipag to be approved, the generic manufacturer must submit an Abbreviated New Drug Application (ANDA) to the FDA. This application must include certifications regarding the validity and enforceability of the listed patents. If the generic manufacturer certifies that the patents are invalid, unenforceable, or will not be infringed, the brand-name manufacturer may initiate litigation within a statutory 45-day period[2][5].
Patent Landscape and Strategies
Patent Thickets and Evergreening
The Selexipag patent portfolio, including patent 10,828,298, is part of a broader strategy that critics argue can extend exclusivity beyond the original 20-year term. Practices such as "patent evergreening" (filing new patents on secondary features as earlier patents expire) and creating "patent thickets" (portfolios of overlapping patents) can deter generic competition and maintain high prices[1][4].
Litigation and Settlements
Litigation related to these patents can be complex and may involve multiple parties. For instance, litigation was initiated against Zydus for infringement of several Selexipag patents, including the '302, '122, and '280 patents, although the case was eventually dismissed[2].
Economic and Competitive Impact
Pricing and Market Exclusivity
The exclusive rights granted by patents like 10,828,298 allow the patent holder to charge higher-than-competitive prices for the protected drug. This exclusivity can lead to significant revenue for the brand-name manufacturer but may also result in higher costs for consumers and healthcare systems[1][4].
Generic Entry and Competition
The expiration of patents like 10,828,298 is crucial for the entry of generic competitors. Generic drugs can significantly reduce the cost of treatment, making it more accessible to a wider population. However, the complex patent landscape and litigation strategies can delay generic entry, maintaining the brand-name manufacturer's market exclusivity for an extended period[1][4].
Key Takeaways
- Patent Expiration: U.S. Patent 10,828,298 expires on December 1, 2036.
- Scope of Protection: The patent protects specific aspects of Selexipag, including its active ingredient, methods of production, and dosage forms.
- Regulatory Context: Listed in the FDA's "Orange Book," this patent affects the approval process for generic versions of Selexipag.
- Patent Strategies: Part of a broader strategy that may include patent evergreening and creating patent thickets to extend exclusivity.
- Economic Impact: Maintains market exclusivity, allowing higher prices, but delays generic competition and potentially higher costs for consumers.
FAQs
Q: What is the expiration date of U.S. Patent 10,828,298?
A: The patent is set to expire on December 1, 2036.
Q: What aspects of Selexipag does U.S. Patent 10,828,298 protect?
A: The patent protects various aspects, including the active ingredient, methods of production, dosage forms, and modes of administration.
Q: How does this patent affect generic drug approval?
A: Generic manufacturers must navigate this patent by submitting certifications regarding its validity and enforceability as part of their ANDA to the FDA.
Q: What are some strategies used by brand-name manufacturers to extend patent exclusivity?
A: Strategies include patent evergreening, creating patent thickets, and pay-for-delay settlements.
Q: How does the expiration of this patent impact drug pricing and competition?
A: The expiration allows for generic competition, potentially reducing drug prices and increasing accessibility, but the complex patent landscape can delay this process.
Sources
- Congressional Research Service, "Drug Prices: The Role of Patents and Regulatory Exclusivities," February 10, 2021.
- U.S. Food & Drug Administration, "Selexipag Tablets - accessdata.fda.gov," May 3, 2022.
- Pharsight, "Uptravi patent expiration - Pharsight."
- Congressional Research Service, "Drug Pricing and Pharmaceutical Patenting Practices," February 11, 2020.
- U.S. Food & Drug Administration, "Selexipag Tablets - accessdata.fda.gov," October 21, 2020.