United States Patent 10,759,814: A Detailed Analysis
Introduction
The United States Patent 10,759,814, hereafter referred to as the '814 Patent, is one of the key patents associated with baloxavir marboxil, a medication used for the treatment of acute uncomplicated influenza. This patent is part of a broader portfolio of patents held by Shionogi and its partners, including Genentech and HLR.
Background on Baloxavir Marboxil
Baloxavir marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor. It was approved by the FDA for the treatment of acute uncomplicated influenza and is marketed under the brand name Xofluza[1].
Patent Overview
The '814 Patent is listed in the FDA's Orange Book, which catalogues approved drug products with therapeutic equivalence evaluations. This patent, along with several others, protects the formulation, method of manufacture, and use of baloxavir marboxil.
Claims of the '814 Patent
The '814 Patent includes multiple claims that cover various aspects of baloxavir marboxil, including:
- Composition Claims: These claims pertain to the pharmaceutical composition containing baloxavir marboxil and its prodrug forms. The patent specifies the chemical structure and the antiviral action of these compounds[4].
- Method of Manufacture Claims: These claims detail the processes involved in synthesizing baloxavir marboxil and its prodrugs. This includes specific steps and conditions necessary for the production of the active pharmaceutical ingredient.
- Use Claims: These claims cover the therapeutic use of baloxavir marboxil for treating influenza. This includes the dosage forms, administration routes, and patient populations for which the drug is indicated.
Patent Landscape
The '814 Patent is part of a complex patent landscape surrounding baloxavir marboxil. Here are some key points:
- Related Patents: The '814 Patent is one of several patents that protect baloxavir marboxil. Other relevant patents include U.S. Patent Nos. 8,927,710, 8,987,441, 9,815,835, 10,392,406, 10,633,397, 11,261,198, and 11,306,106. These patents collectively cover various aspects of the drug's composition, manufacture, and use[2][5].
- Expiration Dates: The '814 Patent is set to expire in 2037, which is part of the broader expiration timeline for the related patents. This timeline is crucial for understanding when generic versions of baloxavir marboxil might enter the market[1][5].
- Litigation and Infringement: The '814 Patent has been involved in patent infringement litigation. Defendants have submitted Abbreviated New Drug Applications (ANDAs) to the FDA, which include Paragraph IV certifications claiming that the patents, including the '814 Patent, are invalid, unenforceable, or will not be infringed by their proposed products[2][5].
Infringement Allegations
The plaintiffs, Shionogi and its partners, have alleged that the defendants' submission of ANDA No. 217449 to the FDA constitutes infringement of the '814 Patent. The allegations include:
- Literal infringement or infringement under the doctrine of equivalents.
- Active inducement of infringement by others.
- Offering to sell or selling components of the patented invention within the United States or importing them into the United States[2][5].
Impact on Generic Competition
The '814 Patent, along with the other related patents, acts as a barrier to generic competition for baloxavir marboxil. Until these patents expire, generic manufacturers cannot commercially manufacture, use, offer for sale, sell, or import their versions of the drug without facing potential infringement claims.
Regulatory Approval
The FDA has tentatively approved ANDA No. 217449, but final approval is pending resolution of the patent infringement issues. This highlights the interplay between patent law and regulatory approval in the pharmaceutical industry[5].
Conclusion
The United States Patent 10,759,814 is a critical component of the intellectual property portfolio protecting baloxavir marboxil. Understanding its claims, the broader patent landscape, and the ongoing litigation is essential for both the original patent holders and potential generic competitors.
Key Takeaways
- The '814 Patent covers the composition, method of manufacture, and use of baloxavir marboxil.
- It is part of a complex patent landscape that includes multiple related patents.
- The patent is involved in ongoing litigation related to ANDA submissions.
- The expiration date of the '814 Patent is in 2037.
- The patent acts as a barrier to generic competition until its expiration.
Frequently Asked Questions (FAQs)
1. What is the primary use of baloxavir marboxil protected by the '814 Patent?
Baloxavir marboxil is used for the treatment of acute uncomplicated influenza.
2. What are the key claims of the '814 Patent?
The key claims include composition, method of manufacture, and use claims related to baloxavir marboxil.
3. How does the '814 Patent fit into the broader patent landscape for baloxavir marboxil?
The '814 Patent is one of several patents that collectively protect various aspects of baloxavir marboxil, including its composition, manufacture, and therapeutic use.
4. What is the current status of the litigation involving the '814 Patent?
The litigation is ongoing, with plaintiffs alleging infringement by defendants who have submitted ANDAs to the FDA.
5. When is the '814 Patent set to expire?
The '814 Patent is set to expire in 2037.
Sources:
- DrugBank: Baloxavir marboxil: Uses, Interactions, Mechanism of Action.
- RPX Insight: Case 1:23-cv-00161-UNA Document 1 Filed 02/13/23.
- USPTO: Supplementary Material - Inventing AI.
- Google Patents: US10759814B2 - Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof.
- RPX Insight: in the united states district court.
