United States Patent 10,385,067: A Detailed Analysis
Overview of the Patent
United States Patent 10,385,067, titled "Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate," was issued on August 20, 2019, to Gilead Sciences, Inc. This patent is crucial in the context of pharmaceuticals, particularly for the drug Biktarvy®, which is a combination therapy for the treatment of HIV-1 infection.
Inventors and Assignees
The patent was invented by Ernest A. Carra, Irene Chen, and Vahid Zia, and it is assigned to Gilead Sciences, Inc.[2][4].
Claims of the Patent
The patent claims cover several key aspects of the compound and its formulations:
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Compound of Formula II: The patent claims a specific compound known as bictegravir, which is a sodium salt, as well as its crystalline and polymorphic forms. Bictegravir is an integral component of Biktarvy®, a drug used in the treatment of HIV-1 infection[2][4].
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Pharmaceutical Compositions: The claims extend to pharmaceutical compositions containing the compound of Formula II. This includes various forms in which the drug can be administered, such as tablets, capsules, or other oral formulations[2].
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Specific Forms and Derivatives: The patent also covers specific forms of the compound, including its sodium salt, crystalline forms, and polymorphic forms. These specific forms are critical for the stability, efficacy, and bioavailability of the drug[2][4].
Patent Landscape
Context within the Orange Book
The patent is listed in the Orange Book, which is a publication of the U.S. Food and Drug Administration (FDA) that lists patents that the New Drug Application (NDA) holder asserts cover the approved drug product. In this case, the patent is associated with Biktarvy®, and at least one claim of the patent covers Biktarvy® and/or its components[2].
Litigation and Enforcement
The patent has been involved in litigation, as seen in the case of Gilead Sciences, Inc. vs. Lupin Ltd., Laurus Labs Limited, and Cipla Limited. Gilead Sciences has asserted that these defendants' Abbreviated New Drug Applications (ANDAs) for generic versions of Biktarvy® infringe on the claims of this patent, among others[2].
Impact on Generic Drug Approval
The presence of this patent in the Orange Book and its enforcement through litigation significantly impact the approval and marketing of generic versions of Biktarvy®. Generic drug manufacturers must either wait for the patent to expire or challenge the patent through legal means, such as filing an ANDA with a Paragraph IV certification, which asserts that the patent is invalid or not infringed[2][5].
Government Funding and March-In Rights
While this specific patent does not fall under the category of patents funded by federal grants, it is worth noting that many pharmaceutical patents, especially those related to critical health needs, may be subject to march-in rights under the Bayh-Dole Act. This act allows the federal government to issue additional licenses to patents if the contractor is not taking effective steps to achieve practical application of the invention or to alleviate health or safety needs[1].
IPC Classification and Patent Trends
The patent falls under the International Patent Classification (IPC) category related to heterocyclic compounds, specifically C07D. This classification is common for many pharmaceutical patents, indicating the prevalence of heterocyclic compounds in drug development[3].
Conclusion
United States Patent 10,385,067 is a critical patent in the pharmaceutical landscape, particularly for the treatment of HIV-1 infection through Biktarvy®. Its claims cover specific forms of the drug bictegravir and its pharmaceutical compositions, which are essential for the drug's efficacy and stability. The patent's listing in the Orange Book and its involvement in litigation highlight its significance in protecting Gilead Sciences' intellectual property and influencing the timeline for generic drug approvals.
Key Takeaways
- Patent Coverage: The patent covers bictegravir, its sodium salt, crystalline forms, and polymorphic forms, as well as pharmaceutical compositions containing these forms.
- Litigation: The patent is involved in litigation against generic drug manufacturers to protect Gilead Sciences' intellectual property.
- Orange Book Listing: The patent is listed in the FDA's Orange Book, affecting the approval of generic versions of Biktarvy®.
- IPC Classification: The patent falls under the IPC category C07D, related to heterocyclic compounds.
- Impact on Generic Drugs: The patent's enforcement delays the market entry of generic versions of Biktarvy®.
FAQs
What is the main compound covered by United States Patent 10,385,067?
The main compound covered is bictegravir, specifically its sodium salt, crystalline forms, and polymorphic forms.
Who are the inventors of this patent?
The inventors are Ernest A. Carra, Irene Chen, and Vahid Zia.
What is the significance of this patent being listed in the Orange Book?
Being listed in the Orange Book means that the patent holder asserts that this patent covers the approved drug product, affecting the approval and marketing of generic versions.
How does this patent impact generic drug manufacturers?
Generic drug manufacturers must either wait for the patent to expire or challenge it through legal means, such as filing an ANDA with a Paragraph IV certification.
What is the IPC classification of this patent?
The patent falls under the IPC category C07D, which includes heterocyclic compounds.
Is this patent subject to march-in rights under the Bayh-Dole Act?
No, this specific patent is not subject to march-in rights as it is not funded by federal grants. However, many other pharmaceutical patents could be subject to such rights if they were funded by federal grants.
