Detailed Analysis of the Scope and Claims of United States Patent 11,744,802
Introduction
United States Patent 11,744,802, assigned to Gilead Sciences, Inc., is a significant patent in the pharmaceutical industry, particularly in the treatment of human immunodeficiency virus (HIV). This patent protects the drug Biktarvy, a fixed-dose combination tablet used for HIV treatment. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Patent Overview
Issuance and Assignee
The patent was issued on August 15, 2023, and is assigned to Gilead Sciences, Inc., a leading biopharmaceutical company[4][5].
Inventors
The inventors listed on the patent include several researchers and scientists from Gilead Sciences, Inc., such as Jin Haolun, Lazerwith Scott E., Pyun Hyung-Jung, Bacon Elizabeth M., Morganelli Philip Anthony, and Ji Mingzhe[4].
Scope of the Patent
Therapeutic Compositions
The patent covers therapeutic compositions for the treatment of HIV, specifically focusing on fixed-dose combination tablets. These tablets combine three active pharmaceutical ingredients:
- The compound of Formula I (or a pharmaceutically acceptable salt thereof)
- Tenofovir alafenamide (or a pharmaceutically acceptable salt thereof)
- Emtricitabine (or a pharmaceutically acceptable salt thereof)[4].
Pharmaceutical Formulations
The patent describes various formulations of these combination tablets, including multilayer tablets where the active ingredients are segregated within separate layers. For example, one formulation includes 50 mg of the compound of Formula I, 25 mg of tenofovir alafenamide, and 200 mg of emtricitabine, all within a tablet weighing less than about 1.5 g[4].
Pharmacokinetic Properties
The inventors have optimized the pharmacokinetic properties of these fixed-dose combination tablets, ensuring that the active ingredients are delivered effectively. The compound of Formula I, for instance, is a weak acid with a pKa of 8.6 and has pH-dependent solubility and stability, which are crucial for its formulation[4].
Claims of the Patent
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific formulations of the combination tablets, including the proportions of the active ingredients and the physical structure of the tablets (e.g., multilayer tablets)[4].
Dependent Claims
Dependent claims further specify the details of the formulations, such as the weight percentages of the active ingredients and the presence of desiccants like silica gel in the kits containing these tablets[4].
Patent Landscape
Related Patents
The patent landscape for Biktarvy includes several related patents that cover various aspects of the drug and its formulations. For example, patents like 10,385,067 and 9,708,342 also cover different formulations and therapeutic uses of the compounds used in Biktarvy[2].
Patent Expiration Dates
The patent 11,744,802 is set to expire on November 8, 2036, which aligns with other related patents protecting Biktarvy. This expiration date is critical for generic drug manufacturers, as it marks the period after which they can begin producing generic versions of the drug[2][5].
Global Dossier and International Protection
The patent is part of a global dossier, which means it is linked to related applications filed at participating IP Offices. This allows for a unified view of the patent family and access to dossier, classification, and citation data across different jurisdictions[1].
Impact on Innovation and Competition
Patent Scope and Quality
The scope of this patent, like many others, is subject to debates over patent quality. Metrics such as independent claim length and count can be used to measure patent scope, which can influence the incentives for innovation and the costs associated with licensing and litigation[3].
Market Domination
Patents like 11,744,802 play a crucial role in allowing companies like Gilead Sciences to maintain market dominance for their drugs. The exclusive rights granted by these patents prevent competitors from producing similar drugs until the patents expire, thereby protecting the company's investment in research and development.
Key Takeaways
- Patent Coverage: The patent covers fixed-dose combination tablets for HIV treatment, combining the compound of Formula I, tenofovir alafenamide, and emtricitabine.
- Formulations: The patent describes various formulations, including multilayer tablets, and specifies the proportions and physical structure of the active ingredients.
- Expiration Date: The patent expires on November 8, 2036, marking the period after which generic versions can be produced.
- Related Patents: Other patents, such as 10,385,067 and 9,708,342, also protect aspects of Biktarvy.
- Global Protection: The patent is part of a global dossier, providing unified access to related applications and data.
FAQs
What is the main subject of United States Patent 11,744,802?
The main subject of this patent is the therapeutic compositions for the treatment of human immunodeficiency virus (HIV), specifically fixed-dose combination tablets combining the compound of Formula I, tenofovir alafenamide, and emtricitabine.
Who is the assignee of this patent?
The assignee of this patent is Gilead Sciences, Inc.
What is the expiration date of this patent?
The patent is set to expire on November 8, 2036.
How does this patent impact the pharmaceutical market?
This patent allows Gilead Sciences to maintain exclusive rights to Biktarvy, preventing competitors from producing similar drugs until the patent expires, thus protecting the company's investment in research and development.
What are the key ingredients in the formulations covered by this patent?
The key ingredients are the compound of Formula I, tenofovir alafenamide, and emtricitabine, which are combined in various formulations, including multilayer tablets.
How can one access information related to this patent?
Information related to this patent can be accessed through the USPTO's Patent Public Search tool, the Global Dossier service, or by visiting the USPTO Public Search Facility[1].
Sources
- USPTO: Search for patents - USPTO
- Drugs.com: Generic Biktarvy Availability - Drugs.com
- SSRN: Patent Claims and Patent Scope - Search eLibrary :: SSRN
- Google Patents: US11744802B2 - Therapeutic compositions for treatment of human immunodeficiency virus
- DrugPatentWatch: Drugs covered by patent 11,744,802. Claims, international patent ...
