United States Patent 10,786,518: A Detailed Analysis of Scope and Claims
Overview of the Patent
The United States Patent 10,786,518, hereafter referred to as the '518 patent, is a significant intellectual property asset in the pharmaceutical sector, particularly in the treatment of HIV infections. This patent is associated with the drug combination known as SYMTUZA®, which includes darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
Patent Holders and Assignees
The '518 patent is held by Janssen Sciences Ireland Unlimited Company, a subsidiary of Johnson & Johnson, in collaboration with Gilead Sciences, Inc.[2].
Scope of the Patent
Drug Combination
The patent covers a specific four-drug combination used in the treatment of HIV infections. This combination includes:
- Darunavir: A protease inhibitor.
- Cobicistat: A CYP3A inhibitor that boosts the levels of darunavir in the body.
- Emtricitabine: A nucleoside reverse transcriptase inhibitor.
- Tenofovir alafenamide: A nucleotide reverse transcriptase inhibitor[2][4].
Therapeutic Use
The '518 patent is directed to methods of treating subjects infected with HIV using this single unit dosage form, which is administered once daily. This combination therapy is designed to provide a convenient and effective treatment regimen for HIV patients[4].
Claims of the Patent
The patent includes several claims that define the scope of the invention. Here are some key aspects:
Composition Claims
The patent claims cover the specific composition of the four-drug combination, including the ratios and formulations of darunavir, cobicistat, emtricitabine, and tenofovir alafenamide[4].
Method Claims
The patent also claims methods of treating HIV infections using this combination therapy. These claims include the administration regimen, dosage forms, and the therapeutic effects achieved by this combination[4].
Specific Claims
- Claims 1-6, 8-10, and 15-24 of the '518 patent are specifically mentioned in litigation documents as being infringed by generic manufacturers seeking to market a generic version of SYMTUZA® before the patent's expiration[2].
Patent Landscape and Litigation
Patent Expiration
The '518 patent is set to expire in 2024, along with other related patents, marking a significant milestone in the patent landscape for HIV treatments[2][5].
Litigation and Challenges
The holders of the '518 patent, Janssen and Gilead, have been involved in litigation against generic manufacturers such as Lupin and MSN Laboratories, who have submitted Abbreviated New Drug Applications (ANDAs) to the FDA. These defendants seek to market a generic version of SYMTUZA® before the expiration of the patents-in-suit, including the '518 patent[2].
Patent Infringement
The litigation documents indicate that the defendants have stipulated to the infringement of several claims of the '518 patent. This stipulation is part of the ongoing legal battle to protect the intellectual property rights associated with SYMTUZA®[2].
Impact on the Pharmaceutical Industry
Market Exclusivity
The expiration of the '518 patent and related patents will likely lead to the introduction of generic versions of SYMTUZA®, potentially reducing the market exclusivity and revenue for Janssen and Gilead. This is a common challenge faced by pharmaceutical companies when their key patents expire[3].
Competition and Innovation
The patent landscape for HIV treatments is highly competitive, with multiple players seeking to develop and market effective treatments. The expiration of patents like the '518 patent can drive innovation as companies invest in new research and development to maintain market share[3].
Key Takeaways
- The '518 patent covers a specific four-drug combination for HIV treatment, including darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
- The patent is held by Janssen Sciences Ireland Unlimited Company and Gilead Sciences, Inc.
- The patent claims include composition and method claims for treating HIV infections.
- Litigation is ongoing against generic manufacturers seeking to market a generic version before the patent's expiration.
- The expiration of the '518 patent will impact market exclusivity and revenue for the patent holders.
FAQs
What is the main subject of the United States Patent 10,786,518?
The main subject of the '518 patent is a four-drug combination for treating HIV infections, including darunavir, cobicistat, emtricitabine, and tenofovir alafenamide.
Who are the holders of the '518 patent?
The '518 patent is held by Janssen Sciences Ireland Unlimited Company and Gilead Sciences, Inc.
What is the significance of cobicistat in the '518 patent?
Cobicistat is a CYP3A inhibitor that boosts the levels of darunavir in the body, enhancing the effectiveness of the HIV treatment regimen.
What is the current status of litigation related to the '518 patent?
Janssen and Gilead are involved in litigation against generic manufacturers who have submitted ANDAs to market a generic version of SYMTUZA® before the patent's expiration.
When is the '518 patent set to expire?
The '518 patent is set to expire in 2024.
How will the expiration of the '518 patent impact the pharmaceutical industry?
The expiration will likely lead to the introduction of generic versions, reducing market exclusivity and revenue for Janssen and Gilead, and potentially driving innovation in HIV treatment research and development.
