United States Patent 8,633,219: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 8,633,219, titled "Combination therapy," is a patent that relates to a combination therapy for treating HIV infection or inhibiting integrase. This patent is crucial in the field of antiretroviral therapy and has significant implications for the treatment of HIV.
Background and Context
The patent was filed on May 7, 2007, and granted on January 21, 2014. It is part of a broader landscape of patents focused on HIV treatments, which have evolved significantly over the years to include various combination therapies.
Key Claims
The patent includes several key claims that define its scope and applicability:
Combination Therapy
- The patent claims a combination therapy that includes at least two active pharmaceutical ingredients, typically an HIV integrase inhibitor and another antiretroviral agent. For example, the combination may include elvitegravir (an integrase inhibitor) and emtricitabine (a nucleoside reverse transcriptase inhibitor)[1].
Active Ingredients
- The patent specifies the use of elvitegravir, which is identified by its chemical structure and formula. This compound is a critical component of the combination therapy[1].
Therapeutic Uses
- The claims cover the use of this combination therapy for treating HIV infection and inhibiting HIV integrase. This is a significant aspect as it addresses a critical need in the management of HIV[1].
Pharmaceutical Compositions
- The patent also describes pharmaceutical compositions that include the combination of active ingredients. These compositions can be formulated in various ways, such as tablets, capsules, or other oral dosage forms[1].
Scope of the Patent
Independent Claims
- The independent claims of the patent define the broadest scope of the invention. These claims typically include the combination of the integrase inhibitor and another antiretroviral agent, along with the therapeutic uses and pharmaceutical compositions[1].
Dependent Claims
- The dependent claims further narrow down the scope by specifying particular combinations, dosages, and formulations. These claims provide additional detail and protection for specific embodiments of the invention[1].
Patent Landscape
Related Patents
- The patent landscape for HIV treatments is complex and includes numerous patents related to antiretroviral therapies. Other patents, such as those for tenofovir alafenamide hemifumarate (US9296769B2), also play a role in the treatment of HIV and related conditions[4].
Litigation and Validity
- Patents in the pharmaceutical sector are often subject to litigation and validity challenges. The scope and claims of a patent like US8633219B2 must be carefully evaluated to ensure they do not infringe on existing patents and to withstand potential challenges to their validity[2][5].
Impact on Treatment
Clinical Significance
- The combination therapy described in this patent has significant clinical implications. It provides a more effective and potentially less toxic treatment option for patients with HIV by combining multiple antiretroviral agents[1].
Patient Outcomes
- The use of such combination therapies has been shown to improve patient outcomes by reducing viral loads and slowing the progression of the disease. This aligns with the broader goal of antiretroviral therapy to manage HIV as a chronic condition rather than a terminal illness[1].
Manufacturing and Formulation
Methods of Preparation
- The patent details methods for preparing the pharmaceutical compositions, including the use of various solvents and excipients. This is crucial for ensuring the stability and efficacy of the final product[1].
Pharmaceutical Excipients
- The patent mentions the use of pharmaceutical excipients such as dimethylsulphoxide, ethyl acetate, and hydrochloric acid in the manufacturing process. These excipients play a vital role in the formulation and stability of the drug[1].
Economic and Regulatory Aspects
Patent Expiration
- The patent's expiration date is critical for understanding when generic versions of the drug can be introduced to the market. This can significantly impact the cost and accessibility of the treatment[1].
Regulatory Approvals
- The approval process for such combination therapies involves rigorous clinical trials and regulatory reviews. The patent's claims must align with the approved indications and formulations to ensure compliance with regulatory requirements[5].
Conclusion
United States Patent 8,633,219 is a pivotal patent in the field of HIV treatment, offering a combination therapy that enhances the efficacy and safety of antiretroviral treatment. Understanding the scope and claims of this patent is essential for pharmaceutical companies, researchers, and healthcare providers.
Key Takeaways
- Combination Therapy: The patent describes a combination therapy involving an HIV integrase inhibitor and another antiretroviral agent.
- Active Ingredients: Elvitegravir and emtricitabine are key components of this therapy.
- Therapeutic Uses: The therapy is used for treating HIV infection and inhibiting HIV integrase.
- Pharmaceutical Compositions: The patent covers various formulations, including tablets and capsules.
- Patent Landscape: The patent is part of a complex landscape of HIV treatment patents.
- Clinical Impact: The therapy improves patient outcomes by reducing viral loads and slowing disease progression.
- Manufacturing: The patent details methods for preparing the pharmaceutical compositions.
FAQs
What is the main focus of United States Patent 8,633,219?
The main focus of this patent is a combination therapy for treating HIV infection, specifically using an HIV integrase inhibitor and another antiretroviral agent.
What are the key active ingredients in this combination therapy?
The key active ingredients include elvitegravir (an HIV integrase inhibitor) and emtricitabine (a nucleoside reverse transcriptase inhibitor).
How does this patent impact the treatment of HIV?
This patent provides a more effective and potentially less toxic treatment option by combining multiple antiretroviral agents, which can improve patient outcomes by reducing viral loads and slowing the progression of the disease.
What is the significance of the patent's expiration date?
The patent's expiration date is crucial because it determines when generic versions of the drug can be introduced to the market, which can significantly impact the cost and accessibility of the treatment.
Are there any regulatory considerations for this patent?
Yes, the approval process for such combination therapies involves rigorous clinical trials and regulatory reviews. The patent's claims must align with the approved indications and formulations to ensure compliance with regulatory requirements.
How does this patent fit into the broader patent landscape for HIV treatments?
This patent is part of a complex landscape of patents related to antiretroviral therapies. It must be evaluated in the context of other related patents to ensure it does not infringe on existing patents and to withstand potential validity challenges.
Sources
- US8633219B2 - Combination therapy - Google Patents
- Adapt Pharma Operations Ltd. v. Teva - CAFC
- Patent Claims and Patent Scope - Hoover Institution
- US9296769B2 - Tenofovir alafenamide hemifumarate - Google Patents
- AIDS Healthcare Foundation, Inc. - Supreme Court
