United States Patent 9,649,311: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,649,311, titled "Solid pharmaceutical compositions containing an integrase inhibitor," is a significant patent in the pharmaceutical industry, particularly in the field of HIV treatment. This patent, granted to Merck & Co., Inc., covers specific formulations of the integrase inhibitor raltegravir, used in the treatment of HIV-1 infection.
Background on Raltegravir
Raltegravir, marketed under the brand name Isentress, is an antiretroviral drug that inhibits the integrase enzyme, which is crucial for the integration of viral DNA into the host cell's genome. This mechanism of action makes raltegravir an effective treatment for HIV-1 infection[4].
Patent Scope
The patent 9,649,311 encompasses solid pharmaceutical compositions, specifically compressed tablets, that contain raltegravir in the form of a pharmaceutically acceptable salt. Here are the key aspects of the patent scope:
Composition
- The tablets include raltegravir or its pharmaceutically acceptable salt.
- The composition also includes various excipients such as fillers, binding agents, lubricants, and superdisintegrants[4].
Formulation
- The patent describes the specific amounts and ranges of raltegravir and other components in the tablet formulation.
- It details the method of preparing these tablets, ensuring they are suitable for oral administration[4].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the solid pharmaceutical composition containing raltegravir or its salt, along with specified excipients.
- Claim 2 specifies the amount of raltegravir in the composition and the type of excipients used[4].
Dependent Claims
- These claims further detail the specific ratios and amounts of the components, such as fillers, binding agents, and lubricants.
- They also describe the physical characteristics of the tablets, such as their size and shape[4].
Patent Landscape
Understanding the patent landscape is crucial for navigating the intellectual property rights surrounding raltegravir formulations.
Related Patents
- Other patents related to raltegravir formulations may exist, covering different aspects such as different salts, formulations, or methods of preparation.
- For example, patents covering other antiretroviral drugs or combination therapies may also be relevant[4].
Litigation and Settlements
- Patents in the pharmaceutical industry are often subject to litigation, particularly when generic manufacturers seek to enter the market.
- Settlements and litigation outcomes, such as those seen in ANDA (Abbreviated New Drug Application) cases, can impact the patent landscape and the availability of generic versions of the drug[2].
Expiry and Expiration Dates
The expiration dates of patents are critical for understanding when generic versions of the drug can be introduced to the market.
Patent Expiry
- The patent 9,649,311 has specific expiry dates listed in the FDA Orange Book, which tracks the expiration dates of patents related to approved drugs.
- These dates determine when the patent protection ends, allowing generic manufacturers to seek approval for their versions of the drug[5].
Impact on the Pharmaceutical Industry
The patent 9,649,311 has significant implications for the pharmaceutical industry:
Innovation and Competition
- The patent encourages innovation by protecting the intellectual property rights of the inventor, allowing them to recoup their investment in research and development.
- However, it also limits competition during the patent term, which can affect the availability and pricing of the drug[4].
Generic Entry
- Once the patent expires, generic manufacturers can enter the market, potentially reducing the cost of the drug and increasing its accessibility.
- This transition can also lead to further innovation as generic manufacturers may develop their own formulations or delivery methods[5].
Regulatory Considerations
Regulatory bodies play a crucial role in the lifecycle of a patent and the drug it covers.
FDA Approval
- The FDA must approve any new drug application, including generics, to ensure safety and efficacy.
- The FDA Orange Book and other regulatory databases track the patent status of approved drugs, helping to manage the transition from branded to generic versions[5].
International Patent Protection
- Patents like 9,649,311 may have international counterparts, providing global protection for the invention.
- International patent databases, such as PATENTSCOPE, can be used to search and analyze patent documents from multiple jurisdictions[1].
Economic and Social Impact
The economic and social impact of this patent is multifaceted:
Cost and Accessibility
- The patent protection period can affect the cost of the drug, making it more expensive during the protected period.
- Once the patent expires, the entry of generic versions can significantly reduce the cost, making the drug more accessible to a wider population[5].
Public Health
- The availability of effective HIV treatments like raltegravir is crucial for public health, especially in regions with high HIV prevalence.
- The balance between patent protection and generic entry is critical for ensuring that these life-saving drugs are accessible while also incentivizing further innovation[4].
Key Takeaways
- Patent Scope: The patent covers specific solid pharmaceutical compositions containing raltegravir or its salt, along with various excipients.
- Claims: The patent includes detailed claims about the composition, formulation, and preparation method of the tablets.
- Patent Landscape: Understanding related patents, litigation, and settlements is essential for navigating the intellectual property landscape.
- Expiry Dates: The patent's expiry dates determine when generic versions can enter the market.
- Impact on Industry: The patent affects innovation, competition, and the availability of the drug.
- Regulatory Considerations: FDA approval and international patent protection are crucial for managing the drug's lifecycle.
- Economic and Social Impact: The patent influences the cost and accessibility of the drug, impacting public health.
FAQs
What is the main subject of United States Patent 9,649,311?
The main subject of United States Patent 9,649,311 is solid pharmaceutical compositions containing the integrase inhibitor raltegravir, used in the treatment of HIV-1 infection.
What are the key components of the patented composition?
The key components include raltegravir or its pharmaceutically acceptable salt, fillers, binding agents, lubricants, and superdisintegrants.
How does the patent impact the availability of generic versions of raltegravir?
The patent protects the branded version of raltegravir until its expiry date, after which generic manufacturers can seek approval for their versions, potentially reducing the drug's cost and increasing its accessibility.
What is the significance of the FDA Orange Book in relation to this patent?
The FDA Orange Book tracks the expiration dates of patents related to approved drugs, including raltegravir, which helps manage the transition from branded to generic versions.
How does international patent protection affect the global availability of raltegravir?
International patent protection ensures that the invention is protected globally, but it also means that generic versions cannot be introduced in those countries until the patent expires, affecting the drug's global accessibility and cost.
