United States Patent 6,888,027: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,888,027, associated with the drug BELEODAQ, is a significant patent in the pharmaceutical industry. This patent, held by Topotarget UK Limited, covers a compound used in the treatment of certain cancers. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background of the Patent
U.S. Patent 6,888,027 was issued for a compound and its pharmaceutical compositions, along with methods of using these compounds. The patent is crucial for the drug BELEODAQ, which is used in oncology[2].
Scope of the Patent
The scope of U.S. Patent 6,888,027 is defined by its claims, which can be categorized into several key areas:
Claims Covering the Approved Product
Claims 1, 2, 19, 20, 37, and 39 specifically cover the approved product itself. These claims detail the chemical structure and composition of the compound, ensuring that the patent holder has exclusive rights to this specific molecule[1].
Claims Covering Pharmaceutical Compositions
Claims 40, 41, and 43 pertain to pharmaceutical compositions that include the approved product. These claims encompass various formulations and preparations of the drug, ensuring that any product containing this compound falls under the patent's protection[1].
Claims Covering Methods of Use
Claims 44, 45, 47-49, 51-53, 55-57, and 59 cover methods of using the approved product. These claims include therapeutic uses, dosing regimens, and other clinical applications of the drug[1].
Claim Language and Patent Scope
The language used in the claims is critical in defining the patent's scope. Research has shown that the length and count of independent claims can be metrics for measuring patent scope. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process[3].
Patent Term Extension
The patent holder applied for a patent term extension under 35 U.S.C. ยง 156, which allows for the extension of a patent term to compensate for the time spent in regulatory review. The requested extension of 1,779 days would extend the patent's expiration from September 27, 2021, to August 11, 2026[1][2].
Regulatory Review Period
The regulatory review period, a key factor in determining the patent term extension, includes the time from the date the exemption under the Federal Food, Drug and Cosmetic Act became effective to the date the New Drug Application (NDA) was initially submitted, and the time from the NDA submission to the approval date. This period is crucial in calculating the extension[1].
Patent Landscape
The patent landscape surrounding U.S. Patent 6,888,027 is complex and involves various stakeholders. Here are some key points:
Competitors and Related Patents
The pharmaceutical industry is highly competitive, with numerous patents covering different aspects of drug development and use. Patents related to histone deacetylase inhibitors, like BELEODAQ, are particularly relevant, as they may overlap or complement the claims of U.S. Patent 6,888,027[4].
Litigation and Licensing
Patents with broad or unclear claims can lead to increased litigation and licensing costs. However, the specific and narrow claims of U.S. Patent 6,888,027 help to mitigate these risks, providing clear boundaries for what is protected[3].
Innovation Incentives
The clarity and specificity of the claims in U.S. Patent 6,888,027 can incentivize innovation by providing a clear understanding of what is protected and what areas are open for further research and development[3].
Impact on the Pharmaceutical Industry
The patent's impact on the pharmaceutical industry is significant:
Market Exclusivity
The patent ensures market exclusivity for BELEODAQ, allowing the patent holder to maintain a competitive edge in the market for the duration of the patent term[1].
Research and Development
The patent's specific claims encourage other researchers and companies to innovate around the protected areas, driving advancements in cancer treatment[3].
Key Takeaways
- Specific Claims: U.S. Patent 6,888,027 has specific claims covering the compound, pharmaceutical compositions, and methods of use.
- Patent Term Extension: The patent term was extended to August 11, 2026, to compensate for regulatory review time.
- Regulatory Review: The regulatory review period is a critical factor in determining the patent term extension.
- Patent Landscape: The patent is part of a complex landscape involving competitors, related patents, and potential litigation.
- Innovation: Clear and specific claims incentivize innovation by defining protected areas clearly.
FAQs
Q: What is the main subject of U.S. Patent 6,888,027?
A: The main subject is a compound and its pharmaceutical compositions, along with methods of using these compounds, specifically related to the drug BELEODAQ.
Q: How long was the patent term extended for U.S. Patent 6,888,027?
A: The patent term was extended by 1,779 days, from September 27, 2021, to August 11, 2026.
Q: What factors determine the regulatory review period for patent term extension?
A: The regulatory review period includes the time from the exemption under the Federal Food, Drug and Cosmetic Act to the NDA submission and from the NDA submission to the approval date.
Q: How do the claims of U.S. Patent 6,888,027 impact innovation?
A: The specific and narrow claims encourage innovation by providing clear boundaries of what is protected, allowing other researchers to innovate around these areas.
Q: What is the significance of the patent term extension for the pharmaceutical industry?
A: The extension ensures market exclusivity for BELEODAQ, allowing the patent holder to maintain a competitive edge and incentivizing further research and development in cancer treatment.
Sources
- FEE TRANSMITIAL - Regulations.gov: "In re: Title: Issue Date: Inventors: Assignee and Owner: U.S. Patent No. 6,888,027."
- Federal Register: "Determination of Regulatory Review Period for Purposes of Patent Extension BELEODAQ."
- SSRN: "Patent Claims and Patent Scope."
- Google Patents: "United States Patent US 7,678,808 B2."
