United States Patent 9,567,363: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,567,363, titled "Certain compounds, compositions and methods," was granted to Otsuka Pharmaceutical Co., Ltd. on February 14, 2017. This patent is significant in the pharmaceutical industry, particularly for its implications on the development and use of specific compounds and their applications.
Background and Inventors
The patent was filed by inventors Gregory S. Hamilton, Takashi Tsukamoto, Dana V. Ferraris, Bridget Duvall, and Rena Lapidus, all associated with Otsuka Pharmaceutical Co., Ltd.[1][4].
Scope of the Patent
Compounds and Compositions
The patent covers certain tetrahydrouridine derivative compounds that act as inhibitors of the enzyme cytidine deaminase (CDA). These compounds are crucial in the field of oncology, particularly in the treatment of cancers where CDA activity is a concern[1][4].
Methods of Use
The patent includes methods for using these compounds, either alone or in combination with other therapeutic agents. This encompasses their use in pharmaceutical compositions and their administration routes, highlighting their potential in clinical settings[1][4].
Claims of the Patent
Compound Claims
The patent claims are broadly categorized into compound claims, composition claims, and method claims. The compound claims specifically describe the tetrahydrouridine derivatives, including their structural formulas and synthetic methods[1][4].
Composition Claims
These claims cover pharmaceutical compositions that include the tetrahydrouridine derivatives, along with other ingredients such as excipients and solvents. The compositions are designed for various administration routes, including oral and parenteral forms[1][4].
Method Claims
The method claims outline the use of these compounds and compositions in treating diseases, particularly those involving CDA activity. This includes their use in combination therapies with other anticancer agents[1][4].
Patent Landscape and Regulatory Context
Regulatory Review and Patent Term Extension
The patent is associated with the product INQOVI® (decitabine and cedazuridine), which has undergone regulatory review. Applications for patent term extension (PTE) have been filed under 35 U.S.C. 156, reflecting the regulatory review period (RRP) before commercial marketing[2][5].
Patent Term and Expiration
The patent is currently active but subject to expiration. The USPTO has received applications for PTE, which could extend the patent term based on the RRP for INQOVI®. The actual extension period will be determined by statutory limitations and regulatory reviews[2][5].
Challenges in Pharmaceutical Patent Landscape
Genus Claims and Enablement
The pharmaceutical industry faces significant challenges in patent protection, particularly with genus claims. The Federal Circuit's rigid stance on Section 112(a) of the U.S. patent laws has made it difficult to obtain broad patent protection for drugs and biologics. This requires patentees to provide detailed descriptions and enablement for all species within a genus, which can be impractical and costly[3].
Impact on Innovation
The strict application of Section 112(a) can hinder innovation by limiting the scope of patent claims. Innovators are caught between claiming too broadly, which may invalidate the patent, and claiming too narrowly, which allows competitors to design around the claims. This balance is crucial for maintaining meaningful patent protection in the pharmaceutical and biotechnology industries[3].
Industry Implications
Market and Financial Considerations
The market for pharmaceuticals and biologics is vast and growing, with estimates suggesting the therapeutic antibody market alone could reach $300 billion by 2025. The ability to secure robust and predictable patent protection is essential for companies to recoup their significant investments in research and development[3].
Competitive Landscape
The patent landscape influences the competitive dynamics within the industry. Companies like Otsuka Pharmaceutical Co., Ltd. rely on strong patent protection to safeguard their innovations and prevent competitors from developing similar products with minor modifications[3].
Key Takeaways
- Compound and Composition Claims: The patent covers specific tetrahydrouridine derivatives and their pharmaceutical compositions.
- Method Claims: It includes methods for using these compounds in treating diseases involving CDA activity.
- Regulatory Context: Associated with INQOVI® and subject to patent term extension based on regulatory review.
- Challenges in Patent Protection: The pharmaceutical industry faces challenges with genus claims and enablement requirements.
- Industry Implications: Strong patent protection is crucial for innovation and market competitiveness in the pharmaceutical and biotechnology sectors.
FAQs
Q: What is the main subject of United States Patent 9,567,363?
A: The patent covers tetrahydrouridine derivative compounds that inhibit the enzyme cytidine deaminase (CDA), along with their compositions and methods of use.
Q: Who are the inventors of this patent?
A: The inventors include Gregory S. Hamilton, Takashi Tsukamoto, Dana V. Ferraris, Bridget Duvall, and Rena Lapidus.
Q: What is the significance of the regulatory review period (RRP) for this patent?
A: The RRP is crucial for determining the potential patent term extension under 35 U.S.C. 156, which affects the commercial marketing and use of the product INQOVI®.
Q: How does the Federal Circuit's stance on Section 112(a) impact pharmaceutical patents?
A: The strict application of Section 112(a) makes it challenging to obtain broad patent protection for drugs and biologics, requiring detailed descriptions and enablement for all species within a genus.
Q: What is the estimated market size for therapeutic antibodies by 2025?
A: The market for therapeutic antibodies is estimated to reach $300 billion by 2025, highlighting the importance of robust patent protection in this sector.
Cited Sources
- United States Patent and Trademark Office, "Certain compounds, compositions and methods," U.S. Patent No. 9,567,363 B2, February 14, 2017.
- Food and Drug Administration, "Application for Patent Term Extension," FDA-2022-E-0276-0004, August 1, 2023.
- DigitalCommons@NYLS, "Eviscerating Patent Scope," accessed December 20, 2024.
- Google Patents, "US9567363B2 - Certain compounds, compositions and methods," accessed December 20, 2024.
- Federal Register, "Patent Term Restoration Applications," Volume 89 Issue 41, February 29, 2024.
