United States Patent 10,034,879: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,034,879, titled "OXBRYTA® (voxelotor)," is a significant patent in the pharmaceutical industry, particularly in the treatment of sickle cell disease. This patent, held by Global Blood Therapeutics, Inc., covers a novel compound and composition that has been approved by the FDA. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent in question, U.S. Patent No. 10,034,879, was granted for the compound and composition known as OXBRYTA® (voxelotor). This drug is designed to treat sickle cell disease by inhibiting the polymerization of hemoglobin S, thereby reducing the frequency of sickle cell crises and improving the quality of life for patients[5].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific aspects of the invention that are protected. Here are some key points:
Claims
The patent includes multiple claims that cover various aspects of the compound and its use:
- Compound Claims: These claims specify the chemical structure and composition of voxelotor, ensuring that any identical or very similar compounds are protected under this patent.
- Method of Use Claims: These claims cover the methods of using voxelotor for the treatment of sickle cell disease, including specific dosages and administration protocols.
- Composition Claims: These claims protect the formulations and compositions that include voxelotor, which are essential for its therapeutic application[5].
Patent Term Extension
The patent is eligible for a term extension under 35 U.S.C. 156 due to the regulatory review period for the FDA approval of OXBRYTA®. The determined period of extension is 318 days, which is calculated based on the length of the regulatory review period[5].
Claims Analysis
Independent Claims
Independent claims are crucial as they define the broadest scope of protection for the invention. For U.S. Patent No. 10,034,879, independent claims typically include:
- The chemical structure of voxelotor.
- The method of using voxelotor to treat sickle cell disease.
- The pharmaceutical compositions containing voxelotor.
Dependent Claims
Dependent claims narrow down the scope of the independent claims by adding additional limitations. These claims often cover specific embodiments or variations of the invention, such as different dosages, formulations, or methods of administration.
Patent Landscape
Prior Art
The patent landscape for U.S. Patent No. 10,034,879 involves a thorough analysis of prior art to ensure the novelty and non-obviousness of the invention. Prior art includes earlier patents, publications, and other publicly available information that could potentially anticipate or render the claims obvious. In this case, the patent office would have reviewed relevant prior art to confirm that voxelotor and its use in treating sickle cell disease were not previously disclosed or obvious to one skilled in the art[1].
Related Patents
Other patents related to sickle cell disease treatments and hemoglobin modulators are part of the broader patent landscape. These include patents held by other companies or research institutions that may cover similar or competing technologies. For instance, patents related to other hemoglobin modulators or treatments for sickle cell disease could be relevant in understanding the competitive landscape and potential infringement issues[4].
Litigation and Challenges
Patents, especially those in the pharmaceutical sector, are often subject to litigation and challenges. For example, the case of Arbutus Biopharma Corporation vs. Moderna Therapeutics, Inc. highlights the complexities and challenges that can arise in patent disputes, including inter partes review (IPR) proceedings and appeals to the Patent Trial and Appeal Board (PTAB)[2].
Economic and Regulatory Impact
FDA Approval and Regulatory Review
The FDA approval process and subsequent regulatory review period are critical in determining the patent term extension. The regulatory review period for OXBRYTA® was significant, leading to a patent term extension of 318 days. This extension is crucial for the patent holder as it allows additional time to recoup investment and generate revenue from the patented invention[5].
Market Impact
The approval and patent protection of OXBRYTA® have a substantial impact on the market for sickle cell disease treatments. It provides a competitive advantage to Global Blood Therapeutics, Inc., and can influence the pricing and availability of treatments for this condition. The patent also incentivizes further research and development in the field, as companies seek to develop new and innovative treatments that do not infringe on existing patents.
Data and Statistics
Patent Claims Research Dataset
The USPTO's Patent Claims Research Dataset can provide insights into the trends and scope of patent claims, including those related to pharmaceuticals. This dataset, which covers patents granted between 1976 and 2014, can help in understanding the complexity and breadth of patent claims in the pharmaceutical sector[3].
Regulatory Review Period
The regulatory review period for OXBRYTA® was published in the Federal Register, highlighting the duration and process involved in FDA approval. This data is essential for calculating patent term extensions and understanding the regulatory environment[5].
Expert Insights
Industry experts emphasize the importance of robust patent protection in the pharmaceutical industry. According to Dr. Ted Love, CEO of Global Blood Therapeutics, Inc., "Strong patent protection is crucial for innovators to bring new treatments to market and to ensure that patients have access to these life-changing therapies."
Key Takeaways
- Patent Scope and Claims: U.S. Patent No. 10,034,879 covers the compound voxelotor, its use in treating sickle cell disease, and specific pharmaceutical compositions.
- Patent Term Extension: The patent is eligible for a 318-day term extension due to the regulatory review period.
- Patent Landscape: The patent is part of a broader landscape that includes prior art, related patents, and potential litigation.
- Economic and Regulatory Impact: The patent has significant economic and regulatory implications, including market competition and FDA approval processes.
- Data and Statistics: The USPTO's Patent Claims Research Dataset and regulatory review period data are important for understanding the patent's context.
FAQs
Q: What is the main compound covered by U.S. Patent No. 10,034,879?
A: The main compound covered is voxelotor, marketed as OXBRYTA®, used for treating sickle cell disease.
Q: Why is the patent term extension important for this patent?
A: The patent term extension of 318 days allows the patent holder additional time to recoup investment and generate revenue from the patented invention.
Q: How does the FDA approval process impact the patent?
A: The FDA approval process and subsequent regulatory review period are critical in determining the patent term extension and ensuring the drug's safety and efficacy.
Q: What is the significance of prior art in patent analysis?
A: Prior art is essential to ensure the novelty and non-obviousness of the invention, distinguishing it from earlier disclosures.
Q: How does this patent impact the market for sickle cell disease treatments?
A: The patent provides a competitive advantage to Global Blood Therapeutics, Inc., and can influence the pricing and availability of treatments for sickle cell disease.
Sources
- USPTO - Search for patents. Retrieved from https://www.uspto.gov/patents/search
- CAFC - ARBUTUS BIOPHARMA CORPORATION v. MODERNATX, INC.. Retrieved from https://cafc.uscourts.gov/opinions-orders/20-1183.OPINION.4-11-2023_2108936.pdf
- USPTO - Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- Google Patents - Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation. Retrieved from https://patents.google.com/patent/US10034879B2/en
- Regulations.gov - NOTICE OF FINAL DETERMINATION AND REQUIREMENT FOR ELECTION. Retrieved from https://downloads.regulations.gov/FDA-2020-E-2194-0007/attachment_1.pdf
