Understanding the Scope and Claims of United States Patent 8,357,713
Introduction
United States Patent 8,357,713, hereafter referred to as the '713 patent, is one of the patents associated with ZURAMPIC (lesinurad), a drug product developed by Ardea Biosciences, Inc. This patent is part of a larger family of patents related to lesinurad, and understanding its scope and claims is crucial for navigating the patent landscape in the pharmaceutical industry.
Background of the Patent
The '713 patent is one of several patents filed by Ardea Biosciences, Inc. under the Hatch-Waxman Act, which allows for patent term extensions (PTE) due to the lengthy regulatory review process for new drugs[2][5].
Claims of the Patent
The '713 patent, along with other related patents (8,003,681; 8,084,483; 8,283,369; and 8,546,437), claims various aspects of lesinurad, including its composition, method of use, and pharmaceutical formulations. Here are some key aspects of the claims:
Composition of Matter
The patent claims specific chemical compounds and their derivatives, which are essential for the drug's efficacy. These claims are critical in defining the scope of protection for the drug's active ingredients[2].
Method of Use
The '713 patent includes claims related to the method of using lesinurad for treating gout and other hyperuricemic conditions. These method claims are important as they specify how the drug should be administered and its therapeutic applications[2].
Pharmaceutical Formulations
The patent also covers various pharmaceutical formulations of lesinurad, including tablets, capsules, and other dosage forms. These claims ensure that the specific formulations developed by Ardea Biosciences are protected[2].
Patent Term Extension
One of the significant aspects of the '713 patent is its eligibility for a patent term extension under 35 U.S.C. ยง 156. This provision allows for the extension of the patent term to compensate for the time spent in the regulatory review process. For ZURAMPIC, the regulatory review period was extensive, lasting 2,245 days, with 1,886 days occurring during the testing phase[5].
Regulatory Review Period
The total length of the regulatory review period for ZURAMPIC is a critical factor in determining the patent term extension. The FDA's review process, which includes clinical trials and other regulatory hurdles, significantly impacts the effective patent life of the drug[5].
Patent Landscape
The '713 patent is part of a complex patent landscape involving multiple related patents. Here are some key points to consider:
Family of Patents
The '713 patent is part of a family of patents that include other related patents such as 8,003,681; 8,084,483; 8,283,369; and 8,546,437. These patents collectively cover various aspects of lesinurad, ensuring comprehensive protection for the drug[2].
Interrelated Claims
The claims of these patents are interrelated, with each patent building upon or complementing the others. This interrelation is crucial for maintaining a strong patent portfolio and preventing infringement[2].
Patent Term Adjustment
Similar to the Cellect case, where patents in the same family received different patent term adjustments (PTA) due to USPTO delays, the '713 patent and its related patents may also have different expiration dates based on PTA grants. However, unlike the Cellect case, these patents are eligible for PTE under the Hatch-Waxman Act[1][2].
Obviousness-Type Double Patenting (ODP)
While the '713 patent and its related patents do not face the same ODP issues as seen in the Cellect case, it is important to note that ODP can be a concern in patent families where multiple patents claim priority from the same application. However, in this case, the focus is more on the regulatory extensions rather than ODP rejections[1].
Industry Impact
The '713 patent and its related patents have significant implications for the pharmaceutical industry:
Competitive Advantage
The comprehensive protection provided by these patents gives Ardea Biosciences a competitive advantage in the market, allowing them to exclusively market and sell lesinurad without fear of immediate generic competition[2].
Research and Development
The patent protection encourages further research and development in the field of gout treatment, as companies can invest in R&D with the assurance of potential returns through exclusive market rights[4].
Conclusion
Understanding the scope and claims of the '713 patent is essential for navigating the complex patent landscape in the pharmaceutical industry. Here are the key takeaways:
- Composition and Method Claims: The patent covers specific chemical compounds, methods of use, and pharmaceutical formulations of lesinurad.
- Patent Term Extension: The patent is eligible for a PTE under the Hatch-Waxman Act due to the lengthy regulatory review period.
- Patent Family: The '713 patent is part of a family of related patents that collectively provide comprehensive protection for lesinurad.
- Industry Impact: The patent protection provides a competitive advantage and encourages further R&D in gout treatment.
Key Takeaways
- The '713 patent covers various aspects of lesinurad, including composition, method of use, and pharmaceutical formulations.
- The patent is eligible for a PTE under the Hatch-Waxman Act.
- The patent is part of a family of related patents that provide comprehensive protection.
- The patent protection has significant implications for the pharmaceutical industry, including competitive advantage and encouragement of R&D.
FAQs
Q: What is the primary focus of the '713 patent?
A: The primary focus of the '713 patent is the protection of lesinurad, a drug used for treating gout and other hyperuricemic conditions.
Q: Why is the '713 patent eligible for a patent term extension?
A: The '713 patent is eligible for a PTE under the Hatch-Waxman Act due to the lengthy regulatory review period for ZURAMPIC.
Q: How does the '713 patent relate to other patents in the same family?
A: The '713 patent is part of a family of related patents that collectively cover various aspects of lesinurad, ensuring comprehensive protection.
Q: What is the impact of the '713 patent on the pharmaceutical industry?
A: The patent provides a competitive advantage to Ardea Biosciences and encourages further research and development in gout treatment.
Q: Can other companies develop generic versions of lesinurad during the patent term?
A: No, during the patent term, including any extensions, other companies cannot develop generic versions of lesinurad without infringing on the patent.
Sources
- In re Cellect - United States Court of Appeals for the Federal Circuit[1]
- FDA U.S. FOOD & DRUG - Re: ZURAMPIC Patent Nos. 8,003,681; 8,084,483; 8,283,369; 8,357,713; and 8,546,437[2]
- Patent Claims Research Dataset - USPTO[3]
- Patent Law in the United States - BitLaw[4]
- U.S. FOOD & DRUG ADMINISTRATION - Re: ZURAMPIC Patent Nos.[5]
