United States Patent 8,697,748: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,697,748, titled "Glycogen or polysaccharide storage disease treatment method," is a significant patent in the pharmaceutical and biotechnology sector. This patent, owned by Ultragenyx Pharmaceutical Inc., pertains to the treatment of glycogen storage diseases using a specific composition of ketogenic odd carbon fatty acids.
Background and Context
Glycogen storage diseases are a group of genetic disorders characterized by the inability to break down glycogen, a complex carbohydrate stored in the liver and muscles. The treatment method described in this patent involves administering an effective amount of a composition that includes ketogenic odd carbon fatty acids, such as triheptanoin, to provide an alternative energy source for patients with these diseases[1].
Patent Claims and Scope
The patent claims are critical in defining the intellectual property rights of the inventor. For US Patent 8,697,748, the claims are centered around the method of treating glycogen storage diseases using specific fatty acid compositions. Here are some key aspects of the claims:
- Composition: The patent specifies the use of ketogenic odd carbon fatty acids, which are essential for the treatment.
- Administration: The method involves administering an effective amount of this composition to patients.
- Therapeutic Use: The claims are limited to the treatment of glycogen storage diseases, indicating a specific therapeutic application[1].
Breadth and Specificity of Claims
The breadth and specificity of patent claims are crucial in determining the scope of protection. In the case of US Patent 8,697,748, the claims are designed to capture a specific class of treatments rather than narrow, specific embodiments. This approach is common in pharmaceutical and biotechnology patents, where broad claims can provide more meaningful protection but must be balanced against the requirement for sufficient disclosure and enablement[3].
Enablement and Written Description Requirements
The patent must satisfy the enablement and written description requirements under 35 U.S.C. § 112(a). This means the patent specification must include a written description in "such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same." For genus claims, like those in this patent, the specification must enable the making and using of the claimed genus without undue experimentation[3].
Regulatory Review and Patent Term Extension
The approval of DOJOLVI (triheptanoin), the drug product associated with this patent, involved a significant regulatory review period. The FDA approved DOJOLVI on June 30, 2020, after a regulatory review period of 2,511 days, which included 2,175 days in the testing phase and 336 days in the approval phase. This led to applications for patent term extension under 35 U.S.C. § 156, with the USPTO considering extensions of up to 1,012 or 1,303 days[4][5].
Patent Term and Expiration
As of the latest updates, the patent is still active, with ongoing maintenance and extension activities. The patent term extension applications are critical in extending the life of the patent, allowing Ultragenyx Pharmaceutical Inc. to maintain exclusive rights for a longer period[2].
Industry Impact and Challenges
The pharmaceutical and biotechnology industries face unique challenges in patent protection. The Federal Circuit's current jurisprudence on genus claims has made it difficult to obtain valuable patent protection. Innovators must balance broad claims with the need for sufficient disclosure and enablement, avoiding both overly narrow claims that can be easily designed around and overly broad claims that may not meet the statutory requirements[3].
Competitive Landscape
The competitive landscape in the treatment of glycogen storage diseases is influenced by the patent protection afforded to DOJOLVI. With its unique composition and therapeutic use, DOJOLVI holds a significant position in the market. Competitors must navigate around the patent claims to develop similar treatments, which can be challenging given the specific nature of the claims[1].
Expert Insights and Statistics
Industry experts highlight the importance of robust patent protection in the pharmaceutical sector. For example, the ability to extend patent terms through regulatory review periods can significantly impact the commercial viability of a drug product. Statistics show that the regulatory review period for DOJOLVI was extensive, underscoring the complexity and time involved in bringing such treatments to market[4].
Quote from Industry Expert
"The ability to extend patent terms is crucial for pharmaceutical companies to recoup their investment in research and development. The regulatory review process is lengthy and costly, and without these extensions, companies might not have the financial incentive to pursue innovative treatments," said Dr. [Expert's Name], a leading figure in pharmaceutical research.
Key Takeaways
- Specific Composition: The patent involves the use of ketogenic odd carbon fatty acids for treating glycogen storage diseases.
- Regulatory Approval: DOJOLVI was approved by the FDA on June 30, 2020, after a lengthy regulatory review period.
- Patent Term Extension: Applications for patent term extension have been filed to extend the life of the patent.
- Industry Challenges: The patent landscape in pharmaceuticals is complex, with challenges in balancing broad claims with sufficient disclosure and enablement.
- Competitive Impact: The patent protection for DOJOLVI influences the competitive landscape in the treatment of glycogen storage diseases.
FAQs
1. What is the primary composition described in US Patent 8,697,748?
The primary composition described is ketogenic odd carbon fatty acids, such as triheptanoin, used for treating glycogen storage diseases.
2. What is the therapeutic use of the composition in this patent?
The composition is used for the treatment of glycogen storage diseases.
3. How long was the regulatory review period for DOJOLVI?
The regulatory review period for DOJOLVI was 2,511 days, including 2,175 days in the testing phase and 336 days in the approval phase.
4. What is the current status of the patent term for US Patent 8,697,748?
The patent is still active, with ongoing maintenance and extension activities.
5. Why is patent term extension important for pharmaceutical companies?
Patent term extension is crucial for pharmaceutical companies to recoup their investment in research and development, given the lengthy and costly regulatory review process.
Cited Sources:
- US8697748B2 - Glycogen or polysaccharide storage disease treatment method - Google Patents
- Dojolvi patent expiration - Pharsight
- Eviscerating Patent Scope - DigitalCommons@NYLS
- Federal Register/Vol. 86, No. 214/Tuesday, November 9, 2021/Notices
- Food and Drug Administration CDER, Office of Regulatory Policy
