Detailed Analysis of the Scope and Claims of United States Patent 9,186,344
Overview of the Patent
United States Patent 9,186,344, titled "Glycogen or polysaccharide storage disease treatment method," is a significant patent held by Ultragenyx Pharmaceutical Inc., although it was originally assigned to Baylor Research Institute. This patent is crucial for the treatment of glycogen storage diseases using a specific therapeutic approach.
Inventor and Assignee
The patent was invented by Charles R. Roe and is currently assigned to Ultragenyx Pharmaceutical Inc., reflecting the transfer of intellectual property rights from the original assignee, Baylor Research Institute[5].
Issuance and Expiration Dates
The patent was issued on November 17, 2015, and is set to expire on July 17, 2025, unless extended through patent term restoration or other mechanisms[2][5].
Scope of the Patent
This patent covers a method for treating glycogen storage diseases, which are genetic disorders that affect the body's ability to store glycogen, a complex carbohydrate. The method involves administering an effective amount of a composition that includes ketogenic odd carbon fatty acids. These fatty acids are designed to ameliorate the symptoms of glycogen storage diseases by providing an alternative energy source for the body.
Claims of the Patent
The patent includes several claims that define the scope of the invention:
- Method Claims: The primary claims describe the method of treating glycogen storage diseases by administering ketogenic odd carbon fatty acids. These claims specify the type of fatty acids, the dosage, and the mode of administration.
- Composition Claims: Additional claims cover the composition itself, including the specific types of ketogenic odd carbon fatty acids and their formulations.
- Therapeutic Claims: The patent also includes claims related to the therapeutic effects of the treatment, such as the amelioration of symptoms associated with glycogen storage diseases[5].
Patent Landscape
Related Patents
There are other patents related to the treatment of glycogen storage diseases, including U.S. Patent 8,697,748, which also covers a similar method of treatment using ketogenic odd carbon fatty acids. Both patents are part of the intellectual property portfolio that protects the proprietary treatment methods developed by the inventors and now owned by Ultragenyx Pharmaceutical Inc.[2][5].
Patent Term Extension
The patent holder has sought patent term extension due to the regulatory review period associated with the FDA approval of the drug Dojolvi, which is based on the technology described in this patent. The FDA determined a regulatory review period of 2,511 days, which could potentially extend the patent term. However, the actual extension will be determined by the USPTO based on statutory limitations[1][2].
Current Status
As of the latest updates, the patent remains active, and there have been recent transactions related to its maintenance and potential extension. For example, the FDA issued final eligibility letters for patent term extension in August 2022, and there were notices of final determination regarding the election required for patent term extension in June 2023[2].
Impact on Market and Competition
The exclusivity granted by this patent and related patents ensures that Ultragenyx Pharmaceutical Inc. maintains a competitive edge in the market for treatments of glycogen storage diseases. Since there is currently no generic version of Dojolvi available, this patent protection is crucial for the company's market dominance in this therapeutic area[5].
Regulatory and Legal Considerations
Any challenges or petitions related to the patent's validity or the extension of its term must comply with FDA regulations and USPTO guidelines. Interested parties can submit petitions to the FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period[1].
Conclusion and Future Outlook
United States Patent 9,186,344 is a vital component of the intellectual property portfolio for Ultragenyx Pharmaceutical Inc., protecting a unique and effective treatment method for glycogen storage diseases. The ongoing efforts to extend the patent term highlight the importance of this patent in maintaining the company's competitive position in the market.
Key Takeaways
- The patent covers a method for treating glycogen storage diseases using ketogenic odd carbon fatty acids.
- It was issued on November 17, 2015, and is set to expire on July 17, 2025.
- The patent is part of a broader intellectual property strategy that includes related patents.
- Efforts are underway to extend the patent term due to the regulatory review period.
- The patent remains crucial for Ultragenyx Pharmaceutical Inc.'s market position in treating glycogen storage diseases.
Frequently Asked Questions (FAQs)
Q: What is the primary claim of U.S. Patent 9,186,344?
A: The primary claim is a method for treating glycogen storage diseases by administering ketogenic odd carbon fatty acids.
Q: Who is the current assignee of this patent?
A: The current assignee is Ultragenyx Pharmaceutical Inc.
Q: When is the patent set to expire?
A: The patent is set to expire on July 17, 2025, unless extended.
Q: What is the significance of the regulatory review period for this patent?
A: The regulatory review period could lead to a patent term extension, potentially extending the exclusivity period beyond the original expiration date.
Q: Is there a generic version of Dojolvi available?
A: No, there is currently no therapeutically equivalent generic version of Dojolvi available in the United States.
Cited Sources:
- Federal Register/Vol. 86, No. 214/Tuesday, November 9, 2021/Notices
- Dojolvi patent expiration - Pharsight
- Report on Statistical Analysis of Green and Low-Carbon Patents (2024)
- US6723358B1 - Encapsulation of components into edible products - Google Patents
- Generic Dojolvi Availability - Drugs.com
