United States Patent 10,610,125: A Detailed Analysis of Scope and Claims
Overview of the Patent
United States Patent 10,610,125, titled "Methods and compositions for cell-proliferation-related disorders," is a significant patent in the field of cancer treatment, particularly for acute myeloid leukemia (AML). This patent is held by Agios Pharmaceuticals, Inc., a company renowned for its innovative approaches to cancer therapy.
Issuance and Expiration
The patent was issued on April 7, 2020, and is estimated to expire on June 21, 2030[2].
Inventors and Assignees
The patent lists several inventors, including Lenny Dang, Valeria Fantin, Stefan Gross, Hyun Gyung Jang, Shengfang Jin, Francesco G. Salituro, Jeffrey O. Saunders, Shin-San Michael Su, and Katharine Yen. The assignee is Agios Pharmaceuticals, Inc.[2].
Scope of the Patent
Methods and Compositions
This patent covers methods and compositions for treating cell-proliferation-related disorders, specifically focusing on cancers such as AML. The patent describes the use of therapeutically active compounds, including enasidenib, which is an inhibitor of the mutant isocitrate dehydrogenase 2 (IDH2) enzyme. This enzyme is implicated in the pathogenesis of AML due to its neomorphic activity that leads to the production of 2-hydroxyglutarate, a metabolite associated with DNA and histone hypermethylation and blocked cellular differentiation[1].
Targeted Mutations
The patent emphasizes the treatment of AML patients with specific mutations in the IDH2 gene, such as R140Q, R172S, and R172K. These mutations are targeted by enasidenib with higher potency compared to the wild-type enzyme form[1].
Claims of the Patent
Therapeutic Use
The patent claims include the administration of compounds described herein for the treatment of cancer. Specifically, it covers the use of enasidenib in treating adult patients with relapsed or refractory AML who have IDH2 mutations. The claims also encompass various methods of preparing these compounds and their pharmaceutical formulations[2].
Pharmaceutical Formulations
The patent details various pharmaceutical formulations, including tablets and film-coated tablets, with specific dosages such as 50 mg and 100 mg. These formulations are designed for oral administration, ensuring patient compliance and effective drug delivery[1].
Patent Landscape
Patent Exclusivity
The patent is part of a broader landscape of intellectual property protection for Agios Pharmaceuticals. The exclusivity period granted by the FDA, which can run concurrently with the patent, ensures that Agios maintains sole marketing rights for enasidenib (marketed as Idhifa) for a specified period. Currently, there is no therapeutically equivalent generic version of Idhifa available in the United States[2].
Related Patents
Agios Pharmaceuticals holds several related patents that cover various aspects of enasidenib and its use in cancer treatment. These include patents such as US9512107, US9732062, US9738625, US10093654, and US10294215, which collectively protect the compound, its methods of use, and pharmaceutical formulations. These patents expire at different dates, with some extending until 2033 and others until 2034[2].
Impact on Innovation and Competition
Innovation Incentives
The patent landscape for enasidenib and related compounds is crucial for incentivizing innovation. By granting exclusive rights, these patents allow Agios Pharmaceuticals to recoup its significant investment in research and development. However, the debate around patent scope and quality suggests that overly broad patents can sometimes hinder innovation by increasing licensing and litigation costs[3][5].
Competitive Landscape
The absence of generic versions of Idhifa in the market means that Agios Pharmaceuticals enjoys a monopoly in this specific therapeutic area. This exclusivity can impact competition, as other companies may be deterred from developing similar treatments due to the strong patent protection. However, this also drives Agios to continue innovating and improving treatments for AML patients[2].
Metrics for Measuring Patent Scope
Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and count can be used to measure the breadth and clarity of patent claims. Narrower claims are often associated with a higher probability of grant and a shorter examination process. This patent, with its specific claims on the use of enasidenib for IDH2-mutated AML, likely underwent a rigorous examination process to ensure its validity and scope[3][5].
Conclusion
United States Patent 10,610,125 is a critical component of the intellectual property portfolio of Agios Pharmaceuticals, protecting the innovative treatment enasidenib for AML patients with IDH2 mutations. The patent's scope and claims are designed to ensure the exclusive use of this therapeutic approach, driving innovation and patient care while navigating the complex landscape of patent law and competition.
Key Takeaways
- Patent Issuance and Expiration: Issued on April 7, 2020, and estimated to expire on June 21, 2030.
- Inventors and Assignees: Held by Agios Pharmaceuticals, Inc., with multiple inventors listed.
- Scope: Covers methods and compositions for treating cell-proliferation-related disorders, specifically AML with IDH2 mutations.
- Claims: Includes therapeutic use, pharmaceutical formulations, and specific dosages.
- Patent Landscape: Part of a broader IP protection strategy, with related patents and exclusivity periods.
- Impact on Innovation: Balances innovation incentives with potential competitive barriers.
FAQs
What is the primary use of the compound described in Patent 10,610,125?
The primary use is for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have specific mutations in the isocitrate dehydrogenase 2 (IDH2) gene.
Who is the assignee of this patent?
The assignee is Agios Pharmaceuticals, Inc.
When is the patent estimated to expire?
The patent is estimated to expire on June 21, 2030.
Are there any generic versions of the drug available?
No, there are currently no therapeutically equivalent generic versions of Idhifa available in the United States.
How does this patent impact competition in the pharmaceutical industry?
The patent grants Agios Pharmaceuticals exclusive rights, which can deter other companies from developing similar treatments, but it also incentivizes Agios to continue innovating and improving treatments for AML patients.
Sources
- DrugBank: Enasidenib: Uses, Interactions, Mechanism of Action.
- Drugs.com: Generic Idhifa Availability.
- Hoover Institution: Patent Claims and Patent Scope.
- USPTO: Patent and Trademark Office Notices.
- SSRN: Patent Claims and Patent Scope.
