Understanding the Scope and Claims of United States Patent 10,493,035
Introduction
United States Patent 10,493,035, owned by Global Blood Therapeutics Inc., is a crucial patent protecting the drug Oxbryta (voxelotor). This patent is part of a broader portfolio of patents that safeguard the exclusive rights to this medication, which is used to treat sickle cell disease and other hematological disorders.
Overview of Oxbryta and Its Importance
Oxbryta, or voxelotor, is a small molecule drug designed to inhibit the polymerization of hemoglobin S, thereby preventing the painful and sometimes lethal vaso-occlusive crises associated with sickle cell disease[4].
Patent Details: US10493035B2
Patent Title and Description
The patent titled "Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde" focuses on the formulation and composition of tablets containing the active ingredient voxelotor[1].
Active Ingredient and Formulation
The patent describes the active ingredient, Compound 1, which is a substantially pure crystalline ansolvate form (Form II) characterized by specific X-ray powder diffraction peaks. This form is critical for the stability and efficacy of the drug. The tablets may also include various excipients such as high-compactable microcrystalline cellulose, disintegrants like croscarmellose sodium, and lubricants like magnesium stearate[1].
Claims and Embodiments
The patent includes multiple claims and embodiments that detail the composition and preparation of the tablets. For instance:
- Embodiment 1: The tablet consists essentially of Compound 1 in the crystalline ansolvate form (Form II) with specific X-ray powder diffraction peaks.
- Embodiment 2: The tablet includes an extragranular component and specifies the types of excipients used, such as CeolusTM UF-711 microcrystalline cellulose and croscarmellose sodium as a disintegrant[1].
Patent Expiration and Legal Status
Expiration Date
The patent is set to expire on October 12, 2037, which is 12 years from the current date. This expiration date is subject to change based on legal activities such as patent term extensions or amendments to the claims[2].
Recent Legal Activities
Recent activities include the issuance of patent grants and notifications, as well as the payment of maintenance fees. These activities are crucial for maintaining the patent's validity and exclusivity[2].
Patent Landscape and Protection
US Patents
Oxbryta is protected by 11 US drug patents filed between 2020 and 2024, none of which have expired yet. These patents cover various aspects of the drug, including the active ingredient, dosage forms, and methods of administration[2].
International Protection
In addition to US patents, Oxbryta is also protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points[2].
Challenges and Oppositions
European Patent Office Oppositions
Oxbryta has faced oppositions in the European Patent Office, with the earliest opposition filed in October 2021. These oppositions can impact the patent's validity and exclusivity in European markets[2].
Impact on Pharmaceutical and Biotechnology Industries
Genus Claims and Patent Scope
The scope of patent claims, particularly genus claims, is a critical issue in the pharmaceutical and biotechnology industries. Broad claims can provide meaningful protection but must be supported by a detailed written description to avoid invalidation. Narrow claims, on the other hand, can be easily designed around by competitors[3].
Enablement and Written Description Requirements
The Federal Circuit's current position on genus claims has made it challenging to obtain valuable patent protection. Patentees must ensure that their claims are supported by a written description that enables any person skilled in the art to make and use the invention, which can be a fact-intensive inquiry[3].
Key Takeaways
- Patent Protection: US Patent 10,493,035 is part of a comprehensive patent portfolio protecting Oxbryta, ensuring exclusivity until October 12, 2037.
- Formulation and Composition: The patent details the specific crystalline ansolvate form of the active ingredient and the composition of the tablets.
- Legal Activities: Recent legal activities include patent grants, notifications, and maintenance fee payments.
- Global Landscape: Oxbryta is protected by patents in multiple countries, and understanding this landscape is crucial for market strategy.
- Challenges: The patent faces oppositions in European markets and must navigate the complexities of genus claims and enablement requirements.
FAQs
What is the primary use of the drug protected by US Patent 10,493,035?
The drug, Oxbryta (voxelotor), is primarily used to treat sickle cell disease by inhibiting the polymerization of hemoglobin S.
When is the patent set to expire?
The patent is set to expire on October 12, 2037, subject to any changes due to legal activities.
What are the key components of the tablets described in the patent?
The tablets consist of Compound 1 in a crystalline ansolvate form (Form II) and may include excipients such as microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.
How many US patents protect Oxbryta?
Oxbryta is protected by 11 US drug patents filed between 2020 and 2024.
What are the challenges faced by Oxbryta in terms of patent oppositions?
Oxbryta has faced oppositions in the European Patent Office, which can impact its validity and exclusivity in European markets.
Sources
- US10493035B2 - Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde.
- Oxbryta patent expiration - Pharsight.
- Eviscerating Patent Scope - DigitalCommons@NYLS.
- Voxelotor: Uses, Interactions, Mechanism of Action | DrugBank Online.
