Pharmaceutical Formulations Comprising Nitrocatechol Derivatives: A Detailed Analysis of US Patent 10,071,085
Introduction
US Patent 10,071,085, titled "Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof," is a significant patent in the pharmaceutical industry, particularly in the realm of central and peripheral nervous system disorders. This patent, assigned to BIAL—Portela & CA, S.A., provides a comprehensive overview of compositions and formulations involving nitrocatechol derivatives.
Patent Overview
Publication and Issuance
The patent was issued on September 11, 2018, and is currently active until its expiration date of March 31, 2030[5].
Inventors and Assignees
The inventors listed on the patent include de Vasconcelos Teofilo Cardoso, dos Santos Lima Ricardo Jorge, and de Campos Costa Rui Cerdeira. The assignee is BIAL—Portela & CA, S.A., a pharmaceutical company known for its innovative drug formulations[5].
Scope and Claims
Active Pharmaceutical Ingredients
The patent focuses on pharmaceutical formulations that include at least one active pharmaceutical ingredient chosen from nitrocatechol derivatives. These derivatives are defined by specific chemical formulas and include various salts, esters, hydrates, solvates, and other derivatives thereof[5].
Pharmaceutical Formulations
The patent describes various methods for preparing these pharmaceutical formulations, including different dosage forms such as tablets, capsules, and injectable solutions. The formulations are designed to enhance the stability, bioavailability, and efficacy of the nitrocatechol derivatives[5].
Methods of Making
The patent details several methods for synthesizing the nitrocatechol derivatives and preparing the pharmaceutical formulations. These methods involve various chemical reactions and purification steps to ensure the quality and consistency of the final product[5].
Patent Claims
Independent Claims
The patent includes several independent claims that define the scope of the invention. These claims cover the specific chemical structures of the nitrocatechol derivatives, the pharmaceutical formulations containing these derivatives, and the methods for preparing these formulations[5].
Dependent Claims
Dependent claims further specify the characteristics of the nitrocatechol derivatives, such as their pharmacological properties, and the various forms in which the pharmaceutical formulations can be administered. These claims also include details on the manufacturing processes and the use of specific excipients to enhance the formulations[5].
Patent Landscape
Related Patents
Several related patents exist that complement the scope of US Patent 10,071,085. For example, patents such as US Patent 9,550,759 and US Patent 8,907,099, also assigned to BIAL—Portela & CA, S.A., cover similar nitrocatechol derivatives and their use as COMT inhibitors. These patents collectively form a robust intellectual property portfolio for the company in the area of central and peripheral nervous system disorders[5].
Exclusivity and Patent Term
The patent term for US Patent 10,071,085 is set to expire on March 31, 2030. Additionally, the patent holder may benefit from FDA exclusivity periods, which can run concurrently with the patent term, providing additional market protection[5].
Regulatory Aspects
FDA Approval and Patent Term Extension
The patent holder may be eligible for patent term extension under 35 U.S.C. 156 if the FDA approves a drug product based on this patent. This is evident from similar cases where patent term extensions were sought based on FDA approvals, such as the case of ONGENTYS® (opicapone)[2].
Impact on Innovation
Patent Scope and Quality
The scope of this patent, measured by metrics such as independent claim length and count, can influence the incentives for innovation. Narrower claims, as seen in this patent, are often associated with a higher probability of grant and a shorter examination process, which can foster more focused and efficient innovation[3].
Market Implications
Generic Availability
As of now, there is no generic version of the drug formulations covered by this patent available in the United States. This lack of generic competition allows the patent holder to maintain market exclusivity until the patent expires or is challenged[5].
Conclusion
US Patent 10,071,085 is a critical piece of intellectual property in the pharmaceutical sector, particularly for BIAL—Portela & CA, S.A. The patent's detailed claims and methods for preparing nitrocatechol derivatives provide a strong foundation for the development and marketing of innovative drug formulations.
Key Takeaways
- Patent Scope: The patent covers specific nitrocatechol derivatives and their pharmaceutical formulations.
- Claims: Independent and dependent claims define the chemical structures, formulations, and methods of making.
- Patent Landscape: Related patents enhance the company's intellectual property portfolio.
- Regulatory Aspects: Eligibility for patent term extension based on FDA approvals.
- Impact on Innovation: Narrower claims can foster more focused innovation.
- Market Implications: No generic versions available, maintaining market exclusivity.
FAQs
What are the main active pharmaceutical ingredients covered by US Patent 10,071,085?
The main active pharmaceutical ingredients are nitrocatechol derivatives, including their salts, esters, hydrates, solvates, and other derivatives.
Who are the inventors and assignees of the patent?
The inventors include de Vasconcelos Teofilo Cardoso, dos Santos Lima Ricardo Jorge, and de Campos Costa Rui Cerdeira. The assignee is BIAL—Portela & CA, S.A.
What is the expiration date of the patent?
The patent is set to expire on March 31, 2030.
Are there any related patents that complement this patent?
Yes, patents such as US Patent 9,550,759 and US Patent 8,907,099 cover similar nitrocatechol derivatives and their use as COMT inhibitors.
Is there a generic version of the drug formulations covered by this patent available?
No, there is currently no generic version available in the United States.
Sources
- US Patent 10,071,085 - Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof.
- Regulations.gov - Application for patent term extension of U.S. Patent No. 9,630,955.
- SSRN - Patent Claims and Patent Scope.
- US Patent 10,719,085 - Therapeutic compounds.
- Drugs.com - Generic Ongentys Availability.
