Patent landscape, scope, and claims: |
Understanding the Scope and Claims of United States Patent 7,959,946
Introduction
United States Patent 7,959,946, titled "Pharmaceutical formulation containing a biguanide and a sulfonylurea," is a patent that combines two distinct pharmaceutical components to create a new formulation. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Patent Overview
The patent, granted on June 14, 2011, describes a pharmaceutical formulation that includes a biguanide, typically metformin, and a sulfonylurea. This combination is designed to treat conditions such as type 2 diabetes by enhancing the efficacy of each component when used together[4].
Claims
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the pharmaceutical formulation comprising a biguanide and a sulfonylurea.
- Claim 2 may specify the particular biguanide and sulfonylurea used, such as metformin and glipizide.
- Claim 3 could detail the dosage forms, such as tablets or capsules.
Dependent Claims
- These claims further specify the formulation, including the ratio of biguanide to sulfonylurea, the presence of additional ingredients, and the method of administration.
Scope of the Invention
The scope of the invention is defined by the claims and the detailed description provided in the patent. Here are some key aspects:
Pharmaceutical Components
- Biguanide: Typically metformin, which is a common medication for type 2 diabetes.
- Sulfonylurea: Often glipizide, which stimulates insulin release from the pancreas.
Dosage Forms
- The patent may cover various dosage forms, including tablets, capsules, and other oral formulations.
Therapeutic Use
- The formulation is intended for the treatment of type 2 diabetes, potentially offering improved efficacy and convenience over separate administrations of the two drugs.
Patent Eligibility
To understand the patent eligibility of this invention, we must consider the standards set by Section 101 of the Patent Act and recent judicial interpretations.
Section 101 of the Patent Act
- The invention must fall under one of the four categories: process, machine, manufacture, or composition of matter. In this case, the pharmaceutical formulation is a composition of matter[5].
Judicial Interpretations
- The Supreme Court's decisions, such as those in Mayo and Alice, have narrowed patent-eligible subject matter. However, since this patent involves a specific combination of known pharmaceuticals rather than an abstract idea or natural phenomenon, it is likely to be considered patent-eligible under the current framework[5].
Patent Landscape
Trends in Pharmaceutical Patents
- The pharmaceutical industry is highly active in patent filings, with a focus on combination therapies and new formulations that enhance efficacy and patient compliance.
- Recent trends include increased scrutiny under the Alice/Mayo framework, particularly for patents that may be characterized as methods of organizing human activity or mathematical concepts[5].
Continuation Procedures
- The USPTO data shows that continuation procedures, such as Requests for Continued Examination (RCEs) and continuation-in-part (CIP) applications, are common in pharmaceutical patent applications. These procedures allow applicants to refine their claims and introduce new subject matter, which can be relevant for patents like 7,959,946[1].
Economic and Innovation Impact
The granting of this patent can have several economic and innovation-related impacts:
Encouraging Innovation
- Patents like 7,959,946 incentivize pharmaceutical companies to invest in research and development by providing exclusive rights to market the formulation.
- The combination of two known drugs can lead to new therapeutic options and improved patient outcomes.
Market Competition
- The patent can influence market competition by allowing the patent holder to monopolize the market for this specific formulation until the patent expires.
- Generic versions of the individual components may still be available, but the specific combination as described in the patent would be protected.
Stakeholder Views
Stakeholders in the pharmaceutical industry have varying views on patent eligibility and its impact on innovation:
Industry Perspectives
- Some industry stakeholders argue that the current patent eligibility standards can hinder innovation in fields like biotechnology and pharmaceuticals by making it harder to patent certain types of inventions[5].
Regulatory Response
- The USPTO has been evaluating comments and considering next steps to clarify and potentially adjust patent subject matter eligibility guidelines to better support innovation in emerging technologies[5].
Key Takeaways
- Patent Scope: The patent covers a specific pharmaceutical formulation combining a biguanide and a sulfonylurea.
- Claims: The claims define the components, dosage forms, and therapeutic use of the formulation.
- Patent Eligibility: The invention is likely patent-eligible under current standards.
- Economic Impact: The patent can incentivize innovation and affect market competition.
- Stakeholder Views: There are varied perspectives on the impact of patent eligibility standards on innovation in the pharmaceutical industry.
FAQs
-
What is the main subject of United States Patent 7,959,946?
- The main subject is a pharmaceutical formulation containing a biguanide and a sulfonylurea, typically used to treat type 2 diabetes.
-
What are the key components of the formulation described in the patent?
- The key components are a biguanide, such as metformin, and a sulfonylurea, such as glipizide.
-
How does the patent eligibility of this invention align with current judicial interpretations?
- The invention is likely patent-eligible as it involves a specific composition of matter rather than an abstract idea or natural phenomenon.
-
What is the potential economic impact of this patent on the pharmaceutical industry?
- The patent can incentivize innovation and provide exclusive market rights to the patent holder, potentially affecting competition.
-
How do continuation procedures apply to pharmaceutical patent applications like 7,959,946?
- Continuation procedures, such as RCEs and CIPs, can be used to refine claims and introduce new subject matter, which is common in pharmaceutical patent applications.
Sources
- Carley, M., & Hegde, D. (n.d.). What Is the Probability of Receiving a US Patent?. Retrieved from https://yjolt.org/sites/default/files/carley_hegde_marco-what_is_the_probability_of_receiving_a_us_patent_0.pdf
- U.S. Patent and Trademark Office. (n.d.). U.S. Patent and Trademark Office (USPTO). Retrieved from https://www.usa.gov/agencies/u-s-patent-and-trademark-office
- U.S. Patent and Trademark Office. (2017, August 28). Patent Claims Research Dataset. Retrieved from https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
- PubChem. (n.d.). Pharmaceutical formulation containing a biguanide and .... Retrieved from https://pubchem.ncbi.nlm.nih.gov/patent/US7959946
- Congressional Research Service. (2024, January 3). Patent-Eligible Subject Matter Reform: An Overview. Retrieved from https://crsreports.congress.gov/product/pdf/IF/IF12563
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