Understanding the Scope and Claims of United States Patent 10,213,487
Overview of the Patent
United States Patent 10,213,487, titled "Nasal powder formulation for treatment of hypoglycemia," was issued on February 26, 2019, to inventors Mantripragada Sankaram, Piche Claude A., and Van Betsbrugge Jo Jan Filip, and is assigned to Eli Lilly and Company[1][2].
Patent Claims and Scope
Primary Claims
The patent primarily covers a nasal powder formulation containing glucagon or a glucagon analog, designed for the treatment of hypoglycemia, particularly severe hypoglycemia. Here are the key aspects of the claims:
-
Formulation: The patent describes a powder formulation that includes glucagon or a glucagon analog, which is administered nasally. This formulation is crucial for rapid and effective treatment of hypoglycemic episodes[1][2].
-
Method of Making: The patent also includes methods for preparing this nasal powder formulation, which involves specific steps and ingredients to ensure the stability and efficacy of the glucagon or glucagon analog[1].
-
Devices and Methods for Use: The patent covers devices and methods for using the nasal powder formulation. This includes the design of the nasal delivery device and the procedure for administering the formulation to patients[1].
Specific Claims
The patent claims are detailed and specific, ensuring broad protection for the invention while adhering to the requirements of patent law. Here are some key points:
-
Composition Claims: The claims specify the composition of the nasal powder, including the active ingredient (glucagon or glucagon analog), excipients, and other components necessary for stability and delivery[1].
-
Method Claims: The patent includes claims related to the method of manufacturing the nasal powder formulation, ensuring that the process is protected against infringement[1].
-
Device Claims: The claims also cover the design and functionality of the nasal delivery device, which is essential for the effective administration of the formulation[1].
Patent Expiration and Generic Launch
The patent is set to expire on February 16, 2036. However, the generic launch date for Baqsimi, which this patent protects, is estimated to be later due to other active patents and exclusivities. The latest generic launch date is projected to be September 23, 2039, based on other patents and regulatory exclusivities[2].
Regulatory Exclusivities
In addition to patent protection, Baqsimi benefits from regulatory exclusivities granted by the FDA. These exclusivities can run concurrently with or independently of patent protection and prevent other companies from marketing generic or bioequivalent versions of the drug until these exclusivities expire[2].
Broader Patent Landscape
Family Patents
Baqsimi is protected by a family of patents, including US10765602 and US10894133, which cover other aspects of the drug such as medication delivery systems and devices for dispensing fluid products. Understanding the full scope of these patents is crucial for strategizing market entry and identifying potential generic entry points in markets with weaker patent protection[2].
International Protection
The patent protection for Baqsimi extends beyond the United States, with patents filed in multiple countries. This global protection landscape is important for companies looking to enter the market with generic versions, as they need to navigate the patent and exclusivity landscape in various jurisdictions[2].
Legal and Regulatory Implications
Enablement and Written Description
The scope of patent claims, particularly in the pharmaceutical industry, is subject to strict enablement and written description requirements. The Federal Circuit has recently applied a heightened test for enablement, which can make it challenging for innovators to claim the full scope of their inventions without violating these requirements[3].
Device Patents and Regulatory Strategies
Drug-device combinations, like the nasal delivery system for Baqsimi, are often subject to extensive patenting. Manufacturers can list patents on the delivery devices, which can extend the duration of expected protection and create barriers to competition. This strategy, known as "device hopping," involves launching products in new devices with the same active ingredients to maintain market exclusivity[4].
Impact on Generic Competition
The combination of patent protection and regulatory exclusivities significantly delays the entry of generic competitors into the market. For Baqsimi, the estimated generic launch date of September 23, 2039, reflects the comprehensive protection afforded by these mechanisms. This extended protection period allows the original manufacturer to maintain market dominance and recoup investment in research and development[2].
Key Takeaways
- Patent Scope: The patent covers a nasal powder formulation for treating hypoglycemia, including the composition, method of making, and devices for use.
- Expiration Date: The patent expires on February 16, 2036, but generic launch is delayed due to other patents and exclusivities.
- Regulatory Exclusivities: FDA-granted exclusivities further protect the drug from generic competition.
- Broader Patent Landscape: Baqsimi is protected by a family of patents and international filings.
- Legal and Regulatory Implications: Strict enablement and written description requirements and device patents impact generic competition.
FAQs
Q: What is the primary focus of United States Patent 10,213,487?
A: The patent focuses on a nasal powder formulation containing glucagon or a glucagon analog for treating hypoglycemia.
Q: Who are the inventors and assignee of this patent?
A: The inventors are Mantripragada Sankaram, Piche Claude A., and Van Betsbrugge Jo Jan Filip, and the assignee is Eli Lilly and Company.
Q: When is the patent set to expire?
A: The patent is set to expire on February 16, 2036.
Q: How do regulatory exclusivities affect the generic launch of Baqsimi?
A: Regulatory exclusivities granted by the FDA prevent generic or bioequivalent versions of Baqsimi from being marketed until these exclusivities expire, delaying the generic launch.
Q: What is the estimated generic launch date for Baqsimi?
A: The estimated generic launch date for Baqsimi is September 23, 2039, based on other active patents and exclusivities.
Cited Sources
- Drugs.com: Generic Baqsimi Availability.
- Pharsight: Baqsimi patent expiration.
- DigitalCommons@NYLS: Eviscerating Patent Scope.
- PLOS Medicine: Patents and regulatory exclusivities on FDA-approved insulin products.
