Understanding the Scope and Claims of United States Patent 10,603,305
Introduction
The United States Patent 10,603,305, titled "Formulations comprising triptan compounds," is a significant patent in the pharmaceutical industry, particularly in the field of migraine treatment. This patent, assigned to Upsher-Smith Laboratories, LLC, involves innovative formulations for intranasal administration of triptan compounds.
Inventors and Assignees
The patent was invented by Rajesh Gandhi, Sagar; Sreekanth Manikonda; Arun Jana; and Sameer Shrinivas Kunte, and is assigned to Upsher-Smith Laboratories, LLC, based in Maple Grove, MN[1].
Patent Issuance and Expiration
The patent was issued on March 31, 2020, and is set to expire on June 16, 2030, which is 20 years from the date of the earliest non-provisional filing[2].
Scope of the Patent
Pharmaceutical Composition
The patent describes a pharmaceutical composition for intranasal administration that includes a salt of sumatriptan or a physiologically acceptable solvate thereof. This composition also includes an alkyl glycoside or saccharide alkyl ester and optionally at least one pharmaceutically acceptable excipient[1][4].
Key Components
- Sumatriptan Salt: The primary active ingredient, which is a well-known triptan compound used for treating migraines.
- Alkyl Glycoside or Saccharide Alkyl Ester: These components enhance the bioavailability of the triptan compound.
- Pharmaceutically Acceptable Excipients: These are optional and can include various ingredients to stabilize the formulation or improve its delivery[1].
Administration and Bioavailability
The formulation is designed for intranasal administration, which provides a rapid onset of action. The composition ensures a T-value (time to reach maximum concentration) of less than 30 minutes, making it highly effective for quick relief from migraine symptoms[1][4].
Claims of the Patent
The patent includes several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically describes the pharmaceutical composition comprising a salt of sumatriptan and an alkyl glycoside or saccharide alkyl ester.
- Subsequent claims detail various aspects of the composition, including the types of solvates, excipients, and the method of administration[1].
Dependent Claims
These claims further specify the characteristics of the composition, such as the concentration of the active ingredients, the type of alkyl glycosides, and the pH range of the formulation[1].
Patent Landscape
Related Patents
- Patent 9,610,280: Also related to formulations comprising triptan compounds, this patent was issued to DR. REDDY'S LABORATORIES LIMITED and has similar claims regarding intranasal administration and bioavailability enhancement[2].
- Patent 9,974,770: Another patent in the series, this one also deals with triptan compound formulations and is a continuation of earlier applications[2].
Exclusivity and Patent Protection
The patent grants exclusive legal rights to the patent holder, protecting the proprietary chemical formulation, brand name, trademark, product dosage form, ingredient formulation, or manufacturing process. This exclusivity can run concurrently with FDA-granted exclusivity periods, which can range from 180 days to seven years depending on the circumstances[2].
Impact on the Pharmaceutical Industry
Innovation in Migraine Treatment
The patent represents a significant innovation in the treatment of migraines by providing a rapid and effective intranasal delivery system. This enhances patient compliance and efficacy, making it a valuable addition to the existing treatment options.
Competitive Landscape
The presence of multiple patents in this area indicates a competitive landscape where several pharmaceutical companies are investing in research and development to improve migraine treatments. This competition drives innovation and potentially leads to better patient outcomes.
Metrics for Measuring Patent Scope
Independent Claim Length and Count
Research suggests that the scope of a patent can be measured using metrics such as independent claim length and independent claim count. Narrower claims are associated with a higher probability of grant and a shorter examination process, which could be relevant for understanding the strategic approach of the patent holders in this field[3].
Conclusion
United States Patent 10,603,305 is a critical patent in the field of pharmaceuticals, particularly for the treatment of migraines. Its scope includes innovative formulations for intranasal administration of triptan compounds, enhancing bioavailability and providing rapid relief. The patent landscape shows a competitive environment with multiple related patents, highlighting the ongoing efforts to improve migraine treatments.
Key Takeaways
- The patent involves a pharmaceutical composition for intranasal administration of sumatriptan.
- It includes an alkyl glycoside or saccharide alkyl ester to enhance bioavailability.
- The formulation ensures a rapid onset of action with a T-value of less than 30 minutes.
- The patent is set to expire on June 16, 2030.
- It is part of a competitive landscape with multiple related patents in the field of migraine treatment.
FAQs
What is the primary active ingredient in the patent 10,603,305?
The primary active ingredient is a salt of sumatriptan or a physiologically acceptable solvate thereof.
What is the purpose of the alkyl glycoside or saccharide alkyl ester in the formulation?
The alkyl glycoside or saccharide alkyl ester enhances the bioavailability of the triptan compound.
What is the expected expiration date of the patent?
The patent is set to expire on June 16, 2030.
How does the intranasal administration of this formulation benefit patients?
The intranasal administration provides a rapid onset of action, with a T-value of less than 30 minutes, offering quick relief from migraine symptoms.
Are there other related patents in this field?
Yes, there are other related patents, such as Patent 9,610,280 and Patent 9,974,770, which also deal with triptan compound formulations for intranasal administration.
Sources
- United States Patent and Trademark Office, "Formulations comprising triptan compounds," US Patent 10,603,305 B2, March 31, 2020.
- Drugs.com, "Generic Tosymra Availability," November 6, 2024.
- SSRN, "Patent Claims and Patent Scope," September 29, 2016.
- Google Patents, "Formulations comprising triptan compounds," US Patent 12,090,139 B2.
- United States Patent and Trademark Office, "Patents Gazette," Week 38, September 17, 2024.
