Detailed Analysis of the Scope and Claims of United States Patent 9,549,926
Overview of the Patent
United States Patent 9,549,926, titled "Compositions and methods of treating pulmonary hypertension," is a crucial patent held by Gilead Sciences, Inc. for the drug Letairis (ambrisentan). Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Patent Details
Patent Number and Title
- Patent Number: US9549926
- Patent Title: Compositions and methods of treating pulmonary hypertension[1][2][5].
Issuance and Expiration Dates
- Issuance Date: January 24, 2017
- Expiration Date: October 14, 2031[1][2][5].
Scope of the Patent
Subject Matter
The patent covers compositions and methods for treating pulmonary hypertension, specifically pulmonary arterial hypertension (PAH). It involves the use of ambrisentan, a selective endothelin type-A receptor antagonist, which is the active ingredient in Letairis[2][5].
Claims
The patent includes various claims that protect different aspects of the drug and its use:
- Composition Claims: These claims cover the specific formulations of ambrisentan, including the dosage forms and the chemical composition of the drug.
- Method Claims: These claims describe the methods for treating pulmonary hypertension using ambrisentan. This includes the administration protocols, dosage regimens, and specific patient populations that can be treated[2][5].
Key Claims
Method for Treating Pulmonary Hypertension
One of the key claims involves the method for treating a pulmonary hypertension condition by administering a therapeutically effective amount of ambrisentan. This claim is specific to the treatment of PAH and outlines the conditions under which the treatment is effective, such as the time from the first diagnosis of the condition[2].
Dosage and Administration
The patent also includes claims related to the dosage and administration of ambrisentan. This includes the specific dosages (5 mg and 10 mg tablets) and the frequency of administration, which are critical for the effective treatment of PAH[5].
Patent Landscape
Related Patents
Letairis is protected by a series of patents, with US9549926 being one of the active patents. Other related patents include:
- US8377933: Method for treating a pulmonary hypertension condition, expiring on December 11, 2027.
- US9474752: Method for treating a pulmonary hypertension condition, also expiring on December 11, 2027[1][2][5].
Exclusivities
In addition to patent protection, Letairis has been granted several exclusivities by the FDA. These exclusivities prevent other companies from marketing generic or bioequivalent versions of Letairis, regardless of the patent status, until these exclusivities expire. This significantly delays the generic launch of the drug[1].
Impact on Generic Launch
Generic Approval and Availability
Although a generic version of Letairis has been approved by the FDA, the commercial availability of these generics is delayed due to the active patents and exclusivities. The estimated generic launch date for Letairis is October 14, 2031, aligning with the expiration of the US9549926 patent[2].
Legal Activities and Patent Life
The life of a patent can be affected by various legal activities such as maintenance fee payments, patent term extensions, or amendments to the claims. For US9549926, recent activities include the payment of maintenance fees, which ensure the patent remains active until its scheduled expiration date[1].
Strategic Implications
Innovation and Competition
The broad scope and active status of US9549926, along with other related patents, create a significant barrier to entry for generic competitors. This allows Gilead Sciences to maintain market exclusivity for Letairis, protecting their investment in research and development and ensuring continued revenue from the drug[1][2].
Patient Access
The delay in generic launch due to patent and exclusivity protections can impact patient access to affordable treatments. Generic drugs are typically cheaper than their brand-name counterparts, so the extended exclusivity period for Letairis may limit access to this critical treatment for patients with PAH[1][2].
Key Takeaways
- Patent Scope: US9549926 covers compositions and methods for treating pulmonary hypertension using ambrisentan.
- Expiration Date: October 14, 2031.
- Related Patents: Other active patents include US8377933 and US9474752.
- Exclusivities: FDA-granted exclusivities delay the generic launch.
- Impact on Generic Launch: Generic versions are approved but not commercially available until the patent expires.
- Strategic Implications: Protects Gilead Sciences' market exclusivity but may limit patient access to affordable treatments.
FAQs
What is the main subject matter of US9549926?
The main subject matter of US9549926 is the compositions and methods for treating pulmonary hypertension using ambrisentan.
When does the patent US9549926 expire?
The patent US9549926 expires on October 14, 2031.
Are there other active patents related to Letairis?
Yes, other active patents include US8377933 and US9474752, both expiring on December 11, 2027.
Why is the generic launch of Letairis delayed?
The generic launch is delayed due to the active patents and FDA-granted exclusivities.
How do patent and exclusivity protections affect patient access to Letairis?
These protections delay the availability of generic versions, potentially limiting patient access to more affordable treatments.
What are the strategic implications of US9549926 for Gilead Sciences?
The patent protects Gilead Sciences' market exclusivity for Letairis, ensuring continued revenue from the drug but potentially limiting competition and patient access to affordable alternatives.
Sources
- Pharsight: Letairis patent expiration.
- Drugs.com: Generic Letairis Availability.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION.
- FDA: Ambrisentan Tablets, 5 mg and 10 mg.
