United States Patent 8,524,777: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 8,524,777, titled "Enhanced Bimatoprost Ophthalmic Solution," is a crucial patent in the pharmaceutical industry, particularly for the drug Lumigan, which is owned by AbbVie Inc. This patent is one of several that protect the formulation and use of bimatoprost, an active ingredient used in treating conditions such as open-angle glaucoma and ocular hypertension.
Background of the Patent
The patent was filed on September 2, 2011, and granted on September 3, 2013. It is a continuation of earlier patent applications, including U.S. patent application Ser. No. 13/254,543, which claims the benefit of a national stage application under 35 U.S.C. ยง371 of PCT patent application PCT/US10/26151[4].
Scope of the Patent
Field of the Invention
This patent pertains to pharmaceutical compositions, specifically enhanced bimatoprost ophthalmic solutions. Bimatoprost is a prostaglandin analog used to reduce intraocular pressure in patients with glaucoma or ocular hypertension[4].
Composition Details
The patented composition includes bimatoprost in a concentration range of 0.005% to 0.02% by weight and benzalkonium chloride in a concentration range of 100 ppm to 250 ppm. This specific formulation is designed to enhance the stability and efficacy of the bimatoprost solution[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention:
Independent Claims
- Claim 1 describes the composition comprising bimatoprost and benzalkonium chloride within the specified concentration ranges.
- Subsequent claims detail various aspects of the composition, including the pH range, preservative systems, and the method of preparation[4].
Dependent Claims
These claims further specify the composition by detailing the concentration of other components, such as the type and amount of buffers, and the method of administration (e.g., once daily)[4].
Patent Landscape
Related Patents
The patent 8,524,777 is part of a larger portfolio of patents protecting Lumigan. Other related patents include U.S. Patent Nos. 8,278,353, 8,299,118, 8,309,605, and several others, all of which expire on March 16, 2025, except for U.S. Patent No. 7,851,504, which expires on June 13, 2027[1][2].
Litigation History
This patent has been involved in several litigation cases, particularly in the context of AbbVie defending its intellectual property against generic manufacturers. For example, in the case of AbbVie Inc. v. Mankind Pharma, AbbVie alleged that Mankind's ANDA (Abbreviated New Drug Application) infringed on the claims of U.S. Patent No. 7,851,504, among others[2].
Exclusivities and Generic Launch
The FDA has granted exclusivities to Lumigan, which delay the launch of generic versions until these exclusivities expire. These exclusivities, combined with the active patents, have protected Lumigan from generic competition until the patents expire[1].
Impact on Generic Competition
The expiration of these patents, particularly those set to expire on March 16, 2025, and June 13, 2027, will significantly impact the market. Generic manufacturers will be able to file ANDAs and potentially launch their versions of bimatoprost ophthalmic solutions once the patents expire, provided there are no additional exclusivities or successful litigation that could delay their entry[1][2].
Litigation and Patent Validity
The validity of these patents has been challenged in various legal proceedings. For instance, earlier litigation involving U.S. Patent No. 7,851,504 resulted in the district court finding the patents valid and infringed, with the decision being affirmed on appeal[2].
Conclusion on Patent Scope and Claims
The United States Patent 8,524,777 is a critical component of the intellectual property protection for Lumigan. Its claims and scope define a specific formulation of bimatoprost ophthalmic solution that enhances its stability and efficacy. Understanding this patent and its place within the broader patent landscape is essential for both the original manufacturer and potential generic competitors.
Key Takeaways
- Patent Details: U.S. Patent 8,524,777 protects an enhanced bimatoprost ophthalmic solution with specific concentrations of bimatoprost and benzalkonium chloride.
- Expiration Dates: The patent expires on March 16, 2025, along with several other related patents, while U.S. Patent No. 7,851,504 expires on June 13, 2027.
- Litigation: The patent has been involved in several litigation cases to protect its claims against generic manufacturers.
- Impact on Market: The expiration of these patents will open the market to generic competition, potentially changing the pricing and availability of bimatoprost ophthalmic solutions.
FAQs
What is the main subject of U.S. Patent 8,524,777?
The main subject of U.S. Patent 8,524,777 is an enhanced bimatoprost ophthalmic solution used for treating conditions like open-angle glaucoma and ocular hypertension.
When does U.S. Patent 8,524,777 expire?
U.S. Patent 8,524,777 is set to expire on March 16, 2025.
What are the key components of the patented composition?
The patented composition includes bimatoprost in a concentration range of 0.005% to 0.02% by weight and benzalkonium chloride in a concentration range of 100 ppm to 250 ppm.
Has the validity of this patent been challenged?
Yes, the validity of this patent and related patents has been challenged in various legal proceedings, with some cases resulting in the patents being found valid and infringed.
How will the expiration of this patent affect the market?
The expiration of this patent and related patents will allow generic manufacturers to enter the market, potentially reducing the price of bimatoprost ophthalmic solutions and increasing their availability.
Cited Sources:
- Pharsight: Lumigan patent expiration - Pharsight
- RPX Insight: Case 1:23-cv-00272-UNA Document 1 Filed 03/13/23
- Hoover Institution: Patent Claims and Patent Scope
- Google Patents: US8524777B2 - Enhanced bimatoprost ophthalmic solution
