United States Patent 7,452,872: A Detailed Analysis of Scope and Claims
Introduction
United States Patent 7,452,872, titled "Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives," is a patent that revolves around the use of balsalazide, a drug commonly used in the treatment of inflammatory bowel diseases such as ulcerative colitis. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of Balsalazide
Balsalazide is an anti-inflammatory drug that is specifically designed to treat conditions like ulcerative colitis, radiation enteritis, and irritable bowel syndrome. It is marketed under the brand names Colazal in the US and Colazide in other regions[1][4].
Patent Overview
The patent US 7,452,872 was granted on November 18, 2008, and is set to expire on February 24, 2027. It covers various formulations and uses of balsalazide, including its application in treating gastrointestinal disorders.
Claim Scope
The claim scope of a patent is crucial as it defines the boundaries of the invention and the protection it offers. For US 7,452,872, the claims are centered around the specific formulations of balsalazide and its therapeutic uses.
Independent Claims
Independent claims are those that stand alone and do not depend on other claims. In this patent, the independent claims typically describe the composition of balsalazide formulations and their methods of use. For example, Claim 1 might describe a pharmaceutical composition comprising balsalazide and a carrier, while Claim 2 might detail a method for treating ulcerative colitis using balsalazide[4].
Dependent Claims
Dependent claims build upon the independent claims and provide additional details or limitations. These claims often specify particular aspects of the formulation, such as the dosage form, the amount of active ingredient, or specific excipients used. Dependent claims help to narrow down the scope and provide additional protection for specific embodiments of the invention[4].
Importance of Claim Scope
The scope of the claims in a patent application is a delicate balance. While broader claims offer more extensive protection, they are also more challenging to get granted and easier to invalidate. The claims in US 7,452,872 must be anchored to the embodiments disclosed in the specification to avoid issues like the abstract idea exception or failure to meet the written description requirement[5].
Patent Landscape
The patent landscape surrounding US 7,452,872 involves several key aspects:
Prior Art and Novelty
The patent office evaluates the novelty and non-obviousness of the invention by comparing it to prior art. For balsalazide formulations, the prior art includes existing treatments for inflammatory bowel diseases and other related pharmaceutical compositions. The claims in US 7,452,872 must demonstrate a significant improvement or a new use that distinguishes it from prior art[5].
Patent Maintenance and Litigation
Patents like US 7,452,872 are subject to maintenance fees and can be involved in litigation. The patent holder must pay periodic fees to keep the patent in force. Litigation can arise if generic manufacturers attempt to challenge the patent or if other companies infringe on the patented claims. Settlements and consent judgments, as seen in other pharmaceutical patent cases, can resolve such disputes[2].
Examination Process
The examination process for patents tends to narrow the scope of claims. This is evident from studies showing that narrower claims at publication are associated with a higher probability of grant and a shorter examination process. The examination process for US 7,452,872 would have involved a thorough review of the claims to ensure they are clear, concise, and supported by the specification[3].
Therapeutic Uses
The patent covers various therapeutic uses of balsalazide, including:
Ulcerative Colitis
Balsalazide is primarily used to treat ulcerative colitis, a chronic condition that causes inflammation and ulcers in the inner lining of the colon and rectum[1][4].
Radiation Enteritis
It is also used to treat radiation enteritis, a condition resulting from radiation therapy that causes inflammation and damage to the small intestine[4].
Irritable Bowel Syndrome
Additionally, balsalazide can be used to treat irritable bowel syndrome (IBS), a disorder that affects the large intestine, causing symptoms such as abdominal pain, bloating, and changes in bowel movements[4].
Formulations
The patent describes various formulations of balsalazide, including:
Oral Formulations
Balsalazide can be formulated into oral capsules or tablets, designed to release the active ingredient in the colon where it is needed most[1][4].
Dosage Forms
The patent specifies different dosage forms and strengths of balsalazide, ensuring that the drug can be tailored to individual patient needs[4].
Key Takeaways
- Balanced Claim Scope: The claims in US 7,452,872 are carefully crafted to balance breadth and specificity, ensuring robust protection without being overly broad.
- Therapeutic Uses: The patent covers a range of therapeutic uses for balsalazide, including ulcerative colitis, radiation enteritis, and irritable bowel syndrome.
- Formulation Variations: The patent describes various formulations of balsalazide, including oral capsules and tablets.
- Patent Landscape: The patent is part of a broader landscape that includes maintenance fees, potential litigation, and the ongoing need to distinguish the invention from prior art.
FAQs
What is the primary use of balsalazide as described in US 7,452,872?
The primary use of balsalazide as described in US 7,452,872 is the treatment of ulcerative colitis.
What other conditions can balsalazide be used to treat according to the patent?
According to the patent, balsalazide can also be used to treat radiation enteritis and irritable bowel syndrome.
Why is the scope of claims important in a patent application?
The scope of claims is crucial because it defines the boundaries of the invention and the protection it offers. Broader claims, while desirable, must be balanced to avoid being too broad and thus easier to invalidate.
What is the significance of the examination process in narrowing claim scope?
The examination process tends to narrow the scope of claims, making narrower claims at publication associated with a higher probability of grant and a shorter examination process.
How does the patent landscape impact the maintenance and litigation of US 7,452,872?
The patent landscape involves periodic maintenance fees and potential litigation. Settlements and consent judgments can resolve disputes related to patent infringement or challenges to the patent's validity.
Cited Sources:
- DrugBank: Balsalazide: Uses, Interactions, Mechanism of Action.
- Robins Kaplan LLP: ANDA Litigation Settlements | Hatch-Waxman.
- SSRN: Patent Claims and Patent Scope.
- Google Patents: Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives.
- Rimon Law: The Importance of Getting the Claim Scope Right in a US Patent Application.
