United States Patent 6,699,885: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,699,885, titled "Substituted benzimidazole dosage forms and methods of using same," is a significant patent in the field of pharmaceuticals, particularly for the treatment of gastric acid disorders. This patent, which has since expired, was crucial for the development and use of specific dosage forms of substituted benzimidazoles, such as omeprazole.
Background
Gastric acid disorders, including conditions like gastroesophageal reflux disease (GERD) and peptic ulcers, are common and can be debilitating. The treatment often involves proton pump inhibitors (PPIs), with omeprazole being one of the most widely used PPIs.
Scope of the Patent
The patent covers various aspects related to the treatment of gastric acid disorders using substituted benzimidazoles. Here are the key components:
Pharmaceutical Compositions
The patent describes pharmaceutical compositions that include substituted benzimidazoles, such as omeprazole, in various dosage forms. These compositions are designed to provide effective and stable delivery of the active ingredient to the gastrointestinal tract[1][4].
Dosage Forms
The patent details several types of dosage forms, including:
- Tablets: Specifically, tablets characterized by shape, structure, or size, including those with holes, special break lines, or identification marks. These tablets can be partially coated or disintegrating flat-shaped forms[1].
- Layered Tablets: Bilayer tablets and tablets with an inert core and an active coat are also described. These layered tablets allow for controlled release of the medication[1].
- Microparticles: The patent includes compositions with drug-containing microparticles in a substantial amount of supporting matrix, which can be in the form of multiparticulate tablets or microcapsules[1].
Methods of Use
The patent outlines methods for treating gastric acid disorders by administering these pharmaceutical compositions. This includes the use of omeprazole in various forms to reduce gastric acid secretion and treat conditions such as GERD and peptic ulcers[1][4].
Claims
The patent contains several claims that define the scope of the invention:
Independent Claims
- Claim 1 typically covers a pharmaceutical composition comprising a substituted benzimidazole, such as omeprazole, in a specific dosage form.
- Claim 2 might cover a method for treating a gastric acid disorder by administering the pharmaceutical composition described in Claim 1[4].
Dependent Claims
- These claims further specify the dosage forms, such as tablets with particular characteristics or layered tablets, and the methods of administration[1].
Patent Landscape
Understanding the patent landscape around US 6,699,885 involves looking at related patents, prior art, and international patent filings.
Prior Art
Prior art cited in the patent includes other methods and compositions for treating gastric acid disorders. For example, U.S. Pat. No. 4,786,505 to Lovgren et al. discloses a pharmaceutical preparation containing omeprazole with an alkaline reacting compound or an alkaline salt of omeprazole[1].
Related Patents
Other patents in the same field include those related to the formulation and administration of PPIs. For instance, the '722 patent mentioned in another context claims a method for treating acid-caused gastrointestinal disorders using a solid dosage form of a PPI[5].
International Filings
The patent landscape extends beyond the United States. International patent offices, such as the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO), provide databases to search for related international patent filings. Tools like the Common Citation Document (CCD) help in consolidating prior art cited by multiple offices for the same invention[2].
Impact on the Pharmaceutical Industry
The expiration of US 6,699,885 has significant implications for the pharmaceutical industry:
Generic Competition
With the patent expired, generic versions of omeprazole and other substituted benzimidazoles can be developed and marketed, increasing competition and potentially reducing costs for consumers.
Innovation
The expiration also opens up opportunities for new innovations in the field of PPIs, as companies are no longer restricted by the claims of this patent.
Key Takeaways
- Pharmaceutical Compositions: The patent covers specific compositions of substituted benzimidazoles for treating gastric acid disorders.
- Dosage Forms: Various dosage forms, including tablets and microparticles, are described.
- Methods of Use: The patent outlines methods for administering these compositions to treat gastric acid disorders.
- Patent Landscape: Understanding related patents, prior art, and international filings is crucial for navigating the patent landscape.
- Impact: The expiration of the patent has led to increased generic competition and potential for new innovations.
FAQs
What is the main subject of US Patent 6,699,885?
The main subject is the use of substituted benzimidazoles, such as omeprazole, in various dosage forms for treating gastric acid disorders.
What types of dosage forms are described in the patent?
The patent describes tablets, layered tablets, and compositions with drug-containing microparticles.
What is the significance of the patent's expiration?
The expiration allows for the development and marketing of generic versions of omeprazole and other substituted benzimidazoles, increasing competition and reducing costs.
How does the patent impact the pharmaceutical industry?
It opens up opportunities for new innovations in PPIs and increases generic competition, potentially reducing consumer costs.
Where can one find related international patent filings?
Related international patent filings can be found through databases provided by the European Patent Office (EPO), Japan Patent Office (JPO), and World Intellectual Property Organization (WIPO)[2].
Sources
- US Patent and Trademark Office, US6699885B2 - Substituted benzimidazole dosage forms and methods of using same, Google Patents.
- US Patent and Trademark Office, Search for patents, USPTO.
- US Patent and Trademark Office, Patent Claims Research Dataset, USPTO.
- Drug Patent Watch, Patent 6,699,885, Drugs covered by patent 6,699,885.
- Aitken Klee, "Second best choice" does not teach away - ZEGERID, Aitken Klee.
