United States Patent 10,143,656: A Comprehensive Analysis
Introduction
United States Patent 10,143,656, titled "Solid oral sulfate salt formulations for cleaning a colon and methods of using same," is a significant patent in the field of gastrointestinal cleansing. This patent, issued on December 4, 2018, is held by Braintree Laboratories, Inc., and it plays a crucial role in the development and use of colon cleansing formulations.
Inventors and Assignees
The patent was invented by Mark vB. Cleveland, Edmund V. Dennett, Jr., and Russell W. Pelham, all associated with Braintree Laboratories, Inc., based in Braintree, Massachusetts[2][4].
Patent Claims and Scope
The patent claims cover solid oral dosage formulations that include sodium sulfate, magnesium sulfate, and potassium chloride. These formulations are designed to induce purgation of the colon, making them essential for bowel cleansing prior to procedures such as colonoscopy or barium enema X-ray examinations.
Key Components
- Sodium Sulfate: The primary active ingredient responsible for inducing purgation.
- Magnesium Sulfate: Another sulfate salt that aids in the cleansing process.
- Potassium Chloride: Included to help maintain electrolyte balance during the cleansing process[2][4].
Methods of Use
The patent not only describes the composition of the formulations but also outlines the methods for inducing purgation and cleansing the colon. These methods involve administering the formulations in sufficient quantities to ensure effective bowel cleansing[2][4].
Patent Expiration Dates
The patent is set to expire on August 4, 2037. This expiration date is crucial as it determines the period during which Braintree Laboratories, Inc. holds exclusive rights to the formulation and methods described in the patent[2][4].
Related Patents
There are several related patents that extend the scope and protection of the original patent. These include:
- US Patent 11,033,498: Issued on June 15, 2021, with the same inventors and assignee, covering similar formulations and methods.
- US Patent 11,382,864 and US Patent 11,638,697: Also set to expire on August 4, 2037, these patents further solidify the intellectual property rights of Braintree Laboratories, Inc. in this area[2][4].
Drug Patent and Exclusivity
The patent assigns exclusive legal rights to Braintree Laboratories, Inc., protecting the proprietary chemical formulation. This exclusivity is crucial for the commercialization strategy of the company, as it prevents other entities from manufacturing or marketing similar products during the patent period. The FDA also grants exclusivity periods that can run concurrently with the patent, ensuring sole marketing rights for the approved drug[2][3].
Impact on the Pharmaceutical Industry
The patent landscape, particularly in the pharmaceutical and biotechnology industries, is heavily influenced by the scope and claims of patents like US 10,143,656. The Federal Circuit's stance on genus claims, as discussed in legal analyses, highlights the challenges innovators face in obtaining and maintaining meaningful patent protection. Broad claims can be invalidated if they do not meet the written description and enablement requirements, while narrow claims can be easily circumvented by competitors[3].
Economic and Market Implications
The market for gastrointestinal cleansing products is significant, and patents like US 10,143,656 play a critical role in protecting the investments made by companies like Braintree Laboratories, Inc. The absence of generic versions, as indicated by the lack of a therapeutically equivalent version of Sutab, further underscores the economic importance of these patents[2].
Legal and Regulatory Considerations
The patent claims must adhere to the statutory requirements outlined in 35 U.S.C. § 112(a), which includes the written description and enablement requirements. The Federal Circuit's rigid position on these requirements can make it challenging for innovators to secure broad patent protection without risking invalidation[3].
Conclusion
United States Patent 10,143,656 is a pivotal patent in the field of colon cleansing formulations. It protects the proprietary formulations and methods developed by Braintree Laboratories, Inc., ensuring exclusive rights until its expiration in 2037. The patent's scope and claims are critical in the pharmaceutical industry, influencing both the commercialization strategies of companies and the broader legal landscape surrounding patent protection.
Key Takeaways
- Patent Scope: Covers solid oral dosage formulations including sodium sulfate, magnesium sulfate, and potassium chloride.
- Methods of Use: Describes methods for inducing purgation and cleansing the colon.
- Expiration Date: August 4, 2037.
- Related Patents: Includes US Patents 11,033,498, 11,382,864, and 11,638,697.
- Impact on Industry: Significant for protecting investments and influencing commercialization strategies.
- Legal Considerations: Must adhere to 35 U.S.C. § 112(a) requirements.
Frequently Asked Questions
Q: What is the primary use of the formulations described in US Patent 10,143,656?
A: The primary use is for bowel cleansing prior to procedures such as colonoscopy or barium enema X-ray examinations.
Q: Who are the inventors of US Patent 10,143,656?
A: The inventors are Mark vB. Cleveland, Edmund V. Dennett, Jr., and Russell W. Pelham.
Q: What is the expiration date of US Patent 10,143,656?
A: The patent is set to expire on August 4, 2037.
Q: Are there any generic versions of Sutab available?
A: No, there is currently no therapeutically equivalent version of Sutab available in the United States[2].
Q: How does the Federal Circuit's stance on genus claims affect pharmaceutical patents?
A: The Federal Circuit's rigid position on genus claims makes it challenging for innovators to secure broad patent protection without risking invalidation, as claims must meet strict written description and enablement requirements[3].