United States Patent 9,827,231: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 9,827,231, issued on November 28, 2017, is a significant patent in the pharmaceutical industry, particularly for the composition and method of making a stable pharmaceutical liquid. This patent is assigned to Ferring International Center S.A. and involves a specific formulation of sodium picosulfate, magnesium oxide, citric acid, and malic acid.
Patent Overview
Inventors and Assignees
The patent was invented by Nam Bong Gil and is assigned to Ferring International Center S.A., a company known for its innovative pharmaceutical products[2].
Composition and Ingredients
The patent describes a physically and chemically stable pharmaceutical liquid composition that includes sodium picosulfate, magnesium oxide, citric acid, and malic acid. This combination is particularly useful for colon cleansing as a preparation for colonoscopy in adults[2][4].
Scope of the Patent
Claims
The patent includes multiple claims that define the scope of the invention. These claims cover the specific formulation of the pharmaceutical liquid, the method of making it, and the use of this composition. The claims are designed to ensure that the patent holder has exclusive rights over the proprietary chemical formulation, including the drug's brand name, trademark, product dosage form, ingredient formulation, and manufacturing process[2].
Enablement and Written Description
The patent must comply with the enablement and written description requirements under 35 U.S.C. § 112(a). This means that the patent application must provide sufficient disclosure to enable a person skilled in the art to make and use the invention without undue experimentation. The written description requirement ensures that the inventor has possession of the invention at the time of filing the patent application[3].
Patent Landscape
Related Patents
Several related patents exist, including U.S. Patents 10,624,879 and 11,191,753, which also pertain to similar pharmaceutical liquid compositions. These patents, issued in 2020 and 2021 respectively, have the same expiration date of June 23, 2024, indicating a coordinated strategy in patent protection by Ferring International Center S.A.[2].
Patent Expiration Dates
The patent 9,827,231 is set to expire on June 26, 2034. This expiration date aligns with the typical 20-year term from the date of filing, although it can be variable based on factors such as the development of new formulations and patent infringement litigation[2].
Legal and Regulatory Context
Drug Patents and Exclusivity
Drug patents, like U.S. Patent 9,827,231, assign exclusive legal rights to the patent holder to protect the proprietary chemical formulation. Exclusivity periods granted by the FDA can run simultaneously with the patent term, providing additional market protection. These exclusivity periods can range from 180 days to seven years, depending on the circumstances[2].
Challenges in Patent Scope
Recent jurisprudence by the Federal Circuit has introduced challenges in the scope of patent claims, particularly in the pharmaceutical and biotechnology industries. The heightened test for enablement and the broader application of the written description doctrine have created uncertainty and made it difficult for innovators to claim the full scope of their inventions without violating these requirements[3].
Litigation and Enforcement
Ferring Pharms. Inc. v. Lupin Inc.
The patent has been involved in litigation, such as the case of Ferring Pharms. Inc. v. Lupin Inc., where the validity and infringement of the '231 patent were contested. This case highlights the importance of robust patent protection and the legal battles that can ensue to protect intellectual property[5].
Impact on the Pharmaceutical Industry
Innovation and Commercialization
Patents like U.S. Patent 9,827,231 are crucial for innovation and commercialization in the pharmaceutical industry. They provide financial incentives for inventors to innovate by offering exclusive rights to their discoveries. However, the current legal landscape, with its stringent requirements for enablement and written description, poses significant challenges for obtaining and maintaining meaningful patent protection[3].
Market and Economic Implications
The market for therapeutic agents, including those covered by this patent, is substantial. For instance, the market for therapeutic antibodies alone is estimated to reach $300 billion by 2025. The stability and predictability of patent protection are essential for supporting commercialization strategies in this lucrative market[3].
Conclusion
United States Patent 9,827,231 represents a significant advancement in pharmaceutical formulations, particularly for colon cleansing preparations. The patent's scope, claims, and the broader patent landscape are critical for understanding the legal and regulatory environment in which pharmaceutical innovations are protected and commercialized.
Key Takeaways
- Composition: The patent covers a stable pharmaceutical liquid composition including sodium picosulfate, magnesium oxide, citric acid, and malic acid.
- Claims: The patent includes claims for the formulation, method of making, and use of the composition.
- Expiration Date: The patent is set to expire on June 26, 2034.
- Legal Context: The patent must comply with enablement and written description requirements under 35 U.S.C. § 112(a).
- Litigation: The patent has been involved in legal disputes, such as Ferring Pharms. Inc. v. Lupin Inc.
- Industry Impact: The patent is crucial for innovation and commercialization in the pharmaceutical industry, despite current legal challenges.
FAQs
Q: What is the main composition covered by U.S. Patent 9,827,231?
A: The main composition covered by the patent includes sodium picosulfate, magnesium oxide, citric acid, and malic acid.
Q: Who is the assignee of U.S. Patent 9,827,231?
A: The assignee of the patent is Ferring International Center S.A.
Q: What is the expiration date of U.S. Patent 9,827,231?
A: The patent is set to expire on June 26, 2034.
Q: What are the key legal requirements for this patent?
A: The patent must comply with the enablement and written description requirements under 35 U.S.C. § 112(a).
Q: How does recent jurisprudence affect pharmaceutical patents like U.S. Patent 9,827,231?
A: Recent jurisprudence by the Federal Circuit has introduced challenges in the scope of patent claims, making it difficult for innovators to claim the full scope of their inventions without violating enablement and written description requirements.
