United States Patent 8,481,083: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 8,481,083, hereafter referred to as the '083 patent, is a critical component in the intellectual property portfolio of Ferring Pharmaceuticals, particularly in the context of their product Prepopik. This patent is central to ongoing litigation and regulatory discussions, especially concerning generic drug approvals. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Ownership
The '083 patent is owned by Ferring International Center S.A. (FICSA) and exclusively licensed to Ferring Pharmaceuticals[2].
- The patent was issued by the USPTO and is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)[2][4].
Claims of the '083 Patent
The '083 patent includes several key claims that define its scope and applicability.
Independent Claims
- The patent claims two types of coated granules:
- Citric acid granules coated with a layer of magnesium oxide.
- Potassium bicarbonate granules coated with a layer of sodium picosulfate[1][5].
Claim 1
- Claim 1 specifically describes a composition comprising these coated granules. For instance, it includes citric acid granules with a continuous layer of magnesium oxide due to the relative proportions of the compounds involved[1].
Patent Scope and Clarity
The scope of the '083 patent is defined by its claims, which are subject to scrutiny for clarity and breadth.
Claim Length and Count
- Research suggests that patent scope can be measured by independent claim length and count. Narrower claims, like those in the '083 patent, are often associated with a higher probability of grant and a shorter examination process[3].
Examination Process
- The examination process tends to narrow the scope of patent claims, ensuring that the claims are clear and specific. This was likely the case for the '083 patent, given its detailed descriptions of the coated granules[3].
Litigation and Regulatory Context
The '083 patent has been at the center of several legal and regulatory battles.
Infringement Actions
- Ferring Pharmaceuticals has initiated patent infringement actions against several generic drug manufacturers, including Teva and Par Pharmaceutical, alleging that their Abbreviated New Drug Applications (ANDAs) infringe the '083 and '338 patents[1][2].
Paragraph IV Certifications
- Generic manufacturers have submitted Paragraph IV certifications, arguing that the patents in question are invalid, unenforceable, or not infringed by their ANDA products. These certifications are part of the regulatory process under 21 U.S.C. § 355(j)(2)[2].
Technical Aspects and Expert Testimony
The technical aspects of the '083 patent are crucial in determining infringement and validity.
Coating Layers
- Expert testimony, such as that from Dr. Davies, highlights the importance of the coating layers. For example, the magnesium oxide layer on citric acid granules is expected to be continuous due to the relative proportions of the compounds[1].
Granule Composition
- The patent specifies the composition of the granules, including the use of sodium picosulfate and potassium bicarbonate. These specifications are key in distinguishing the patented product from generic alternatives[1].
Market Impact and Exclusivity
The '083 patent plays a significant role in maintaining market exclusivity for Prepopik.
Orange Book Listings
- The patent is listed in the Orange Book, ensuring that any generic version must address these patents before gaining FDA approval. The patents expire on October 10, 2028[4].
Competitive Landscape
- The exclusivity provided by the '083 patent helps Ferring Pharmaceuticals maintain a competitive edge in the market for colonoscopy preparation products[4].
Industry Perspectives and Criticisms
The broader patent landscape and industry perspectives offer additional context.
Patent Quality Debates
- There are ongoing debates about patent quality, with some arguing that broader patents can stifle innovation. However, the '083 patent's specific claims suggest a narrower scope, which is generally seen as more favorable for innovation[3].
Litigation Costs
- Litigation over patents like the '083 patent can be costly and complex. This has led to discussions about the balance between protecting intellectual property and promoting innovation[3].
Key Takeaways
- The '083 patent is crucial for Ferring Pharmaceuticals' product Prepopik, defining specific coated granules.
- The patent is subject to litigation and regulatory scrutiny, particularly from generic drug manufacturers.
- The technical aspects, such as coating layers and granule composition, are key in determining infringement and validity.
- The patent's listing in the Orange Book ensures market exclusivity until its expiration in 2028.
FAQs
What are the main claims of the '083 patent?
The '083 patent claims two types of coated granules: citric acid granules coated with magnesium oxide and potassium bicarbonate granules coated with sodium picosulfate.
Who owns the '083 patent?
The '083 patent is owned by Ferring International Center S.A. (FICSA) and exclusively licensed to Ferring Pharmaceuticals.
What is the significance of the '083 patent in litigation?
The '083 patent is central in patent infringement actions against generic drug manufacturers, such as Teva and Par Pharmaceutical, who have submitted ANDAs for generic versions of Prepopik.
How does the '083 patent affect market exclusivity?
The patent's listing in the Orange Book ensures that any generic version must address these patents before gaining FDA approval, maintaining market exclusivity for Prepopik until the patent's expiration in 2028.
What are the technical aspects that distinguish the '083 patent?
The patent specifies the composition of the granules, including the use of continuous coating layers of magnesium oxide on citric acid granules and sodium picosulfate on potassium bicarbonate granules.
Cited Sources:
- District of Delaware, "Opinions", July 2017.
- United States District Court for the District of Delaware, "Ferring Pharmaceuticals Inc. v. Teva USA, Inc.", July 2017.
- Hoover Institution, "Patent Claims and Patent Scope", August 2016.
- FDA, "Clenpiq (sodium picosulfate, magnesium oxide and anhydrous citric acid) Tablets", November 2017.
- Casetext, "Ferring Pharms. Inc. v. Par Pharm., Inc.", July 2017.
