United States Patent 10,098,866: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,098,866, titled "Pharmaceutical preparation containing copolyvidone," is a significant patent in the pharmaceutical industry, particularly for the drug Rozerem (ramelteon). This patent, owned by Takeda Pharmaceuticals USA Inc., has recently expired, opening the door for generic versions of the drug. Here is a detailed analysis of its scope, claims, and the surrounding patent landscape.
Patent Overview
Patent Title and Number
- Patent Title: Pharmaceutical preparation containing copolyvidone
- Patent Number: US10098866B2
Patent Owner
The patent is owned by Takeda Pharmaceuticals USA Inc., a major player in the pharmaceutical industry[2].
Patent Expiration
The patent expired on November 16, 2021, marking the end of Takeda's exclusive rights to manufacture and market the specific formulation of Rozerem covered by this patent[2].
Scope of the Patent
Pharmaceutical Preparation
The patent describes a stabilized pharmaceutical preparation that includes an unstable drug in a polyethylene glycol-containing preparation, coated with a specific coating agent. This coating agent is crucial for maintaining the stability of the drug[1].
Coating Agent
The coating agent contains copolyvidone, an organic macromolecular compound, which is mixed with a coating base and optionally other additives. The copolyvidone content in the coating agent can range from about 5% to 50% by weight, with a preferred range of 10% to 30% by weight[1].
Dosage Forms
The patent covers various dosage forms, including tablets, powders, granules, fine granules, and pills. This versatility allows for different administration methods, enhancing the drug's usability[1].
Claims of the Patent
Key Claims
- The patent claims a pharmaceutical preparation with a specific coating agent containing copolyvidone.
- It specifies the range of copolyvidone content and the method of manufacturing the coating agent.
- The claims also include the use of various solvents and additives in the coating agent[1].
Claim Language and Scope
The claims are detailed to ensure that the coating agent and the pharmaceutical preparation meet specific criteria for stability and efficacy. The language is precise, defining the composition and manufacturing process to prevent infringement by similar but distinct formulations[1].
Patent Landscape
Related Patents
Rozerem, the drug protected by this patent, is also covered by other patents, some of which have also expired. For example, US6034239, another patent related to Rozerem, expired on July 22, 2019[2].
Generic Versions
With the expiration of the US10098866B2 patent, several companies have filed for and launched generic versions of ramelteon. Companies like Zydus Pharmaceuticals USA Inc., Granules Pharmaceuticals Inc., and Xiromed Pharma Espana Sl have introduced their generic versions of the drug[2].
Manufacturing and Distribution
The generic versions are manufactured in various locations, including the United States and India. This global manufacturing footprint ensures widespread availability of the generic drug[2].
Impact of Patent Expiration
Market Competition
The expiration of the patent has opened the market to generic competition, which is expected to reduce the cost of the drug and increase its accessibility to patients. This competition can also drive innovation as companies seek to differentiate their products through improved formulations or delivery methods[2].
Legal Activities
The patent's expiration was preceded by various legal activities, including maintenance fee reminders and issue notifications. These activities are crucial in the patent lifecycle and affect the timing and availability of generic drugs[2].
Metrics for Patent Scope
Claim Length and Count
Research on patent scope suggests that narrower claims, as seen in this patent, are associated with a higher probability of grant and a shorter examination process. The detailed claims in US10098866B2 reflect a focused scope, which likely contributed to its successful grant and maintenance[3].
Conclusion
The United States Patent 10,098,866 is a significant example of how pharmaceutical patents can protect innovative formulations and ensure drug stability. With its expiration, the landscape for ramelteon has changed, allowing for generic competition and potentially broader patient access.
Key Takeaways
- Patent Title and Number: "Pharmaceutical preparation containing copolyvidone," US10098866B2.
- Patent Owner: Takeda Pharmaceuticals USA Inc.
- Patent Expiration: November 16, 2021.
- Scope: Covers a stabilized pharmaceutical preparation with a specific coating agent containing copolyvidone.
- Claims: Detailed claims specifying the composition and manufacturing process of the coating agent.
- Impact: Expiration has led to generic competition, reducing drug costs and increasing accessibility.
- Metrics: Narrower claims are associated with a higher grant probability and shorter examination process.
FAQs
What is the main subject of the United States Patent 10,098,866?
The main subject is a pharmaceutical preparation containing copolyvidone, specifically used in the drug Rozerem (ramelteon).
Who owns the United States Patent 10,098,866?
The patent is owned by Takeda Pharmaceuticals USA Inc.
When did the patent expire?
The patent expired on November 16, 2021.
What are the key components of the coating agent described in the patent?
The coating agent contains copolyvidone, a coating base, and optionally other additives, with copolyvidone content ranging from about 5% to 50% by weight.
What are the implications of the patent's expiration?
The expiration has led to the introduction of generic versions of ramelteon, increasing market competition and potentially reducing drug costs.
How does the patent's claim language impact its scope?
The precise claim language ensures that the coating agent and pharmaceutical preparation meet specific criteria, preventing infringement by similar but distinct formulations.
Sources
- Google Patents: Pharmaceutical preparation containing copolyvidone - Google Patents
- Pharsight: Drug Patents containing Ramelteon - Pharsight
- Hoover Institution: Patent Claims and Patent Scope - Hoover Institution
