United States Patent 7,780,987: A Detailed Analysis of Scope and Claims
Introduction
The United States Patent 7,780,987, hereafter referred to as the "'987 Patent," is part of a series of patents held by Depomed, Inc. and Valeant International (Barbados) SLR, related to advanced drug-delivery systems. This patent is crucial in the pharmaceutical industry, particularly for controlled release formulations.
Background and Context
The '987 Patent is one of several patents asserted in a patent infringement action against Sun Pharma Global FZE, Sun Pharmaceutical Industries Ltd., and Sun Pharmaceutical Industries Inc.[1][2].
These patents collectively pertain to drug-delivery systems designed for the controlled release of incorporated drugs in the upper gastrointestinal system, which includes the stomach and upper small intestines.
Patent Claims and Scope
Claim Construction
The '987 Patent involves specific claim constructions that are critical for understanding its scope. Claim construction is a legal process where the court determines the meaning and scope of the patent claims. In the case of the '987 Patent, the claims are related to a drug-delivery system that allows for extended, controlled release of a drug.
Key Terms and Definitions
- Polymeric Matrix: This term, also found in other related patents like the '475 and '280 Patents, is defined differently by the plaintiffs and defendants. Plaintiffs define it as "a surrounding medium comprising polymer," while defendants construe it as "a polymeric formulation containing a sufficient amount of suitable polymer or polymer mix to provide extended, controlled release of a drug dispersed throughout the formulation."[1]
- Coating and Poly Glycerol: The patent specifies that the coating must be "cured at a temperature at least equal to or greater than the melting point of the poly glycol," which must have a melting point greater than 55° C. This coating can be manipulated to achieve a desired drug release profile[1].
Technical Aspects
Drug Delivery System
The '987 Patent describes a drug-delivery system that ensures the controlled release of an incorporated drug. This system is designed to release the drug in the upper gastrointestinal system, which is crucial for drugs like metformin hydrochloride, used in the treatment of diabetes.
Extended Release Mechanism
The mechanism involves a polymeric matrix and a specific coating process. The polymeric matrix ensures that the drug is released over an extended period, while the coating process allows for the manipulation of the release profile. This is achieved by curing the coating at a temperature equal to or greater than the melting point of the poly glycol, ensuring a consistent and controlled release[1].
Patent Landscape
Related Patents
The '987 Patent is part of a suite of patents that include:
- United States Patent No. 6,340,475 (the "'475 Patent")
- United States Patent No. 6,635,280 (the "'280 Patent")
- United States Patent No. 6,488,962 (the "'962 Patent")
- United States Patent No. 7,736,667 (the "'667 Patent")[1][2].
Litigation and Enforcement
These patents have been involved in several litigation cases, particularly against generic drug manufacturers seeking to market generic versions of Depomed's products, such as Glumetza (metformin hydrochloride). Defendants have submitted Abbreviated New Drug Applications (ANDAs) to the FDA, certifying that the patents are either invalid or will not be infringed by their generic products[1][2].
Impact on Pharmaceutical Industry
Innovation and Competition
The '987 Patent and related patents play a significant role in the pharmaceutical industry by protecting innovative drug-delivery technologies. This protection allows companies like Depomed to invest in research and development, knowing their intellectual property is safeguarded. However, it also creates barriers for generic manufacturers, potentially delaying the entry of cheaper alternatives into the market[1][3].
Regulatory Compliance
The FDA's approval process for generic drugs, particularly through the ANDA pathway, is heavily influenced by patent litigation. Companies must certify the status of relevant patents, which can lead to legal disputes and delays in the approval process[1][2].
Metrics for Patent Scope
Independent Claim Length and Count
Research on patent scope suggests that metrics such as independent claim length and independent claim count can be used to measure the breadth and clarity of patent claims. Narrower claims, as measured by these metrics, are associated with a higher probability of grant and a shorter examination process[3].
Challenges and Critiques
Patent Quality and Litigation
There are ongoing debates about patent quality, with some arguing that patents with overly broad or unclear claims can hinder innovation. The '987 Patent and similar patents have been subject to claim construction disputes, highlighting the complexity and potential for litigation in patent law[3].
Economic and Innovation Impacts
The granting of broad patents can lead to increased licensing and litigation costs, potentially diminishing incentives for innovation. However, the '987 Patent and related patents demonstrate the importance of clear and well-defined claims in protecting intellectual property and fostering innovation[3].
Key Takeaways
- The '987 Patent is part of a series of patents related to controlled drug-delivery systems.
- The patent involves specific claim constructions, particularly around terms like "polymeric matrix" and the coating process.
- It plays a crucial role in protecting innovative drug-delivery technologies and influencing the pharmaceutical industry.
- The patent has been involved in significant litigation, highlighting the importance of clear claim constructions and the impact on generic drug manufacturers.
- Metrics such as independent claim length and count can help in evaluating the scope and clarity of patent claims.
FAQs
What is the main subject of the '987 Patent?
The '987 Patent pertains to drug-delivery systems designed for the controlled release of incorporated drugs in the upper gastrointestinal system.
How does the coating process in the '987 Patent work?
The coating must be cured at a temperature at least equal to or greater than the melting point of the poly glycol, which must be greater than 55° C. This allows for the manipulation of the drug release profile.
What are the implications of the '987 Patent for generic drug manufacturers?
Generic drug manufacturers must navigate patent litigation and certification processes, which can delay the approval and market entry of their products.
How is the scope of the '987 Patent measured?
The scope can be measured using metrics such as independent claim length and independent claim count, which help in evaluating the breadth and clarity of the patent claims.
What are the broader economic and innovation impacts of the '987 Patent?
The patent protects innovative technologies, fostering investment in research and development. However, it can also create barriers for generic competition, potentially affecting drug prices and availability.
Cited Sources:
- Depomed, Inc. v. Sun Pharma Global Fze, Sun Pharm. Indus. Ltd., Case No. C 06-00100, 2006 U.S. Dist. LEXIS 100311 (N.D. Cal. December 20, 2006).
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT ..., IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT, Case 1:12-cv-00492-SLR Document 53 Filed 02/27/13.
- Patent Claims and Patent Scope, Alan C. Marco, Joshua D. Sarnoff, Charles A. deGrazia, U.S. Patent and Trademark Office, August 18, 2016.
