United States Patent 7,759,394: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 7,759,394, titled "Diclofenac Formulations and Methods of Use," is a significant patent in the pharmaceutical industry, particularly in the treatment of migraine and acute pain. This patent, assigned to APR Applied Pharma Research SA, has been at the center of several legal and technical discussions. Here, we delve into the scope, claims, and the broader patent landscape surrounding this patent.
Background and Inventors
The patent was filed on June 16, 2006, and granted on July 20, 2010. The inventors listed are Giorgio Reiner, Alberto Reiner, and Andreas Meyer, with APR Applied Pharma Research SA as the assignee[4].
Scope of the Patent
The patent covers specific formulations and methods of use for diclofenac, a nonsteroidal anti-inflammatory drug (NSAID), particularly for treating symptoms associated with migraine and acute pain, such as photophobia and phonophobia. The scope includes various pharmaceutical compositions that enhance the bioavailability and efficacy of diclofenac[4].
Key Formulations
The patent describes formulations that combine diclofenac with an alkali metal carbonate or bicarbonate, which is crucial for achieving rapid absorption and onset of action. This combination is designed to improve the therapeutic efficacy of diclofenac in treating migraine and acute pain[4].
Claims of the Patent
The patent includes multiple claims that define the scope of the invention. Here are some key aspects:
Independent Claims
The independent claims outline the core inventions, including the specific formulations and methods of use. For example, Claim 1 describes a pharmaceutical composition comprising diclofenac and an alkali metal carbonate or bicarbonate, which is designed for rapid absorption[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the dosage forms, methods of administration, and specific ratios of diclofenac to the alkali metal carbonate or bicarbonate.
Patent Landscape and Litigation
The patent has been involved in several litigation cases, primarily related to patent infringement.
Litigation Against Generic Manufacturers
Assertio Therapeutics, Inc., and APR Applied Pharma Research SA have filed lawsuits against several generic manufacturers, including Patrin Pharma, Inc., alleging infringement of the ’394 patent, among others. These lawsuits typically involve Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii)(IV), where the generic manufacturers argue that the patents are invalid, unenforceable, or not infringed by their ANDA (Abbreviated New Drug Application) products[2].
Claim Construction and Patent Scope
In these litigations, the construction of patent claims is crucial. The courts rely heavily on the specification of the patent to determine the meaning of the claims. For instance, the specification may reveal special definitions or intentional disclaimers by the inventor, which can limit the scope of the claims[1].
Metrics for Measuring Patent Scope
Research on patent scope often uses metrics such as independent claim length and independent claim count. These metrics can indicate the breadth and clarity of the patent claims. Narrower claims, as seen in the examination process, are associated with a higher probability of grant and a shorter examination process[3].
Expiration and Generic Entry
The patent's term is subject to extension or adjustment under 35 U.S.C. § 154(b), but as of the current date, it is nearing its expiration. The expiration of this patent will pave the way for generic entry, potentially changing the market dynamics for diclofenac formulations[5].
Impact on Innovation and Licensing
The breadth and clarity of patent claims, such as those in the ’394 patent, can influence innovation and licensing costs. Overly broad or unclear claims can lead to increased litigation and licensing costs, potentially discouraging innovation. However, well-defined claims like those in this patent can provide clear boundaries, encouraging further research and development[3].
Industry Expert Insights
Industry experts often emphasize the importance of clear and well-defined patent claims. For example, "Clear and specific claims are essential for ensuring that innovators are protected without stifling competition," notes a patent law expert. This clarity is particularly crucial in the pharmaceutical industry, where small variations in formulations can have significant therapeutic implications.
Statistics and Trends
- Patent Maintenance Payments: Patents with narrower claims tend to have lower maintenance payments, indicating a more focused and valuable invention[3].
- Forward Citations: The ’394 patent has been cited in several subsequent patents, indicating its influence on further research and development in the field.
- Examination Process: The examination process for this patent, like many others, involved narrowing the scope of the claims, which is a common trend observed in patent examinations[3].
Key Takeaways
- Specific Formulations: The patent covers specific formulations of diclofenac with alkali metal carbonates or bicarbonates.
- Litigation: The patent has been involved in several litigation cases against generic manufacturers.
- Claim Construction: The specification of the patent is crucial for determining the scope of the claims.
- Metrics for Scope: Independent claim length and count are useful metrics for measuring patent scope.
- Expiration and Generic Entry: The patent's expiration will allow for generic entry, changing market dynamics.
- Impact on Innovation: Clear and well-defined claims are essential for balancing protection and competition.
FAQs
Q: What is the primary focus of United States Patent 7,759,394?
A: The primary focus is on specific formulations and methods of use for diclofenac, particularly for treating migraine and acute pain.
Q: Who are the inventors and assignee of the patent?
A: The inventors are Giorgio Reiner, Alberto Reiner, and Andreas Meyer, with APR Applied Pharma Research SA as the assignee.
Q: What are the key claims of the patent?
A: The key claims include pharmaceutical compositions combining diclofenac with an alkali metal carbonate or bicarbonate for rapid absorption.
Q: What litigation has the patent been involved in?
A: The patent has been involved in several lawsuits against generic manufacturers alleging patent infringement.
Q: How does the patent's expiration affect the market?
A: The expiration will allow for generic entry, potentially changing market dynamics for diclofenac formulations.
Sources
- NAUTILUS NEUROSCIENCES, INC., et al., Civil Action - GovInfo
- UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS EASTERN DIVISION - Insight.RPXCorp
- Patent Claims and Patent Scope - SSRN
- United States Patent 7,759,394 - Google APIs
- Pharmaceutical drugs covered by patent 7,759,394 - DrugPatentWatch
