United States Patent 7,867,996: A Detailed Analysis
Introduction
United States Patent 7,867,996, hereafter referred to as the '996 Patent, is a crucial component of the patent portfolio related to Corlanor® (ivabradine hydrochloride), a medication used for the treatment of heart failure and to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic heart failure with left ventricular ejection fraction (LVEF) ≤ 35% and in the absence of a contraindication to beta-blocker therapy.
Background and Inventors
The '996 Patent was filed by Les Laboratoires Servier, a French pharmaceutical company, and is part of a series of patents related to ivabradine, the active ingredient in Corlanor®. The inventors and the detailed filing history are closely tied to other patents in the same family, such as U.S. Patent Nos. 7,361,649, 7,361,650, and 7,879,842[2][5].
Claims and Scope
The '996 Patent claims specific aspects of ivabradine hydrochloride, including its formulation, methods of use, and particular crystalline forms.
Active Ingredient and Formulations
The patent claims ivabradine hydrochloride, a heart rate reducer, and its various formulations. This includes the γ-crystalline form of ivabradine hydrochloride, which is characterized by its powder X-ray diffraction data. This specific crystalline form is important for the stability and efficacy of the drug[4].
Methods of Use
The '996 Patent also includes claims related to the method of using ivabradine hydrochloride for therapeutic purposes. This encompasses the treatment of heart failure and other cardiovascular conditions where heart rate reduction is beneficial[5].
Patent Landscape
The patent landscape surrounding the '996 Patent is complex and involves multiple related patents.
Related Patents
The '996 Patent is part of a family of patents that include U.S. Patent Nos. 7,361,649, 7,361,650, and 7,879,842. These patents collectively cover various aspects of ivabradine, including its synthesis, formulations, and methods of use. This extensive coverage ensures broad protection for the drug and its applications[2][5].
Regulatory Review and Patent Term Extension
The '996 Patent, along with other related patents, has undergone regulatory review and has been subject to patent term extension applications under 35 U.S.C. § 156. This section of the law allows for the extension of patent terms to compensate for the time spent in regulatory review, ensuring that the patent holder has a reasonable period to exploit the patent after regulatory approval[1][5].
Litigation and Infringement
The '996 Patent has been involved in litigation related to generic versions of Corlanor®. Companies seeking to market generic versions of ivabradine have faced legal challenges from the patent holders, who argue that these generic versions infringe on the claims of the '996 Patent and other related patents. These legal battles highlight the importance of these patents in protecting the intellectual property rights of pharmaceutical companies[2].
Impact on Generic Competition
The '996 Patent, along with other patents in the same family, acts as a barrier to generic competition. Generic manufacturers must wait until the expiration of these patents or obtain a court ruling that their product does not infringe on the patent claims. This delay can significantly impact the availability and cost of the medication, as generic versions are typically cheaper than brand-name drugs[2].
Statistical Analysis and Innovation Tracks
While the '996 Patent itself does not provide a detailed statistical analysis, the broader patent landscape around ivabradine involves extensive research and development. The innovation tracks for ivabradine include continuous protection through various patent filings, ensuring that the drug remains under patent protection for an extended period. This strategy is common in the pharmaceutical industry to protect investments in research and development[3].
Conclusion
The '996 Patent is a critical component of the intellectual property portfolio for Corlanor® (ivabradine hydrochloride). It covers specific formulations and methods of use for the drug, contributing to a comprehensive patent landscape that protects the drug from generic competition. The patent's involvement in regulatory review and litigation underscores its importance in the pharmaceutical industry.
Key Takeaways
- Scope and Claims: The '996 Patent covers specific formulations of ivabradine hydrochloride and its methods of use.
- Related Patents: It is part of a family of patents that collectively protect various aspects of ivabradine.
- Regulatory Review: The patent has been subject to regulatory review and patent term extension applications.
- Litigation: It has been involved in litigation related to generic versions of Corlanor®.
- Impact on Generic Competition: The patent acts as a barrier to generic competition, affecting the availability and cost of the medication.
Frequently Asked Questions
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What is the main subject of the '996 Patent?
- The '996 Patent primarily covers specific formulations of ivabradine hydrochloride, including its γ-crystalline form, and methods of use for therapeutic purposes.
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Which company holds the '996 Patent?
- The '996 Patent is held by Les Laboratoires Servier, a French pharmaceutical company.
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What is the significance of the γ-crystalline form of ivabradine hydrochloride?
- The γ-crystalline form is important for the stability and efficacy of the drug, characterized by its powder X-ray diffraction data.
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How does the '996 Patent impact generic competition?
- The patent acts as a barrier to generic competition by preventing generic manufacturers from marketing their versions of ivabradine until the patent expires or they obtain a non-infringement ruling.
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Is the '996 Patent involved in any litigation?
- Yes, the '996 Patent has been involved in litigation related to generic versions of Corlanor®, with the patent holders seeking to protect their intellectual property rights.
Cited Sources
- Regulations.gov - Patent Term Extension Request of 3 June 2015 SERVIER 488 US CONT 2
- Insight.rpxcorp.com - IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT
- WIPO - Patent Landscape Report on Ritonavir
- Patents.google.com - γ-Crystalline form of ivabradine hydrochloride
- Regulations.gov - CORLANOR Patent Nos. 7,879,842 and 7,867,996
