United States Patent 7,879,842: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,879,842, hereafter referred to as the '842 Patent, is a significant intellectual property asset related to the drug Corlanor® (ivabradine), a medication used for the treatment of heart failure. This patent is part of a broader patent portfolio that protects the active ingredient ivabradine and its various uses.
Patent Overview
The '842 Patent was issued on February 1, 2011, and is set to expire on February 22, 2026. It is owned by Servier, a pharmaceutical company, and claims the active ingredient ivabradine as well as methods of using the approved product[1].
Claims and Scope
The '842 Patent includes six claims, all of which pertain to ivabradine. These claims cover the active ingredient itself and methods of using it, specifically in the context of Corlanor®, a drug approved for reducing the risk of hospitalization for worsening heart failure in patients with stable, symptomatic heart failure with left ventricular ejection fraction (LVEF) ≤ 35%[1].
Claim Specifics
- The claims are specific to the crystalline form of ivabradine and its use in therapeutic applications.
- They protect the unique characteristics and formulations of ivabradine that are essential for its efficacy and safety profile[2].
Regulatory Approval and Patent Term Extension
The '842 Patent underwent a regulatory review period before its commercial marketing. The New Drug Application (NDA) for Corlanor® was submitted to the FDA on June 27, 2014, and approved on April 15, 2015. This regulatory review period is crucial for determining the eligibility for patent term extension under 35 USC § 156. The patent term extension request was submitted within the 60-day period following the FDA approval, ensuring that the patent term could be extended to account for the time spent in regulatory review[1].
Patent Term Extension Request
The patent term extension request for the '842 Patent was filed on June 3, 2015. This request was made to extend the patent term due to the time spent in regulatory review, which is a common practice to ensure that the effective patent life is not significantly reduced by the lengthy approval process. The request was submitted within the required timeframe and met all the eligibility criteria set forth in 37 CFR §§ 1.710 and 1.720[1].
Litigation and Infringement
The '842 Patent has been involved in several patent infringement lawsuits. For instance, Amgen Inc., the marketer of Corlanor® in the United States, has filed lawsuits against generic drug manufacturers seeking to market generic versions of ivabradine before the expiration of the '842 Patent and other related patents (U.S. Patent Nos. 7,361,649, 7,361,650, and 7,867,996)[2][5].
ANDA Filings and Infringement Allegations
Generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) with the FDA, which include paragraph IV certifications stating that the patents are invalid, unenforceable, or will not be infringed by their manufacture, use, or sale of ivabradine tablets. These filings have led to infringement allegations by Amgen, claiming that the proposed generic products would infringe one or more claims of the '842 Patent[2][5].
Patent Landscape
The '842 Patent is part of a complex patent landscape surrounding ivabradine and Corlanor®. Other patents, such as U.S. Patent Nos. 7,361,649, 7,361,650, and 7,867,996, also protect various aspects of ivabradine, including its crystalline forms and methods of use. This multi-patent strategy helps to ensure broad protection against generic competition and maintains the exclusivity of Corlanor® in the market[2][4].
Exclusivity and Generic Competition
The expiration dates of these patents are critical for determining when generic versions of Corlanor® can enter the market. The '842 Patent, along with the other patents, is set to expire on August 22, 2026, which marks the end of the exclusivity period for Corlanor®. After this date, generic manufacturers can legally market their versions of ivabradine, provided they have received FDA approval[4].
Impact on Innovation and Competition
The scope and claims of the '842 Patent, along with the broader patent portfolio, have significant implications for innovation and competition in the pharmaceutical industry. These patents protect the intellectual property of Servier and Amgen, ensuring they can recoup their investment in research and development. However, they also delay the entry of generic competitors, which can affect the affordability and accessibility of the medication[3].
Conclusion on Patent Scope and Claims
The '842 Patent is a critical component of the intellectual property protection for Corlanor®. Its claims are specific and protect the unique aspects of ivabradine, ensuring that Servier and Amgen maintain exclusivity over this medication. The patent's involvement in litigation and its role in the broader patent landscape highlight its importance in the pharmaceutical industry.
Key Takeaways
- The '842 Patent protects the active ingredient ivabradine and its methods of use.
- It underwent a regulatory review period, leading to a patent term extension request.
- The patent is involved in several infringement lawsuits against generic manufacturers.
- It is part of a complex patent landscape that includes other patents protecting ivabradine.
- The expiration of this patent and related patents will determine when generic versions can enter the market.
FAQs
What is the '842 Patent, and what does it protect?
The '842 Patent protects the active ingredient ivabradine and methods of using it, specifically in the context of Corlanor®, a medication for heart failure.
Why was a patent term extension requested for the '842 Patent?
A patent term extension was requested to account for the time spent in regulatory review before the FDA approved Corlanor® for commercial marketing.
What are the implications of the '842 Patent on generic competition?
The '842 Patent, along with other related patents, delays the entry of generic versions of Corlanor® into the market until their expiration dates.
How is the '842 Patent involved in litigation?
The '842 Patent is involved in several patent infringement lawsuits filed by Amgen against generic manufacturers seeking to market generic versions of ivabradine before the patent's expiration.
What is the current status of the '842 Patent's expiration?
The '842 Patent is set to expire on February 22, 2026, although other related patents may expire on slightly different dates.
Cited Sources:
- US Patent No. 7,879,842 Patent Term Extension Request of 3 June 2015 - Regulations.gov
- Amgen Inc. et al v. Zydus Pharmaceuticals (USA) Inc. - RPX Insight
- Patent Claims and Patent Scope - Hoover Institution
- Ivabradine Tablets - FDA
- Amgen Inc. et al v. Centaur Pharmaceuticals Private Limited - RPX Insight
