United States Patent 7,361,649: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,361,649, titled "β-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it," is a significant patent in the pharmaceutical industry, particularly in the context of cardiovascular treatments. This patent is held by Les Laboratoires Servier and is crucial for the protection of the drug CORLANOR®.
Background of the Patent
The patent was issued on April 22, 2008, and it is part of a series of patents related to ivabradine, a medication used to reduce the risk of hospitalization for worsening heart failure in patients with stable, symptomatic heart failure with left ventricular ejection fraction (LVEF) less than 35%[2].
Claims of the Patent
The patent includes several key claims that define its scope:
β-Crystalline Form of Ivabradine Hydrochloride
- The patent claims the β-crystalline form of ivabradine hydrochloride, which is a specific polymorphic form of the drug. This form is critical for the stability, efficacy, and bioavailability of the medication[2].
Process for Preparation
- It includes a process for preparing the β-crystalline form of ivabradine hydrochloride. This process is essential for ensuring the consistent production of the drug in its desired form[2].
Pharmaceutical Compositions
- The patent also covers pharmaceutical compositions containing the β-crystalline form of ivabradine hydrochloride. These compositions are formulated to deliver the drug effectively and safely to patients[2].
Patent Scope and Clarity
The scope of the patent is defined by its claims, which are specific and detailed. The clarity of these claims is crucial for determining the patent's validity and enforceability. Research has shown that patent claim scope and clarity are significant concerns for patent quality, as overly broad or unclear claims can lead to increased litigation and licensing costs[3].
Patent Landscape
The patent landscape surrounding U.S. Patent 7,361,649 is complex and involves several related patents and legal disputes.
Related Patents
- The patent is part of a family of patents related to ivabradine, including U.S. Patent 7,361,650, which covers the γ-crystalline form of ivabradine hydrochloride, and U.S. Patent 7,879,842, which claims the active ingredient ivabradine and methods of using it[1][2].
Litigation
- There have been several legal disputes involving this patent. For example, Amgen Inc. and Les Laboratoires Servier have sued Zydus Pharmaceuticals (USA) Inc. for infringement of U.S. Patent Nos. 7,361,649, 7,361,650, and 7,867,996, among others[2].
Regulatory Approval and Commercial Use
The patent is closely tied to the regulatory approval and commercial use of CORLANOR®.
New Drug Application (NDA)
- The patent is included in two New Drug Applications (NDAs) for CORLANOR®, which has received permission for commercial marketing or use from regulatory authorities[5].
Patent Term Extension
- The patent term of U.S. Patent 7,879,842, which is related to U.S. Patent 7,361,649, has been extended due to the regulatory review period for CORLANOR®. This extension ensures that the patent holder maintains exclusive rights for a longer period[1].
Impact on Innovation and Competition
The patent has significant implications for innovation and competition in the pharmaceutical industry.
Innovation Incentives
- The patent provides incentives for innovation by protecting the intellectual property of the inventors and allowing them to recoup their investment in research and development[3].
Competition
- However, it also limits competition by preventing generic or biosimilar versions of the drug from entering the market until the patent expires. This can lead to higher drug prices and reduced access to treatment for patients[3].
Expiry and Future Implications
The patent is set to expire on February 22, 2026, unless further extensions are granted.
Generic Competition
- Once the patent expires, generic versions of CORLANOR® can enter the market, potentially reducing prices and increasing access to the medication[5].
Continued Innovation
- The expiry of the patent may also spur further innovation as other companies may develop new formulations or uses for ivabradine, leading to additional therapeutic options for patients[3].
Key Takeaways
- Specific Claims: U.S. Patent 7,361,649 specifically claims the β-crystalline form of ivabradine hydrochloride, its preparation process, and pharmaceutical compositions containing it.
- Regulatory Approval: The patent is tied to the regulatory approval and commercial use of CORLANOR®.
- Litigation: The patent has been involved in several legal disputes related to infringement.
- Impact on Innovation: The patent provides incentives for innovation but also limits competition.
- Expiry: The patent is set to expire on February 22, 2026, which could lead to generic competition and further innovation.
Frequently Asked Questions (FAQs)
What is the main subject of U.S. Patent 7,361,649?
The main subject of U.S. Patent 7,361,649 is the β-crystalline form of ivabradine hydrochloride, a process for its preparation, and pharmaceutical compositions containing it.
Which drug is protected by this patent?
The patent protects the drug CORLANOR®, which is used to treat heart failure.
When is the patent set to expire?
The patent is set to expire on February 22, 2026.
What are the implications of the patent expiry?
The expiry of the patent could lead to the entry of generic versions of CORLANOR®, reducing prices and increasing access to the medication.
Has this patent been involved in any legal disputes?
Yes, the patent has been involved in several legal disputes related to infringement, including a case against Zydus Pharmaceuticals (USA) Inc.
Cited Sources
- Regulations.gov: Patent Term Extension Request of 3 June 2015 for U.S. Patent No. 7,879,842.
- JDSupra: Life Sciences Court Report - January 2020.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: WO 2013/102919 A1.
- DrugPatentWatch: Patent 7,361,649.
