Detailed Analysis of the Scope and Claims of United States Patent 7,361,650
Introduction to Patent 7,361,650
United States Patent 7,361,650, hereafter referred to as the '650 Patent, is one of the key patents protecting the drug Corlanor (ivabradine), which is used in the treatment of systolic heart failure. This patent is crucial in understanding the intellectual property landscape surrounding Corlanor.
Patent Overview
The '650 Patent is titled "Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it." It was granted to protect specific crystalline forms of ivabradine hydrochloride, a critical component of Corlanor.
Claims of the Patent
Independent Claims
The '650 Patent includes several independent claims that define the scope of the invention. Here are some key aspects:
- Crystalline Form: The patent claims a specific beta-crystalline form of ivabradine hydrochloride, known as the "g crystalline form"[4].
- Preparation Process: It describes a process for preparing this crystalline form, which involves specific steps and conditions to achieve the desired crystal structure[4].
- Pharmaceutical Compositions: The patent also covers pharmaceutical compositions that contain this beta-crystalline form of ivabradine hydrochloride, including the 5 mg and 7.5 mg tablets of Corlanor[4].
Dependent Claims
Dependent claims further specify the details of the independent claims, such as the physical and chemical characteristics of the crystalline form, the methods of synthesis, and the formulations of the pharmaceutical compositions.
Patent Scope and Breadth
Claim Language and Scope
The scope of the '650 Patent is defined by the language used in its claims. The independent claim length and the number of independent claims are metrics that can indicate the breadth and clarity of the patent. In this case, the patent focuses on a specific crystalline form and its preparation process, which suggests a relatively narrow scope compared to broader patents that might cover a wide range of compounds or processes[3].
Patent Quality and Litigation
The clarity and specificity of the claims in the '650 Patent are important factors in patent quality. Clear and specific claims reduce the likelihood of litigation and ensure that the patent provides strong protection without overly broad claims that could be challenged for lack of clarity or validity[3].
Patent Expiration and Generic Entry
Expiration Dates
The '650 Patent is set to expire on February 22, 2026. Additionally, there is a pediatric extension (PED) that extends the patent expiration to August 22, 2026[5].
Generic Challenges
Generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) with the FDA, challenging the '650 Patent among others. These challenges are part of the process to gain approval for generic versions of Corlanor before the patent expires[2].
Litigation and Patent Infringement
Current Litigation
There are ongoing legal battles related to the '650 Patent, with Amgen Inc., the patent holder, suing generic manufacturers for patent infringement. These lawsuits aim to prevent the early entry of generic versions of Corlanor into the market before the patent expires[2].
Infringement Claims
The lawsuits allege that the generic versions of Corlanor infringe on the claims of the '650 Patent, specifically the use and presence of the beta-crystalline form of ivabradine hydrochloride in the proposed generic products[2].
Impact on the Pharmaceutical Industry
Protection of Intellectual Property
The '650 Patent and other related patents protect Amgen's intellectual property rights, ensuring that the company can maintain market exclusivity for Corlanor until the patents expire.
Generic Competition
The expiration of the '650 Patent and other related patents will open the market to generic competition, potentially reducing the cost of the drug and increasing accessibility for patients.
Conclusion
The '650 Patent is a critical component of the intellectual property landscape surrounding Corlanor. Its specific claims regarding the beta-crystalline form of ivabradine hydrochloride and its preparation process provide strong protection for Amgen's product. However, with the patent set to expire in 2026, the market is poised for the entry of generic versions, which will likely impact both the pricing and availability of the drug.
Key Takeaways
- Patent Scope: The '650 Patent covers a specific beta-crystalline form of ivabradine hydrochloride and its preparation process.
- Expiration Dates: The patent expires on February 22, 2026, with a pediatric extension to August 22, 2026.
- Litigation: Ongoing lawsuits against generic manufacturers aim to prevent early market entry.
- Impact: Expiration will lead to generic competition, potentially reducing drug costs and increasing accessibility.
Frequently Asked Questions (FAQs)
1. What is the main subject of the '650 Patent?
The '650 Patent covers the beta-crystalline form of ivabradine hydrochloride, a process for its preparation, and pharmaceutical compositions containing it.
2. When is the '650 Patent set to expire?
The '650 Patent is set to expire on February 22, 2026, with a pediatric extension to August 22, 2026.
3. What are the implications of the '650 Patent expiration for generic manufacturers?
The expiration of the '650 Patent will allow generic manufacturers to enter the market with their versions of Corlanor, potentially reducing the drug's cost and increasing its accessibility.
4. Are there any ongoing legal challenges related to the '650 Patent?
Yes, Amgen Inc. is involved in lawsuits against generic manufacturers to prevent early market entry of generic versions of Corlanor.
5. How does the '650 Patent impact the pharmaceutical industry?
The '650 Patent protects Amgen's intellectual property rights, ensuring market exclusivity until the patent expires. After expiration, generic competition will likely reduce the drug's cost and increase its availability.
Cited Sources:
- DrugPatentWatch: Summary for CORLANOR.
- RPX Insight: United States District Court - Patent Infringement Action.
- Hoover Institution: Patent Claims and Patent Scope.
- Google Patents: Process of making ivabradine hydrochloride drug product.
- Drugs.com: Generic Corlanor Availability.
