Understanding the Scope and Claims of United States Patent 6,696,481
Introduction
United States Patent 6,696,481, titled "Salt of perindopril and pharmaceutical compositions containing it," is a significant patent in the pharmaceutical industry, particularly in the treatment of hypertension. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it operates within.
Background of Perindopril
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor used primarily to treat hypertension and heart failure. It works by relaxing blood vessels, allowing blood to flow more smoothly and reducing blood pressure.
Patent Overview
The patent US 6,696,481 was granted on February 17, 2003, and has since expired. Here are the key aspects of this patent:
Inventors and Assignees
The patent was assigned to various entities globally, reflecting its international significance and the collaborative nature of pharmaceutical research.
Claims
The patent includes multiple claims that define the scope of the invention. Here are some key claims:
- Claim 1: This claim describes a new salt of perindopril, specifically the tert-butylamine salt, which is a novel compound not previously disclosed.
- Claim 2: This claim pertains to pharmaceutical compositions containing the tert-butylamine salt of perindopril.
- Claim 3: This claim covers methods of treating hypertension using the pharmaceutical compositions containing the tert-butylamine salt of perindopril[1].
Scope of the Patent
The scope of the patent is defined by its claims, which are critical in determining the boundaries of the patent owner’s rights.
Specific Embodiments
The patent specifically claims the tert-butylamine salt of perindopril and pharmaceutical compositions that include this salt. This narrow focus ensures that the patent does not overly broaden its claims beyond what is described and taught in the patent application.
Pharmaceutical Compositions
The patent covers various pharmaceutical compositions, including tablets, capsules, and other forms that contain the tert-butylamine salt of perindopril. This ensures that the patent protects not just the compound itself but also its practical applications in medicine.
Patent Landscape
The patent landscape for pharmaceuticals, especially those involving novel salts and compositions, is complex and highly regulated.
Generic Launches
With the expiration of the patent, generic versions of perindopril can now be developed and marketed. This is a common scenario where patents expire, allowing generic manufacturers to enter the market and potentially reduce the cost of the medication for consumers[4].
Patent Expiration and Its Impact
The expiration of US 6,696,481 has significant implications for the pharmaceutical industry. It opens up the market for generic versions of perindopril, which can lead to increased competition and potentially lower prices for patients. This is a critical aspect of the patent system, as it balances the need to reward innovation with the need to make essential medications accessible.
Legal and Regulatory Considerations
The validity and enforceability of pharmaceutical patents are subject to stringent legal and regulatory scrutiny.
Section 112(a) and Enablement Requirements
The Federal Circuit’s interpretation of Section 112(a) of the U.S. patent laws, particularly regarding enablement and written description requirements, can significantly impact the validity of pharmaceutical patents. Patents must demonstrate that the claimed invention is enabled and described in sufficient detail to avoid being deemed invalid[3].
ANDA Litigation and Settlements
When generic manufacturers seek to enter the market, they often file Abbreviated New Drug Applications (ANDAs) and may engage in litigation with the original patent holders. These litigations can result in settlements that allow generic products to enter the market under certain conditions, such as delayed launch dates or royalty payments[5].
Industry Impact
The expiration of US 6,696,481 and similar patents has a broader impact on the pharmaceutical industry.
Market Expansion and Competition
The entry of generic drugs into the market can lead to increased competition, which can drive down prices and improve patient access to essential medications. This is particularly significant in the context of hypertension treatment, where affordable options are crucial for public health.
Innovation and Research
While the expiration of patents can reduce the exclusive market rights of innovators, it also encourages further innovation. Companies may invest in new research and development to create novel compounds or formulations that can be patented and marketed exclusively.
Key Takeaways
- Patent Scope: The patent US 6,696,481 specifically covers the tert-butylamine salt of perindopril and its pharmaceutical compositions.
- Expiration: The patent has expired, allowing for the development and marketing of generic versions.
- Legal Considerations: Pharmaceutical patents are subject to strict legal and regulatory requirements, including enablement and written description under Section 112(a).
- Industry Impact: The expiration of such patents can lead to increased competition, lower prices, and improved patient access to medications.
FAQs
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What is the main subject of United States Patent 6,696,481?
- The main subject is the tert-butylamine salt of perindopril and pharmaceutical compositions containing it.
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Why is the tert-butylamine salt of perindopril significant?
- It is a novel compound used in the treatment of hypertension and heart failure.
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What happens when a pharmaceutical patent expires?
- Generic versions of the drug can be developed and marketed, increasing competition and potentially reducing prices.
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How do legal requirements like Section 112(a) impact pharmaceutical patents?
- These requirements ensure that patents are valid and enforceable by demanding sufficient enablement and written description of the claimed invention.
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What is the impact of ANDA litigation on the pharmaceutical industry?
- ANDA litigation can result in settlements that allow generic products to enter the market, often with delayed launch dates or other conditions.
Sources
- US6696481B2 - Salt of perindopril and pharmaceutical compositions containing it - Google Patents
- Prestalia patent expiration - Pharsight
- Eviscerating Patent Scope - DigitalCommons@NYLS
- List - 91 Drug Patents that are Expiring between 2020 to 2022 - GreyB
- ANDA Litigation Settlements | Robins Kaplan LLP Law Firm
