United States Patent 11,103,490: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,103,490, titled "Clevidipine Emulsion Formulations Containing Antimicrobial Agents," is a crucial patent in the pharmaceutical industry, particularly in the realm of injectable emulsions. This patent, assigned to Chiesi Farmaceutici S.P.A., protects formulations of clevidipine, a calcium channel blocker used in the management of hypertension. Here, we delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Invention
Clevidipine is a short-acting calcium channel blocker that is administered intravenously. The formulation protected by this patent is designed to be resistant to microbial growth and stable against the formation of impurities, which is critical for pharmaceutical products[5].
Patent Claims
The patent includes several claims that define the scope of the invention. Here are the key aspects of the claims:
Claim 6: The Core Claim
Claim 6 of the '490 patent is one of the asserted claims in the litigation against Aurobindo Pharma. This claim typically outlines the essential components of the pharmaceutical formulation:
- An effective amount of clevidipine or its pharmaceutically acceptable salt or ester.
- An antimicrobial agent, such as EDTA, present in a specific concentration.
- A lipid.
- An emulsifier.
- A tonicity modifier.
- Water.
The formulation must be resistant to microbial growth[1].
Scope of the Patent
The scope of the patent is defined by the language of the claims and the specifications provided in the patent document.
Independent Claim Length and Count
Research on patent scope suggests that the length and count of independent claims can be significant metrics. Narrower claims, as measured by independent claim length and count, are often associated with a higher probability of grant and a shorter examination process. This patent's claims are structured to be specific yet broad enough to cover the essential aspects of the invention[2].
Claim Clarity and Validity
The clarity and validity of the claims are critical. Overly broad claims can lead to invalidation due to issues such as the abstract idea exception or failure to meet the written description requirement. The claims in this patent are anchored to the embodiments disclosed in the specification, which helps in avoiding such pitfalls[4].
Patent Landscape
The patent landscape for clevidipine emulsion formulations is complex, involving multiple patents and ongoing litigation.
Related Patents
The '490 patent is part of a family of patents that include United States Patent No. 8,658,676 and Patent No. 10,010,537. These patents collectively protect various aspects of clevidipine emulsion formulations, including the use of antimicrobial agents and specific formulation components[1].
Litigation
The patent has been at the center of a significant litigation case, Chiesi U.S. Inc. v. Aurobindo Pharma U.S. Inc., where Chiesi alleged that Aurobindo's ANDA filing infringed the claims of the '490 patent, among others. The court found that Aurobindo's ANDA literally infringed the claims of the patents in suit and that the patents were not invalid or unenforceable[1].
Expiration and Market Impact
The '490 patent, along with the other patents in the family, is scheduled to expire on October 10, 2031. This expiration date is crucial for the market, as it will open up opportunities for generic or biosimilar versions of clevidipine emulsions once the patent protection lapses[1].
Inventors and Assignees
The inventors listed on the patent are Rajeshwar Motheram and Gregory Charles Williams. The assignee is Chiesi Farmaceutici S.P.A., an Italian pharmaceutical company known for its innovative products in various therapeutic areas[5].
Technical Aspects
The patent specifies the use of antimicrobial agents like EDTA in concentrations between about 0.001 to about 1.5% w/v. This ensures the formulation's resistance to microbial growth, which is a critical factor in pharmaceutical stability and safety[1].
Economic and Regulatory Implications
The patent's scope and claims have significant economic and regulatory implications. The protection afforded by this patent allows Chiesi to maintain market exclusivity for its product, Cleviprex®, until the patent expires. This exclusivity can impact the pricing and availability of the drug in the market[1].
Industry Expert Insights
Industry experts emphasize the importance of getting the claim scope right to avoid invalidation and ensure the patent's enforceability. "A patent with overly broad claims runs the risks of being invalidated," as noted in recent court decisions and legal analyses[4].
Statistics and Trends
Research indicates that narrower claims tend to have a higher success rate during the patent examination process. For instance, studies have shown that claims with shorter lengths and fewer independent claims are more likely to be granted and have a shorter examination duration[2].
Conclusion
The United States Patent 11,103,490 is a pivotal patent in the pharmaceutical industry, protecting innovative formulations of clevidipine. Understanding the scope, claims, and the broader patent landscape is essential for navigating the complex world of pharmaceutical patents. The patent's specificity, clarity, and the ongoing litigation highlight the importance of precise claim drafting and the strategic management of intellectual property.
Key Takeaways
- Specific Claims: The patent's claims are specific and anchored to the embodiments disclosed in the specification.
- Litigation: The patent has been involved in significant litigation, with the court finding infringement and upholding the patent's validity and enforceability.
- Expiration: The patent is set to expire on October 10, 2031, which will impact the market for clevidipine emulsions.
- Technical Aspects: The formulation includes antimicrobial agents to ensure stability and safety.
- Economic Implications: The patent's protection affects market exclusivity and pricing.
FAQs
What is the main subject of United States Patent 11,103,490?
The main subject is clevidipine emulsion formulations containing antimicrobial agents.
Who are the inventors listed on the patent?
The inventors are Rajeshwar Motheram and Gregory Charles Williams.
What is the significance of the antimicrobial agent in the formulation?
The antimicrobial agent, such as EDTA, ensures the formulation is resistant to microbial growth, which is crucial for pharmaceutical stability and safety.
What is the current status of the litigation involving this patent?
The court has found that Aurobindo's ANDA infringed the claims of the patents in suit, and the patents were not invalid or unenforceable.
When is the patent scheduled to expire?
The patent is scheduled to expire on October 10, 2031.
Cited Sources
- Chiesi U.S. Inc. v. Aurobindo Pharma U.S. Inc. - Casetext
- Patent Claims and Patent Scope - Hoover Institution
- United States Patent 11,103,490 - Google Patents
- The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law
- Summary for Patent: 11,103,490 - Drug Patent Watch
