United States Patent 11,090,386: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 11,090,386, titled "Method for Suppressing Bitterness of Quinoline Derivative," is a significant patent in the pharmaceutical industry, particularly for the drug Lenvima, which is owned by Eisai Inc. This patent is part of a broader portfolio of patents protecting the active ingredients and manufacturing methods of Lenvima.
Patent Overview
Patent Number and Issue Date
The patent number is US 11,090,386 B2, and it was issued on August 17, 2021[1].
Applicants and Inventors
The patent was applied for by Eisai R & D Management Co., Ltd., Tokyo, Japan. The inventors listed are Kentaro Nagane, Kakamigahara; Yosuke Ueki, Kakamigahara; Shusuke Sano, Kakamigahara; and Takahisa Sakaguchi, Tsukuba[1].
Scope of the Patent
Title and Abstract
The patent is focused on a method for suppressing the bitterness of quinoline derivatives. Quinoline derivatives are a class of compounds that can exhibit bitter taste, which can be a significant issue in pharmaceutical formulations. The method described in this patent aims to reduce or eliminate this bitterness, making the drug more palatable for patients.
Claims
The patent includes several claims that define the scope of the invention. These claims typically cover the specific methods and compositions used to suppress bitterness. Here are some key aspects of the claims:
- Method Claims: These claims outline the steps involved in preparing the quinoline derivatives in a way that minimizes bitterness. This may include specific manufacturing processes, formulation techniques, and the use of particular excipients or additives[1][5].
- Composition Claims: These claims describe the specific compositions of the quinoline derivatives and any additional components that are used to reduce bitterness. This could include the concentration of the active ingredient, the type of excipients used, and the form of the final product (e.g., tablets, capsules)[1][5].
Patent Landscape
Related Patents
The patent landscape for Lenvima is complex, with multiple patents protecting different aspects of the drug. Here are a few key points:
- Multiple Patents: Lenvima is protected by 15 US drug patents filed between 2015 and 2024, none of which have expired yet. These patents cover various aspects, including the high-purity quinoline derivative and methods for its manufacture[2].
- Expiry Dates: The patents related to Lenvima, including those for high-purity quinoline derivatives, are set to expire in August 2035. This extended protection period ensures that Eisai maintains exclusivity over the active ingredient and manufacturing processes for several years[2].
Competitive Impact
The extensive patent protection for Lenvima significantly impacts the competitive landscape in the pharmaceutical industry. Here are some implications:
- Market Exclusivity: The patents prevent other companies from launching products that use the same active ingredient until the patents expire. This gives Eisai a monopoly on the market for Lenvima, allowing them to maintain high prices and market share[2].
- Innovation Barrier: The broad and extensive patent coverage can act as a barrier to innovation for other companies. It may discourage research and development in similar areas, as any new products would need to avoid infringing on Eisai's patents[2].
Regulatory and Legal Aspects
Patent Term Extension
Patents can be subject to term extensions under certain conditions, such as delays in regulatory approval. For example, the patent term extension request for another drug (DuvyzatTM) illustrates how regulatory review periods can impact patent expiration dates. However, there is no indication that US 11,090,386 has undergone a similar extension process[4].
Maintenance Fees
To keep the patent in force, the patent holder must pay maintenance fees at specified intervals. Records show that maintenance fees have been paid for related patents, ensuring the continued validity of the patent protection[2].
Industry Impact and Future Outlook
Pharmaceutical Industry Implications
The patent protection for Lenvima has significant implications for the pharmaceutical industry:
- Drug Development: The extensive patent coverage influences drug development strategies. Companies may need to invest in research to develop alternative treatments or formulations that do not infringe on Eisai's patents[2].
- Patient Access: The exclusivity period can affect patient access to affordable treatments. Generic versions of Lenvima cannot be launched until the patents expire, which may delay the availability of cheaper alternatives[2].
Future Outlook
As the patents for Lenvima approach their expiration dates, the landscape is likely to change:
- Generic Competition: Once the patents expire, generic versions of Lenvima can enter the market, potentially reducing prices and increasing competition[2].
- Innovation Opportunities: The expiration of these patents may open up new opportunities for innovation, as other companies can then develop and market similar products without infringing on Eisai's patents.
Key Takeaways
- Patent Protection: US 11,090,386 provides significant protection for the method of suppressing bitterness in quinoline derivatives, a key aspect of Lenvima.
- Market Exclusivity: The extensive patent portfolio for Lenvima ensures market exclusivity for Eisai until the patents expire in 2035.
- Regulatory and Legal Considerations: Maintenance fees and potential patent term extensions are crucial for maintaining the validity of the patent.
- Industry Impact: The patent landscape influences drug development, patient access, and future competition in the pharmaceutical industry.
FAQs
What is the main focus of US Patent 11,090,386?
The main focus of US Patent 11,090,386 is a method for suppressing the bitterness of quinoline derivatives, which is crucial for the pharmaceutical formulation of drugs like Lenvima.
Who owns the patent for Lenvima?
The patent for Lenvima is owned by Eisai Inc.
When do the patents for Lenvima expire?
The patents for Lenvima are set to expire in August 2035.
How does the patent protection impact the pharmaceutical industry?
The patent protection prevents other companies from launching similar products, giving Eisai market exclusivity and influencing drug development strategies.
What happens when the patents for Lenvima expire?
Once the patents expire, generic versions of Lenvima can enter the market, potentially reducing prices and increasing competition.
Cited Sources
- United States Patent and Trademark Office. (2021). Method for Suppressing Bitterness of Quinoline Derivative. US Patent 11,090,386 B2.
- Pharsight. Lenvima patent expiration.
- DrugPatentWatch. Details for Patent: 9700530.
- US FDA. (2024). Patent Term Extension Request of 17 May 2024.
- Google Patents. (2021). High-purity quinoline derivative and method for manufacturing same. US Patent 10259791 B2.
