United States Patent 10,888,547: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 10,888,547, titled "Amorphous and a crystalline form of genz 112638 hemitartrate," is a significant patent in the pharmaceutical sector. This patent, issued to protect specific forms of a drug compound, is crucial for understanding the patent landscape, particularly in the context of drug development and intellectual property.
Patent Overview
Patent Title and Description
The patent 10,888,547 covers amorphous and crystalline forms of genz 112638 hemitartrate, a compound used in pharmaceutical applications. This patent is essential for the protection of specific physical forms of the drug, which can affect its efficacy, stability, and bioavailability[5].
Issuance and Expiration
The patent was issued on January 12, 2021, and is set to expire on January 31, 2031, assuming no extensions or adjustments are made[4].
Scope of the Patent
Claim Structure
The scope of a patent is largely defined by its claims. For patent 10,888,547, the claims would typically include descriptions of the amorphous and crystalline forms of genz 112638 hemitartrate, methods of preparation, and any specific characteristics or properties that distinguish these forms.
- Independent Claims: These are the broadest claims in the patent and define the core invention. For example, an independent claim might describe the amorphous form of genz 112638 hemitartrate and its unique properties.
- Dependent Claims: These claims are narrower and depend on the independent claims. They might specify particular methods of preparing the amorphous or crystalline forms or additional characteristics of these forms[3].
Patent Scope Metrics
Metrics such as independent claim length and independent claim count can provide insights into the breadth and clarity of the patent claims. Generally, narrower claims with shorter lengths and fewer counts are associated with a higher probability of grant and a shorter examination process[3].
Claims Analysis
Claim Language and Clarity
The clarity and specificity of the claim language are critical for determining the patent's scope. Clear and specific claims reduce the risk of litigation and ensure that the patent holder's rights are well-defined. For example, if the claims in patent 10,888,547 are overly broad or unclear, they might face challenges during litigation or when generic manufacturers attempt to develop similar products[3].
Claim Scope and Patent Quality
The scope of the claims in patent 10,888,547 would be evaluated during the patent examination process to ensure they are not overly broad or vague. The examination process tends to narrow the scope of patent claims, ensuring that the granted patent is more focused and less likely to impede innovation[3].
Patent Landscape
Related Patents and Exclusivity
The patent landscape for genz 112638 hemitartrate includes other related patents that might cover different aspects of the drug, such as other physical forms, methods of use, or formulations. For instance, patents like 10,888,544 and 10,888,547 are part of a broader portfolio protecting various aspects of the drug[4].
Generic Entry and Paragraph IV Certifications
Generic manufacturers often challenge the validity or enforceability of patents through Paragraph IV certifications under the Hatch-Waxman Act. For patent 10,888,547, any generic manufacturer seeking to market a generic version of the drug would need to address these patents, potentially leading to litigation or settlements[4].
Government Interest and Public-Sector Patents
Bayh-Dole Act and Government Rights
If the research leading to patent 10,888,547 was funded by federal grants, the Bayh-Dole Act would apply, giving the government certain rights, including march-in rights. These rights allow the government to issue additional licenses if the patent holder is not taking effective steps to achieve practical application of the invention or to alleviate health or safety needs[1].
Reporting and Registering Government-Interest Statements
Patents with government-interest statements must be reported in various databases, such as the USPTO PatentsView Database and the Government Patent Register/UPAD. Ensuring these statements are accurately reported is crucial for tracking government rights and potential march-in actions[1].
Litigation and Enforcement
Patent Litigation and Challenges
Patent 10,888,547, like other pharmaceutical patents, is subject to litigation challenges. These challenges can arise from generic manufacturers, other pharmaceutical companies, or even from within the company itself if there are disputes over ownership or infringement.
Impact on Innovation
The breadth and clarity of the claims in patent 10,888,547 can impact innovation in the pharmaceutical sector. Overly broad or unclear claims can lead to increased licensing and litigation costs, potentially stifling innovation. Conversely, well-defined claims can provide clear boundaries, encouraging further research and development[3].
Key Takeaways
- Patent Scope and Claims: The scope of patent 10,888,547 is defined by its claims, which must be clear and specific to ensure enforceability and avoid litigation.
- Patent Landscape: The patent is part of a broader landscape that includes other related patents and potential generic entry challenges.
- Government Interest: If federally funded, the patent is subject to government rights under the Bayh-Dole Act.
- Litigation and Enforcement: The patent's validity and enforceability can be challenged through litigation, affecting its impact on innovation.
FAQs
Q: What is the expiration date of United States Patent 10,888,547?
A: The patent is set to expire on January 31, 2031[4].
Q: What does the patent 10,888,547 cover?
A: The patent covers amorphous and crystalline forms of genz 112638 hemitartrate, a pharmaceutical compound[5].
Q: How are the claims in patent 10,888,547 structured?
A: The claims include independent claims that define the core invention and dependent claims that specify additional details or characteristics[3].
Q: What is the significance of government-interest statements in patents?
A: Government-interest statements are crucial for tracking government rights, including march-in rights, if the research was federally funded[1].
Q: How can the scope of patent claims impact innovation?
A: Clear and specific claims can encourage innovation by providing clear boundaries, while overly broad or unclear claims can increase licensing and litigation costs, potentially stifling innovation[3].
Sources
- The Feasibility of Using Bayh-Dole March-In Rights to Lower Drug Prices - National Bureau of Economic Research.
- Drugs covered by patent 10,888,547 - Drug Patent Watch.
- Patent Claims and Patent Scope - Hoover Institution.
- Eliglustat Capsules - U.S. Food and Drug Administration.
- Amorphous and a crystalline form of genz 112638 hemitartrate - PubChem.
