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Last Updated: March 19, 2025

Details for Patent: 10,745,343


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Which drugs does patent 10,745,343 protect, and when does it expire?

Patent 10,745,343 protects ORSERDU and is included in one NDA.

This patent has thirty-three patent family members in nineteen countries.

Summary for Patent: 10,745,343
Title:Polymorphic forms of RAD1901-2HCl
Abstract:Various polymorphic forms of RAD1901-2HCl, including three crystalline and amorphous forms, are prepared and characterized. Uses of the various polymorphic forms of RAD1901-2HCl for cancer treatment are also disclosed.
Inventor(s):Cruskie, Jr. Michael Paul, Bolger Joshua Kyle, McKenzie Jonathan Blake, Sheth Pratik, Edwards Richard, Eberlin Alex, Markey Michael
Assignee:RADIUS PHARMACEUTICALS, INC.
Application Number:US16456314
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Understanding the Scope and Claims of U.S. Patents: A Detailed Analysis

Introduction

Patents are a crucial component of intellectual property law, providing inventors and innovators with exclusive rights to their inventions. In the United States, the patent landscape is complex and heavily regulated, particularly in industries like pharmaceuticals and biotechnology. This article will delve into the scope and claims of U.S. patents, using the example of U.S. Patent 10,745,343 to illustrate key concepts.

What are Patents and Why Are They Important?

Patents are a form of intellectual property that grant the inventor the right to exclude others from making, using, selling, and importing the invention for a specified period, typically 20 years from the filing date[4].

The Role of Patent Claims

Patent claims are the heart of a patent application, defining the scope of the invention and the rights granted to the patent holder. These claims must be clear, concise, and enable any person skilled in the art to make and use the invention[4].

Types of Patent Claims

  • Independent Claims: These claims stand alone and define the invention without reference to other claims.
  • Dependent Claims: These claims refer back to and further limit an independent claim.
  • Genus Claims: These claims cover a broad category of inventions rather than a specific embodiment[3].

The Importance of Patent Scope

The scope of a patent claim determines the breadth of protection granted to the inventor. Broader claims can provide more comprehensive protection but risk being invalidated if they are not supported by the patent application's written description[3].

Factors Influencing Patent Scope

  • Written Description Requirement: The patent application must contain a written description of the invention that is sufficient to enable any person skilled in the art to make and use it[4].
  • Enablement Requirement: The description must be clear, concise, and exact enough to enable the invention's use[4].
  • Best Mode Requirement: The inventor must disclose the best mode contemplated for carrying out the invention[4].

Case Study: U.S. Patent 10,745,343

While the specific details of U.S. Patent 10,745,343 are not provided in the sources, we can use general principles to analyze its scope and claims.

Identifying Core Chemical Structures

In the pharmaceutical industry, identifying the core chemical structure is critical. Tools like PatentAgent, an intelligent agent for automated pharmaceutical patent analysis, can help in this process by extracting chemical compound images, converting them to SMILES (Simplified Molecular Input Line Entry System), and identifying top candidates with high probabilities[1].

Drafting Patent Claims

For a patent like U.S. Patent 10,745,343, the claims would need to be carefully drafted to capture the essence of the invention without being too broad or too narrow. This involves a delicate balance to ensure that the claims are supported by the written description and enablement requirements[3].

Challenges in Pharmaceutical and Biotechnology Patents

The pharmaceutical and biotechnology industries face unique challenges in obtaining and maintaining patent protection.

Genus Claims and Their Challenges

Genus claims, which cover a broad category of compounds, are particularly challenging. The Federal Circuit's rigid application of patent disclosure laws, such as Section 112(a), has made it difficult to obtain valuable patent protection for drugs and biologics. These claims must include a written description that enables any person skilled in the art to make and use the invention[3].

Market Impact

The market for pharmaceuticals and biologics is vast and expanding, with therapeutic antibodies expected to reach a market size of $300 billion by 2025. Robust and predictable patent protection is essential for innovators to commercialize their inventions effectively[3].

Patent Claims Research Dataset

The USPTO's Patent Claims Research Dataset provides valuable insights into patent claims and their scope. This dataset includes detailed information on claims from U.S. patents granted between 1976 and 2014 and U.S. patent applications published between 2001 and 2014. It helps in understanding the dependency relationships between claims and the statistical measures of patent scope[2].

The Need for a Small Claims Patent Court

The complexity and cost of patent litigation have led to discussions about establishing a small claims patent court. This would provide a more accessible and efficient way for smaller entities to resolve patent disputes, which is crucial for innovators who may not have the resources to engage in lengthy and expensive legal battles[5].

Best Practices for Drafting Patent Claims

  • Clarity and Conciseness: Claims should be clear and concise to avoid ambiguity.
  • Support from the Written Description: Claims must be fully supported by the written description in the patent application.
  • Enablement: The claims should enable any person skilled in the art to make and use the invention.
  • Avoiding Overbreadth: Claims should not be too broad, as this can lead to invalidation[4].

Tools and Technologies in Patent Analysis

Advanced tools like PatentAgent are revolutionizing the landscape of pharmaceutical research by automating the analysis of patent claims and identifying core chemical structures with high accuracy. These tools can significantly improve the efficiency and accuracy of patent analysis[1].

Conclusion

Understanding the scope and claims of U.S. patents is essential for innovators and businesses, especially in the pharmaceutical and biotechnology sectors. The delicate balance between broad and narrow claims, the importance of written description and enablement, and the challenges posed by genus claims are all critical factors. As the patent landscape continues to evolve, tools and technologies like PatentAgent and initiatives such as the potential small claims patent court will play significant roles in shaping the future of intellectual property protection.

Key Takeaways

  • Patent Claims Define the Scope: Patent claims are crucial in defining the scope of the invention and the rights granted to the patent holder.
  • Balance in Claim Drafting: Claims must be balanced between being too broad and too narrow to ensure validity.
  • Written Description and Enablement: Claims must be supported by a clear and enabling written description.
  • Genus Claims Challenges: Genus claims face significant challenges due to strict application of patent disclosure laws.
  • Market Impact: Robust patent protection is essential for commercializing pharmaceutical and biotechnology inventions.
  • Technological Advancements: Tools like PatentAgent are improving the efficiency and accuracy of patent analysis.

FAQs

What is the purpose of patent claims in a patent application?

Patent claims define the scope of the invention and the rights granted to the patent holder, distinguishing what is protected from what is not.

How do genus claims impact patent protection in the pharmaceutical industry?

Genus claims, which cover broad categories of compounds, face challenges due to the Federal Circuit's strict application of patent disclosure laws, making it difficult to obtain valuable patent protection for drugs and biologics.

What is the significance of the written description requirement in U.S. patent law?

The written description requirement ensures that the patent application contains a clear and enabling description of the invention, allowing any person skilled in the art to make and use it.

How does the Patent Claims Research Dataset help in understanding patent scope?

The Patent Claims Research Dataset provides detailed information on claims from U.S. patents and applications, helping to understand the dependency relationships between claims and statistical measures of patent scope.

Why is there a need for a small claims patent court?

A small claims patent court would provide a more accessible and efficient way for smaller entities to resolve patent disputes, reducing the complexity and cost associated with traditional patent litigation.

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Drugs Protected by US Patent 10,745,343

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Patented / Exclusive UseSubmissiondate
Stemline Therap ORSERDU elacestrant hydrochloride TABLET;ORAL 217639-001 Jan 27, 2023 RX Yes No 10,745,343 ⤷  Try for Free TREATMENT OF AN ER-POSITIVE BREAST CANCER ⤷  Try for Free
Stemline Therap ORSERDU elacestrant hydrochloride TABLET;ORAL 217639-002 Jan 27, 2023 RX Yes Yes 10,745,343 ⤷  Try for Free TREATMENT OF AN ER-POSITIVE BREAST CANCER ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Patented / Exclusive Use>Submissiondate
Showing 1 to 2 of 2 entries

International Family Members for US Patent 10,745,343

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Australia 2018205285 ⤷  Try for Free
Australia 2023202085 ⤷  Try for Free
Canada 3047411 ⤷  Try for Free
China 110191707 ⤷  Try for Free
China 117417263 ⤷  Try for Free
Denmark 3565542 ⤷  Try for Free
European Patent Office 3565542 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 7 of 7 entries

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