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Last Updated: December 27, 2024

Details for Patent: 10,660,904


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Which drugs does patent 10,660,904 protect, and when does it expire?

Patent 10,660,904 protects KORLYM and is included in one NDA.

Summary for Patent: 10,660,904
Title:Optimizing mifepristone levels for cushing's patients
Abstract: The present invention provides a method for optimizing levels of mifepristone in a patient suffering from Cushing's syndrome. The method comprises the steps of treating the patient with seven or more daily doses of mifepristone over a period of seven or more days; testing the serum levels of the patient to determine whether the blood levels of mifepristone are greater than 1631 ng/mL; and adjusting the daily dose of the patient to achieve mifepristone blood levels greater than 1631 ng/mL.
Inventor(s): Belanoff; Joseph (Woodside, CA), Gross; Coleman (Menlo Park, CA)
Assignee: Corcept Therapeutics, Inc. (Menlo Park, CA)
Application Number:16/219,496
Patent Claim Types:
see list of patent claims
Use; Delivery;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,660,904

Introduction

Patents are a crucial component of intellectual property law, providing inventors and companies with exclusive rights to their innovations. The United States Patent 10,660,904, like other patents, is governed by the Patent Act (35 U.S. Code) and managed by the United States Patent and Trademark Office (USPTO). Here, we will delve into the details of this specific patent, analyzing its scope, claims, and the broader patent landscape.

Patent Overview

Patent Type and Duration

United States Patent 10,660,904 is likely a utility patent, given that utility patents are the most common type. Utility patents have a duration of 20 years from the date of filing but are not enforceable until the day of issuance[1].

Subject Matter Eligibility

To be eligible for a patent, the invention must fall within one of the four statutory categories under Section 101 of the Patent Act: processes, machines, manufactures, or compositions of matter. The patent must also pass the tests for abstract ideas, natural phenomena, and laws of nature, as outlined in the Alice test[1].

Claims Analysis

Independent and Dependent Claims

Patent claims define the scope of the invention and are crucial for determining patentability and infringement. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims. The length and count of independent claims can be metrics for measuring patent scope, with narrower claims often associated with a higher probability of grant and a shorter examination process[3].

Claim Language and Scope

The language used in the claims is critical. Broader claims may face more scrutiny and challenges during the examination process, while narrower claims are generally more straightforward to defend. The scope of the claims in Patent 10,660,904 would need to be carefully crafted to ensure they are specific enough to be enforceable but broad enough to cover the invention's core aspects.

Patent Landscape

Competitors and Related Patents

The patent landscape includes other patents and innovations in the same field. For a patent like 10,660,904, understanding the competitive environment is essential. This involves identifying similar patents, ongoing research, and potential competitors. For example, in the pharmaceutical sector, patents often face challenges from generic drug manufacturers, as seen in the case of Corcept's Korlym, which faced ANDA applications and patent validity challenges[4].

Litigation and Challenges

Patents are often subject to litigation and challenges. The Hatch-Waxman Act, for instance, allows generic drug manufacturers to challenge the validity of patents listed in the Orange Book through Paragraph IV certifications. This can lead to a 30-month stay on FDA approval of the generic drug application. Patent holders must be prepared to defend their patents against such challenges, as Corcept did in its litigation with Teva and Hikma[4].

Examination Process

USPTO Review

The USPTO reviews patent applications to determine if the invention is patentable. This process involves examining the claims for subject matter eligibility, novelty, non-obviousness, and written description. The examiner may issue rejections based on these criteria, and the applicant must respond to these rejections to proceed with the patent application[1].

Responding to Rejections

When responding to rejections, applicants must address the examiner's concerns. For Section 101 rejections, this might involve arguing that the invention is not an abstract idea or natural phenomenon and that it has an "inventive concept" that makes it patentable. The machine-or-transformation test and the Markedly Different Characteristics test are also relevant here[1].

Industry Impact

Innovation and Competition

Patents like 10,660,904 can significantly impact innovation and competition within an industry. By granting exclusive rights, patents incentivize innovation but can also create barriers to entry for other companies. The balance between encouraging innovation and promoting competition is a delicate one, and the scope and claims of a patent play a crucial role in this balance.

Economic Considerations

The economic implications of a patent are substantial. Patent holders can use their patents to secure market exclusivity, which can lead to higher profits but also higher costs for consumers. The litigation costs associated with defending patents can also be significant, as seen in the pharmaceutical industry where patent disputes are common[4].

Key Takeaways

  • Patent Type and Duration: Utility patents, like 10,660,904, have a 20-year duration from the filing date.
  • Claims Analysis: Independent and dependent claims define the patent's scope, with narrower claims often preferred.
  • Patent Landscape: Understanding competitors and related patents is crucial for navigating the patent landscape.
  • Examination Process: The USPTO review involves checking for subject matter eligibility, novelty, non-obviousness, and written description.
  • Industry Impact: Patents balance innovation incentives with competitive concerns and have significant economic implications.

FAQs

Q: What is the typical duration of a utility patent in the United States? A: A utility patent in the United States has a duration of 20 years from the date of filing but is not enforceable until the day of issuance[1].

Q: How do independent and dependent claims differ in a patent? A: Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[3].

Q: What is the purpose of the Alice test in patent law? A: The Alice test is used to determine if a patent claim is eligible under Section 101 by checking for abstract ideas, natural phenomena, and laws of nature[1].

Q: How do generic drug manufacturers challenge pharmaceutical patents? A: Generic drug manufacturers can challenge pharmaceutical patents through Paragraph IV certifications under the Hatch-Waxman Act, which can lead to a 30-month stay on FDA approval[4].

Q: Why is the scope of patent claims important? A: The scope of patent claims is important because it defines what is protected by the patent and affects the patent's enforceability and the likelihood of litigation[3].

Sources

  1. BitLaw: Patent Law in the United States.
  2. Gale: Patent Issued for Optimizing Mifepristone Levels For Cushing'S.
  3. SSRN: Patent Claims and Patent Scope.
  4. Annual Reports: UNITED STATES SECURITIES AND EXCHANGE COMMISSION - Corcept Therapeutics Incorporated.

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Drugs Protected by US Patent 10,660,904

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Corcept Therap KORLYM mifepristone TABLET;ORAL 202107-001 Feb 17, 2012 AB RX Yes Yes 10,660,904 ⤷  Subscribe TREATING CUSHING'S SYNDROME ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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