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Last Updated: December 22, 2024

Details for Patent: 10,322,139


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Which drugs does patent 10,322,139 protect, and when does it expire?

Patent 10,322,139 protects ZULRESSO and is included in one NDA.

This patent has forty-five patent family members in twenty-four countries.

Summary for Patent: 10,322,139
Title:Neuroactive steroid formulations and methods of treating CNS disorders
Abstract: Formulations of comprising a neuroactive steroid, e.g., allopregnanolone; and optionally a cyclodextrin, e.g., a .beta.-cyclodextrin, e.g., a sulfo butyl ether .beta.-cyclodextrin, e.g., a .beta.-cyclodextrin, e.g., a sulfo butyl ether .beta.-cyclodextrin, e.g., CAPTISOL.RTM.; and methods of use in treating CNS disorders.
Inventor(s): Reddy; Kiran (Boston, MA)
Assignee: Sage Therapeutics, Inc. (Cambridge, MA)
Application Number:15/649,583
Patent Claim Types:
see list of patent claims
Composition; Dosage form;
Patent landscape, scope, and claims:

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

Introduction

Patents are a cornerstone of innovation, providing inventors and companies with exclusive rights to their inventions. In the United States, the patent landscape is governed by the Patent Act (35 U.S. Code) and managed by the United States Patent and Trademark Office (USPTO). This article will delve into the specifics of patent scope, claims, and the broader patent landscape, using U.S. Patent 10,322,139 as a case study.

Types of Patents

In the U.S., there are several types of patents, each protecting different aspects of an invention.

Utility Patents

These are the most common type and protect new and useful processes, machines, manufactures, or compositions of matter, or any improvement thereof. Utility patents have a duration of 20 years from the date of filing but are not enforceable until the day of issuance[1].

Design Patents

Design patents protect the ornamental design of a functional item. They have a term of 15 years from the date of grant[1].

Plant Patents

Plant patents protect new varieties of asexually reproducing plants. Like utility patents, they last for 20 years from the date of filing[1].

Patent Application and Examination Process

To obtain a patent, an applicant must submit a patent application to the USPTO. The application is then reviewed by an examiner to determine if the invention is patentable. This process involves several key steps:

Filing the Application

The applicant submits a detailed description of the invention, including drawings and claims that define the scope of the invention[1].

Examination

The USPTO examiner reviews the application to ensure it meets the statutory requirements for novelty, non-obviousness, and subject matter eligibility. This includes evaluating the claims against prior art and determining if the invention is significantly different from what already exists[1].

Patent Claims

Patent claims are crucial as they define the scope of the invention and what is protected by the patent.

Independent and Dependent Claims

Independent claims stand alone and define the invention without reference to other claims. Dependent claims, on the other hand, refer back to and further limit an independent claim[3].

Metrics for Measuring Patent Scope

Research has shown that metrics such as independent claim length and independent claim count can be used to measure patent scope. These metrics have explanatory power for several correlates of patent scope, including patent maintenance payments, forward citations, and the breadth of patent classes[3].

Patent Subject Matter Eligibility

Section 101 of the Patent Act sets out the criteria for what can be patented. However, certain exceptions exist, including laws of nature, natural phenomena, and abstract ideas.

The Alice Test

The Supreme Court's decision in Alice Corp. v. CLS Bank International established a two-step test to determine if a patent claim is directed to patent-ineligible subject matter:

  1. Step One: Determine if the claim is directed to an abstract idea.
  2. Step Two: If it is, determine if the claim includes elements that transform it into a patent-eligible application by adding something "significantly more" than the abstract idea itself[2].

Case Study: U.S. Patent 10,322,139

While specific details about U.S. Patent 10,322,139 are not provided here, we can apply the general principles outlined above to understand its scope and claims.

Claim Construction

The claims of a patent are often the subject of litigation, where courts must construe the meaning of the claim terms. This process involves interpreting the language of the claims in the context of the specification and the prior art. For example, in Contour IP Holding LLC v. GoPro, Inc., the court had to construe disputed claim terms to determine if GoPro's products infringed Contour's patents[2].

Patent Eligibility

To ensure that U.S. Patent 10,322,139 is enforceable, it must pass the Alice test. This involves examining whether the claims are directed to an abstract idea and, if so, whether they include sufficient elements to transform them into a patent-eligible application.

Scope and Breadth

The scope of U.S. Patent 10,322,139 would be defined by its independent and dependent claims. Narrower claims are generally associated with a higher probability of grant and a shorter examination process, while broader claims may face more scrutiny and potential challenges[3].

Patent Quality and Examination Time

The quality of patents is a significant concern, with stakeholders often defining a quality patent as one that meets statutory requirements for novelty and clarity and would be upheld if challenged.

USPTO Initiatives

The USPTO has implemented various initiatives to improve patent quality, including the Enhanced Patent Quality Initiative. This includes defining patent quality in agency documents, reassessing examination time, and analyzing the effects of incentives on patent quality[4].

Examination Time

The time allotted for examination is critical. The USPTO has increased the time available for certain art units to ensure thorough examinations, reflecting the complexity of modern inventions[4].

Small Claims Patent Court

There is ongoing discussion about the feasibility of a small claims patent court to address the high costs associated with patent litigation.

ACUS Study

The Administrative Conference of the United States (ACUS) conducted a study on the need for and potential structure of a small claims patent court. This study involved extensive public input and consultation with academic experts and legal practitioners[5].

Key Takeaways

  • Patent Types: Utility, design, and plant patents each protect different aspects of an invention.
  • Patent Claims: Claims define the scope of the invention and must be carefully crafted to ensure enforceability.
  • Subject Matter Eligibility: The Alice test is crucial for determining if a patent claim is directed to patent-ineligible subject matter.
  • Patent Quality: Ensuring patent quality involves meeting statutory requirements and withstanding potential challenges.
  • Examination Process: The examination time and process are vital for ensuring that patents are thoroughly reviewed.

FAQs

What are the main types of patents in the United States?

The main types of patents in the United States are utility patents, design patents, and plant patents.

How long does a utility patent last?

A utility patent lasts for 20 years from the date of filing but is not enforceable until the day of issuance.

What is the Alice test?

The Alice test is a two-step test used to determine if a patent claim is directed to patent-ineligible subject matter, specifically abstract ideas.

Why is patent quality important?

Patent quality is important because it ensures that patents meet statutory requirements and can withstand challenges, thereby maintaining the integrity of the patent system.

What is the purpose of a small claims patent court?

A small claims patent court is proposed to address the high costs associated with patent litigation, providing a more accessible and cost-effective option for resolving patent disputes.

Sources

  1. BitLaw: Patent Law in the United States.
  2. CAFC: CONTOUR IP HOLDING LLC v. GOPRO, INC.
  3. SSRN: Patent Claims and Patent Scope.
  4. GAO: Intellectual Property: Patent Office Should Define Quality, Reassess Examination Time.
  5. ACUS: U.S. Patent Small Claims Court.

More… ↓

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Drugs Protected by US Patent 10,322,139

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes 10,322,139 ⤷  Subscribe Y ⤷  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

International Family Members for US Patent 10,322,139

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013212287 ⤷  Subscribe
Australia 2018201307 ⤷  Subscribe
Australia 2020217402 ⤷  Subscribe
Brazil 112014018110 ⤷  Subscribe
Canada 2862076 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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