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Last Updated: January 5, 2025

Details for Patent: 9,907,780


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Which drugs does patent 9,907,780 protect, and when does it expire?

Patent 9,907,780 protects SILENOR and is included in one NDA.

This patent has three patent family members in three countries.

Summary for Patent: 9,907,780
Title:Low-dose doxepin formulations and methods of making and using the same
Abstract: The invention disclosed herein generally relates to low-dose oral doxepin pharmaceutical formulations and the use of these formulations to promote sleep.
Inventor(s): Schioppi; Luigi (Escondido, CA), Dorsey; Brian Talmadge (Encinitas, CA), Skinner; Michael (San Diego, CA), Carter; John (Keswick, CA), Mansbach; Robert (San Diego, CA), Jochelson; Philip (San Diego, CA), Rogowski; Roberta L. (Rancho Santa Fe, CA), Casseday; Cara Baron (San Diego, CA), Perry; Meredith (El Cajon, CA), Knox; Bryan (San Diego, CA)
Assignee: Pernix Sleep, Inc. (Morristown, NJ)
Application Number:15/394,912
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,907,780
Patent Claim Types:
see list of patent claims
Composition; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 9,907,780: A Detailed Analysis

Introduction

When analyzing a patent, particularly one like United States Patent 9,907,780, it is crucial to delve into the specifics of its claims, the scope of the invention, and the broader patent landscape. This analysis will help in understanding the patent's validity, its potential for enforcement, and its position within the industry.

Patent Claims: The Heart of the Patent

Claim Structure and Types

Patent claims are the legal boundaries of what the patent protects. They are typically divided into independent and dependent claims. Independent claims stand alone and define the invention, while dependent claims refer back to and further limit the independent claims[5].

Claim Scope and Its Importance

The scope of the claims is critical. A common misconception is that broader claims are always better, but this is not the case. Broader claims can be more difficult to get granted and are easier to invalidate. The claim scope must be anchored to the embodiments disclosed in the specification to avoid issues like the abstract idea exception and failure to meet the written description requirement[5].

Analyzing the Claims of U.S. Patent 9,907,780

Independent Claims

To understand the scope of U.S. Patent 9,907,780, one must start with the independent claims. These claims define the broadest aspects of the invention and set the stage for the dependent claims. For example, if the patent is related to a technological innovation, the independent claims might describe the core functionality and components of the invention.

Dependent Claims

Dependent claims further narrow down the invention by adding specific limitations. These claims can help in distinguishing the invention from prior art and can provide additional protection by covering various embodiments of the invention.

Patent Scope and Its Measurement

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].

Narrowing Claims During Examination

The examination process often narrows the scope of patent claims. This is because examiners may require more specific language to ensure the claims are not overly broad and to distinguish them from prior art. Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Obviousness-Type Double Patenting (ODP)

ODP Analysis

In cases where multiple patents are involved, such as in the Cellect LLC case, the issue of obviousness-type double patenting (ODP) arises. ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of Patent Term Adjustment (PTA)[1].

Impact on Patent Term

The analysis of ODP must consider the adjusted expiration date of the patent, including any PTA. This ensures that the patent term is not extended beyond what is legally permissible, even if a terminal disclaimer is involved[1].

Patent Landscape and Industry Context

Prior Art and Competitors

Understanding the prior art and the competitive landscape is essential. For instance, in the pharmaceutical industry, as seen in the Amgen Inc. v. Sanofi case, patents often cover specific biological processes or compounds. The scope of these patents must be carefully defined to avoid overlapping with existing patents and to ensure they meet the enablement requirement under ยง112 of the Patent Act[4].

Litigation and Enforcement

The scope and claims of a patent also play a crucial role in litigation. Overly broad claims can lead to invalidation, as seen in cases like Alice v. CLS Bank, where the abstract idea exception is often invoked. Patent holders must ensure that their claims are specific enough to be enforceable but broad enough to provide meaningful protection[5].

Key Considerations for Drafting Patent Claims

Balancing Breadth and Specificity

Patent drafters must balance the breadth of the claims with the specificity required to avoid invalidation. Claims should be anchored to the embodiments disclosed in the specification and should not preempt abstract ideas or generic processes[5].

Current Trends and Legislative Landscape

The legal landscape for patents is constantly evolving. Drafters must be aware of recent court decisions and legislative activities that could impact the validity and enforceability of the patent claims.

Case Studies and Industry Examples

Amgen Inc. v. Sanofi

In the Amgen Inc. v. Sanofi case, the Supreme Court addressed the issue of claiming a genus of antibodies. Amgen's patents were invalidated because they failed to meet the enablement requirement, as they sought to claim millions of antibodies without teaching how to make them. This case highlights the importance of ensuring that claims are specific and enabled by the specification[4].

Cellect LLC

The Cellect LLC case illustrates the complexities of ODP and PTA. The Federal Circuit's decision emphasized that ODP analysis must consider the adjusted expiration date of the patent, including any PTA, to prevent extending the patent term beyond what is legally permissible[1].

Key Takeaways

  • Claim Scope: The scope of patent claims must be carefully balanced between breadth and specificity to ensure validity and enforceability.
  • ODP Analysis: Obviousness-type double patenting analysis is crucial and must consider the adjusted expiration date of the patent, including any PTA.
  • Industry Context: Understanding the prior art and competitive landscape is essential for drafting and enforcing patent claims.
  • Legal Landscape: Recent court decisions and legislative activities can significantly impact the validity and enforceability of patent claims.
  • Drafting Considerations: Claims must be anchored to the embodiments disclosed in the specification and should avoid preempting abstract ideas or generic processes.

FAQs

What is the importance of claim scope in a patent application?

The claim scope is critical because it defines the legal boundaries of what the patent protects. A balanced scope between breadth and specificity is necessary to ensure the patent is valid and enforceable.

How does obviousness-type double patenting (ODP) affect patent claims?

ODP prevents an inventor from securing a second, later-expiring patent for an invention covered by a patent that was filed at the same time but has a different patent term due to a grant of PTA. ODP analysis must consider the adjusted expiration date of the patent.

What are the risks of overly broad patent claims?

Overly broad claims are easier to invalidate and can run afoul of the abstract idea exception or fail to meet the written description requirement. They can also lead to increased licensing and litigation costs.

How do recent court decisions impact patent claims?

Recent court decisions, such as Alice v. CLS Bank and Amgen Inc. v. Sanofi, have set important precedents for what constitutes a valid patent claim. These decisions emphasize the need for specificity and enablement in patent claims.

What role does the U.S. Patent and Trademark Office (USPTO) play in patent claims?

The USPTO is responsible for granting U.S. patents and ensures that patent claims meet the statutory requirements, including novelty, non-obviousness, and enablement.

Sources

  1. In re Cellect - United States Court of Appeals for the Federal Circuit[1]
  2. U.S. Patent and Trademark Office (USPTO) - USA.gov[2]
  3. Patent Claims and Patent Scope - SSRN[3]
  4. Amgen Inc. v. Sanofi - Supreme Court of the United States[4]
  5. The Importance of Getting the Claim Scope Right in a US Patent Application - Rimon Law[5]

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Drugs Protected by US Patent 9,907,780

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010 AB RX Yes No 9,907,780 ⤷  Subscribe Y ⤷  Subscribe
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010 AB RX Yes Yes 9,907,780 ⤷  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 9,907,780

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2721133 ⤷  Subscribe
European Patent Office 2148659 ⤷  Subscribe
World Intellectual Property Organization (WIPO) 2008128115 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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