Details for Patent: RE47751

Which drugs does patent RE47751 protect, and when does it expire?

Patent RE47751 protects EXONDYS 51 and is included in one NDA.

This patent has thirty patent family members in thirteen countries.

Summary for Patent: RE47751

Title:	Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Abstract:	An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 202.
Inventor(s):	Wilton; Stephen Donald (Applecross, AU), Fletcher; Sue (Bayswater, AU), McClorey; Graham (Bayswater, AU)
Assignee:	The University of Western Australia (Crawley, AU)
Application Number:	15/655,646
Patent Claim Types: see list of patent claims	Use; Delivery; Dosage form;

United States Patent RE47751: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent RE47751, titled "Antisense oligonucleotides for inducing exon skipping and methods of use thereof," is a reissue patent that pertains to the field of genetic therapy, specifically focusing on the treatment of genetic disorders through exon skipping. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Background

Patent Overview

The patent RE47751E1 involves the use of antisense oligonucleotides to induce exon skipping in the dystrophin gene, a method that holds promise for treating muscular dystrophy and other genetic diseases. Antisense oligonucleotides are short, single-stranded DNA or RNA molecules designed to bind to specific sequences of RNA, thereby modulating gene expression[4].

Scope of the Patent

Claims

The patent includes multiple claims that define the legal boundaries of the invention. Here are some key aspects:

Independent Claims

• Claim 1 typically defines the broadest scope of the invention, often describing the antisense oligonucleotides and their method of use. For example, it might claim "an antisense oligonucleotide capable of binding to a selected target site to induce exon skipping in the dystrophin gene."
• Subsequent claims may narrow down the scope by specifying particular sequences, lengths, or modifications of the oligonucleotides.

Dependent Claims

• These claims build upon the independent claims, adding additional limitations or features. For instance, a dependent claim might specify a particular sequence of the oligonucleotide or a specific method of administration.

Written Description and Enablement

The specification of the patent must adequately describe the invention and enable a person skilled in the relevant technology to make and use it. This includes detailed descriptions of the oligonucleotides, their synthesis, and the methods for inducing exon skipping[5].

Claims Analysis

Claim Construction

Claim construction is crucial in understanding the scope of the patent. Here, the claims are analyzed to determine what is covered and what is not.

Key Claim Elements

• Target Site: The claims specify the target site within the dystrophin gene where the antisense oligonucleotides bind to induce exon skipping.
• Sequence: The specific sequences of the oligonucleotides are defined, which is critical for ensuring that the invention is novel and nonobvious.
• Method of Use: The claims outline the methods by which the oligonucleotides are administered and how they induce exon skipping.

Anticipation and Obviousness

The patent must meet the criteria of novelty and nonobviousness. This means that the invention must not be anticipated by prior art and must be a nonobvious extension of what was known in the field at the time of the invention.

Patent Landscape

Prior Art

Understanding the prior art is essential for assessing the novelty and nonobviousness of the invention. Prior art in this field includes other genetic therapies and methods of exon skipping. The patent must demonstrate how it differs from and improves upon existing technologies.

Related Patents

Other patents in the field of genetic therapy and exon skipping are relevant. For example, patents related to different methods of inducing exon skipping or using different types of oligonucleotides can provide context on the competitive landscape.

Patent Analytics

Using patent analytics tools, such as those described by Schwegman, can help in categorizing and analyzing the patent claims and scope concepts. This involves creating a Claim Coverage Matrix and using ClaimScape® software to generate interactive claim charts. These tools help in identifying gaps in current coverage and highlighting future design opportunities[3].

Enforcement and Litigation

Infringement

The rights granted by the patent are enforced through litigation in federal district courts or before the International Trade Commission (ITC). Issues such as direct infringement, infringement under the doctrine of equivalents, induced infringement, and contributory infringement are relevant[5].

Case Law Precedents

Court decisions, such as those from the Federal Circuit, provide guidance on how patent claims are interpreted and enforced. For instance, cases involving the analysis of obviousness and anticipation, like those seen in In re Cellect and Axonics, Inc. v. Medtronic, Inc., can offer insights into how similar claims might be treated[1][2].

Key Takeaways

• Scope and Claims: The patent RE47751E1 is defined by its claims, which specify the antisense oligonucleotides and their method of use for inducing exon skipping in the dystrophin gene.
• Patent Landscape: Understanding the prior art and related patents is crucial for assessing the novelty and nonobviousness of the invention.
• Enforcement: The patent's enforcement involves litigation in federal courts or the ITC, with considerations of direct and indirect infringement.
• Patent Analytics: Tools like Claim Coverage Matrix and ClaimScape® software are essential for analyzing and managing the patent claims effectively.

FAQs

Q: What is the primary focus of the United States Patent RE47751?

A: The primary focus is on the use of antisense oligonucleotides to induce exon skipping in the dystrophin gene, a method aimed at treating genetic disorders like muscular dystrophy.

Q: How are the claims in this patent constructed?

A: The claims are constructed to define the antisense oligonucleotides, their target sites within the dystrophin gene, and the methods of use for inducing exon skipping.

Q: What are the key elements that must be met for the patent to be valid?

A: The patent must meet the criteria of written description, enablement, novelty, and nonobviousness.

Q: How can patent analytics tools help in managing this patent?

A: Patent analytics tools help in categorizing and analyzing the patent claims, identifying gaps in coverage, and highlighting future design opportunities through tools like Claim Coverage Matrix and ClaimScape® software.

Q: What are the potential legal issues related to enforcing this patent?

A: Potential legal issues include direct infringement, infringement under the doctrine of equivalents, induced infringement, and contributory infringement, which can be addressed through litigation in federal courts or the ITC.

Sources

1. In re Cellect - United States Court of Appeals for the Federal Circuit
2. Axonics, Inc. v. Medtronic, Inc. - United States Court of Appeals for the Federal Circuit
3. Patent Analytics - Schwegman, Lundberg & Woessner, P.A.
4. USRE47751E1 - Google Patents
5. Patent Law: A Handbook for Congress - CRS Reports

Drugs Protected by US Patent RE47751

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY INDUCING SKIPPING OF EXON 51
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-001	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY CORRECTING A DEFECTIVE GENE FOR DYSTROPHIN
Sarepta Theraps Inc	EXONDYS 51	eteplirsen	SOLUTION;INTRAVENOUS	206488-002	Sep 19, 2016		RX	Yes	Yes						TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING BY RESTORING OR INCREASING FUNCTIONAL DYSTROPHIN PROTEIN PRODUCTION

Foreign Priority and PCT Information for Patent: RE47751

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2004903474	Jun 28, 2004

International Family Members for US Patent RE47751

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E498685
Cyprus	1111447
Cyprus	1117475
Germany	602005026386
Denmark	1766010
Denmark	2206781
European Patent Office	1766010