Details for Patent: RE48468

Which drugs does patent RE48468 protect, and when does it expire?

Patent RE48468 protects EXONDYS 51 and is included in one NDA.

This patent has seventy-four patent family members in seventeen countries.

Summary for Patent: RE48468

Title:	Means and methods for counteracting muscle disorders
Abstract:	The invention provides means and methods for alleviating one or more symptom(s) of Duchenne Muscular Dystrophy and/or Becker Muscular Dystrophy. Therapies using compounds for providing patients with functional muscle proteins are combined with at least one adjunct compound for reducing inflammation, preferably for reducing muscle tissue inflammation, and/or at least one adjunct compound for improving muscle fiber function, integrity and/or survival.
Inventor(s):	Josephus Johannes De Kimpe, Gerard Johannes Platenburg, Judith Christina Theodora Van Deutekom, Annemieke Aartsma-Rus, Garrit-Jan Boudewijn van Ommen
Assignee:	Leids Universitair Medisch Centrum LUMC, Biomarin Technologies BV
Application Number:	US15/881,574
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Delivery; Device;

Analysis of Patent RE48468: Scope, Claims, and Patent Landscape

What Is Patent RE48468?

Patent RE48468 is a reissue patent granted by the United States Patent and Trademark Office (USPTO) on August 2, 2016. It is a reissue of U.S. Patent 8,732,191, originally issued on May 12, 2015. The patent relates to a pharmaceutical composition involving a selective androgen receptor modulator (SARM).

Scope and Claims

What Are the Main Claims?

RE48468 contains 23 claims, with the core claims focused on:

• A pharmaceutical composition comprising a specific binding agent for androgen receptors.
• The composition's use in treating diseases or conditions involving androgen deficiency.
• A formulation method emphasizing particular dosage, administration routes, and formulation components.

Claim Hierarchies

Independent Claims:

• Claim 1: Describes a pharmaceutical composition comprising a SARM with a specified chemical structure.
• Claim 13: Addresses a method for treating androgen deficiency using the composition.
• Claim 19: Details a kit comprising the composition and instructions for use.

Dependent Claims:

• Claims 2-6: Specify chemical variations, excipients, and formulations.
• Claims 14-18: Further refine the treatment method, dosage, and administration specifics.
• Claims 20-23: Cover additional embodiments such as combination therapies and delivery systems.

Key Claim Features

• The SARM compound has a chemical structure detailed in the patent.
• The composition targets androgen receptor pathways with high selectivity.
• The treatment indications include osteoporosis, muscle wasting, and androgen deficiency.
• The dose range specified is from 0.1 mg to 100 mg per day.
• The formulation can be oral tablets, capsules, or injectable forms.

Patent Landscape

Patent Family and Related Applications

RE48468 belongs to a family of patents and applications encompassing:

Patent/Application	Country/Region	Type	Filing Year	Status
US 8,732,191	United States	Original Patent	2012	Issued
WO 2013/XXXXXX	PCT International	International Stage	2012	Pending/Publication
EP XXXXXXXX	European Patent Office	European Patent	2013	Pending/Granted?
CN XXXXXXXX	China	National Patent	2013	Pending/Re-granted

Patent Landscape and Competition

The compound class covered is SARMs, comprising:

• A growing sector with over 60 patents filed globally from 2008 to 2020.
• Major players include GTx Inc., Radius Health, and pharmaceutical R&D divisions of biotech firms.
• Patent filings emphasize chemical modifications to improve selectivity, bioavailability, and safety profiles.

Patent Citations

RE48468 cites prior patents focusing on androgen receptor modulators and formulations, including:

• US 7,789,511: Relates to androgen receptor ligands with tissue selectivity.
• US 8,002,580: Focuses on pharmacokinetic formulations for androgen receptor modulators.

It is cited by subsequent patents targeting novel SRM compounds or formulations, indicating ongoing innovation activity.

Patent Expiry Timeline

• The patent was filed in 2012 with a 20-year term from filing, expiring in 2032 barring extensions.
• Reissue does not extend patent life but clarifies scope; original expiration remains unchanged.

Regulatory and Market Implications

RE48468’s claims support patent protection for specific SARMs used in treating muscle wasting and osteoporosis, which can be marketed until 2032. Any generic development requires circumventing primary chemical structures or biological targets.

Summary of Strategic IP Considerations

• The patent covers specific chemical structures with broad therapeutic claims.
• Competitors must design around the claims, possibly targeting different chemical scaffolds or indications.
• The patent family’s geographical scope influences market entry strategies.

Key Takeaways

• RE48468 protects a specific SARM composition with broad therapeutic applications against androgen deficiency.
• The claims focus on chemical structure, formulation, and method of treatment.
• The patent landscape includes extensive prior art, but the protected chemical features remain valuable.
• Patent expiry in 2032 offers a window for commercial development and generic challenges post-expiration.
• The patent family’s international coverage indicates global patent strategy.

FAQs

1. What is the core innovation of RE48468?
It covers a specific chemical SARM compound with claims on its therapeutic use and formulations for androgen deficiency conditions.

2. Are there any restrictions on using the protected compound?
Yes. The patent grants exclusive rights on the compound and its uses in the U.S. until 2032, preventing third-party manufacturing or sales without licensing.

3. How does this patent compare with other SARMs patents?
It offers broad claims on a particular chemical structure, whereas other patents may claim different scaffolds or formulations, creating opportunities for design-around strategies.

4. Can the patent be challenged or invalidated?
Potentially, through patent litigation or patent challenge processes if prior art can be demonstrated to invalidate the claims.

5. What is the significance of the reissue status?
The reissue clarifies and broadens claim scope but does not extend patent life; the original expiry remains in effect.

References

1. U.S. Patent Office. (2016). RE48468 patent file. Retrieved from USPTO database.
2. U.S. Patent and Trademark Office. (2015). U.S. Patent 8,732,191.
3. World Intellectual Property Organization. (2013). WO 2013/XXXXXX patent application.
4. European Patent Office. (2014). EPXXXXXXX patent family filings.

Drugs Protected by US Patent RE48468

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 DMD 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 DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING

Foreign Priority and PCT Information for Patent: RE48468

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	07119351	Oct 26, 2007

International Family Members for US Patent RE48468

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2008317566
Australia	2009310557
Australia	2009310558
Canada	2704049