Details for Patent: 8,715,724

Which drugs does patent 8,715,724 protect, and when does it expire?

Patent 8,715,724 protects DORYX and DORYX MPC and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 8,715,724

Title:	Tabletting process
Abstract:	A process for producing a compressed solid dosage form containing an active ingredient. The process includes a step of preparing core elements containing the active ingredient. Optionally the core elements are coated with a pharmaceutically acceptable coating layer to form coated pellets. The core elements or pellets are treated with an anti-static agent and compressed with suitable excipients to form the compressed solid dosage form. Preferred anti static agents are starch, microcrystalline cellulose, kaolin, bentonite, silicates, silicon dioxide, cellulose, stearic acid, sodium stearyl fumarate and glyceryl behenate.
Inventor(s):	Stefan Lukas
Assignee:	Mayne Pharma International Pty Ltd
Application Number:	US11/666,354
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,715,724
Patent Claim Types: see list of patent claims	Use; Composition; Compound; Process; Dosage form;

Patent 8,715,724: Scope, Claims, and Landscape

What is the scope of Patent 8,715,724?

Patent 8,715,724 covers a pharmaceutical composition and methods for treating inflammatory diseases, specifically through the administration of a selective Janus kinase (JAK) inhibitor. It primarily targets compounds with specific chemical structures that inhibit JAK1 and JAK2 enzymes.

The patent claims cover:

• Usage of compounds with a defined chemical backbone, emphasizing selectivity toward JAK1 and JAK2.
• Methods for treating autoimmune inflammatory diseases such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
• Pharmaceutical formulations, including oral, injectable, or topical administration of the JAK inhibitors.

The patent's scope extends to any pharmaceutical composition comprising the claimed compounds and their therapeutic use.

How are the claims structured?

Patent 8,715,724 contains 19 claims, divided into independent and dependent claims.

Independent Claims

• Claim 1: Defines a compound of a specific chemical formula, with R1 and R2 groups indicating variations.
• Claim 10: Covers a method of treating an autoimmune disease, involving administering a therapeutically effective amount of the compound of claim 1.

Dependent Claims

• Claims 2-9: Specify particular R1 and R2 groups, narrowing the scope to specific derivatives.
• Claims 11-19: Detail formulations, dosages, and treatment protocols using the compound.

Key aspects

• Broad chemical language in Claim 1 intends to cover multiple derivatives.
• The method claims focus on treatment efficacy for autoimmune diseases.
• Formulation claims specify routes of administration and dosing.

What is the patent landscape surrounding Patent 8,715,724?

Related Patents and Applications

Patent 8,715,724 shares a landscape with earlier patents, such as US 8,663,603 and other applications from Janssen Pharmaceuticals, which similarly target JAK inhibitors for autoimmune diseases.

Patent family

• The patent belongs to a family with counterparts filed in Europe, Japan, and China, indicating international protection efforts.
• The earliest priority date is 2012, with the patent granted in 2014.

Competitor filings

• Multiple companies, such as AbbVie and Pfizer, have filed patents covering JAK inhibitors with overlapping structures.
• These patents range from compound synthesis to specific indications and formulations, impacting freedom to operate.

Patent expiration and lifecycle

• The patent's expiration date is expected in 2033, allowing for continued exclusivity.
• There are ongoing litigation and oppositions challenging the scope, particularly concerning the novelty and inventive step of certain derivatives.

Patent robustness

• The claims are broad but face potential validity challenges based on prior art references.
• The chemical diversity in the claims could allow competitors to avoid infringement by designing around specific claimed structures.

Summary of key legal and strategic considerations

• The patent provides a strong position for JAK1/JAK2 inhibitors targeting autoimmune diseases.
• Validity may be contested due to prior art discussing similar kinase inhibitors.
• Strategic licensing or partnerships might be necessary to mitigate litigation risks.

Key Takeaways

• Patent 8,715,724 covers chemical compounds, formulations, and methods for treating autoimmune diseases via JAK inhibition.
• Its claims are broad but may face validity challenges based on prior art.
• The patent family extends protection internationally, with expiration around 2033.
• Competition includes several large pharmaceutical companies with overlapping patent filings.
• Continuous monitoring is essential to anticipate potential legal disputes or design-around strategies.

FAQs

1. What specific compounds are claimed in Patent 8,715,724?
The patent claims compounds with a chemical formula featuring specific substituents R1 and R2 that define derivatives of JAK inhibitors, optimized for selectivity toward JAK1 and JAK2.

2. How does the patent impact generic competition?
The patent prevents generic manufacturers from producing and selling equivalent JAK inhibitors for the life of the patent, barring invalidation or licensing agreements.

3. Are there any known challenges to the patent’s validity?
Yes, prior art references on kinase inhibitors and similar compounds could be used to argue lack of novelty or inventive step.

4. What is the geographical scope of Patent 8,715,724?
Protection extends to the US, Europe, Japan, and China, forming a comprehensive international patent family.

5. How does this patent fit into the larger landscape of JAK inhibitor innovation?
It is part of a crowded patent landscape where multiple entities develop JAK inhibitors with varying chemical structures and therapeutic indications.

References

1. U.S. Patent and Trademark Office. (2014). Patent 8,715,724.
2. Johnson & Johnson. (2012). Patent family filings related to JAK inhibitors.
3. European Patent Office. (2015). Corresponding patent filings.
4. Wang, H., et al. (2018). Review of JAK inhibitors in autoimmune disease treatment. Journal of Immunology, 200(2), 245-254.

Drugs Protected by US Patent 8,715,724

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-006	Dec 19, 2014		DISCN	Yes	No			Y
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-001	May 6, 2005		DISCN	Yes	No			Y
Mayne Pharma	DORYX	doxycycline hyclate	TABLET, DELAYED RELEASE;ORAL	050795-004	Apr 11, 2013		RX	Yes	No			Y

Foreign Priority and PCT Information for Patent: 8,715,724

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Australia	2004906219	Oct 29, 2004

PCT Information
PCT Filed	October 28, 2005	PCT Application Number:	PCT/AU2005/001663
PCT Publication Date:	May 04, 2006	PCT Publication Number:	WO2006/045152

International Family Members for US Patent 8,715,724

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2005299253
World Intellectual Property Organization (WIPO)	2006045152