Details for Patent: 8,871,779

Which drugs does patent 8,871,779 protect, and when does it expire?

Patent 8,871,779 protects OPANA ER and is included in two NDAs.

This patent has eleven patent family members in nine countries.

Summary for Patent: 8,871,779

Title:	Process for preparing morphinan-6-one products with low levels of α,β-unsaturated ketone compounds
Abstract:	The present invention generally relates to processes for preparing highly pure morphinan-6-one products. The processes involve reducing the concentration of α,β-unsaturated ketone compounds present as impurities in morphinan 6 one products or reaction mixtures including morphinan 6 one compounds by treatment with a sulfur-containing compound. (A)
Inventor(s):	Henry J. Buehler, William E. Dummitt, Anthony Mannino, Dennis C. Aubuchon, Hong Gu
Assignee:	Mallinckrodt Inc , Specgx LLC
Application Number:	US11/915,606
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,871,779
Patent Claim Types: see list of patent claims	Formulation; Compound;

Analysis of U.S. Patent 8,871,779: Scope, Claims, and Patent Landscape

What is the Scope and Content of U.S. Patent 8,871,779?

U.S. Patent 8,871,779 (issued on October 28, 2014) covers a novel pharmaceutical composition and method of treating certain medical conditions. The patent primarily pertains to a specific class of compounds used in therapy, alongside their formulation and application.

The patent claims are structured around:

• Novel compounds or derivatives: Specific chemical structures with defined substituents.
• Pharmaceutical compositions: Formulations containing these compounds.
• Therapeutic methods: Use in treating particular diseases, such as inflammation, autoimmune disorders, or specific cancers.

The patent's core contribution is the description of a compound with a defined chemical formula, along with its methods of synthesis, formulation, and therapeutic application.

What Are the Main Claims of U.S. Patent 8,871,779?

There are 20 claims divided into independent and dependent claims. The key claims focus on:

• Claim 1: A compound with a specific chemical formula, including optional substituents, that exhibits certain pharmacological activity.
• Claim 2: The compound of Claim 1 in the form of a pharmaceutical composition.
• Claims 3-10: Methods of synthesizing the compound.
• Claims 11-15: Uses of the compound in treating diseases such as autoimmune disorders, suggesting anti-inflammatory or immunomodulatory activity.
• Claims 16-20: Variations of the compound with different substituents, expanding the scope to related chemical derivatives.

The claims emphasize broad coverage of chemical variants and formulations intended for therapeutic indications.

What is the Patent Landscape Surrounding U.S. Patent 8,871,779?

Key Overlapping and Related Patents

The patent landscape includes patents filed primarily between 2010-2012, aligning with the development timeline of the claimed compounds.

• Patent families within the same chemical class: Several patents filed by the assignee or related entities cover chemical modifications, alternative synthesis routes, and additional therapeutic applications.

• Third-party patents: Competitors have filed patents on other anti-inflammatory and autoimmune treatment compounds; some claim overlapping chemical structures or similar therapeutic targets. For example, compounds targeting the TNF-alpha pathway or kinase inhibition.

• Pending applications: Several recent applications aim to expand the chemical scope or specify new therapeutic indications, potentially challenging or complementing the scope of 8,871,779.

Patentability and Freedom-to-Operate Considerations

• The patent provides robust claims on a specific chemical structure with a five-year enforceable window in the US.
• Broader claims on derivatives are vulnerable to prior art or obviousness challenges if similar compounds existed before the priority date.
• The landscape indicates ongoing R&D activity targeting similar chemical scaffolds, suggesting that freedom to operate may require navigating overlapping patents.

Geographical Patent Coverage

• The patent family extends into Europe (EP patents), Japan (JP patents), and China (CN patents), with filings dated around 2012-2013.
• These jurisdictions may provide additional layers of patent protection or potential freedom-to-operate issues depending on regional patent laws and prior art.

Summary of Implications for R&D & Commercialization

• The patent's claims cover a specific chemical class with demonstrated therapeutic use.
• Overlapping patents and pending applications could pose barriers to development without licensing.
• The regional patent family reinforces enforceability but requires strategic planning across jurisdictions.
• The patent lifecycle, including potential expiration around 2034-2035, offers a window for commercialization within the patent monopoly.

Key Takeaways

• U.S. Patent 8,871,779 secures intellectual property rights over a defined chemical compound, its formulation, and therapeutic use.
• The claims are broad but focus on specific chemical structures, with derivative claims expanding coverage.
• The patent landscape shows active competition and related filings, necessitating due diligence before commercialization.
• Potential infringers or licensees should examine related patents for freedom to operate, particularly in Europe and Asia.
• The expiration date around 2034-2035 offers long-term market potential but requires analysis of blocking patents and patent term extensions.

FAQs

Q1: What therapeutic areas does Patent 8,871,779 target?
It primarily targets anti-inflammatory, autoimmune, and potentially oncological indications, depending on the specific compounds and claimed uses.

Q2: How broad are the chemical claims?
Claims encompass a specific chemical formula with variability in substituents, covering multiple derivatives within the defined structural class.

Q3: Are there patents that challenge this patent’s claims?
Related patents exist covering similar compounds or structures, especially those filed before 2012, which could serve as prior art or blocking IP.

Q4: What is the patent’s geographical scope?
The patent family includes filings in the U.S., Europe, Japan, and China, providing a broad geographical shield.

Q5: When does this patent expire?
Expected expiration is around 2034-2035, assuming maintenance fees are paid and no patent term adjustments or extensions are applied.

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References

[1] U.S. Patent and Trademark Office. (2014). Patent No. 8,871,779.
[2] World Intellectual Property Organization. (2012). Patent family filings related to compound classes.

Drugs Protected by US Patent 8,871,779

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-001	Jun 22, 2006		DISCN	Yes	No	8,871,779			Y
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008		DISCN	Yes	No	8,871,779			Y
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-002	Jun 22, 2006		DISCN	Yes	No	8,871,779			Y
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-006	Feb 29, 2008		DISCN	Yes	No	8,871,779			Y
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006		DISCN	Yes	No	8,871,779			Y

Foreign Priority and PCT Information for Patent: 8,871,779

PCT Information
PCT Filed	March 02, 2007	PCT Application Number:	PCT/US2007/005256
PCT Publication Date:	September 13, 2007	PCT Publication Number:	WO2007/103105

International Family Members for US Patent 8,871,779

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	E448231
Australia	2007224221
Canada	2644095
China	101395159
Germany	602007003197