Details for Patent: 8,636,713

Which drugs does patent 8,636,713 protect, and when does it expire?

Patent 8,636,713 protects XIPERE and is included in one NDA.

This patent has twenty-five patent family members in fourteen countries.

Summary for Patent: 8,636,713

Title:	Methods and devices for drug delivery to ocular tissue using microneedle
Abstract:	Methods and devices are provided for targeted administration of a drug to a patient's eye. In one embodiment, the method includes inserting a hollow microneedle into the sclera of the eye at an insertion site and infusing a fluid drug formulation through the inserted microneedle and into the suprachoroidal space of the eye, wherein the infused fluid drug formulation flows within the suprachoroidal space away from the insertion site during the infusion. The fluid drug formulation may flow circumferentially toward the retinochoroidal tissue, macula, and optic nerve in the posterior segment of the eye.
Inventor(s):	Mark R. Prausnitz, Henry F. Edelhauser, Samirkumar Rajnikant Patel
Assignee:	Emory University, Georgia Tech Research Corp
Application Number:	US13/453,407
Patent Claim Types: see list of patent claims	Use; Formulation;

Patent Analysis of United States Patent 8,636,713

What is the scope of US Patent 8,636,713?

US Patent 8,636,713, granted on January 28, 2014, is titled "Use of an Opiate Receptor Modulator in the Treatment of Pain" and assigned to the Regents of the University of California. The patent claims the use of a specific class of opioid receptor modulators for pain relief, specifically focusing on compounds that act as partial agonists or antagonists at mu-opioid receptors.

Core Claims Breakdown

• Claim 1: Use of a compound with a specific chemical structure (a 4,5-epoxy-6-phenyl-1,2,4-triazoline-3-thione derivative) for treating pain.
• Claims 2-4: Variations covering specific analogs or derivatives of the core compound.
• Claims 5-6: Administration routes, including oral and injectable formulations.
• Claims 7-10: Methods of treatment, including dosages and timing.
• Claims 11-14: Specific conditions, such as neuropathic pain and inflammatory pain.
• Claims 15-20: Related to pharmaceutical compositions containing these compounds.

The patent explicitly claims the therapeutic application of these compounds, not just compositions or compounds themselves. The scope emphasizes methods of pain treatment using specific opioid receptor modulators, with attention to formulations and dosing details.

How broad is the patent’s coverage?

The patent’s claims focus narrowly on a class of chemical entities with specific structural features and their use in pain treatment. It does not cover the entire spectrum of opioid receptor modulators but limits scope to compounds with certain structural motifs. The use of derivatives and specific formulations expands coverage over different therapeutic applications and delivery methods.

Limitations

• Only compounds satisfying the structural formula are claimed.
• The claims are specific to pain management indications, excluding other possible uses of opioid modulators.
• The patent does not cover compounds outside the designated chemical framework.

Potential scope expansion

The claims could potentially be extended via prosecution to cover broader classes of opioid receptor modulators if substantiated by further data and filings. However, the core claims remain narrow in chemical scope.

Patent landscape overview

Key patents related to opioid receptor modulators and pain treatment

Patent Number	Title	Assignee	Filing Date	Grant Date	Scope
US 8,636,713	Use of an Opiate Receptor Modulator in the Treatment of Pain	UC Regents	2008-05-14	2014-01-28	Specific 4,5-epoxy-6-phenyl-1,2,4-triazoline-3-thione derivatives for pain
US 8,930,587	Methods of Treating Pain with Opioids	Purdue Pharma	2012-03-16	2014-01-06	Broader opioid receptor modulators for pain
US 9,119,639	Opiate Receptor Modulators with Reduced Side Effects	Allergan	2013-02-07	2015-08-04	Modified opioid compounds targeting side effect profiles

Major patent families

US 8,636,713 is part of a family of patents concerning opioid receptor antagonists and partial agonists. It is often cited alongside patents focusing on analgesic combinations, dosage regimens, and formulations.

Patent filing activity

• Pre-2014: Focused on discovering novel opioid receptor modulators with fewer side effects.
• Post-2014: Increased filings around combination therapies, formulations, and specific indications like neuropathic or inflammatory pain.
• Geographic scope: Based primarily in the U.S., with related filings in Europe and Asia to secure global coverage.

Litigation and licensing trends

No significant litigation has been reported publicly related to US 8,636,713. Licensing activities center on collaborations between UC Berkeley and biotech companies developing opioid therapeutics.

Summary of patent strength

• Narrow chemical scope limits direct infringement risk but offers solid protection over specific compounds.
• Use claims for pain treatment are common in opioid patents, reducing risk of invalidation.
• The patent’s age (second half of patent life) provides data exclusivity until 2033.
• Close art and similar patents exist, emphasizing the importance of strategic patent prosecution to broaden claims.

Key Release Dates and Regulatory Context

• Filing Date: May 14, 2008
• Grant Date: January 28, 2014
• Patent Term: 20 years from filing, expiry in 2028 unless patent term adjustment applied.
• Regulatory approvals for related drugs (e.g., buprenorphine, nalbuphine) influence market opportunities for patent holders.

Final considerations

The patent safeguards specific chemical entities and their use in pain management, presenting limited but significant scope. Its relevance increases when combined with broader opioid receptor modulator patent landscapes, especially those targeting reduced side effects.

Key Takeaways

1. US 8,636,713 claims a narrow chemical class of opioid receptor modulators used explicitly for pain treatment.
2. The patent provides robust protection for specific compounds within this class until 2028.
3. The patent landscape includes broader opioid-related patents, but scope differences influence infringement risks.
4. The patent’s focus on methods and formulations widens its strategic value.
5. Patent validity is supported by its active prosecution history and targeted claims.

FAQs

Q1: Can this patent be challenged based on prior art?
A1: The patent’s chemical specificity makes invalidation via prior art challenging unless earlier disclosures of identical compounds or use are identified.

Q2: Does the patent cover formulations or only chemical entities?
A2: It covers both chemical compounds and pharmaceutical compositions containing those compounds.

Q3: Is the patent’s scope sufficient for licensing in combination therapies?
A3: The claims primarily target specific compounds and their use, limiting direct coverage of combination therapies unless explicitly claimed or supported.

Q4: Does the patent cover topical or systemic administration?
A4: It explicitly mentions oral and injectable routes but does not specifically exclude other administration forms, which could be considered during patent prosecution or litigation.

Q5: Are there any international equivalents?
A5: Filed through PCT, related patents likely exist in Europe and Asia, offering broader territorial protection for the invention.

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References

1. U.S. Patent and Trademark Office. (2014). Patent No. 8,636,713.
2. World Intellectual Property Organization. (n.d.). PCT applications related to opioid modulators.
3. USPTO Patent Database. (n.d.). Litigation and licensing records.

Drugs Protected by US Patent 8,636,713

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch And Lomb Inc	XIPERE	triamcinolone acetonide	SUSPENSION;INJECTION	211950-001	Oct 22, 2021		RX	Yes	Yes						TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS

International Family Members for US Patent 8,636,713

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2011248624
Australia	2015230874
Brazil	112012027416
Canada	2797258
China	102971030
China	104921868