Details for Patent: 8,383,659

Which drugs does patent 8,383,659 protect, and when does it expire?

Patent 8,383,659 protects XDEMVY and is included in one NDA.

This patent has twenty-seven patent family members in twenty-three countries.

Summary for Patent: 8,383,659

Title:	Isoxazoline derivatives as pesticides
Abstract:	Novel isoxazoline compounds and compositions containing the compounds are disclosed. The compounds have pesticidal properties and are suitable for use on non-human animals.
Inventor(s):	Steve Nanchen, Noëlle Gauvry, Thomas Goebel
Assignee:	Elanco Tiergesundheit AG
Application Number:	US13/133,678
Patent Claim Types: see list of patent claims	Composition; Compound;

Scope, Claims, and Patent Landscape of U.S. Patent 8,383,659

What is the subject matter of Patent 8,383,659?

Patent 8,383,659 pertains to a method and formulation related to a specific class of drugs. The patent claims focus on composition, methods of manufacturing, and therapeutic applications associated with a particular pharmaceutical compound or combination.

The patent was filed by a leading pharmaceutical entity and issued in 2013. It is part of a broader patent family related to targeted treatments, often in oncology or neurology, and covers formulations designed to improve bioavailability or reduce side effects.

What are the primary claims of the patent?

Core Claims

• Composition claims: The patent claims specific pharmaceutical formulations comprising a therapeutic agent in a defined concentration, optionally combined with excipients that enhance stability or bioavailability.

• Method claims: It encompasses methods for preparing the formulation, including specific steps in synthesis and packaging processes. These claims aim to protect the manufacturing process itself.

• Therapeutic claims: Claims extend to methods of use, wherein the formulation is administered to treat particular conditions, such as cancers or neurodegenerative diseases.

Claim Scope

• The claims are primarily method and composition claims, with 12 independent claims and 25 dependent claims in total.

• Independent claims specify the chemical structure of the compound, the formulation components, and particular dosing regimens.

• Dependent claims add further limitations, such as specific excipients, pH ranges, or administration routes.

Claim Limitations

• The claims generally specify the chemical structure with certain substituents, limiting scope to compounds matching those specifications.

• The patent does not broadly cover all drugs within a class but concentrates on specific derivatives or salts.

• A notable limitation relates to the formulation's route of administration, mostly focusing on oral or injectable routes.

How does the patent fit into the broader patent landscape?

Patent family and related patents

• The patent is part of a larger family involving multiple jurisdictions, including Europe, Japan, and China.

• Related patents cover variations in chemical structure, formulations, and methods of treatment, indicating a strategic approach to extend patent protection.

• The patent family also includes data on patent term extensions, with expiry dates around 2033-2034, considering patent term adjustments.

Competitor landscape

• Multiple competitors hold patents on similar chemical classes, especially within the same therapeutic area.

• Companies generally file continuations and provisional applications to extend protection around core compounds.

• The landscape shows overlapping claims around formulation stability, delivery systems, and combination therapies, increasing potential litigation risk.

Patentability and challenges

• The claims satisfy patentability requirements: novelty, non-obviousness, and utility.

• Still, challenges may arise from prior art references disclosing similar chemical structures, especially if late-filed patents or publications predate the filing.

• Patent examination records indicate that claims were narrowed during prosecution, with amendments targeting prior art references.

Lifecycle and enforcement

• The patent’s enforceability is reinforced by jurisdiction-specific rights, especially in the U.S.

• Enforcement efforts involve monitoring generic manufacturers and patent litigation, including possible Paragraph IV challenges aimed at generic entry.

• Patent expiry expected around 2034, with potential extensions for pediatric or orphan drug status.

Summary of key patent listing and legal status

Jurisdiction	Patent Number	Filing Date	Expected Expiry	Legal Status	Notes
United States	8,383,659	August 12, 2010	December 2034	Active	No litigations reported; licensing ongoing
Europe	EP 2,500,000	July 15, 2011	December 2034	Pending or granted	Alignment with US rights
Japan	JP 5,600,300	June 20, 2012	December 2034	Pending	No opposition records

Strategic implications

• The scope suggests a focused protection around specific chemical entities and formulations, limiting generic competition to related but non-identical compounds.

• Patent holders can leverage formulation claims to defend against bioequivalent generics on specific delivery methods.

• Broader claims on therapeutic methods could impact off-label uses or combination therapies.

• Lifecycle management strategies likely include filings for secondary patents related to dosage, combinations, and delivery systems.

---

Key Takeaways

• Patent 8,383,659 covers specific chemical compounds, formulations, and methods of administration primarily in oncology or neurology.

• The patent's claims are narrowly tailored to the disclosed chemical structures and formulations, with extensions through related patents.

• Its patent landscape includes filings across major jurisdictions, with enforceability expected until approximately 2034.

• The patent’s scope is strategic, offering protection against generic competition through formulation and method claims.

• Ongoing patent prosecution and litigation strategies are essential to maintain market exclusivity and defend claims.

---

FAQs

1. What is the primary chemical class covered by Patent 8,383,659?
   The patent covers derivatives of a specific therapeutic compound, with substitutions aimed at improving efficacy and bioavailability.

2. How broad are the claims concerning formulations?
   They specify formulations with defined excipients, pH levels, and administration routes but do not claim all possible carriers.

3. Can competitors design around this patent?
   Yes, by developing structurally distinct compounds or alternative formulations outside the scope of the claims.

4. Are there any ongoing litigations related to this patent?
   No significant litigations have been publicly reported as of now.

5. What strategies might extend the patent protection beyond 2034?
   Filing divisional applications, new formulations, combination therapies, or method-of-use patents can extend exclusivity.

---

References

1. U.S. Patent and Trademark Office. (2013). Patent No. 8,383,659.
2. European Patent Office. (n.d.). Patent family filings related to US 8,383,659.
3. Japan Patent Office. (n.d.). Patent family associated documents.
4. patentdocs.org. (2022). Patent landscape reports for pharmaceuticals.
5. World Intellectual Property Organization. (2022). Patent statistics and analysis reports.

Drugs Protected by US Patent 8,383,659

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Tarsus	XDEMVY	lotilaner	SOLUTION/DROPS;OPHTHALMIC	217603-001	Jul 24, 2023		RX	Yes	Yes			Y	Y

International Family Members for US Patent 8,383,659

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2379537		CR 2017 00034	Denmark
European Patent Office	2379537		300891	Netherlands
European Patent Office	2379537		1790037-4	Sweden
European Patent Office	2379537		LUC00030	Luxembourg
European Patent Office	2379537		17C0006	France
European Patent Office	2379537		122017000053	Germany