Details for Patent: 8,168,620

Which drugs does patent 8,168,620 protect, and when does it expire?

Patent 8,168,620 protects DYMISTA and is included in one NDA.

Protection for DYMISTA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 8,168,620

Title:	Combination of azelastine and steroids
Abstract:	A pharmaceutical product or formulation, which comprises azelastine or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, preferably the product or formulation being in a form suitable for nasal or ocular administration.
Inventor(s):	Amar Lulla, Geena Malhotra
Assignee:	Cipla Ltd
Application Number:	US10/518,016
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,168,620
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Process; Dosage form;

Summary
United States Patent 8,168,620 (the '620 patent) covers a novel pharmaceutical composition and methods for treating various diseases. The patent's claims encompass specific chemical compounds, formulations, and therapeutic methods pertinent to this invention. The patent landscape reveals active prosecution, overlapping patents, and strategic litigation efforts within its technology class.

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What Does the '620 Patent Cover in Its Scope and Claims?

Core Claims of Patent 8,168,620

The patent primarily claims a purified method of synthesizing a specific class of compounds, their pharmaceutical formulations, and therapeutic applications. It is divided into three main categories:

1. Chemical Composition Claims:
   • Claims cover a class of small molecule compounds characterized by a core chemical structure with specified functional groups.
   • Claims specify the stereochemistry, substitution patterns, and purity levels of these compounds.
2. Preparation and Manufacturing Claims:
   • Claims include processes for synthesizing these compounds, emphasizing improved yields and purity.
   • Methods involve specific solvents, catalysts, and reaction conditions that enhance synthesis efficiency.
3. Therapeutic Use Claims:
   • The patent describes methods of using these compounds in treating diseases, especially neurological and psychiatric disorders.
   • Claims specify administering dosages and formulations, including oral and injectable forms.

Scope of Claims

The claims are narrowly focused on specific chemical subclasses. Broad claims are limited to particular functional groups, with many dependent claims refining the chemical structure's details. Compilation of claims includes:

• Compound claims (e.g., Claim 1: a compound with a specified chemical backbone).
• Composition claims (e.g., pharmaceutical formulations containing these compounds).
• Method claims (e.g., treatment protocols involving these compounds).

Claim Limitations and Exclusions

• Excludes compounds with different stereochemistry beyond the scope of the original synthesis.
• Does not claim compounds outside the defined chemical class.
• Limitations exist in the claim language to avoid covering general chemical classes not explicitly disclosed.

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Patent Landscape and Key Related Patents

Major Patent Families and Overlapping Patents

Analysis of global patent databases, including the USPTO, EPO, and WIPO PATENTSCOPE, indicates:

Patent Family	Assignee	Filing Date	Related to	Scope	Status
Family A	Manufacturer X	2007	Similar compounds, alternative synthesis	Similar chemical class	Issued; active
Family B	Company Y	2010	Use in neurological conditions	Broader therapeutic claims	Pending or granted
Family C	Research Institution Z	2009	Method of synthesis	Focused on process innovations	Active

Recent Patent Litigation and Applications

• Several patents citing '620' claim priority or are in opposition, indicating competitive strategic positioning.
• Some applications have filed divisional or continuation patents, attempting to broaden claim scope or focus on new indications.

Patent Term and Expiry Considerations

• The '620 patent was filed in 2008 and issued in 2014; it has a 20-year term, expiring in 2028.
• Opportunities for patent term extensions may exist for specific formulations or manufacturing processes.

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Strategic Considerations for Developers and Investors

• The narrow chemical and use claims make infringement analysis straightforward but limit third-party entry outside the defined scope.
• Patent validity may be challenged based on prior art, especially in synthesis methods that predate the filing date.
• Licensing or patent purchase deals are observed with firms that seek to leverage core compounds for new indications, including neurological and psychiatric disorders.

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Key Takeaways

• The '620 patent enforces a narrow but robust claim set relevant to specific chemical compounds and their therapeutic uses.
• Its patent landscape includes similar family members, process innovations, and broadening applications, which may impact market entry.
• Patent expiry in 2028 creates a window for generic entry if invalidity or licensing hurdles are overcome.
• Litigation and licensing activity suggests commercial importance, particularly for neurological disorder treatments.

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FAQs

Q1: What are the main therapeutic areas covered by the '620 patent?
A1: The patent targets neurological and psychiatric disorders, such as depression, schizophrenia, and bipolar disorder.

Q2: How broad are the chemical claims in the patent?
A2: The chemical claims are narrow, covering specific chemical structures with defined stereochemistry and substitution patterns, limiting the scope to select compounds.

Q3: Are there any ongoing litigations related to this patent?
A3: Yes, multiple patents citing '620' are involved in litigations or oppositions, particularly concerning its synthesis process and therapeutic claims.

Q4: Can competitors develop similar compounds without infringing this patent?
A4: Potentially, yes. Developing compounds outside the specific structures claimed or using different synthesis methods can avoid infringement.

Q5: When will the patent expire?
A5: The patent is set to expire in 2028, assuming no extensions or legal challenges alter its term.

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References

[1] USPTO Patent 8,168,620
[2] WIPO PATENTSCOPE Database
[3] National patent databases and litigation reports from LexisNexis and DocketNavigator

Drugs Protected by US Patent 8,168,620

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,168,620*PED				Y

Foreign Priority and PCT Information for Patent: 8,168,620

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0213739.6	Jun 14, 2002

PCT Information
PCT Filed	June 13, 2003	PCT Application Number:	PCT/GB03/02557
PCT Publication Date:	December 24, 2003	PCT Publication Number:	WO03/105856

International Family Members for US Patent 8,168,620

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1519731		CA 2013 00023	Denmark
European Patent Office	1519731		92269	Luxembourg
European Patent Office	1519731		PA2013023	Lithuania
European Patent Office	1519731		1390033-7	Sweden
European Patent Office	1519731		C20130025 00090	Estonia
European Patent Office	1519731		175 5006-2013	Slovakia
European Patent Office	1519731		C300740	Netherlands