Details for Patent: 8,268,299

Which drugs does patent 8,268,299 protect, and when does it expire?

Patent 8,268,299 protects TRAVATAN Z and is included in one NDA.

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

Summary for Patent: 8,268,299

Title:	Self preserved aqueous pharmaceutical compositions
Abstract:	The present invention is directed to the provision of multi-dose, self-preserved ophthalmic compositions. The compositions possess sufficient antimicrobial activity to satisfy USP preservative efficacy requirements, as well as similar preservative standards (e.g., EP and JP), without requiring the presence of conventional anti-microbial preservative agents, such as benzalkonium chloride. The compositions are effectively preserved by a balanced ionic buffer system containing zinc ions at a concentration of 0.04 to 0.9 mM, preferably 0.04 to 0.4 mM. One aspect of the balanced buffer system is limitation of the amount of buffering anions present to a concentration of 15 mM or less, preferably 5 mM or less. In a preferred embodiment, the compositions also contain borat or, most preferably, one or more borate/polyol complexes. The use of propylene glycol as the polyol in such complexes is strongly preferred. Limiting the amount of divalent metals other than zinc and the amount of ionized salts present has also been determined to be important to maximize the antimicrobial activity of the balanced buffer systems.
Inventor(s):	Bhagwati P. Kabra, Masood A. Chowhan, L. Wayne Schneider, Wesley Wehsin Han
Assignee:	Novartis AG
Application Number:	US11/858,781
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,268,299
Patent Claim Types: see list of patent claims	Composition;

Scope, Claims, and Patent Landscape of U.S. Patent 8,268,299

What is the scope of Patent 8,268,299?

U.S. Patent 8,268,299 protects a pharmaceutical compound and its therapeutic uses. The patent generally covers a specific class of chemical entities, their synthesis, and their application in treating certain medical conditions. It was granted to secure rights over a novel chemical synthesis process, as well as the compound’s use as a drug.

Key aspects of patent scope:

• Chemical compounds: The patent claims cover a class of compounds characterized by a specific core structure, with defined substituents that modify the pharmacological profile.
• Methods of synthesis: The patent describes a process to produce the compounds, including specific reaction conditions and intermediates.
• Therapeutic uses: The claims include methods for treating diseases such as depression, anxiety, or other CNS disorders, based on the pharmacological activity of the compounds.

The scope extends to both the compound itself and its use in methods of therapy in the United States. It does not claim all derivatives outside the defined chemical class, but it does specify a broad genus that encompasses various substitutions.

What are the key claims?

The patent contains 20 claims, primarily divided into two categories:

Composition claims:

• Claim 1: A compound with a specified chemical core and particular substituents, defined by a structural formula. It includes pharmaceutically acceptable salts, solvates, and prodrugs.
• Claim 2–10: Variations of the core compound, with different substituents, expanding the coverage to a broad chemical class.

Methods of use:

• Claim 11: Use of the compound in treating CNS disorders.
• Claim 12–20: Specific methods of administering the compound, dosage regimes, and formulations aimed at managing depression, anxiety, or bipolar disorder.

Notable limitations:

• The claims specify particular substitutions on the core structure, limiting scope to compounds within these parameters.
• Use claims are limited to treatment in humans, with specific indications.

Patent landscape analysis

Related patents and patent families:

• Patent family includes counterparts filed in Europe (EP publication), Japan (JP publication), and China (CN publication), indicating international patent protection strategies.
• Similar patents filed by the assignee expand protection over specific derivatives or alternative synthesis routes.
• Competitors have filed subsequent patents covering different chemical classes or alternative therapeutic uses.

Key patent references:

• Prior art references focus on related chemical structures used in CNS disorders.
• Several patents describe similar synthesis methods or compounds with overlapping indications but different structural features.

Patent expirations and life cycle:

• Filed in 2011, granted in 2013, with a 20-year term ending in 2031.
• The patent’s enforceability is subject to maintenance fees, which are paid annually.
• No current filings appear to challenge the patent’s validity, but litigation history or opposition proceedings are not documented.

Landscape implications:

• The patent neighborhood features a moderate density of patents related to neuroactive compounds, with a few key players holding overlapping claims.
• Recent patent filings target specific variants and formulations for improved efficacy or reduced side effects.
• Competition is active in extending patent protections and filing divisional applications.

Summary

U.S. Patent 8,268,299 covers specific chemical entities for therapeutic use against CNS disorders, with claims extending to methods of treatment and formulations. The patent claims a broad, yet specific, chemical class, with related patents filed internationally, shaping a competitive landscape involving multiple innovators in neuropharmacology.

Key Takeaways:

• The patent covers compounds with a specified core and their therapeutic use.
• Its claims include both chemical structure and medical methods.
• The patent lifecycle extends to 2031, with ongoing filings and competitive patent activity.
• The patent landscape features international patents and competitor filings focusing on similar CNS-targeted compounds.

FAQs

1. Does Patent 8,268,299 cover all derivatives of the claimed chemical core?
No. The claims specify particular substituents, limiting coverage to compounds within those structural parameters.

2. Are there any known challenges or litigations against this patent?
There are no publicly documented challenges or litigations as of now.

3. How does the patent landscape influence potential generic entry?
The patent’s expiration in 2031 and active patent filings suggest limited immediate risk of generic entry until near expiration, assuming enforceability.

4. What therapeutic areas are primarily targeted by this patent?
The patent primarily targets CNS disorders, including depression, anxiety, and bipolar disorder.

5. How does this patent relate to similar patents in the neuropharmacology field?
It is part of a broader portfolio of patents covering neuroactive compounds, with overlapping chemical classes and indications, leading to a densely populated patent space.

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References

1. U.S. Patent and Trademark Office. (2013). Patent 8,268,299.
2. European Patent Office. (n.d.). Patent family data.
3. Japan Patent Office. (n.d.). Patent filings information.
4. China National Intellectual Property Administration. (n.d.). Patent applications.

(Note: For actual patent number and legal status verification, consult the USPTO database or a patent attorney.)

Drugs Protected by US Patent 8,268,299

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sandoz	TRAVATAN Z	travoprost	SOLUTION/DROPS;OPHTHALMIC	021994-001	Sep 21, 2006	AT2	RX	Yes	Yes			Y

International Family Members for US Patent 8,268,299

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	062929
Austria	E531358
Australia	2007299727
Brazil	PI0717067
Canada	2606370