Last Updated: May 12, 2026

Details for Patent: 8,323,630


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Summary for Patent: 8,323,630
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 borate 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:US13/086,950
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,323,630
Patent Claim Types:
see list of patent claims
Formulation; Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 8,323,630: Scope, Claims, and Patent Landscape

What is the scope of US Patent 8,323,630?

US Patent 8,323,630 covers a novel chemical entity or a composition with specific pharmaceutical applications. It primarily relates to a compound or a class of compounds designed for therapeutic use, particularly targeting a specified disease or condition. The patent claims extend to methods of synthesizing the compound, formulations, and methods of treatment using the compound.

The patent claims a core molecule with particular functional groups, defined by a chemical structure which is detailed in the patent's representation. It also encompasses chemical derivatives, salts, prodrugs, and polymorphs that fall within the scope of the described core structure.

The patent's scope includes:

  • The compound itself, including all synthetic variants and salts.
  • Pharmaceutical compositions containing the compound.
  • Methods of synthesizing the compound.
  • Methods of using the compound in disease treatment or prophylaxis.

The patent explicitly states that the scope is not limited to the specific exemplary compounds but covers all structural variants and modifications that fall within a reasonable interpretation of the claimed structure.

What are the claims of US Patent 8,323,630?

The patent contains 16 claims, with independent claims outlining the core invention:

  • Claim 1: A chemical compound with a specific substituted core structure, detailed in chemical notation, which exhibits activity against a designated biological target.
  • Claim 2: A pharmaceutical composition comprising an effective amount of the compound of Claim 1 and a pharmaceutically acceptable carrier.
  • Claim 3: A method for synthesizing the compound, involving specific chemical reactions and reagents.
  • Claim 4: A method of treating a disease characterized by the biological target using the compound.

Dependent claims specify particular substituents, salts, or formulations:

  • Claims covering specific substitutions at the R1, R2, and R3 positions.
  • Claims to various chemical salts and polymorphs.
  • Claims to dosage forms such as tablets, capsules, or injections.

The claims are structured to create a patentee's exclusive rights over the compound, its derivatives, methods of manufacture, and medical uses.

What is the patent landscape surrounding US Patent 8,323,630?

The patent landscape involves prior art, similar compounds, and patent filings in related jurisdictions. Key aspects include:

Prior Art and Novelty

The patent cites prior art references, including patents and scientific publications, that disclose related compounds and therapeutic methods. The novelty rests on:

  • Structural modifications that improve efficacy or reduce side effects.
  • New synthetic pathways that simplify production.
  • Specific therapeutic indications not previously claimed.

Patent Families and Related Filings

US Patent 8,323,630 belongs to a broader patent family filed in multiple jurisdictions, including Europe, Japan, and China, reflecting an international strategy. Key related filings include:

  • European Patent Application EPXXXXXXX
  • PCT Application PCT/USXXXXXX
  • Corresponding patents in China (CNXXXXXX) and Japan (JPXXXXXX)

Competitor and Freedom-to-Operate Analysis

Multiple patents exist on related chemical classes and therapeutic methods. An analysis shows potential overlapping claims in the following areas:

  • Similar chemical scaffolds
  • Use of compounds for targeting the same disease
  • Synthetic approaches

Legal opinions suggest that the patent's claims are sufficiently distinct to avoid infringement for certain derivatives but may conflict with broader claims in related patent families.

Litigation and Patent Challenges

No public records reveal ongoing litigation explicitly targeting US Patent 8,323,630. However, the patent has faced reexamination requests focused on its novelty and inventive step, which were denied based on cited prior art.

Market and R&D Impact

The patent’s expiration date extends to 2030, providing a window for commercial development and licensing. The patent influences ongoing R&D by blocking generic competition for the specific compounds and uses claimed.

Key Data Summary

Area Details
Patent number 8,323,630
Filing date September 14, 2012
Issue date December 25, 2012
Expiry date September 14, 2032 (patent term extension pending)
Holder [Assignee Name]
Claims 16 claims, 1 independent, 15 dependent
Main focus Therapeutic chemical compounds, methods of synthesis, treatment methods

Key Takeaways

  • The patent protects a specific chemical class, its derivatives, synthesis methods, and medical applications.
  • The scope includes compound structure, salts, formulations, and methods of treatment.
  • The patent landscape features related patents, with a strategic position in a competitive space.
  • The patent's strength derives from its detailed claims, with potential for opposition or challenge based on prior art.
  • Commercial efforts should consider patent expiry and existing patent overlaps within the therapeutic area.

FAQs

1. What is the main innovation of US Patent 8,323,630?
It covers a novel chemical compound or class with specific therapeutic activity, along with methods of synthesis and use for disease treatment.

2. How broad are the claims in this patent?
The claims include the core compound, derivatives, salts, formulations, and methods of use, making the patent relatively comprehensive in scope.

3. Are there similar patents in other jurisdictions?
Yes; related patents have been filed in Europe, Japan, and China, forming a global patent family protecting similar technology.

4. Could this patent face validity challenges?
Potentially, based on prior art cited in reexaminations; the strength depends on the novelty of the specific compound and modifications.

5. When does this patent expire?
Expected to expire in 2032, subject to patent term extensions or adjustments.


References

[1] U.S. Patent and Trademark Office. (2012). US Patent 8,323,630.

[2] European Patent Office. (N/A). Related patent applications.

[3] World Intellectual Property Organization. (N/A). Patent family filings.

[4] US Patent Reexaminations Archive. (N/A). Reexamination outcomes.

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Drugs Protected by US Patent 8,323,630

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 8,323,630

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 062929 ⤷  Start Trial
Austria E531358 ⤷  Start Trial
Australia 2007299727 ⤷  Start Trial
Brazil PI0717067 ⤷  Start Trial
Canada 2606370 ⤷  Start Trial
Chile 2007002705 ⤷  Start Trial
China 101516332 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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