United States Patent 9,044,484: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 9,044,484, titled "Aqueous pharmaceutical compositions containing borate-polyol complexes," is a significant patent in the field of ophthalmic pharmaceuticals. This patent, held by Alcon Inc., Alcon Vision, LLC, and Alcon Laboratories, Inc., pertains to multi-dose ophthalmic compositions with enhanced preservation properties. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.
Background of the Patent
The patent, issued on May 26, 2015, addresses the need for stable and preserved ophthalmic compositions. It describes aqueous pharmaceutical compositions that utilize borate-polyol complexes to improve the preservation of these formulations, particularly those containing therapeutically effective amounts of brimonidine[2].
Scope of the Patent
The scope of the patent is defined by its claims, which outline the specific elements and limitations of the invention. Here are the key aspects:
Independent Claims
Claim 1 of the '484 patent is representative and specifies:
- A multi-dose ophthalmic composition.
- A therapeutically effective amount of brimonidine.
- A first polyol selected from mannitol, sorbitol, or a combination thereof.
- The presence of borate and benzalkonium chloride (BAC) or other preservatives[1].
Dependent Claims
Dependent claims further narrow down the scope by adding additional limitations. For example, dependent claim 19 specifies that the composition must be "free of any anti-infective or anti-biotic ophthalmic drug," which are considered preservative aids[1].
Claim Construction
The claim construction is crucial for understanding the patent's scope. Key points include:
- Polyols: The patent defines polyols as compounds having at least one hydroxyl group on each of two adjacent carbon atoms that are not in trans configuration relative to each other. Preferred polyols include mannitol, glycerin, xylitol, sorbitol, and propylene glycol[1].
- Preservatives: The composition can include BAC or other preservatives like hydrogen peroxide and polymeric quaternary ammonium compounds[1].
- Administration: The specification defines the administration period as "for an extended period of time," typically at least one month, more typically at least six months, and even more typically at least one year[1].
Patent Landscape
Competitors and Litigation
The '484 patent has been involved in litigation, particularly in the context of the Hatch-Waxman Act. Alcon Inc. and its affiliates have asserted this patent against Padagis Israel Pharmaceuticals Ltd., Padagis US LLC, and Padagis LLC, alleging infringement related to their Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension[1][4].
Expiration Dates
The '484 patent is set to expire on October 30, 2030. This expiration date is significant for generic manufacturers and competitors who may seek to enter the market post-expiration[4].
Bioequivalence and Therapeutic Equivalence
The FDA has determined that Padagis US, LLC's Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension is bioequivalent and therapeutically equivalent to the branded product, despite the ongoing patent litigation[4].
Measuring Patent Scope
Claim Length and Scope
Research indicates that the length of a patent claim can be a predictive measure of its scope. Generally, longer claims imply more conditions that must be met for a patent to be violated, thus indicating a narrower scope. The '484 patent's claims, particularly the independent claims, are detailed and specific, suggesting a well-defined but potentially narrower scope[3].
Traditional Measures
Traditional measures of patent scope, such as the number of patent classes, citations, and claims, have been found to be less reliable. The number of claims, for instance, does not necessarily correlate with broader protection; instead, it may reflect the complexity or the fallback positions of the patent[3].
Industry Impact
Preservation in Ophthalmic Compositions
The use of borate-polyol complexes as described in the '484 patent has significant implications for the preservation of ophthalmic compositions. This technology ensures the stability and safety of multi-dose formulations, which is critical in ophthalmic care[2].
Market Competition
The patent's protection period and the ongoing litigation highlight the competitive landscape in the ophthalmic pharmaceutical market. Companies like Padagis are seeking to enter the market with generic or bioequivalent products, which could challenge Alcon's market dominance post-patent expiration[4].
Expert Insights
Patent attorneys emphasize that broad patents offer more protection against infringers but are harder to design around. Thomas Kulaga notes, "Broad patents typically offer more protection against infringers than a narrow patent" because they are "oftentimes very hard to design around"[3].
Conclusion
The United States Patent 9,044,484 is a critical asset for Alcon Inc. and its affiliates, providing protection for their multi-dose ophthalmic compositions. The patent's scope is defined by its detailed claims, which specify the use of borate-polyol complexes and preservatives like BAC. The ongoing litigation and the patent's expiration date in 2030 are key factors in the competitive landscape of ophthalmic pharmaceuticals.
Key Takeaways
- The patent describes aqueous pharmaceutical compositions using borate-polyol complexes for improved preservation.
- Claim 1 specifies a multi-dose ophthalmic composition with brimonidine, polyols, borate, and BAC.
- Dependent claims add further limitations, such as the absence of anti-infective or anti-biotic ophthalmic drugs.
- The patent is involved in litigation under the Hatch-Waxman Act.
- The patent expires on October 30, 2030.
- The use of borate-polyol complexes is significant for the preservation of ophthalmic compositions.
FAQs
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What is the main invention described in the '484 patent?
The main invention is an aqueous pharmaceutical composition containing borate-polyol complexes for improved preservation, particularly for multi-dose ophthalmic formulations.
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What are the key components of the composition as per the '484 patent?
The composition includes a therapeutically effective amount of brimonidine, a first polyol (such as mannitol or sorbitol), borate, and benzalkonium chloride (BAC) or other preservatives.
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Why is the '484 patent significant in the ophthalmic pharmaceutical market?
It is significant because it provides a method for preserving multi-dose ophthalmic compositions, ensuring their stability and safety over an extended period.
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What is the current status of the litigation involving the '484 patent?
The patent is currently involved in litigation initiated by Alcon Inc. against Padagis US, LLC, under the Hatch-Waxman Act, alleging infringement related to their Brinzolamide and Brimonidine Tartrate Ophthalmic Suspension.
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When does the '484 patent expire?
The '484 patent is set to expire on October 30, 2030.
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ALCON INC., ALCON VISION, LLC, and ALCON LABORATORIES, INC., Plaintiffs, v. PADAGIS ISRAEL PHARMACEUTICALS LTD., PADAGIS US LLC, and PADAGIS LLC, Defendants.
- US Patent for Aqueous pharmaceutical compositions containing borate-polyol complexes for improved preservation of the compositions.
- The Ways We've been Measuring Patent Scope are Wrong: How to Measure and Draw Causal Inferences with Patent Scope.
- ANDA 212137 ANDA TENTATIVE APPROVAL Padagis US, LLC.
