Detailed Analysis of the Scope and Claims of United States Patent 11,116,721
Introduction
United States Patent 11,116,721, titled "Pharmaceutical Formulations Comprising 4-{(1R)-2-[(6-{2-[(2,6-Dichlorobenzyl)oxyethoxy]}hexylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol," is a significant patent in the pharmaceutical industry. This analysis will delve into the scope, claims, and patent landscape surrounding this patent.
Inventors and Assignee
The patent was invented by Darrell Baker, Mark Bruce, and Marian Thomas, and it is assigned to Glaxo Group Limited, a prominent pharmaceutical company based in Middlesex, UK[2].
Patent Details
- Patent Number: US 11,116,721 B2
- Date of Patent: September 14, 2021
- Application Number: 13/148,982
- PCT Filed: February 26, 2009
- PCT No.: PCT/EP2009/052306[2].
Scope of the Patent
The patent covers specific pharmaceutical formulations containing the compound 4-{(1R)-2-[(6-{2-[(2,6-Dichlorobenzyl)oxyethoxy]}hexylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol. This compound is part of the active ingredient in BREO ELLIPTA, a medication used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma[5].
Claims of the Patent
The patent includes multiple claims that define the scope of protection. These claims are crucial as they specify what aspects of the invention are protected. Here are some key types of claims:
- Composition Claims: These claims cover the specific pharmaceutical formulations containing the mentioned compound.
- Method Claims: These might include methods of preparing the formulations or methods of using the formulations for therapeutic purposes.
- Use Claims: These claims specify the therapeutic uses of the formulations, such as the treatment of COPD and asthma[2].
Patent Term and Adjustments
The patent term for US 11,116,721 B2 is subject to adjustments and extensions under U.S. patent law.
- Patent Term Adjustment (PTA): The patent term can be adjusted under 35 U.S.C. § 154(b) if there are delays in the patent prosecution process. However, any PTA granted must be considered in the context of obviousness-type double patenting (ODP) analysis, where the adjusted expiration date including PTA is used to determine potential unpatentability[1].
- Patent Term Extension (PTE): While not explicitly mentioned for this patent, PTE under 35 U.S.C. § 156 can extend the patent term for certain regulatory delays, but it is treated differently in ODP analysis compared to PTA. The expiration date for PTE is calculated from the original expiration date before the addition of PTE[1].
Obviousness-Type Double Patenting (ODP)
ODP is a judicial doctrine aimed at preventing the extension of patent term beyond the statutory 20 years from the earliest priority filing date. For US 11,116,721 B2, if there are other patents in the same family with overlapping claims, the expiration dates must be carefully calculated to avoid ODP issues. The Federal Circuit has clarified that PTA and PTE are treated differently in ODP analysis, with PTA adjustments considered after the grant, and PTE considered before any terminal disclaimers[1].
Patent Landscape and Analytics
To understand the full scope of protection and potential gaps, patent analytics can be employed.
- Claim Coverage Matrix: This tool helps in categorizing patents by claims and scope concepts, making it easier to identify which patents and claims are actively protecting the intellectual property related to BREO ELLIPTA[3].
- Claim Charts: Interactive claim charts generated by tools like ClaimScape® can help technical experts review patent coverage and identify gaps or future design opportunities. These charts can be updated as new patents are filed or as development avenues are explored[3].
Regulatory and Legal Considerations
The patent's validity and scope can also be influenced by regulatory and legal frameworks.
- Bayh-Dole Act: Although not directly applicable here since the invention was not conceived or reduced to practice using federal funds, this act is relevant for patents arising from federally funded research. It allows federal agencies to exercise march-in rights under certain conditions, such as unreasonable price or unmet health and safety needs[4].
Expiration Date and Future Implications
The expiration date of the patent is crucial for understanding when the protected formulations will enter the public domain.
- Current Expiration Date: The patent expires on the date calculated based on the original filing date and any adjustments or extensions granted.
- Future Implications: As the patent approaches its expiration date, generic or biosimilar versions of BREO ELLIPTA may be developed, potentially altering the market landscape for COPD and asthma treatments[5].
Key Takeaways
- Scope and Claims: The patent protects specific pharmaceutical formulations of BREO ELLIPTA.
- Patent Term Adjustments: PTA and PTE are treated differently in ODP analysis.
- Patent Landscape: Patent analytics tools are essential for understanding claim coverage and identifying gaps.
- Regulatory Considerations: The patent is subject to standard U.S. patent law and not under the Bayh-Dole Act.
- Expiration Date: The patent's expiration date will impact the availability of generic or biosimilar versions.
Frequently Asked Questions (FAQs)
Q1: What is the main compound protected by US Patent 11,116,721 B2?
A1: The main compound is 4-{(1R)-2-[(6-{2-[(2,6-Dichlorobenzyl)oxyethoxy]}hexylamino)-1-hydroxyethyl]-2-(hydroxymethyl)phenol.
Q2: What is the therapeutic use of the formulations covered by this patent?
A2: The formulations are used for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.
Q3: How are Patent Term Adjustment (PTA) and Patent Term Extension (PTE) treated differently in ODP analysis?
A3: PTA is calculated after the grant, while PTE is calculated from the original expiration date before the addition of PTE.
Q4: What tools can be used to analyze the patent landscape for this patent?
A4: Tools such as Claim Coverage Matrix and Claim Charts generated by ClaimScape® can be used to analyze the patent landscape.
Q5: When does the patent expire, and what are the implications?
A5: The patent expires on a date calculated based on the original filing date and any adjustments or extensions. As it approaches expiration, generic or biosimilar versions of BREO ELLIPTA may be developed.
Cited Sources:
- Duanemorris.com - Patent Term Adjustment and Patent Term Extension Analyzed Differently in Consideration of Obviousness-Type Double Patenting.
- Googleapis.com - United States Patent - Baker et al.
- Slwip.com - Patent Analytics.
- CRS Reports - Pricing and March-In Rights Under the Bayh-Dole Act.
- Drugpatentwatch.com - Patent 11,116,721.
