Understanding the Scope and Claims of United States Patent 9,695,122
Introduction
United States Patent 9,695,122, hereafter referred to as the '122 Patent, is a critical component in the intellectual property portfolio of pharmaceutical companies, particularly those involved in the development and manufacture of antibiotics. This patent is part of a broader suite of patents related to the antibiotic AVYCAZ® (ceftazidime and avibactam), and it plays a significant role in the ongoing patent infringement disputes in the pharmaceutical industry.
Patent Overview
The '122 Patent, titled "Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt," was issued on July 5, 2017. It is assigned to Allergan Pharmaceuticals International Limited, which is now part of AbbVie Inc.[1].
Claims of the '122 Patent
The '122 Patent includes several claims that define the scope of the invention. Here are some key aspects:
Independent Claims
- The patent claims cover specific crystalline forms of the compound trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt, which is a component of the antibiotic AVYCAZ®.
- These claims specify the physical and chemical characteristics of these crystalline forms, including their X-ray powder diffraction patterns, infrared spectra, and other distinguishing features[1].
Dependent Claims
- The dependent claims further narrow down the scope by specifying particular aspects of the crystalline forms, such as their purity, stability, and methods of preparation.
- These claims are contingent on the independent claims and provide additional detail on the invention[1].
Patent Scope and Landscape
Patent Scope Metrics
The scope of a patent can be measured using various metrics, including independent claim length and independent claim count. Research suggests that narrower claims, as measured by these metrics, are associated with a higher probability of grant and a shorter examination process[3].
Examination Process
The examination process for the '122 Patent, like other patents, would have involved a thorough review by the U.S. Patent and Trademark Office (USPTO). This process tends to narrow the scope of patent claims, ensuring that the claims are clear, specific, and not overly broad[3].
Patent Infringement and Litigation
The '122 Patent is currently at the center of a patent infringement lawsuit filed by AbbVie Inc. and Allergan Pharmaceuticals International Limited against Fresenius Kabi USA, LLC and Fresenius Kabi iPSUM SRL. The lawsuit alleges that Fresenius's submission to the FDA for approval of a generic version of AVYCAZ® infringes on the '122 Patent, among others[1].
Key Allegations
- The plaintiffs argue that Fresenius's proposed generic product will induce direct infringement of at least one claim of the '122 Patent.
- They also contend that there is no substantial non-infringing use for Fresenius’s proposed generic AVYCAZ® product, as it is especially adapted for a use that infringes the '122 Patent[1].
Impact on the Pharmaceutical Industry
The '122 Patent and similar patents in the pharmaceutical sector have significant implications for innovation and competition.
Innovation Incentives
Patents like the '122 Patent provide exclusive rights to the patent holders, which can incentivize investment in research and development. However, overly broad or unclear patents can impede innovation by increasing licensing and litigation costs[3].
Generic Competition
The approval of generic versions of patented drugs can significantly reduce healthcare costs. However, patent infringement lawsuits can delay the entry of generics into the market, affecting patient access to affordable medications[1].
Expiration and Exclusivity
The '122 Patent, along with the other patents-in-suit, is listed in the FDA's Orange Book and is set to expire on August 12, 2031. Any additional periods of exclusivity will extend this date, affecting when generic versions can enter the market[1].
Conclusion
The '122 Patent is a crucial element in the patent landscape surrounding AVYCAZ®, a significant antibiotic in the fight against resistant bacterial infections. Understanding the scope and claims of this patent is essential for navigating the complex world of pharmaceutical intellectual property.
Key Takeaways
- Patent Claims: The '122 Patent covers specific crystalline forms of a compound used in AVYCAZ®, with detailed physical and chemical characteristics.
- Patent Scope: Narrower claims are generally associated with a higher probability of grant and shorter examination processes.
- Litigation: The patent is involved in a current lawsuit against Fresenius Kabi for alleged infringement related to a generic version of AVYCAZ®.
- Impact on Industry: Patents like the '122 Patent can both incentivize innovation and impede generic competition, affecting healthcare costs and patient access.
- Expiration: The patent is set to expire on August 12, 2031, with potential additional exclusivity periods.
FAQs
Q: What is the '122 Patent related to?
A: The '122 Patent is related to specific crystalline forms of a compound used in the antibiotic AVYCAZ® (ceftazidime and avibactam).
Q: Who is the assignee of the '122 Patent?
A: The '122 Patent is assigned to Allergan Pharmaceuticals International Limited, now part of AbbVie Inc.[1].
Q: What is the current litigation involving the '122 Patent?
A: AbbVie Inc. and Allergan Pharmaceuticals International Limited are suing Fresenius Kabi USA, LLC and Fresenius Kabi iPSUM SRL for alleged patent infringement related to a generic version of AVYCAZ®[1].
Q: How does the '122 Patent impact the pharmaceutical industry?
A: The patent can incentivize innovation but also delay the entry of generic versions of AVYCAZ®, affecting patient access to affordable medications[1][3].
Q: When is the '122 Patent set to expire?
A: The '122 Patent is set to expire on August 12, 2031, with potential additional exclusivity periods[1].
Sources
- IN THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF ILLINOIS ABBVIE INC. and ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED, Plaintiffs, v. FRESENIUS KABI USA, LLC and FRESENIUS KABI IPSUM SRL, Defendants. - Insight.rpxcorp.com
- Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents - PubChem.ncbi.nlm.nih.gov
- Patent Claims and Patent Scope - Hoover Institution
- Case 3:24-cv-06759-ZNQ Document 1 Filed 06/06/24 Page 1 of 56 - Insight.rpxcorp.com
