United States Patent 7,560,122: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 7,560,122, titled "Pharmaceutical dosage form bearing pregnancy-friendly indicia," is a patent that has been part of the intellectual property portfolio protecting the drug Bonjesta. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it is part of.
Patent Overview
Patent Title and Description
The patent, US 7,560,122, pertains to a specific formulation and presentation of the drug Bonjesta, which is a combination of doxylamine and pyridoxine used for treating nausea and vomiting during pregnancy. The patent focuses on the pharmaceutical dosage form and the inclusion of pregnancy-friendly indicia, which is crucial for ensuring the safe and appropriate use of the medication by pregnant women[2].
Claims and Scope
Claim Structure
The claims of US 7,560,122 define the specific aspects of the pharmaceutical dosage form that are protected. These claims typically include the composition of the drug, the dosage form (e.g., tablets, capsules), and any specific features such as the pregnancy-friendly indicia. The scope of these claims is critical in determining what constitutes infringement and what variations are allowed without infringing the patent[3].
Patent Scope Metrics
Research on patent scope often uses metrics such as independent claim length and independent claim count to measure the breadth of a patent. For US 7,560,122, these metrics would help in understanding how narrowly or broadly the claims are defined. Narrower claims are generally associated with a higher probability of grant and a shorter examination process, while broader claims may face more scrutiny and potential litigation[3].
Patent Expiration and Status
Expiration Date
US 7,560,122 has already expired, with its expiration date being January 2019. This expiration is significant as it marks the end of the exclusive rights granted to the patent holder for this specific invention[2].
Impact on Generic Launch
The expiration of this patent, along with other patents protecting Bonjesta, influences the timing of generic drug launches. The generic launch date for Bonjesta is estimated to be February 18, 2033, based on the expiration of the last outstanding patent protecting the drug[2].
Patent Landscape
Family Patents
US 7,560,122 is part of a family of patents that protect various aspects of Bonjesta. Other patents in this family include US 9,089,489, US 9,937,132, US 9,375,404, and US 9,526,703, which cover different formulations and modes of administration of the drug. Understanding the full scope of these patents is crucial for strategizing market entry and identifying potential generic entry points[2].
International Protection
While US 7,560,122 is specific to the United States, Bonjesta is protected by patents in multiple countries. Analyzing the global patent landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry[2].
Obviousness-Type Double Patenting (ODP)
Relevance to Patent Term
The doctrine of ODP is designed to prevent the extension of patent term by securing a second patent for the same invention. Recent decisions, such as the Gilead and In re Cellect cases, have clarified that ODP analysis should focus on the expiration dates of the patents rather than the issue dates. This ensures that a later-issued but earlier-expiring patent cannot be used to extend the term of an earlier-issued but later-expiring patent[1][4].
Implications for Bonjesta Patents
For Bonjesta, the ODP doctrine is relevant in ensuring that the various patents protecting the drug do not unfairly extend the exclusivity period. The Federal Circuit's decisions emphasize that the expiration dates of the patents are critical in determining whether a patent is valid under ODP analysis[1][4].
Maintenance and Legal Activities
Maintenance Fees
The maintenance of a patent involves the payment of fees at various intervals to keep the patent in force. For US 7,560,122, these fees would have been paid until its expiration. Other patents in the Bonjesta family continue to require maintenance fee payments to maintain their validity[2].
Legal Activities and Patent Term Adjustments
Legal activities such as term extensions, amendments to claims, or other patent office actions can affect the life of a patent. For example, the five-year term extension of the '772 patent in the Novartis case due to a PTE (Patent Term Extension) highlights how such activities can alter the patent landscape[1].
Key Takeaways
- Patent Scope and Claims: US 7,560,122 defines specific aspects of the pharmaceutical dosage form of Bonjesta, including pregnancy-friendly indicia.
- Expiration and Status: The patent has expired, contributing to the overall patent landscape and generic launch timing.
- Patent Landscape: Part of a family of patents protecting Bonjesta, with global protection in multiple countries.
- ODP Doctrine: Ensures that patents do not unfairly extend exclusivity periods, focusing on expiration dates rather than issue dates.
- Maintenance and Legal Activities: Regular maintenance fees and legal activities can impact the life and validity of patents.
FAQs
What is the current status of US 7,560,122?
US 7,560,122 has expired as of January 2019.
How does the expiration of US 7,560,122 affect the generic launch of Bonjesta?
The expiration of this patent, along with other patents, influences the timing of the generic launch, which is estimated to be February 18, 2033.
What is the significance of the ODP doctrine in the context of Bonjesta patents?
The ODP doctrine prevents the extension of patent term by ensuring that later-issued but earlier-expiring patents do not unfairly extend the exclusivity period of earlier-issued patents.
How do maintenance fees impact the life of a patent?
Maintenance fees are necessary to keep a patent in force. Failure to pay these fees can result in the patent lapsing.
Can legal activities alter the patent term of a drug like Bonjesta?
Yes, legal activities such as term extensions or amendments to claims can alter the patent term, as seen in cases where PTEs are granted.
Cited Sources
- Finnegan, "US Update: Double Patenting," Finnegan, May 2019.
- Pharsight, "Bonjesta patent expiration," Pharsight.
- SSRN, "Patent Claims and Patent Scope," SSRN, September 29, 2016.
- JDSupra, "Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting," JDSupra, August 16, 2024.
