With the introduction of AQX Pharma™, pharmaceutical companies now have the tools to maximize their market exclusivity, improve decision-making on product and IP lifecycles, and improve profitability. To find out more about how pharmaceutical management in the AQX® IP management platform continues to evolve, we sat down with Patrick Terry, Pharma Solutions Product Owner at Anaqua.
You’ve been at Anaqua for nearly five years now and you head up the pharma solutions product. Could you share more about your background and how you’ve worked together with pharmaceutical companies?
I’ve been involved in pharma implementations of IP docketing software for over a decade. When I started working on pharma IP docketing software implementations with companies such as GSK, Roche, Abbott, and AbbVie, I gained a deep appreciation for the differences in the management of intellectual property in the life sciences area versus other industries.
A key example of the differences is that pharmaceutical companies enjoy additional protection called market exclusivity. This is the period in which a government allows the originating drug company to sell the drug without competition to recoup the costs of developing the drug. The length of this period is generally tied to the expiration of certain types of patents associated with the drug.
Given that new drug development is complicated, lengthy, and, above all, very expensive, pharmaceutical companies look for ways to lengthen the market exclusivity period. This can be achieved by way of patent term extensions and optimizing the product and IP lifecycle relationships from discovery products through approved new drug applications.
How did the development of pharma capabilities at Anaqua begin?
It all began three years ago when Vincent Brault, SVP of Product and Innovation, reached out and asked for a couple of suggestions about what we needed to do with our IP management platform to meet the challenges Anaqua’s pharma clients were facing.
The initial priority of our clients was the ability to manage patent term extension (PTE) records. In the US & Japan, they're known as PTEs, and in Europe, they are called Supplemental Protection Certificates (SPC). They’re the most valuable IP associated with the drug because they lengthen the time that the drug has market exclusivity.
These extensions are granted based on approval by the regulatory authorities so it’s critical to have the statutory linkage between intellectual property and the drug products that it supports. We’ve focused on building the statutory linkages and the requirements that we needed for workflow for our pharma clients. I’ve worked closely with Anaqua’s Client Working Groups over the last three years, listening to what they needed and strengthening AQX to help them manage their pharma IP portfolios more efficiently.
We've recently released a US Orange Book Report in AQX. Can you tell us more?
Yes, the next area of focus has been adding the Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) into AQX. The Hatch-Waxman Act mandates that the US Food and Drug Administration collects patent data associated with certain types of patents and publishes them in the Orange Book, with the expiration dates associated with them.
Pharmaceutical companies have a responsibility to provide accurate and timely updates to the FDA. From what I’ve seen working with our pharmaceutical clients, the FDA US Orange Book data wasn’t easily accessible in their IP management software for verification. To address this, we worked with our AcclaimIP team to create a US Orange Book Analytics Report based on their expertise in Patent Analytics, so IP professionals don’t need to search for this data.
This supports pharma teams to be able to visualize when a product’s protection ends over time and communicate upcoming deadlines. With this data visualized, IP leaders in pharma companies can make timely decisions that help to extend the life of a patent and in doing so protect their IP and increase revenue.
Fig.1: The US Orange Book Report in AQX
What other important challenges have our clients raised and how are we planning to address those?
For pharma clients, managing the relationship between IP assets and the products they protect is key to meeting regulatory and business process requirements. We’re developing new pharma-specific features in close collaboration with our clients, including a way to docket patent data from the pharma record.
Focusing on the Product to IP relationships, we have been making modifications to product and IP records to better display the relationships visually and dynamically. This is particularly important in managing Japan Patent Term Extensions because a base patent may have multiple extensions corresponding to multiple drug product approvals to which the patent is related to.
There is much more to come—we have exciting additional functionality for pharma customers that will be available soon in the upcoming release of AQX. Through collaboration with our clients and our knowledge of this area of IP management, Anaqua is addressing unmet IP industry needs!
AQX is a fully connected IP platform that is designed to make the day-to-day managing of IP automated and more efficient. Now pharmaceutical companies can maximize market exclusivity and profitability with AQX Pharma to:
- Manage product-to-IP lifecycle relationships: Manage your statutory and business process relationships between the pharma product and IP lifecycles through AQX's Pharma product tool and visual dashboards.
- Enable decision-making: Provide your business leaders with a view of upcoming patent and product deadlines to help make decisions on market exclusivity and determine how to increase revenue.
Tove Fabritius de Tengnagel, Project Manager of Corporate Patents for Novo Nordisk recently mentioned in her new client spotlight, “Anaqua has continued to develop their capabilities and strength in the pharma space, and we are pleased to see that they are now really prioritizing the pharma support provided by the AQX® IP management platform. We have just upgraded to version 10.6 and are looking forward to testing the pharma setup in this release and the new features it brings.”
Learn more here:
- Novo Nordisk: Driving Change in Pharma IP Management
- Video: US Orange Book Analytics Report
- Anaqua and PatSnap Team Up to Deliver an End-to-End IP Management Solution