Extend your patents’ terms. Extend your exclusivity. ExtendiP.
ExtendiP helps extend your pharmaceutical patents’ terms and your exclusivity.
Pharmaceuticals improve and extend the lives of millions of people. However, to get a drug to the stage where it can successfully deliver its clinical purpose requires a huge amount of investment, research, development and strategy.
Yet even after you’ve invested this time, resource and budget, there’s no guarantee your drug will be approved.
This is why maintaining your exclusivity in the market for the maximum possible term is essential.
It’s the only way to allow your pharmaceuticals to realise the required return on your investment - by excluding competitors from the market for as long as possible.
A pivotal part of this process is deciding how best to maintain your exclusivity.
Working in tandem with an informed pricing strategy and a solid IP strategy, making use of all the available tools to prolong the exclusivity maximises the chances of your drug becoming the valuable asset you need it to be.
That won’t happen if your competitors have the opportunity to flood the market with their own versions of your hard work - which is why you need ExtendiP.
HOW WILL ExtendiP HELP YOU CREATE A CONCLUSIVE AND COMPREHENSIVE EXCLUSIVITY STRATEGY FOR YOUR PHARMACEUTICAL PATENTS?
Once your new drug approaches the final stages of regulatory approval, you need to do everything you can to extend its exclusivity.
The longer the period of exclusivity, the more time you have to recoup your investment and maximise your drug’s revenues.
When it comes to extending the potential period of exclusivity there are several options to consider, including:
- Paediatric extensions
- Patent term extensions in other territories
- Data and marketing exclusivity
- Orphan medicines and paediatric incentives
Together, we call these "regulatory IP".
Taking full advantage of each option in the different jurisdictions where you plan to sell your drug requires a series of business-critical decisions. These will form the basis of your exclusivity strategy and your immediate action plan.
Your strategy should also reflect the three different sources of exclusivity that exist in Europe, arising from the patent, SPC and regulatory legal frameworks. It should show exactly how these three sources will overlap and interact to ensure your drug achieves the maximum period of exclusivity.
However, given the enormous financial implications at stake, your exclusivity strategy should always be based on a comprehensive analysis of your current circumstances and your commercial objectives, supported by impartial advice from an experienced pharmaceutical sector specialist.
If you’re in close communication with your IP attorneys and regulatory consultants during the research and development process, you’ll have already formulated your exclusivity strategy during your regular discussions.
But as the end of your patent’s life comes into view, it may be time to reassess where you are, reconfirm you’re ready to take advantage of the available extensions to your protection, and obtain any additional IP rights you may need.
The last thing you can afford is to leave any cracks that could allow your generic competition to enter the market you’ve worked so hard to create.
So it’s important you take a step back and:
- Analyse your current exclusivity position (patents and "regulatory IP").
- Consider any additional tools you can use (e.g. PTEs) and understand how to obtain them.
- Understand how your patent exclusivity maps on to your regulatory exclusivity.
- Weigh up the respective scope and expiry dates of each option against current competitor activity so you can make your final decisions based on value.
This is where ExtendiP can help.