ExtendiP
Bringing a new drug to market is expensive and takes time. That's why effective patent lifecycle management is essential in the pharmaceutical industry. Our cutting-edge ExtendiP service helps extend your patents and market exclusivity.
Why Maximise Drug Exclusivity?
Drug development takes years of research, funding and strategic planning to reach regulatory approval stage. This means the commercial window to market and sell your product is often limited before patents expire.
Because of this, maximising your exclusivity in the market for as long as possible is crucial to making your product successful and profitable.
A longer period of exclusivity means you can:
- Hold off competitors from flooding the market with alternative versions of your drug.
- Buy more time to recoup your R&D investment and maximise revenues.
- Maintain a competitive edge and protect your market share.
To do this effectively, you'll need the right tools and intellectual property (IP) strategies in place. That's where ExtendiP comes in.
Pharmaceutical Patent Exclusivity: How ExtendiP Can Help
As you approach the final stages of the regulatory approval process, it's important to take steps to prolong your drug's exclusivity period. ExtendiP can help you obtain any additional IP rights you may need.
There are several ways to do this, including:
- Supplementary protection certificates (SPCs)
- Paediatric extensions
- Patent extensions in other countries
- Data and marketing exclusivity
- Orphan medicines and paediatric incentives
ExtendiP can help you navigate the complexities of patent and regulatory legal frameworks to maximise the commercial value of your innovation.
Step 1: IP portfolio review
We'll carry out a detailed examination of your current patent portfolio and ongoing regulatory procedures.
Step 2: Exclusivity mapping
We'll determine if any of your patents can be extended or an SPC strategy can be beneficial. We'll also identify any relevant data and marketing exclusivity options.
Step 3: Strategy development
We'll recommend a course of action to follow and how to make use of all the available tools to prolong patent and regulatory IP exclusivity.
Step 4: IP action plan
You'll receive a clear, structured action plan outlining next steps and key deadlines for you to follow. Having a tailored regulatory IP strategy in place offers reassurance that there are no cracks in your protection.
FAQs About Pharmaceutical Patent Exclusivity
How long is drug patent exclusivity?
A patent will give your drug an initial 20 years’ exclusivity from the date of filing. Once the patent expires, other companies can apply to sell generic versions of the drug unless you extend your exclusivity rights.
How do pharmaceutical companies extend patents?
An SPC can extend your patent for up to five years in the UK and EU, while you can also obtain patents for new formulations or dosage routines. Another option is to secure patent term extensions in countries outside Europe.
What happens when a drug patent expires?
When a pharmaceutical patent expires, your competitors are free to manufacture the drug which is likely to lead to a drop in revenue. If your patent has expired, you do have several options – including M&A. If you’re not ready to give up exclusivity, our specialists IP lawyers can help you make a plan.
