18percentgrey / Shutterstock.com
Bringing a ‘repurposed’ drug to market requires a clear patent strategy, but clarity is unfortunately lacking in this field, say Simon Kremer and Rachel Jones of law firm Mewburn Ellis.
The drug discovery and development path for a new chemical entity (NCE) can take ten to 15 years and cost between $1 billion and $2 billion. ‘Repurposing’ is the practice of finding novel therapeutic indications for existing drugs. Typically the selected drug will have already been shown to be safe in patients, thereby significantly reducing the time it takes to bring the drug to market.
Indeed, it has been reported that repurposed agents are more than twice as likely across all disease indications to make it to market compared to NCEs. Furthermore, price support for a repurposed drug is in principle no different from that for an NCE, being likewise dependent on its substitutability and its clinical and economic advantages.
Policy makers, being aware of these benefits, have made efforts to encourage repurposing—for example the US National Institutes of Health has programmes aimed at utilising existing, partially developed therapeutic candidates in new disease indications. In the UK an ‘off-patent’ drugs bill was recently proposed, with one of its aims being to give generic drug makers new marketable indications for their products.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
To continue reading this article and to access 4,500+ articles, our digital magazines and special reports published for LSIPR subscribers only then you will need a subscription.
If you are already subscribed please login.
Official LSIPR subscribers include:
Allen & Overy
Arnold & Siedsma
Birch, Stewart, Kolasch & Birch LLP (BSKB)
Carpmaels & Ransford
Cooley
European Patent Office
Finnegan LLP
GH Research
Gowling WLG
George Washington Law School
HGF Limited
IQVIA
Kirkland & Ellis International LLP
Marks & Clerk
Mintz Levin
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
Taylor Wessing
The United States Patent and Trademark Office (USPTO)
Valea AB
World Intellectual Property Office
For multi-user price options, or to check if your company has an existing subscription we can add you into for FREE, please contact Atif at achoudhury@newtonmedia.co.
If you have any technical issues please email tech support.
repurposing; NCE; drugs; NIH