The law of patents and SPCs has yet to be tested in the context of medicines which can be used to treat specific groups of patients, as Paul England explains.
An industry under pressure
A combination of high research costs and dwindling opportunities for small molecule targets has diminished the number of candidates entering the product pipelines of some leading originator pharmaceutical companies. At the other end of the pharmaceutical product lifecycle, patents on the active ingredients of many ‘blockbuster’ drugs are expiring. This allows generic challenges to what are often perceived to be weaker secondary patents and thus increased competition in the marketplace.
A further pressure on pharmaceutical pipelines is the need for each new drug candidate to pass a rigorous approvals process before it can be authorised for public use. Added to this is the need to secure a favourable price and reimbursement from public funds where the emphasis is on the need to show that a drug has clear benefits over and above those already on the market.
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.
personalised medicine, SPCs, generics, Dr Reddy's, Agrevo