The rise of so-called personalised medicine presents new challenges and opportunities for drugs companies, says Robert Andrews.
In the not-so-distant past, obtaining patent protection for a new therapeutic drug (or new use of a known drug) was simpler than it is today. The therapeutic landscape was comparatively unexplored, and our knowledge of disease pathology was uninformed by the battery of molecular techniques available today. This lack of detailed information meant the factors to consider when assessing a new therapeutic application were relatively few and, consequently, the required analysis was relatively straightforward.
Fast-forward to today, and the number and sophistication of the analytical techniques available mean that it is not uncommon for researchers to make discoveries beyond simply which disease(s) a compound has the potential to treat. For example, the research may characterise the subset of patients in which a drug works best (or not at all). Illustrations of this type of ‘personalised’ medicine abound in the scientific literature, and patients can be defined by, for example, genotype, single-nucleotide polymorphisms (SNPs), or protein markers.
This allows targeted treatment of the patients who respond best, and the avoidance of non-responders or those likely to suffer adverse effects. In some cases, defining the patient group means the difference between clinical trial success and failure, enabling rational design of smaller trials with high success rates in defined patient sub-groups.
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
European Patent Office
George Washington Law School
Kirkland & Ellis International LLP
Marks & Clerk
NiKang Therapeutics Inc.
Powell Gilbert LLP
Procopio, Cory, Hargreaves & Savitch LLP
The United States Patent and Trademark Office (USPTO)
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 firstname.lastname@example.org.
If you have any technical issues please email tech support.
personalised medicine, EPC, T1020/03, Enlarged Board of Appeal